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Journal of Medical Internet Research Aug 2023Digital therapeutics (DTx), a class of software-based clinical interventions, are promising new technologies that can potentially prevent, manage, or treat a spectrum of... (Review)
Review
BACKGROUND
Digital therapeutics (DTx), a class of software-based clinical interventions, are promising new technologies that can potentially prevent, manage, or treat a spectrum of medical disorders and diseases as well as deliver unprecedented portability for patients and scalability for health care providers. Their adoption and implementation were accelerated by the need for remote care during the COVID-19 pandemic, and awareness about their utility has rapidly grown among providers, payers, and regulators. Despite this, relatively little is known about the capacity of DTx to provide economic value in care.
OBJECTIVE
This study aimed to systematically review and summarize the published evidence regarding the cost-effectiveness of clinical-grade mobile app-based DTx and explore the factors affecting such evaluations.
METHODS
A systematic review of economic evaluations of clinical-grade mobile app-based DTx was conducted following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. Major electronic databases, including PubMed, Cochrane Library, and Web of Science, were searched for eligible studies published from inception to October 28, 2022. Two independent reviewers evaluated the eligibility of all the retrieved articles for inclusion in the review. Methodological quality and risk of bias were assessed for each included study.
RESULTS
A total of 18 studies were included in this review. Of the 18 studies, 7 (39%) were nonrandomized study-based economic evaluations, 6 (33%) were model-based evaluations, and 5 (28%) were randomized clinical trial-based evaluations. The DTx intervention subject to assessment was found to be cost-effective in 12 (67%) studies, cost saving in 5 (28%) studies, and cost-effective in 1 (6%) study in only 1 of the 3 countries where it was being deployed in the final study. Qualitative deficiencies in methodology and substantial potential for bias, including risks of performance bias and selection bias in participant recruitment, were identified in several included studies.
CONCLUSIONS
This systematic review supports the thesis that DTx interventions offer potential economic benefits. However, DTx economic analyses conducted to date exhibit important methodological shortcomings that must be addressed in future evaluations to reduce the uncertainty surrounding the widespread adoption of DTx interventions.
TRIAL REGISTRATION
PROSPERO International Prospective Register of Systematic Reviews CRD42022358616; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022358616.
Topics: Humans; Cost-Benefit Analysis; COVID-19; Mobile Applications; Pandemics; Clinical Trials as Topic
PubMed: 37526973
DOI: 10.2196/47094 -
The Cochrane Database of Systematic... Jun 2021Older adults are the most sedentary segment of society, often spending in excess of 8.5 hours a day sitting. Large amounts of time spent sedentary, defined as time spend... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Older adults are the most sedentary segment of society, often spending in excess of 8.5 hours a day sitting. Large amounts of time spent sedentary, defined as time spend sitting or in a reclining posture without spending energy, has been linked to an increased risk of chronic diseases, frailty, loss of function, disablement, social isolation, and premature death.
OBJECTIVES
To evaluate the effectiveness of interventions aimed at reducing sedentary behaviour amongst older adults living independently in the community compared to control conditions involving either no intervention or interventions that do not target sedentary behaviour.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, PsycINFO, PEDro, EPPI-Centre databases (Trials Register of Promoting Health Interventions (TRoPHI) and the Obesity and Sedentary behaviour Database), WHO ICTRP, and ClinicalTrials.gov up to 18 January 2021. We also screened the reference lists of included articles and contacted authors to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and cluster-RCTs. We included interventions purposefully designed to reduce sedentary time in older adults (aged 60 or over) living independently in the community. We included studies if some of the participants had multiple comorbidities, but excluded interventions that recruited clinical populations specifically (e.g. stroke survivors).
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles and abstracts and full-text articles to determine study eligibility. Two review authors independently extracted data and assessed risk of bias. We contacted authors for additional data where required. Any disagreements in study screening or data extraction were settled by a third review author.
MAIN RESULTS
We included seven studies in the review, six RCTs and one cluster-RCT, with a total of 397 participants. The majority of participants were female (n = 284), white, and highly educated. All trials were conducted in high-income countries. All studies evaluated individually based behaviour change interventions using a combination of behaviour change techniques such as goal setting, education, and behaviour monitoring or feedback. Four of the seven studies also measured secondary outcomes. The main sources of bias were related to selection bias (N = 2), performance bias (N = 6), blinding of outcome assessment (N = 2), and incomplete outcome data (N = 2) and selective reporting (N=1). The overall risk of bias was judged as unclear. Primary outcomes The evidence suggests that interventions to change sedentary behaviour in community-dwelling older adults may reduce sedentary time (mean difference (MD) -44.91 min/day, 95% confidence interval (CI) -93.13 to 3.32; 397 participants; 7 studies; I = 73%; low-certainty evidence). We could not pool evidence on the effect of interventions on breaks in sedentary behaviour or time spent in specific domains such as TV time, as data from only one study were available for these outcomes. Secondary outcomes We are uncertain whether interventions to reduce sedentary behaviour have any impact on the physical or mental health outcomes of community-dwelling older adults. We were able to pool change data for the following outcomes. • Physical function (MD 0.14 Short Physical Performance Battery (SPPB) score, 95% CI -0.38 to 0.66; higher score is favourable; 98 participants; 2 studies; I = 26%; low-certainty evidence). • Waist circumference (MD 1.14 cm, 95% CI -1.64 to 3.93; 100 participants; 2 studies; I = 0%; low-certainty evidence). • Fitness (MD -5.16 m in the 6-minute walk test, 95% CI -36.49 to 26.17; higher score is favourable; 80 participants; 2 studies; I = 29%; low-certainty evidence). • Blood pressure: systolic (MD -3.91 mmHg, 95% CI -10.95 to 3.13; 138 participants; 3 studies; I = 73%; very low-certainty evidence) and diastolic (MD -0.06 mmHg, 95% CI -5.72 to 5.60; 138 participants; 3 studies; I = 97%; very low-certainty evidence). • Glucose blood levels (MD 2.20 mg/dL, 95% CI -6.46 to 10.86; 100 participants; 2 studies; I = 0%; low-certainty evidence). No data were available on cognitive function, cost-effectiveness or adverse effects.
AUTHORS' CONCLUSIONS
It is not clear whether interventions to reduce sedentary behaviour are effective at reducing sedentary time in community-dwelling older adults. We are uncertain if these interventions have any impact on the physical or mental health of community-dwelling older adults. There were few studies, and the certainty of the evidence is very low to low, mainly due to inconsistency in findings and imprecision. Future studies should consider interventions aimed at modifying the environment, policy, and social and cultural norms. Future studies should also use device-based measures of sedentary time, recruit larger samples, and gather information about quality of life, cost-effectiveness, and adverse event data.
Topics: Aged; Behavior; Bias; Blood Glucose; Blood Pressure; Female; Goals; Humans; Independent Living; Male; Middle Aged; Randomized Controlled Trials as Topic; Sedentary Behavior; Selection Bias; Sitting Position; Time Factors; Waist Circumference; Walk Test
PubMed: 34169503
DOI: 10.1002/14651858.CD012784.pub2 -
Journal of Cachexia, Sarcopenia and... Dec 2023Metabolic acidosis unfavourably influences the nutritional status of patients with non-dialysis dependent chronic kidney disease (CKD) including the loss of muscle mass... (Meta-Analysis)
Meta-Analysis Review
Metabolic acidosis unfavourably influences the nutritional status of patients with non-dialysis dependent chronic kidney disease (CKD) including the loss of muscle mass and functionality, but the benefits of correction are uncertain. We investigated the effects of correcting metabolic acidosis on nutritional status in patients with CKD in a systematic review and meta-analysis. A search was conducted in MEDLINE and the Cochrane Library from inception to June 2023. Study selection, bias assessment, and data extraction were independently performed by two reviewers. The Cochrane risk of bias tool was used to assess the quality of individual studies. We applied random effects meta-analysis to obtain pooled standardized mean difference (SMD) and 95% confidence intervals (CIs). We retrieved data from 12 intervention studies including 1995 patients, with a mean age of 63.7 ± 11.7 years, a mean estimated glomerular filtration rate of 29.8 ± 8.8 mL/min per 1.73 m , and 58% were male. Eleven studies performed an intervention with oral sodium bicarbonate compared with either placebo or with standard care and one study compared veverimer, an oral HCl-binding polymer, with placebo. The mean change in serum bicarbonate was +3.6 mEq/L in the intervention group and +0.4 mEq/L in the control group. Correcting metabolic acidosis significantly improved muscle mass assessed by mid-arm muscle circumference (SMD 0.35 [95% CI 0.16 to 0.54], P < 0.001) and functionality assessed with the sit-to-stand test (SMD -0.31 [95% CI -0.52 to 0.11], P = 0.003). We found no statistically significant effects on dietary protein intake, handgrip strength, serum albumin and prealbumin concentrations, and blood urea nitrogen. Correcting metabolic acidosis in patients with CKD improves muscle mass and physical function. Correction of metabolic acidosis should be considered as part of the nutritional care for patients with CKD.
Topics: Humans; Male; Middle Aged; Aged; Female; Dietary Proteins; Hand Strength; Renal Insufficiency, Chronic; Acidosis; Muscles
PubMed: 37728018
DOI: 10.1002/jcsm.13330 -
International Ophthalmology Jun 2024This meta-analysis reviews the evidence for the risks and benefits associated with orthokeratology (OK) treatment compared with other methods of myopia control in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This meta-analysis reviews the evidence for the risks and benefits associated with orthokeratology (OK) treatment compared with other methods of myopia control in children and adults.
METHODS
A systematic search of Cochrane Central Register of Controlled Trials, Pubmed, Embase and Ovid was conducted from database inception to 22nd August 2021. Studies that reported on risks, visual and ocular biometric effects of OK in patients > 5 years of age with myopia (- 0.75 to - 6.00D) were included. Main outcomes are change in axial length and any adverse event.
RESULTS
Fourty-five papers were included in this systematic review and meta-analysis. The quality of data was variable and of moderate certainty, and selection bias likely skewed the results towards a relative benefit for OK. The rate of axial elongation in children was lower for OK treatment compared to other treatment modalities at one year (MD - 0.16 mm, 95% CI - 0.25 to - 0.07). Rate of change in axial length in children rebounded after OK discontinuation compared to participants who continued treatment (MD 0.10 mm, 95% CI 0.06 to 0.14). Adults and children wearing OK were up to 3.79 times more likely to experience an adverse event when compared with conventional contact lenses (OR 3.79, 95% CI 1.24 to ll.), though this evidence base is underdeveloped and requires additional well-designed studies for substantial conclusions to be drawn.
CONCLUSIONS
OK arrests myopia progression while in use, however, there remain unanswered questions about the optimal duration of treatment, discontinuation effects and long-term risk for adverse events.
Topics: Humans; Orthokeratologic Procedures; Myopia; Refraction, Ocular; Visual Acuity; Axial Length, Eye; Contact Lenses; Child; Risk Assessment
PubMed: 38904856
DOI: 10.1007/s10792-024-03175-w -
Hemodialysis International.... Oct 2022Thrice weekly hemodialysis (HD) is currently the norm in high income countries but there is mounting interest in twice weekly HD in certain settings. We performed this... (Review)
Review
INTRODUCTION
Thrice weekly hemodialysis (HD) is currently the norm in high income countries but there is mounting interest in twice weekly HD in certain settings. We performed this systematic review to summarize the available evidence comparing twice to thrice weekly HD.
METHODS
A systematic literature search was performed in Ovid MEDLINE, Ovid Embase, and the Cochrane Central Register of Controlled Trials to identify cohort and randomized controlled trials evaluating outcomes of twice versus thrice weekly HD. The bibliographies of identified studies were hand searched to find any additional studies. Risk of bias was assessed using the Newcastle-Ottawa scale for observational studies.
FINDINGS
No randomized controlled trials and 21 cohort studies were identified. Overall study quality was modest with high risk of selection bias and inadequate controlling for confounders. The most commonly evaluated outcome measures were survival and residual kidney function. No studies assessed quality of life. Study results were variable and there was no clear signal for overwhelming risk or benefit of twice versus thrice weekly HD with the exception of residual kidney function which consistently showed slower decline in the twice weekly group.
DISCUSSION
There is a paucity of high quality data comparing the risks and benefits of twice vs thrice weekly HD. Randomized controlled trial evidence is required to inform clinicians and HD prescription guidelines.
Topics: Cohort Studies; Humans; Kidney Failure, Chronic; Quality of Life; Renal Dialysis
PubMed: 36097718
DOI: 10.1111/hdi.13045 -
Neurologia Sep 2020No formal indication currently exists for seizure prophylaxis in neurosurgical oncology patients. Neither have specific recommendations been made on the use of... (Review)
Review
INTRODUCTION
No formal indication currently exists for seizure prophylaxis in neurosurgical oncology patients. Neither have specific recommendations been made on the use of antiepileptic drugs (AED) in seizure-free patients with meningiomas scheduled for surgery. AEDs are generally prescribed on a discretionary basis, taking into consideration a range of clinical and radiological risk factors. We present a systematic review and meta-analysis exploring the effectiveness of antiepileptic prophylaxis in patients with meningioma and no history of seizures.
METHODS
We performed a systematic review of the PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, Embase, and clinicaltrials.gov databases. Of a total of 4368 studies initially identified, 12 were selected for extraction of data and qualitative analysis. Based on the clinical data presented, we were only able to include 6 studies in the meta-analysis. We performed heterogeneity studies, calculated a combined odds ratio, evaluated publication bias, and conducted a sensitivity analysis.
RESULTS
AED prophylaxis in patients with meningioma and no history of seizures did not significantly reduce the incidence of post-operative seizures in comparison to controls (Mantel-Haenszel combined odds ratio, random effects model: 1.26 [95% confidence interval, 0.60-2.78]; 2041 patients). However, we are unable to establish a robust recommendation against this treatment due to the lack of prospective studies, the presence of selection bias in the studies reviewed, the likelihood of underestimation of seizure frequency during follow-up, and the strong influence of one study on the overall effect.
CONCLUSIONS
Despite the limitations of this review, the results of the meta-analysis do not support the routine use of seizure prophylaxis in patients with meningioma and no history of seizures.
PubMed: 32896461
DOI: 10.1016/j.nrl.2020.06.014 -
A Systematic Review and Meta-Analysis of the Association Between Perceived Injustice and Depression.The Journal of Pain Jun 2021Perceived injustice is increasingly recognized as a risk factor for problematic recovery, with a growing body of evidence documenting its association with heightened... (Meta-Analysis)
Meta-Analysis
Perceived injustice is increasingly recognized as a risk factor for problematic recovery, with a growing body of evidence documenting its association with heightened pain, disability, medication use, anger and post-traumatic stress. The aim of this paper was to systematically review and critically appraise the association between perceived injustice and depressive symptomatology across a wide range of medical and mental health populations, including acute and chronic pain samples. A search of published, English language studies in the PubMed, EMBASE, CINAHL, and PsycINFO databases from 1990 to June 2020 was performed. Thirty-three studies met inclusion criteria with a total sample of 5,425 individuals (61% female), primarily with acute injury or chronic pain. Results indicated a moderate to strong positive association between perceived injustice and depressive symptomatology (meta-analysis pooled effect of r = .57, 95% confidence interval [.55, .58], P< .001). A narrative synthesis of regression models indicated standardized beta coefficients between .19 and .66, with perceived injustice consistently contributing significant unique variance to the prediction of depression in final regression equations. Selection bias and response bias were common limitations in the studies. The clinical implications of an association between injustice and depression in acute and chronic pain are discussed. PROSPERO: CRD42019143465. PERSPECTIVE: This review demonstrates that in acute injury and chronic pain samples, perceived injustice is associated with depression. These findings could help clinicians in the field of pain and rehabilitation identify who may be at greater risk for a problematic recovery trajectory.
Topics: Depression; Humans; Social Justice; Social Perception
PubMed: 33465504
DOI: 10.1016/j.jpain.2020.12.009 -
Obstetrics and Gynecology Apr 2023To evaluate the risk of recurrence and reintervention after uterine-sparing treatment options for symptomatic adenomyosis, including adenomyomectomy, uterine artery... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the risk of recurrence and reintervention after uterine-sparing treatment options for symptomatic adenomyosis, including adenomyomectomy, uterine artery embolization (UAE), and image-guided thermal ablation.
DATA SOURCES
We searched electronic databases such as Web of Science, MEDLINE, Cochrane Library, EMBASE, ClinicalTrials.gov , and Google Scholar from January 2000 to January 2022. The search was conducted using the following search terms: "adenomyosis," "recurrence," "reintervention," "relapse," and "recur."
METHODS OF STUDY SELECTION
All studies that described the risk of recurrence or reintervention after uterine-sparing interventions for symptomatic adenomyosis were reviewed and screened according to the eligibility criteria. Recurrence was defined as the reappearance of symptoms (painful menses or heavy menstrual bleeding) after significant or complete remission, or the reappearance of adenomyotic lesions confirmed by ultrasonography or magnetic resonance imaging.
TABULATION, INTEGRATION, AND RESULTS
The outcome measures were presented as the frequency with percentage and pooled with 95% CI. A total of 42 studies (single-arm retrospective and prospective studies) that represented 5,877 patients were included. The recurrence rates after adenomyomectomy, UAE, and image-guided thermal ablation were 12.6% (95% CI 8.9-16.4%), 29.5% (95% CI 17.4-41.5%), and 10.0% (95% CI 5.6-14.4%), respectively. The reintervention rates were 2.6% (95% CI 0.9-4.3%), 12.8% (95% CI 7.2-18.4%), and 8.2% (95% CI 4.6-11.9%) after adenomyomectomy, UAE, and image-guided thermal ablation, respectively. Subgroup analysis and sensitivity analysis were performed, and the heterogeneity was reduced in several analyses.
CONCLUSION
Uterine-sparing techniques were successful in treating adenomyosis with low reintervention rates. Uterine artery embolization had higher recurrence and reintervention rates than other techniques; however, patients treated with UAE had larger uteri and larger adenomyosis, indicating that selection bias may influence these results. More randomized controlled trials with a larger population are needed in the future.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42021261289.
Topics: Female; Humans; Adenomyosis; Uterine Neoplasms; Leiomyoma; Retrospective Studies; Prospective Studies; Neoplasm Recurrence, Local; Uterus; Uterine Artery Embolization; Treatment Outcome
PubMed: 36897132
DOI: 10.1097/AOG.0000000000005080 -
International Journal of Molecular... Sep 2023Blood biomarkers hold potential for the early diagnosis of ischaemic stroke (IS). We aimed to evaluate the current weight of evidence and identify potential biomarkers... (Meta-Analysis)
Meta-Analysis Review
Blood biomarkers hold potential for the early diagnosis of ischaemic stroke (IS). We aimed to evaluate the current weight of evidence and identify potential biomarkers and biological pathways for further investigation. We searched PubMed, EMBASE, the Cochrane Library and Web of Science, used R package meta4diag for diagnostic meta-analysis and applied Gene Ontology (GO) analysis to identify vital biological processes (BPs). Among 8544 studies, we included 182 articles with a total of 30,446 participants: 15675 IS, 2317 haemorrhagic stroke (HS), 1798 stroke mimics, 846 transient ischaemic attack and 9810 control subjects. There were 518 pooled biomarkers including 203 proteins, 114 genes, 108 metabolites and 88 transcripts. Our study generated two shortlists of biomarkers for future research: one with optimal diagnostic performance and another with low selection bias. Glial fibrillary acidic protein was eligible for diagnostic meta-analysis, with summary sensitivities and specificities for differentiating HS from IS between 3 h and 24 h after stroke onset ranging from 73% to 80% and 77% to 97%, respectively. GO analysis revealed the top five BPs associated with IS. This study provides a holistic view of early diagnostic biomarkers in IS. Two shortlists of biomarkers and five BPs warrant future investigation.
Topics: Humans; Stroke; Brain Ischemia; Ischemic Stroke; Hemorrhagic Stroke; Early Diagnosis; Biomarkers
PubMed: 37762122
DOI: 10.3390/ijms241813821 -
Journal of Affective Disorders Mar 2020The prevalence of paternal perinatal depression (PPD) is approximately 10%. Despite this epidemiology and what is known about the importance of paternal mental health to... (Review)
Review
BACKGROUND
The prevalence of paternal perinatal depression (PPD) is approximately 10%. Despite this epidemiology and what is known about the importance of paternal mental health to family functioning, there is limited research on evidence-based interventions for PPD. This systematic review aimed to investigate the literature for randomized-controlled trials (RCT) of interventions for PPD.
METHODS
This systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Databases searched included Medline, EMBASE, EBM Reviews, PubMed, PsycInfo, and CINAHL. Search terms included depression, depressive disorder, fathers, pregnancy, and peripartum period, etc. RESULTS: The search strategy identified 2949 items. A total of 10 interventions over the course of 25 years of research met inclusion criteria. Three of the included studies found a small but significant effect on paternal depression scores. However, none of the included studies exclusively targeted paternal mental health. Instead, they addressed paternal well-being indirectly by focusing on the mother, infant, or couple relationship.
LIMITATIONS
Studies did not require fathers to meet criteria for depression at baseline. This may have resulted in a selection bias, whereby the included fathers may not have required any treatment. We were also unable to perform additional statistical analyses because of the limited research available as well as the inconsistent outcome measures.
CONCLUSIONS
There remains limited research on interventions assessing paternal depressive symptomatology, and none have targeted diagnosed PPD. Because of the prevalence and impact of this disorder, it is imperative to identify and offer treatments and interventions specifically tailored towards this population.
Topics: Depression; Depressive Disorder; Fathers; Female; Humans; Infant; Male; Mental Health; Mothers; Pregnancy
PubMed: 32090778
DOI: 10.1016/j.jad.2019.12.029