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Usage Metrics of Web-Based Interventions Evaluated in Randomized Controlled Trials: Systematic Review.

ABSTRACT: BACKGROUND:The evaluation of web-based interventions (defined as an intervention that can be downloaded or accessed on the internet through a web browser) in randomized controlled trials (RCTs) has increased over the past two decades. Little is known about how participants' use of the intervention is measured, reported, and analyzed in these studies. OBJECTIVE:This study aimed to review the evaluation of web-based interventions in RCTs, assessing study characteristics and the methods used to record, and adjust for, intervention usage. METHODS:A systematic review of the literature was undertaken to identify all published reports of RCTs that involved a web-based intervention. A random sample of 100 published trials was selected for detailed data extraction. Information on trial characteristics was extracted, including whether web usage data were recorded, and if so, the methods used to gather these data and whether these data were used to inform efficacy analyses. RESULTS:A PubMed search identified 812 trials of web-based interventions published up to the end of 2017 and demonstrated a growing trend over time. Of the 100 studies reviewed, 90 studies collected web usage data, but more than half (49/90, 54%) of these studies did not state the method used for recording web usage. Only four studies attempted to check on the reliability of their web usage data collection methods. A total of 39% (35/90) studies reported patterns or levels of web intervention use, of which 21% (19/90) studies adjusted for intervention use in their outcome analysis, but only two of these used appropriate statistical methods. CONCLUSIONS:Trialists frequently report a measure of web-based intervention usage but do not always report the collection method or provide enough detail on their analysis of web usage. Appropriate statistical methods to account for intervention use are rarely used and are not well reported even in the very few trials in which they are used. The number of trialists who attempt to check on the reliability of their web usage collection methods is extremely low.

SUBMITTER: Koneska E

PROVIDER: S-EPMC7193439 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Usage Metrics of Web-Based Interventions Evaluated in Randomized Controlled Trials: Systematic Review.

Koneska Elena E Appelbe Duncan D Williamson Paula R PR Dodd Susanna S

Journal of medical Internet research 20200416 4

<h4>Background</h4>The evaluation of web-based interventions (defined as an intervention that can be downloaded or accessed on the internet through a web browser) in randomized controlled trials (RCTs) has increased over the past two decades. Little is known about how participants' use of the intervention is measured, reported, and analyzed in these studies.<h4>Objective</h4>This study aimed to review the evaluation of web-based interventions in RCTs, assessing study characteristics and the meth ...[more]

PMID: 32297870

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Project description:BackgroundThis systematic review evaluated the effectiveness of process interventions (education for clinicians, parent presence, education of parents [before and on day of vaccination], and education of patients on day of vaccination) on reducing vaccination pain, fear, and distress and increasing the use of interventions during vaccination.Design/methodsDatabases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Critical outcomes were pain, fear, distress (when applicable), and use of pain management interventions. Data were extracted according to procedure phase (preprocedure, acute, recovery, combinations of these) and pooled using established methods. Analyses were conducted using standardized mean differences (SMD) and risk ratios (RR).ResultsThirteen studies were included. Results were generally mixed. On the basis of low to very low-quality evidence, the following specific critical outcomes showed significant effects suggesting: (1) clinicians should be educated about vaccine injection pain management (use of interventions: SMD 0.66; 95% confidence interval [CI]: 0.47, 0.85); (2) parents should be present (distress preprocedure: SMD -0.85; 95% CI: -1.35, -0.35); (3) parents should be educated before the vaccination day (use of intervention preprocedure: SMD 0.83; 95% CI: 0.25, 1.41 and RR, 2.08; 95% CI: 1.51, 2.86; distress acute: SMD, -0.35; 95% CI: -0.57, -0.13); (4) parents should be educated on the vaccination day (use of interventions: SMD 1.02; 95% CI: 0.22, 1.83 and RR, 2.42; 95% CI: 1.47, 3.99; distress preprocedure+acute+recovery: SMD -0.48; 95% CI: -0.82, -0.15); and (5) individuals 3 years of age and above should be educated on the day of vaccination (fear preprocedure: SMD -0.67; 95% CI: -1.28, -0.07).ConclusionsEducating individuals involved in the vaccination procedure (clinicians, parents of children being vaccinated; individuals above 3 y of age) is beneficial to increase use of pain management strategies, reduce distress surrounding with vaccination, and to reduce fear. When possible, parent presence is also recommended for children undergoing vaccination.

Project description:BackgroundType 2 diabetes mellitus (T2DM) is among the most prevalent noncommunicable health conditions worldwide, affecting over 500 million people globally. Diet is a key aspect of T2DM management with dietary modification shown to elicit clinically meaningful outcomes such as improved glycemic control, and reductions in weight and cardiovascular disease risk factors. Web-based interventions provide a potentially convenient and accessible method for delivering dietary education, but its effects on dietary behavior in people with T2DM are unknown.ObjectiveThe objective of this review was to determine the effectiveness of web-based interventions on dietary behavior change and glycemic control in people with T2DM.MethodsPer PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, systematic literature searches were performed using Medline, Embase, The Cochrane Library, and CINAHL to retrieve papers from January 2013 to May 2019. Randomized controlled trials of web-based interventions in adults with T2DM with reported dietary assessment were included. Population and intervention characteristics, dietary guidelines and assessments, and significant clinical outcomes were extracted. Differences between groups and within groups were assessed for dietary behavior and clinical outcomes.ResultsThere were 714 records screened, and five studies comprising 1056 adults were included. Studies measured dietary changes by assessing overall diet quality, changes in specific dietary components, or dietary knowledge scores. Significant improvements in dietary behavior were reported in four out of the five studies, representing healthier food choices, improvements in eating habits, reductions in carbohydrates, added sugar, sodium, saturated fat and overall fat intake, and/or increases in dietary knowledge. Three studies found significant mean reductions for hemoglobin A1c ranging from -0.3% to -0.8%, and/or weight ranging from -2.3 kg to -12.7 kg, fasting blood glucose (-1 mmol/L), waist circumference (-1 cm), and triglycerides (-60.1 mg/dL). These studies provided varied dietary recommendations from standard dietary guidelines, national health program guidelines, and a very low carbohydrate ketogenic diet.ConclusionsThis review provided evidence that web-based interventions may be an effective way to support dietary behavior change in people with T2DM, potentially leading to changes in glycemic control and other clinical outcomes. However, the evidence should be viewed as preliminary as there were only five studies included with considerable heterogeneity in terms of the diets recommended, the dietary assessment measures used, the complexity of the interventions, and the modes and methods of delivery.

Project description:BackgroundThis systematic review evaluated the effectiveness of physical and procedural interventions for reducing pain and related outcomes during vaccination.Design/methodsDatabases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Data were extracted according to procedure phase (preprocedure, acute, recovery, and combinations of these) and pooled using established methods.ResultsA total of 31 studies were included. Acute infant distress was diminished during intramuscular injection without aspiration (n=313): standardized mean difference (SMD) -0.82 (95% confidence interval [CI]: -1.18, -0.46). Injecting the most painful vaccine last during vaccinations reduced acute infant distress (n=196): SMD -0.69 (95% CI: -0.98, -0.4). Simultaneous injections reduced acute infant distress compared with sequential injections (n=172): SMD -0.56 (95% CI: -0.87, -0.25). There was no benefit of simultaneous injections in children. Less infant distress during the acute and recovery phases combined occurred with vastus lateralis (vs. deltoid) injections (n=185): SMD -0.70 (95% CI: -1.00, -0.41). Skin-to-skin contact in neonates (n=736) reduced acute distress: SMD -0.65 (95% CI: -1.05, -0.25). Holding infants reduced acute distress after removal of the data from 1 methodologically diverse study (n=107): SMD -1.25 (95% CI: -2.05, -0.46). Holding after vaccination (n=417) reduced infant distress during the acute and recovery phases combined: SMD -0.65 (95% CI: -1.08, -0.22). Self-reported fear was reduced for children positioned upright (n=107): SMD -0.39 (95% CI: -0.77, -0.01). Non-nutritive sucking (n=186) reduced acute distress in infants: SMD -1.88 (95% CI: -2.57, -1.18). Manual tactile stimulation did not reduce pain across the lifespan. An external vibrating device and cold reduced pain in children (n=145): SMD -1.23 (95% CI: -1.58, -0.87). There was no benefit of warming the vaccine in adults. Muscle tension was beneficial in selected indices of fainting in adolescents and adults.ConclusionsInterventions with evidence of benefit in select populations include: no aspiration, injecting most painful vaccine last, simultaneous injections, vastus lateralis injection, positioning interventions, non-nutritive sucking, external vibrating device with cold, and muscle tension.

Project description:BackgroundThis systematic review evaluated the effectiveness of exposure-based psychological and physical interventions for the management of high levels of needle fear and/or phobia and fainting in children and adults.Design/methodsA systematic review identified relevant randomized and quasi-randomized controlled trials of children, adults, or both with high levels of needle fear, including phobia (if not available, then populations with other specific phobias were included). Critically important outcomes were self-reported fear specific to the feared situation and stimulus (psychological interventions) or fainting (applied muscle tension). Data were pooled using standardized mean difference (SMD) or relative risk with 95% confidence intervals.ResultsThe systematic review included 11 trials. In vivo exposure-based therapy for children 7 years and above showed benefit on specific fear (n=234; SMD: -1.71 [95% CI: -2.72, -0.7]). In vivo exposure-based therapy with adults reduced fear of needles posttreatment (n=20; SMD: -1.09 [-2.04, -0.14]) but not at 1-year follow-up (n=20; SMD: -0.28 [-1.16, 0.6]). Compared with single session, a benefit was observed for multiple sessions of exposure-based therapy posttreatment (n=93; SMD: -0.66 [-1.08, -0.24]) but not after 1 year (n=83; SMD: -0.37 [-0.87, 0.13]). Non in vivo e.g., imaginal exposure-based therapy in children reduced specific fear posttreatment (n=41; SMD: -0.88 [-1.7, -0.05]) and at 3 months (n=24; SMD: -0.89 [-1.73, -0.04]). Non in vivo exposure-based therapy for adults showed benefit on specific fear (n=68; SMD: -0.62 [-1.11, -0.14]) but not procedural fear (n=17; SMD: 0.18 [-0.87, 1.23]). Applied tension showed benefit on fainting posttreatment (n=20; SMD: -1.16 [-2.12, -0.19]) and after 1 year (n=20; SMD: -0.97 [-1.91, -0.03]) compared with exposure alone.ConclusionsExposure-based psychological interventions and applied muscle tension show evidence of benefit in the reduction of fear in pediatric and adult populations.

Project description:BackgroundWeb-based delivered interventions have become an innovative option to treat health problems, like obesity. The aim of this systematic review and network meta-analysis was to analyze the effectiveness of web-based behavioral treatments for adults with overweight and obesity. Web-based interventions and comparison interventions (traditional weight control programs) were classified according to the following feedback characteristics: frequency, personalization, and provider (human versus machine).MethodFrom the initial 1789 studies, 15 were included in this review. A network meta-analysis was conducted to analyze the efficacy of web-based programs with traditional interventions, considering direct and indirect comparisons. The main outcome was the weight loss mean difference (kg) between baseline and post-treatment. Heterogeneity and consistency assumptions were validated to conduct the network meta-analysis.ResultsNetwork meta-analysis showed comparisons between different treatment options. The main results were that Intensive Contact Web-based programs were more effective than wait-list (Mean Difference - 1.86 kg; 95% Confidence Interval: - 3.61, - 0.12). Moreover, Intensive Contact Web-based programs were more effective than the other web-based options and self-help traditional interventions. However, the only significant comparison was Intensive Contact Web-based programs versus Guided Self-Help Web-based programs (Mean Difference - 4.31 kg; 95% Confidence Interval: - 5,22, - 3,41). Intensive Contact Web-based programs were the most effective treatment option according the obtained results, achieving the first place in the ranking provided by the network meta-analysis with 98.5% of probabilities.ConclusionsIntensive Contact Web-based interventions have obtained the first position in the ranking, proving the relevance of frequent, personalized, and professional feedback and their association with a better prognosis for people with overweight and obesity. These results provide relevant information to design more effective treatments for people with overweight and obesity, in a new format especially appropriate for the current situation.

Project description:BackgroundComputerized psychological interventions can overcome logistical and psychosocial barriers to the use of mental health care in the Veterans Affairs and Department of Defense settings.ObjectiveIn this systematic review, we aim to outline the existing literature, with the goal of describing: the scope and quality of the available literature, intervention characteristics, study methods, study efficacy, and study limitations and potential directions for future research.MethodsSystematic searches of two databases (PsycINFO and PubMed) using PRISMA (Preferred Reporting Item for Systematic Reviews and Meta-Analyses) guidelines were conducted from inception until November 15, 2020. The following inclusion criteria were used: the study was published in an English language peer-reviewed journal, participants were randomly allocated to a computerized psychological intervention or a control group (non-computerized psychological intervention active treatment or nonactive control group), an intervention in at least one treatment arm was primarily delivered through the computer or internet with or without additional support, participants were veterans or service members, and the study used validated measures to examine the effect of treatment on psychological outcomes.ResultsThis review included 23 studies that met the predefined inclusion criteria. Most studies were at a high risk of bias. Targeted outcomes, participant characteristics, type of support delivered, adherence, and participant satisfaction were described. Most of the examined interventions (19/24, 79%) yielded positive results. Study limitations included participant characteristics limiting study inference, high rates of attrition, and an overreliance on self-reported outcomes.ConclusionsRelatively few high-quality studies were identified, and more rigorous investigations are needed. Several recommendations for future research are discussed, including the adoption of methods that minimize attrition, optimize use, and allow for personalization of treatment.

Project description:BackgroundBlended care interventions combine therapeutic guidance with digital care. Current research results show the promising role of the blended care approach in clinical care. This new way of delivering health care could have the potential to effectively promote physical activity in different public health settings.ObjectiveThe aim of the systematic review is to investigate the varieties of intervention characteristics of blended care interventions to promote physical activity in terms of structure, behavior change goals, behavior change techniques, and effectiveness of blended care interventions compared to a control group.MethodsWe searched for randomized controlled trials published from 2000 to March 2021 in MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, SPORTDiscus, PsycINFO, and Web of Science according to the PRISMA guidelines. Risk of bias was assessed using the Cochrane Collaboration tool. Study characteristics, intervention characteristics, and outcome data were extracted. Furthermore, the effect size on the outcome of physical activity was examined or calculated.ResultsIn total, the number of reports identified from the database searches was 4828. Of these, 25 studies were included in the review, with a total of 5923 study participants. Results indicated that the characteristics of blended care interventions showed a high heterogeneity. The combinations of therapist-guided interventions and digital interventions allowed the identification of specific subgroups, but they varied in length (range 8-52 weeks, SD 16.6), intensity, and the combination of the components. The most used combination of blended care interventions to promote physical activity was the combination of one-on-one meetings via telephone and Web-based interventions. Motivational models of behavior change were used most frequently as underlying theoretical foundations. Certain behavior change techniques were used consistently across the individual components, e.g., "problem solving" in the therapist-guided component and "feedback on behavior" in the digital component. Considering the effect size of blended care interventions compared with control groups, most studies showed a small effect.ConclusionsIt can be concluded that blended care interventions have potential to promote physical activity. In the future, further high-quality studies should investigate which type of blended care intervention is effective for which target group. Additionally, insights are required on which intervention characteristics are most effective, taking into account new evidence on behavior change. Registration This systematic literature review was registered in PROSPERO ( CRD42020188556 ).

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Usage Metrics of Web-Based Interventions Evaluated in Randomized Controlled Trials: Systematic Review.

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Usage Metrics of Web-Based Interventions Evaluated in Randomized Controlled Trials: Systematic Review.

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