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International Journal of Molecular... Jul 2022There is an urgent need for analgesics with improved efficacy, especially in neuropathic and other chronic pain conditions. Unfortunately, in recent decades, many...
There is an urgent need for analgesics with improved efficacy, especially in neuropathic and other chronic pain conditions. Unfortunately, in recent decades, many candidate analgesics have failed in clinical phase II or III trials despite promising preclinical results. Translational assessment tools to verify engagement of pharmacological targets and actions on compartments of the nociceptive system are missing in both rodents and humans. Through the Innovative Medicines Initiative of the European Union and EFPIA, a consortium of researchers from academia and the pharmaceutical industry was established to identify and validate a set of functional biomarkers to assess drug-induced effects on nociceptive processing at peripheral, spinal and supraspinal levels using electrophysiological and functional neuroimaging techniques. Here, we report the results of a systematic literature search for pharmacological probes that allow for validation of these biomarkers. Of 26 candidate substances, only 7 met the inclusion criteria: evidence for nociceptive system modulation, tolerability, availability in oral form for human use and absence of active metabolites. Based on pharmacokinetic characteristics, three were selected for a set of crossover studies in rodents and healthy humans. All currently available probes act on more than one compartment of the nociceptive system. Once validated, biomarkers of nociceptive signal processing, combined with a pharmacometric modelling, will enable a more rational approach to selecting dose ranges and verifying target engagement. Combined with advances in classification of chronic pain conditions, these biomarkers are expected to accelerate analgesic drug development.
Topics: Analgesics; Biomarkers, Pharmacological; Chronic Pain; Drug Development; Humans; Neuralgia; Reproducibility of Results; Spine
PubMed: 35955432
DOI: 10.3390/ijms23158295 -
Journal of Clinical Medicine May 2022(1) Background: Anemia affects about 40% of patients with chronic kidney disease (CKD). Daprodustat improves serum hemoglobin in anemic patients by inhibiting prolyl... (Review)
Review
(1) Background: Anemia affects about 40% of patients with chronic kidney disease (CKD). Daprodustat improves serum hemoglobin in anemic patients by inhibiting prolyl hydroxylase of hypoxia-inducible factor. We conducted a network meta-analysis to investigate the direct and indirect effects of different doses of daprodustat compared to each other and erythropoietin and placebo. (2) Methods: We searched PubMed, Cochrane Library, Web of Science, and Scopus, for randomized clinical trials (RCTs) reporting data about different doses of daprodustat for anemia in nondialysis of CKDs. (3) Results: We eventually included five RCTs with a total sample size of 4566 patients. We found that the higher the dose of daprodustat, the greater the change in serum total iron binding capacity (TIBC), hemoglobin, and ferritin from baseline. Compared to placebo, daprodustat 25-30 mg was associated with the highest significant increase in serum hemoglobin (MD = 3.27, 95% CI = [1.89; 4.65]), a decrease in serum ferritin (MD = -241.77, 95% CI = [-365.45; -118.09]) and increase in serum TIBC (MD = 18.52, 95% CI = [12.17; 24.87]). (4) Conclusion: Higher daprodustat doses were associated with a higher impact on efficacy outcomes as serum total iron-binding capacity (TIBC), hemoglobin, and ferritin. However, data about the safety profile of different doses of daprodustat is still missing.
PubMed: 35628849
DOI: 10.3390/jcm11102722 -
Canadian Journal of Anaesthesia =... Jul 2022Hip fractures are debilitating in older adults because of their impact on quality of life. Opioids are associated with adverse effects in this population, so oral... (Review)
Review
PURPOSE
Hip fractures are debilitating in older adults because of their impact on quality of life. Opioids are associated with adverse effects in this population, so oral acetaminophen is commonly prescribed to minimize opioid use. Intravenous (iv) acetaminophen has been reported to have superior efficacy and bioavailability than oral acetaminophen. Nevertheless, its effect on postoperative outcomes in emergency hip fractures is unclear. This systematic review assessed the effect of iv acetaminophen on postoperative outcomes in older hip fracture patients.
SOURCE
We searched multiple databases from inception to June 2021 for studies on adults > 50 yr of age undergoing emergency hip fracture surgery who received iv acetaminophen (or paracetamol) and that reported postoperative outcomes. Relevant titles, abstracts, and full texts were screened based on the eligibility criteria. The Newcastle-Ottawa scale was used to assess the quality of the selected papers.
PRINCIPAL FINDINGS
Of 3,510 initial studies, four met the inclusion criteria. One was a prospective cohort study and three were retrospective cohort studies. All four studies used historical control groups. Three studies reported a significantly lower mean opioid dose with iv acetaminophen than with oral acetaminophen. Three studies also reported a significantly shorter hospital stay. One study each reported a significant decrease in the number of missed physical therapy sessions, the need for one-to-one supervision, and episodes of delirium.
CONCLUSION
There is very limited low-level evidence that iv acetaminophen improves preoperative and postoperative analgesia and shortens hospital stay in older hip fracture patients. Nevertheless, our results should be interpreted with caution since there are no prospective randomized trials investigating whether iv acetaminophen improves postoperative outcomes in this patient population.
STUDY REGISTRATION
PROSPERO (CRD42021198174); registered 15 August 2021.
Topics: Acetaminophen; Aged; Analgesics, Non-Narcotic; Analgesics, Opioid; Hip Fractures; Humans; Pain, Postoperative; Prospective Studies; Quality of Life; Retrospective Studies
PubMed: 35534770
DOI: 10.1007/s12630-022-02257-6 -
Pediatric Health, Medicine and... 2022Children with juvenile arthritis (JA) experience pain, stiffness, fatigue, and decreased motion leading to difficulties with daily activities and low physical activity... (Review)
Review
INTRODUCTION
Children with juvenile arthritis (JA) experience pain, stiffness, fatigue, and decreased motion leading to difficulties with daily activities and low physical activity (PA). PA is critical to improve health and function and mitigate JA-associated symptoms. This study evaluated the evidence for PA interventions in children with JA.
MATERIALS AND METHODS
A systematic review of randomized controlled trials (RCTs) of PA interventions in children with JA was conducted. Ovid (Medline), Cochrane Library, EMBASE, and CINAHL databases were searched for papers published in English between 1/1/1946 and 9/1/2021. Studies which concurrently assessed medical interventions were excluded. Participant and intervention characteristics and outcomes were extracted. Study internal validity and intervention attributes were assessed.
RESULTS
A total of 555 studies were identified, with 13 studies from 10 countries included. Data from 672 children diagnosed with juvenile idiopathic arthritis (JIA) (range of mean ages, 8.7 to 16.1 years) were analyzed. Fifty-two percent of intervention arms incorporated strengthening exercise alone or combined with other exercise, with 61.9% performed 3x/week. About 43.5% of sessions lasted >45 to ≤60 minutes and 65.2% of programs were ≥12 to <28 weeks. PA interventions improved function and symptoms without adverse events. Intervention details were missing especially regarding PA intensity, reasons for dropouts, and adherence. Only two studies incorporated strategies to promote adherence.
DISCUSSION
RCTs of PA interventions in JA only include JIA. Available RCTs used mixed modes of interventions. Reporting of PA interventions lacks sufficient detail to discern the dose-response relationship. Strategies to motivate engagement in PA and to support families to promote PA are lacking, as are studies of long-term outcomes.
CONCLUSION
There are limited RCTs of PA interventions in JIA. Adherence was better with low intensity programs. PA interventions for JIA yield positive health benefits but better reporting of PA intervention details is needed to generate more high-quality evidence and inform clinical practice.
PROSPERO REGISTRATION
Maura Iversen, Johan von Heideken, Marie Andre. Physical Activity in Children with Rheumatic Diseases: a systematic review. PROSPERO 2021 CRD42021274634 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021274634.
PubMed: 35444485
DOI: 10.2147/PHMT.S282611 -
The Cochrane Database of Systematic... Apr 2022Infants born preterm (before 37 weeks' gestation) are at risk of respiratory distress syndrome (RDS) and need for respiratory support due to lung immaturity. One course... (Review)
Review
BACKGROUND
Infants born preterm (before 37 weeks' gestation) are at risk of respiratory distress syndrome (RDS) and need for respiratory support due to lung immaturity. One course of prenatal corticosteroids, administered to women at risk of preterm birth, reduces the risk of respiratory morbidity and improves survival of their infants, but these benefits do not extend beyond seven days. Repeat doses of prenatal corticosteroids have been used for women at ongoing risk of preterm birth more than seven days after their first course of corticosteroids, with improvements in respiratory outcomes, but uncertainty remains about any long-term benefits and harms. This is an update of a review last published in 2015.
OBJECTIVES
To assess the effectiveness and safety, using the best available evidence, of a repeat dose(s) of prenatal corticosteroids, given to women who remain at risk of preterm birth seven or more days after an initial course of prenatal corticosteroids with the primary aim of reducing fetal and neonatal mortality and morbidity.
SEARCH METHODS
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials, including cluster-randomised trials, of women who had already received one course of corticosteroids seven or more days previously and were still at risk of preterm birth, randomised to further dose(s) or no repeat doses, with or without placebo. Quasi-randomised trials were excluded. Abstracts were accepted if they met specific criteria. All trials had to meet criteria for trustworthiness, including a search of the Retraction Watch database for retractions or expressions of concern about the trials or their publications.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane Pregnancy and Childbirth methods. Two review authors independently selected trials, extracted data, and assessed trial quality and scientific integrity. We chose primary outcomes based on clinical importance as measures of effectiveness and safety, including serious outcomes, for the women and their fetuses/infants, infants in early childhood (age two to less than five years), the infant in mid- to late childhood (age five to less than 18 years) and the infant as an adult. We assessed risk of bias at the outcome level using the RoB 2 tool and assessed certainty of evidence using GRADE.
MAIN RESULTS
We included 11 trials (4895 women and 5975 babies). High-certainty evidence from these trials indicated that treatment of women who remain at risk of preterm birth seven or more days after an initial course of prenatal corticosteroids with repeat dose(s) of corticosteroids, compared with no repeat corticosteroid treatment, reduced the risk of their infants experiencing the primary infant outcome of RDS (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.74 to 0.90; 3540 babies; number needed to treat for an additional beneficial outcome (NNTB) 16, 95% CI 11 to 29) and had little or no effect on chronic lung disease (RR 1.00, 95% CI 0.83 to 1.22; 5661 babies). Moderate-certainty evidence indicated that the composite of serious infant outcomes was probably reduced with repeat dose(s) of corticosteroids (RR 0.88, 95% CI 0.80 to 0.97; 9 trials, 5736 babies; NNTB 39, 95% CI 24 to 158), as was severe lung disease (RR 0.83, 95% CI 0.72 to 0.97; NNTB 45, 95% CI 27 to 256; 4955 babies). Moderate-certainty evidence could not exclude benefit or harm for fetal or neonatal or infant death less than one year of age (RR 0.95, 95% CI 0.73 to 1.24; 5849 babies), severe intraventricular haemorrhage (RR 1.13, 95% CI 0.69 to 1.86; 5066 babies) and necrotising enterocolitis (RR 0.84, 95% CI 0.59 to 1.22; 5736 babies). In women, moderate-certainty evidence found little or no effect on the likelihood of a caesarean birth (RR 1.03, 95% CI 0.98 to 1.09; 4266 mothers). Benefit or harm could not be excluded for maternal death (RR 0.32, 95% 0.01 to 7.81; 437 women) and maternal sepsis (RR 1.13, 95% CI 0.93 to 1.39; 4666 mothers). The evidence was unclear for risk of adverse effects and discontinuation of therapy due to maternal adverse effects. No trials reported breastfeeding status at hospital discharge or risk of admission to the intensive care unit. At early childhood follow-up, moderate- to high-certainty evidence identified little or no effect of exposure to repeat prenatal corticosteroids compared with no repeat corticosteroids for primary outcomes relating to neurodevelopment (neurodevelopmental impairment: RR 0.97, 95% CI 0.85 to 1.10; 3616 children), survival without neurodevelopmental impairment (RR 1.01, 95% CI 0.98 to 1.04; 3845 children) and survival without major neurodevelopmental impairment (RR 1.02, 95% CI 0.98 to 1.05; 1816 children). An increase or decrease in the risk of death since randomisation could not be excluded (RR 1.06, 95% CI 0.81 to 1.40; 5 trials, 4565 babies randomised). At mid-childhood follow-up, moderate-certainty evidence identified little or no effect of exposure to repeat prenatal corticosteroids compared with no repeat corticosteroids on survival free of neurocognitive impairment (RR 1.01, 95% CI 0.95 to 1.08; 963 children) or survival free of major neurocognitive impairment (RR 1.00, 95% CI 0.97 to 1.04; 2682 children). Benefit or harm could not be excluded for death since randomisation (RR 0.93, 95% CI 0.69 to 1.26; 2874 babies randomised) and any neurocognitive impairment (RR 0.96, 95% CI 0.72 to 1.29; 897 children). No trials reported data for follow-up into adolescence or adulthood. Risk of bias across outcomes was generally low although there were some concerns of bias. For childhood follow-up, most outcomes had some concerns of risk of bias due to missing data from loss to follow-up.
AUTHORS' CONCLUSIONS
The short-term benefits for babies included less respiratory distress and fewer serious health problems in the first few weeks after birth with repeat dose(s) of prenatal corticosteroids for women still at risk of preterm birth seven days or more after an initial course. The current available evidence reassuringly shows no significant harm for the women or child in early and mid-childhood, although no benefit. Further research is needed on the long-term benefits and risks for the baby into adulthood.
Topics: Adolescent; Adrenal Cortex Hormones; Adult; Child; Child, Preschool; Female; Humans; Infant; Infant, Newborn; Odds Ratio; Outcome Assessment, Health Care; Pregnancy; Premature Birth; Vitamins
PubMed: 35377461
DOI: 10.1002/14651858.CD003935.pub5 -
BMC Cancer Mar 2022High-dose methotrexate (HD-MTX) is used in the treatment of different childhood cancers, including leukemia, the most common cancer type and is commonly defined as an...
BACKGROUND
High-dose methotrexate (HD-MTX) is used in the treatment of different childhood cancers, including leukemia, the most common cancer type and is commonly defined as an intravenous dose of at least 1 g/m body surface area per application. A systematic review on late effects on different organs due to HD-MTX is lacking.
METHOD
We conducted a systematic literature search in PubMed, including studies published in English or German between 1985 and 2020. The population of each study had to consist of at least 75% childhood cancer survivors (CCSs) who had completed the cancer treatment at least twelve months before late effects were assessed and who had received HD-MTX. The literature search was not restricted to specific cancer diagnosis or organ systems at risk for late effects. We excluded case reports, case series, commentaries, editorial letters, poster abstracts, narrative reviews and studies only reporting prevalence of late effects. We followed PRISMA guidelines, assessed the quality of the eligible studies according to GRADE criteria and registered the protocol on PROSPERO (ID: CRD42020212262).
RESULTS
We included 15 out of 1731 identified studies. Most studies included CCSs diagnosed with acute lymphoblastic leukemia (n = 12). The included studies investigated late effects of HD-MTX on central nervous system (n = 10), renal (n = 2) and bone health (n = 3). Nine studies showed adverse outcomes in neuropsychological testing in exposed compared to non-exposed CCSs, healthy controls or reference values. No study revealed lower bone density or worse renal function in exposed CCSs. As a limitation, the overall quality of the studies per organ system was low to very low, mainly due to selection bias, missing adjustment for important confounders and low precision.
CONCLUSIONS
CCSs treated with HD-MTX might benefit from neuropsychological testing, to intervene early in case of abnormal results. Methodological shortcomings and heterogeneity of the tests used made it impossible to determine the most appropriate test. Based on the few studies on renal function and bone health, regular screening for dysfunction seems not to be justified. Only screening for neurocognitive late effects is warranted in CCSs treated with HD-MTX.
Topics: Antineoplastic Agents; Cancer Survivors; Case-Control Studies; Child; Female; Humans; Long Term Adverse Effects; Male; Methotrexate; Neoplasms
PubMed: 35287628
DOI: 10.1186/s12885-021-09145-0 -
Health Science Reports Mar 2022Scientists and healthcare workers have expressed their concerns on the impacts of the COVID-19 pandemic on vaccination coverage in children and adolescents. Therefore,... (Review)
Review
BACKGROUND AND AIMS
Scientists and healthcare workers have expressed their concerns on the impacts of the COVID-19 pandemic on vaccination coverage in children and adolescents. Therefore, we aimed to systematically review the studies addressing this issue worldwide.
METHODS
We conducted a systematic search of relevant studies using the keywords on databases of PubMed, Web of Science, and Cochrane on May 22, 2021. The identified records were imported into EndNote software and underwent a two-phase screening process consisting of title/abstract and full-text screenings against inclusion criteria. The data of the included studies were summarized into a table and the findings were analyzed in a systematic approach.
RESULTS
From 26 eligible studies, 21 studies demonstrated decreased vaccination rates in the children during the COVID-19 pandemic, while three studies found increased or no significant changes only in influenza vaccination. The two remaining studies from Brazil and Sweden also showed no significant changes in vaccination rates in the children during the pandemic.
CONCLUSION
Most of the reports worldwide reported a decline or delay in vaccination at the time of the COVID-19 pandemic. A sustained catch-up program seems to be necessary, especially in low-income countries, to avoid any vaccine dose missing. Facilitating the vaccination process is recommended, such as decreasing the waiting time for vaccination at the health center, addressing the fear and concerns related to COVID infection for parents, and enhancing vaccine availability, and promoting access in remote areas. Countries should ensure proper vaccination to prevent future pandemics related to vaccine-preventable diseases.
PubMed: 35224217
DOI: 10.1002/hsr2.516 -
The Cochrane Database of Systematic... Feb 2022Attention deficit hyperactivity disorder (ADHD) is a psychiatric diagnosis increasingly used in adults. The recommended first-line pharmacological treatment is central... (Review)
Review
BACKGROUND
Attention deficit hyperactivity disorder (ADHD) is a psychiatric diagnosis increasingly used in adults. The recommended first-line pharmacological treatment is central nervous system (CNS) stimulants, such as methylphenidate, but uncertainty remains about its benefits and harms.
OBJECTIVES
To assess the beneficial and harmful effects of extended-release formulations of methylphenidate in adults diagnosed with ADHD.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, nine other databases and four clinical trial registries up to February 2021. We searched 12 drug regulatory databases for clinical trial data up to 13 May 2020. In addition, we cross-referenced all available trial identifiers, handsearched reference lists, searched pharmaceutical company databases, and contacted trial authors.
SELECTION CRITERIA
Randomised, double-blind, parallel-group trials comparing extended-release methylphenidate formulations at any dose versus placebo and other ADHD medications in adults diagnosed with ADHD.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data. We assessed dichotomous outcomes as risk ratios (RRs), and rating scales and continuous outcomes as mean differences (MDs) or standardised mean differences (SMDs). We used the Cochrane risk of bias tool to assess risks of bias, and GRADE to assess the certainty of the evidence. We meta-analysed the data using a random-effects model. We assessed three design characteristics that may impair the trial results' 'generalisability'; exclusion of participants with psychiatric comorbidity; responder selection based on previous experience with CNS stimulants; and risk of withdrawal effects. Our prespecified primary outcomes were functional outcomes, self-rated ADHD symptoms, and serious adverse events. Our secondary outcomes included quality of life, ADHD symptoms rated by investigators and by peers such as family members, cardiovascular variables, severe psychiatric adverse events, and other adverse events.
MAIN RESULTS
We included 24 trials (5066 participants), of which 21 reported outcome data for this review. We also identified one ongoing study. We included documents from six drug regulatory agencies covering eight trials. Twenty-one trials had an outpatient setting and three were conducted in prisons. They were primarily conducted in North America and Europe. The median participant age was 36 years. Twelve trials (76% of participants) were industry-sponsored, four (14% of participants) were publicly funded with industry involvement, seven (10% of participants) were publicly funded, and one had unclear funding. The median trial duration was eight weeks. One trial was rated at overall unclear risk of bias and 20 trials were rated at overall high risk of bias, primarily due to unclear blinding of participants and investigators, attrition bias, and selective outcome reporting. All trials were impaired in at least one of the three design characteristics related to 'generalisability'; for example, they excluded participants with psychiatric comorbidity such as depression or anxiety, or included participants only with a previous positive response to methylphenidate, or similar drugs. This may limit the trials' usefulness for clinical practice, as they may overestimate the benefits and underestimate the harms. Extended-release methylphenidate versus placebo (up to 26 weeks) For the primary outcomes, we found very low-certainty evidence that methylphenidate had no effect on 'days missed at work' at 13-week follow-up (mean difference (MD) -0.15 days, 95% confidence interval (CI) -2.11 to 1.81; 1 trial, 409 participants) or serious adverse events (risk ratio (RR) 1.43, CI 95% CI 0.85 to 2.43; 14 trials, 4078 participants), whereas methylphenidate improved self-rated ADHD symptoms (small-to-moderate effect; SMD -0.37, 95% CI -0.43 to -0.30; 16 trials, 3799 participants). For secondary outcomes, we found very low-certainty evidence that methylphenidate improved self-rated quality of life (small effect; SMD -0.15, 95% CI -0.25 to -0.05; 6 trials, 1888 participants), investigator-rated ADHD symptoms (small-to-moderate effect; SMD -0.42, 95% CI -0.49 to -0.36; 18 trials, 4183 participants), ADHD symptoms rated by peers such as family members (small-to-moderate effect; SMD -0.31, 95% CI -0.48 to -0.14; 3 trials, 1005 participants), and increased the risk of experiencing any adverse event (RR 1.27, 95% CI 1.19 to 1.37; 14 trials, 4214 participants). We rated the certainty of the evidence as 'very low' for all outcomes, primarily due to high risk of bias and 'indirectness of the evidence'. One trial (419 participants) had follow-up at 52 weeks and two trials (314 participants) included active comparators, hence long-term and comparative evidence is limited.
AUTHORS' CONCLUSIONS
We found very low-certainty evidence that extended-release methylphenidate compared to placebo improved ADHD symptoms (small-to-moderate effects) measured on rating scales reported by participants, investigators, and peers such as family members. Methylphenidate had no effect on 'days missed at work' or serious adverse events, the effect on quality of life was small, and it increased the risk of several adverse effects. We rated the certainty of the evidence as 'very low' for all outcomes, due to high risk of bias, short trial durations, and limitations to the generalisability of the results. The benefits and harms of extended-release methylphenidate therefore remain uncertain.
Topics: Adult; Anxiety Disorders; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Humans; Methylphenidate; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 35201607
DOI: 10.1002/14651858.CD012857.pub2 -
Journal of Medical Internet Research Feb 2022Nonadherence to medication in tuberculosis (TB) hampers optimal treatment outcomes. Digital health technology (DHT) seems to be a promising approach to managing problems... (Review)
Review
BACKGROUND
Nonadherence to medication in tuberculosis (TB) hampers optimal treatment outcomes. Digital health technology (DHT) seems to be a promising approach to managing problems of nonadherence to medication and improving treatment outcomes.
OBJECTIVE
This paper systematically reviews the effect of DHT in improving medication adherence and treatment outcomes in patients with TB.
METHODS
A literature search in PubMed and Cochrane databases was conducted. Randomized controlled trials (RCTs) that analyzed the effect of DHT interventions on medication adherence outcomes (treatment completion, treatment adherence, missed doses, and noncompleted rate) and treatment outcomes (cure rate and smear conversion) were included. Adult patients with either active or latent TB infection were included. The Jadad score was used for evaluating the study quality. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline was followed to report study findings.
RESULTS
In all, 16 RCTs were selected from 552 studies found, and 6 types of DHT interventions for TB were identified: 3 RCTs examined video directly observed therapy (VDOT), 1 examined video-observed therapy (VOT), 1 examined an ingestible sensor, 1 examined phone call reminders, 2 examined medication monitor boxes, and 8 examined SMS text message reminders. The outcomes used were treatment adherence, including treatment completion, treatment adherence, missed dose, and noncompleted rate, as well as clinical outcomes, including cure rate and smear conversion. In treatment completion, 4 RCTs (VDOT, VOT, ingestible sensor, SMS reminder) found significant effects, with odds ratios and relative risks (RRs) ranging from 1.10 to 7.69. Treatment adherence was increased in 1 study by SMS reminders (RR 1.05; 95% CI 1.04-1.06), and missed dose was reduced in 1 study by a medication monitor box (mean ratio 0.58; 95% CI 0.42-0.79). In contrast, 3 RCTs of VDOT and 3 RCTs of SMS reminders did not find significant effects for treatment completion. Moreover, no improvement was found in treatment adherence in 1 RCT of VDOT, missed dose in 1 RCT of SMS reminder, and noncompleted rate in 1 RCT of a monitor box, and 2 RCTs of SMS reminders. For clinical outcomes such as cure rate, 2 RCTs reported that phone calls (RR 1.30; 95% CI 1.07-1.59) and SMS reminders (OR 2.47; 95% CI 1.13-5.43) significantly affected cure rates. However, 3 RCTs found that SMS reminders did not have a significant impact on cure rate or smear conversion.
CONCLUSIONS
It was found that DHT interventions can be a promising approach. However, the interventions exhibited variable effects regarding effect direction and the extent of improving TB medication adherence and clinical outcomes. Developing DHT interventions with personalized feedback is required to have a consistent and beneficial effect on medication adherence and outcomes among patients with TB.
Topics: Adult; Biomedical Technology; Cell Phone; Humans; Medication Adherence; Randomized Controlled Trials as Topic; Reminder Systems; Text Messaging; Treatment Outcome; Tuberculosis
PubMed: 35195534
DOI: 10.2196/33062 -
Vascular Jun 2023Exercise therapy is an important treatment option for people with intermittent claudication (IC). Appropriate reporting of exercise interventions in populations with IC...
BACKGROUND
Exercise therapy is an important treatment option for people with intermittent claudication (IC). Appropriate reporting of exercise interventions in populations with IC within randomised controlled trials (RCTs) is important to ensure that research can be translated into clinical practice. Therefore, the purpose of our review is to evaluate the reporting of exercise interventions in RCTs of exercise therapy in patients with IC.
METHODS
A systematic search was performed to identify relevant trials in patients with IC published until May 2020. Studies including only participants with critical limb ischaemia or asymptomatic peripheral artery disease were excluded. Each trial was scored using the recently developed 'Consensus on Exercise Reporting Template' (CERT) which has a maximum obtainable score of 19.
RESULTS
Of 1489 unique records identified from the search, 73 trials were included, reporting 107 exercise interventions. Overall, the average CERT score was 10/19. The exercise equipment used, the use of supervision and a description of whether the exercise prescription was tailored or generic were the most frequently reported intervention components. The motivational strategies used, intervention adherence and intervention fidelity were the most underreported CERT components. There was no trend indicating that CERT scores were higher in more recent publications.
CONCLUSIONS
We have identified that important details about exercise interventions are frequently missing from the published literature. These missing data hinder replication of research findings and limit the translation of evidence into clinical practice.
Topics: Humans; Intermittent Claudication; Exercise Therapy; Exercise; Peripheral Arterial Disease
PubMed: 35130092
DOI: 10.1177/17085381211070700