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Clinical and Experimental Dental... Oct 2022Proton pump inhibitors, such as omeprazole and pantoprazole, are frequently prescribed for the treatment of acid reflux. However, those medications have been shown to... (Review)
Review
OBJECTIVES
Proton pump inhibitors, such as omeprazole and pantoprazole, are frequently prescribed for the treatment of acid reflux. However, those medications have been shown to affect a variety of physiologic processes, including bone homeostasis and the gastrointestinal microbiome. The objective of this study was to assess the relationship between proton pump inhibitors and attachment levels around teeth and dental implants. A scoping review was performed to assess the extent and quality of the relevant literature.
MATERIALS AND METHODS
We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews (PRISMA-ScR) and searched four relevant biomedical literature databases in addition to the grey literature. Keywords in the title and abstract fields, and subject headings for proton pump inhibitors, teeth, and dental implants were included as search terms.
RESULTS
Overall search results identified 791 publications which, after applying the inclusion and exclusion criteria, yielded 27 publications that were further analyzed for relevance and quality of scientific evidence. The majority of eligible publications were retrospective cohort studies. Following critical analysis, 13 publications, including six abstracts, were used to assess the effect of proton pump inhibitors on tissue attachment around teeth and dental implants.
CONCLUSIONS
There are few high-quality studies describing the effect of proton pump inhibitors on tissue attachment around teeth and dental implants. Nevertheless, among the included papers with the fewest confounding factors, there was a positive relationship between proton pump inhibitors and soft tissue attachment levels around teeth, and a predominantly negative but variable effect of proton pump inhibitors on the bone level around dental implants. Additional well-controlled prospective studies are required to fully elucidate those relationships.
Topics: Dental Implants; Humans; Omeprazole; Pantoprazole; Proton Pump Inhibitors; Retrospective Studies
PubMed: 35799099
DOI: 10.1002/cre2.616 -
Nutrition Research (New York, N.Y.) Sep 2022Various reports show the beneficial effect of naringenin on the development of cancer. We hypothesized that naringenin suppresses cancer cells by activating intrinsic... (Meta-Analysis)
Meta-Analysis Review
Various reports show the beneficial effect of naringenin on the development of cancer. We hypothesized that naringenin suppresses cancer cells by activating intrinsic and extrinsic apoptosis pathways. This systematic review and meta-analysis was performed to reveal the effect of naringenin on cancer inhibition in vitro and in vivo by altering apoptotic factors. Literature search was carried out using electronic databases including PubMed, Web of Science, Scopus, Google Scholar, and Embase up to February 2021. The heterogeneity test of the included studies was performed using the PRISMA checklist protocol and I statistic, respectively. Pooled standard mean difference and effect size (ES) with 95% confident interval (CI) were used to evaluate each relationship. A total of 32 articles were enrolled in our final analysis. Meta-analysis of the pooled findings for apoptosis, viability percentage, and apoptotic factors determined that treatment with naringenin affects viability and apoptosis in cancer cells in vitro and in vivo. Moreover, the results of in vitro experiments showed that naringenin increases the activity of caspase-3 (ES, 5.04; 95% CI, 2.61-7.47; I = 99.9), caspase-9 (ES, 2.99; 95% CI, 2.47-3.51; I = 93.7%), caspase-8 (ES, 2.86; 95% CI, 1.11-4.61; I = 99.7%), and Bax expression (ES, 2.73; 95% CI, 1.91-3.55; I = 99.4%) in cancer cells. It also increased the apoptotic rate and the activity of caspase-3 and caspase-9 in tumor-bearing animals. Overall, our findings highlight the potential therapeutic effects of naringenin in cancer inhibition through caspases cascade.
Topics: Animals; Apoptosis; Caspase 3; Caspase 9; Flavanones; Neoplasms; Signal Transduction
PubMed: 35797732
DOI: 10.1016/j.nutres.2022.05.003 -
PloS One 2022Actovegin is a hemodialysate of calf's blood and has been used for several decades in the countries of Central Asia, East Asia, Russia and some European countries. It...
BACKGROUND
Actovegin is a hemodialysate of calf's blood and has been used for several decades in the countries of Central Asia, East Asia, Russia and some European countries. It has been used to treat patients with various neurological conditions, vascular disorders, and ischemic stroke.
OBJECTIVES
To perform a systematic review to evaluate the effect of Actovegin in patients who have suffered an ischemic stroke.
METHODS
A search of MEDLINE, PubMed, Cochrane and Embase was carried out from inception to October 10, 2021 for clinical trials and observational studies with a control group, published in English or Russian.
RESULTS
Of 220 identified unique records, 84 full-text articles were screened, and 5 studies were selected that met the inclusion criteria. This included 4 observational studies with control groups and one randomized, placebo-controlled clinical trial. These studies enrolled a total of 3879 patients of which 720 patients received Actovegin administered intravenously and/or orally for a duration ranging from 10 to 180 days. Because of study heterogeneity, meta-analysis was not performed. No consistent evidence on improved survival, quality of life, neurologic symptoms, activities of daily living or disability was identified. One study showed statistically significant improvements in the Alzheimer's Disease Assessment Scale, cognitive subscale, extended version (ADAS-cog+) for Actovegin compared with placebo at 6 months but the clinical relevance of this change is uncertain. One study reported a higher incidence of recurrent ischemic stroke, transient ischemic attack or intracerebral hemorrhage in patients taking Actovegin compared to placebo.
CONCLUSIONS
The benefits of Actovegin are uncertain and that there is potential risk of harm in patients with stroke. More evidence is needed from rigorously designed clinical trials to justify the role of Actovegin in patients with ischemic stroke.
Topics: Activities of Daily Living; Heme; Humans; Ischemic Attack, Transient; Ischemic Stroke; Observational Studies as Topic; Quality of Life; Randomized Controlled Trials as Topic; Stroke
PubMed: 35771887
DOI: 10.1371/journal.pone.0270497 -
The Journal of Obstetrics and... Aug 2022To evaluate the efficacy of misoprostol to minimized blood loss during and after cesarean delivery (CD). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To evaluate the efficacy of misoprostol to minimized blood loss during and after cesarean delivery (CD).
SEARCH STRATEGY
Screening of MEDLINE, EMBASE, Web of Science, the Cochrane Central Register of Controlled Trials from inception to February 2021 using the keywords related to misoprostol, CD, postpartum hemorrhage, and intraoperative blood loss and their MeSH terms.
SELECTION CRITERIA
Only RCTs were included. Participants included women undergoing CD whether elective or selective. Thirty studies including 6593 women, 26 in English, 2 in Thai, 1 in French, and 1 in Chinese.
DATA COLLECTION AND ANALYSIS
Data from all selected studies were extracted independently by two authors. Data extracted included location of the trial, sample size, inclusion and exclusion criteria, participants characteristics, intervention details including timing, dose, and route of drug administration. Outcomes assessed included estimated intraoperative and postoperative blood loss, occurrence of postpartum hemorrhage, the need for additional uterotonics, and hemoglobin difference.
MAIN RESULTS
Four studies (968 women) compared preoperative to postoperative misoprostol and found a mean difference in intraoperative blood loss of -205.00 (-339.22, -70.77), p = 0.003 and in postoperative blood loss -216.27 (-347.08, -85.46), p < 0.001 and a significantly lower need for additional uterotonics with a risk ratio of 0.54 (0.46, 0.64), p < 0.00001. Twenty-two studies (4701 participants) compared misoprostol to oxytocin. There was a mean difference in intraoperative blood loss of -108.43 (-156.04, -60.82), p < 0.0001. Nine of these trials with 1978 participants evaluated postoperative blood loss. These found a mean difference of -64.12 (-116.19, -12.04) with a p = 0.02. Fourteen trials with 3166 participants measured the difference between preoperative and postoperative hemoglobin. These found a mean difference of -0.25 (-0.35, -0.15) with a p < 0.001. Twenty trials with 4416 participants measured the need for administration of additional uterotonics. These found a risk ratio of 0.62 (0.49, 0.78) with a p value of <0.001.
CONCLUSION
The combined use of misoprostol and oxytocin during CD is effective in reducing blood loss during and after CD.
Topics: Blood Loss, Surgical; Cesarean Section; Female; Humans; Misoprostol; Oxytocics; Oxytocin; Postoperative Hemorrhage; Postpartum Hemorrhage; Pregnancy
PubMed: 35661336
DOI: 10.1111/jog.15318 -
Journal of Obstetrics and Gynaecology :... Aug 2022We aimed to conduct a systematic review and meta-analysis to compare the efficacy and safety of titrated oral misoprostol versus static oral misoprostol for labour... (Meta-Analysis)
Meta-Analysis
We aimed to conduct a systematic review and meta-analysis to compare the efficacy and safety of titrated oral misoprostol versus static oral misoprostol for labour induction. We searched for the available randomised clinical trials (RCTs) in the Cochrane Library, PubMed, ISI web of science, Scopus, and ClinicalTrials.gov. We included RCTs compared titrated oral misoprostol versus static regimen of oral misoprostol during labour induction. Our main outcomes were vaginal and caesarean delivery rates, uterine tachysystole, misoprostol side effects, and neonatal adverse events. Three RCTs met our inclusion criteria with a total number of 360 patients. The vaginal delivery rate did not significantly differ between both groups (p = 0.49). Titrated oral misoprostol was associated with significant increase in the caesarean delivery rate compared to static oral misoprostol (p = 0.04). Moreover, titrated oral misoprostol led to significant increase in the uterine tachysystole and misoprostol side effects (p = 0.01 & p = 0.003, respectively). There were no differences among both groups regarding different neonatal adverse events. In conclusion, titrated oral misoprostol increases the incidence of caesarean delivery, uterine tachysystole, and misoprostol side effects with a similar vaginal delivery rate compared to static dose misoprostol. Thus, static oral misoprostol should be used instead of titrated oral misoprostol during labour induction. Impact Statement Different studies have evaluated titrated oral misoprostol administration for induction of labour and proved their efficacy in comparison with other induction methods. However, there is controversy among the published studies between titrated oral misoprostol and static oral misoprostol during induction of labour. A recent study concluded that hourly titrated misoprostol and static oral misoprostol are equally safe and effective when utilised for induction of labour with no fear of any adverse events. However, another study recommended static oral misoprostol administration for labour induction as it was linked to a lower caesarean section incidence, fewer drug side effects, and decline in complication rates in comparison with titrated oral misoprostol. Titrated oral misoprostol increases the incidence of caesarean delivery, uterine tachysystole, and misoprostol side effects with a similar vaginal delivery rate compared to static dose misoprostol. Static oral misoprostol should be used instead of titrated oral misoprostol during labour induction. More future trials are required to confirm our findings.
Topics: Administration, Intravaginal; Cervical Ripening; Delivery, Obstetric; Dystocia; Female; Humans; Infant, Newborn; Labor, Induced; Misoprostol; Oxytocics; Pregnancy
PubMed: 35611858
DOI: 10.1080/01443615.2022.2054687 -
The Cochrane Database of Systematic... May 2022Medical abortion became an alternative method of pregnancy termination following the development of prostaglandins and antiprogesterone in the 1970s and 1980s. Recently,... (Review)
Review
BACKGROUND
Medical abortion became an alternative method of pregnancy termination following the development of prostaglandins and antiprogesterone in the 1970s and 1980s. Recently, synthesis inhibitors of oestrogen (such as letrozole) have also been used to enhance efficacy. The most widely researched drugs are prostaglandins (such as misoprostol, which has a strong uterotonic effect), mifepristone, mifepristone with prostaglandins, and letrozole with prostaglandins. More evidence is needed to identify the best dosage, regimen, and route of administration to optimise patient outcomes. This is an update of a review last published in 2011.
OBJECTIVES
To compare the effectiveness and side effects of different medical methods for first trimester abortion.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, Global Health, and LILACs on 28 February 2021. We also searched Clinicaltrials.gov and the World Health Organization's (WHO) International Clinical Trials Registry Platform, and reference lists of retrieved papers.
SELECTION CRITERIA
We considered randomised controlled trials (RCTs) that compared different medical methods for abortion before the 12th week of gestation. The primary outcome is failure to achieve complete abortion. Secondary outcomes are mortality, surgical evacuation, ongoing pregnancy at follow-up, time until passing of conceptus, blood transfusion, side effects and women's dissatisfaction with the method.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected and evaluated studies for inclusion, and assessed the risk of bias. We processed data using Review Manager 5 software. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included 99 studies in the review (58 from the original review and 41 new studies). 1. Combined regimen mifepristone/prostaglandin Mifepristone dose: high-dose (600 mg) compared to low-dose (200 mg) mifepristone probably has similar effectiveness in achieving complete abortion (RR 1.07, 95% CI 0.87 to 1.33; I = 0%; 4 RCTs, 3494 women; moderate-certainty evidence). Prostaglandin dose: 800 µg misoprostol probably reduces abortion failure compared to 400 µg (RR 0.63, 95% CI 0.51 to 0.78; I= 0%; 3 RCTs, 4424 women; moderate-certainty evidence). Prostaglandin timing: misoprostol administered on day one probably achieves more success on complete abortion than on day three (RR 1.94, 95% CI 1.05 to 3.58; 1489 women; 1 RCT; moderate-certainty evidence). Administration strategy: there may be no difference in failure of complete abortion with self-administration at home compared with hospital administration (RR 1.63, 95% CI 0.68 to 3.94; I = 84%; 2263 women; 4 RCTs; low-certainty evidence), but failure may be higher when administered by nurses in hospital compared to by doctors in hospital (RR 2.69, 95% CI 1.39 to 5.22; I = 66%; 3 RCTs, 3056 women; low-certainty evidence). Administration route: oral misoprostol probably leads to more failures than the vaginal route (RR 2.38, 95% CI 1.46 to 3.87; I = 39%; 3 RCTs, 1704 women; moderate-certainty evidence) and may be associated with more frequent side effects such as nausea (RR 1.14, 95% CI 1.03 to 1.26; I = 0%; 2 RCTs, 1380 women; low-certainty evidence) and diarrhoea (RR 1.80 95% CI 1.49 to 2.17; I = 0%; 2 RCTs, 1379 women). Compared with the vaginal route, complete abortion failure is probably lower with sublingual (RR 0.68, 95% CI 0.22 to 2.11; I = 59%; 2 RCTs, 3229 women; moderate-certainty evidence) and may be lower with buccal administration (RR 0.71, 95% CI 0.34 to 1.46; I = 0%; 2 RCTs, 479 women; low-certainty evidence), but sublingual or buccal routes may lead to more side effects. Women may experience more vomiting with sublingual compared to buccal administration (RR 1.33, 95% CI 1.01 to 1.77; low-certainty evidence). 2. Mifepristone alone versus combined regimen The efficacy of mifepristone alone in achieving complete abortion compared to combined mifepristone/prostaglandin up to 12 weeks is unclear (RR of failure 3.25, 95% CI 0.81 to 13.09; I = 83%; 3 RCTs, 273 women; very low-certainty evidence). 3. Prostaglandin alone versus combined regimen Nineteen studies compared prostaglandin alone to a combined regimen (prostaglandin combined with mifepristone, letrozole, estradiol valerate, tamoxifen, or methotrexate). Compared to any of the combination regimens, misoprostol alone may increase the risk for failure to achieve complete abortion (RR of failure 2.39, 95% CI 1.89 to 3.02; I = 64%; 18 RCTs, 3471 women; low-certainty evidence), and with more diarrhoea. 4. Prostaglandin alone (route of administration) Oral misoprostol alone may lead to more failures in complete abortion than the vaginal route (RR 3.68, 95% CI 1.56 to 8.71, 2 RCTs, 216 women; low-certainty evidence). Failure to achieve complete abortion may be slightly reduced with sublingual compared with vaginal (RR 0.69, 95% CI 0.37 to 1.28; I = 87%; 5 RCTs, 2705 women; low-certainty evidence) and oral administration (RR 0.58, 95% CI 0.11 to 2.99; I = 66%; 2 RCTs, 173 women). Failure to achieve complete abortion may be similar or slightly higher with sublingual administration compared to buccal administration (RR 1.11, 95% CI 0.71 to 1.74; 1 study, 401 women).
AUTHORS' CONCLUSIONS
Safe and effective medical abortion methods are available. Combined regimens (prostaglandin combined with mifepristone, letrozole, estradiol valerate, tamoxifen, or methotrexate) may be more effective than single agents (prostaglandin alone or mifepristone alone). In the combined regimen, the dose of mifepristone can probably be lowered to 200 mg without significantly decreasing effectiveness. Vaginal misoprostol is probably more effective than oral administration, and may have fewer side effects than sublingual or buccal. Some results are limited by the small numbers of participants on which they are based. Almost all studies were conducted in settings with good access to emergency services, which may limit the generalisability of these results.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Spontaneous; Diarrhea; Drug Therapy, Combination; Estradiol; Female; Humans; Letrozole; Methotrexate; Mifepristone; Misoprostol; Oxytocics; Pregnancy; Pregnancy Trimester, First; Prostaglandins; Tamoxifen
PubMed: 35608608
DOI: 10.1002/14651858.CD002855.pub5 -
The Cochrane Database of Systematic... May 2022Abortion is common worldwide and increasingly abortions are performed at less than 14 weeks' gestation using medical methods, specifically using a combination of... (Review)
Review
BACKGROUND
Abortion is common worldwide and increasingly abortions are performed at less than 14 weeks' gestation using medical methods, specifically using a combination of mifepristone and misoprostol. Medical abortion is known to be a painful process, but the optimal method of pain management is unclear. We sought to identify and compare pain management regimens for medical abortion before 14 weeks' gestation. OBJECTIVES: Primary objective To determine if there is evidence of superiority of any particular pain relief regimen in the management of combination medical abortion (mifepristone + misoprostol) under 14 weeks' gestation (i.e. up to 13 + 6 weeks or 97 days). Secondary objectives To compare the rate of gastrointestinal side effects resulting from different methods of analgesia To compare the rate of complete abortion resulting from different methods of analgesia during medical abortion To determine if the induction-to-abortion interval is associated with different methods of analgesia To determine if any method of analgesia is associated with unscheduled contact with the care provider in relation to pain.
SEARCH METHODS
On 21 August 2019 we searched CENTRAL, MEDLINE, Embase, CINAHL, LILACs, PsycINFO, the World Health Organization International Clinical Trials Registry and ClinicalTrials.gov together with reference checking and handsearching of conference abstracts of relevant learned societies and professional organisations to identify further studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and observational studies (non-randomised studies of interventions (NRSIs)) of any pain relief intervention (pharmacological and non-pharmacological) for mifepristone-misoprostol combination medical abortion of pregnancies less than 14 weeks' gestation.
DATA COLLECTION AND ANALYSIS
Two review authors (JRW and MA) independently assessed all identified papers for inclusion and risks of bias, resolving any discrepancies through discussion with a third and fourth author as required (CM and SC). Two review authors independently conducted data extraction, including calculations of pain relief scores, and checked for accuracy. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included four RCTs and one NRSI. Due to the heterogeneity of study designs, interventions and outcome reporting, we were unable to perform meta-analysis for any of the primary or secondary outcomes in this review. Only one study found evidence of an effect between interventions on pain score: a prophylactic dose of ibuprofen 1600 mg likely reduces the pain score when compared to a dose of paracetamol 2000 mg (mean difference (MD) 2.26 out of 10 lower, 95% confidence interval (CI) 3.00 to 1.52 lower; 1 RCT 108 women; moderate-certainty evidence). There may be little to no difference in pain score when comparing pregabalin 300 mg with placebo (MD 0.5 out of 10 lower, 95% CI 1.41 lower to 0.41 higher; 1 RCT, 107 women; low-certainty evidence). There may be little to no difference in pain score when comparing ibuprofen 800 mg with placebo (MD 1.4 out of 10 lower, 95% CI 3.33 lower to 0.53 higher; 1 RCT, 61 women; low-certainty evidence). Ambulation or non-ambulation during medical abortion treatment may have little to no effect on pain score, but the evidence is very uncertain (MD 0.1 out of 5 higher, 95% CI 0.26 lower to 0.46 higher; 1 NRSI, 130 women; very low-certainty evidence). There may be little to no difference in pain score when comparing therapeutic versus prophylactic administration of ibuprofen 800 mg (MD 0.2 out of 10 higher, 95% CI 0.41 lower to 0.81 higher; 1 RCT, 228 women; low-certainty evidence). Other outcomes of interest were reported inconsistently across studies. Where these outcomes were reported, there was no evidence of difference in incidence of gastrointestinal side effects, complete abortion rate, interval between misoprostol administration to pregnancy expulsion, unscheduled contact with a care provider, patient satisfaction with analgesia regimen nor patient satisfaction with abortion experience overall. However, the certainty of evidence was very low to low.
AUTHORS' CONCLUSIONS
The findings of this review provide some support for the use of ibuprofen as a single dose given with misoprostol prophylactically, or in response to pain as needed. The optimal dosing of ibuprofen is unclear, but a single dose of ibuprofen 1600 mg was shown to be effective, and it was less certain whether 800 mg was effective. Paracetamol 2000 mg does not improve pain scores as much as ibuprofen 1600 mg, however its use does not appear to cause greater frequency of side effects or reduce the success of the abortion. A single dose of pregabalin 300 mg does not affect pain scores during medical abortion, but like paracetamol, does not appear to cause harm. Ambulation or non-ambulation during the medical abortion procedure does not appear to affect pain scores, outcomes, or duration of treatment and so women can be advised to mobilise or not, as they wish. The majority of outcomes in this review had low- to very low-certainty evidence, primarily due to small sample sizes and two studies at high risk of bias. High-quality, large-scale RCT research is needed for pain management during medical abortion at gestations less than 14 weeks. Consistent recording of pain with a validated measure would be of value to the field going forward.
Topics: Abortion, Induced; Abortion, Spontaneous; Acetaminophen; Female; Humans; Ibuprofen; Mifepristone; Misoprostol; Pain; Pain Management; Pregabalin; Pregnancy
PubMed: 35553047
DOI: 10.1002/14651858.CD013525.pub2 -
Journal of Clinical Gastroenterology Jul 2022This systematic review and network meta-analysis aimed to assess the relative efficacy of vonoprazan and proton pump inhibitors (PPIs) on early heartburn symptom... (Meta-Analysis)
Meta-Analysis
GOALS
This systematic review and network meta-analysis aimed to assess the relative efficacy of vonoprazan and proton pump inhibitors (PPIs) on early heartburn symptom resolution in patients with erosive esophagitis.
BACKGROUND
Limited available data directly compare the efficacy of vonoprazan, a first-in-class potassium-competitive acid blocker, with PPIs in erosive esophagitis.
STUDY
We conducted a systematic literature review (in MEDLINE and CENTRAL) and subsequent network meta-analysis according to Cochrane and PRISMA guidelines. Double-blind, randomized controlled trials in adults with erosive esophagitis treated with vonoprazan or a PPI were included in the analysis. Primary outcomes were heartburn symptom resolution rate on Day 1 and Day 7. The study was performed with all available data, using a random effects model within a Bayesian framework.
RESULTS
Overall, 10 randomized controlled trials were included in the network meta-analysis. For heartburn resolution rate on Day 1 (9 of 10 trials), vonoprazan 20 mg once daily (QD) was superior to placebo (median odds ratio=16.75, 95% credible interval: 2.16-207.80). Point estimates numerically favored vonoprazan 20 mg QD over other comparators. For heartburn resolution rate on Day 7 (10 of 10 trials), vonoprazan 20 mg QD was superior to placebo and other comparators except rabeprazole 20 mg QD. Point estimates numerically favored vonoprazan 20 mg QD over rabeprazole 20 mg QD.
CONCLUSIONS
In this study, vonoprazan 20 mg QD was equally effective in heartburn resolution on Day 1, and equally or more effective on Day 7 versus PPIs in adults with erosive esophagitis.
Topics: Adult; Bayes Theorem; Esophagitis; Gastroesophageal Reflux; Heartburn; Humans; Network Meta-Analysis; Proton Pump Inhibitors; Pyrroles; Rabeprazole; Randomized Controlled Trials as Topic; Sulfonamides; Treatment Outcome
PubMed: 35470298
DOI: 10.1097/MCG.0000000000001707 -
Journal of Medical Internet Research Apr 2022Suboptimal adherence to data collection procedures or a study intervention is often the cause of a failed clinical trial. Data from connected sensors, including... (Review)
Review
BACKGROUND
Suboptimal adherence to data collection procedures or a study intervention is often the cause of a failed clinical trial. Data from connected sensors, including wearables, referred to here as biometric monitoring technologies (BioMeTs), are capable of capturing adherence to both digital therapeutics and digital data collection procedures, thereby providing the opportunity to identify the determinants of adherence and thereafter, methods to maximize adherence.
OBJECTIVE
We aim to describe the methods and definitions by which adherence has been captured and reported using BioMeTs in recent years. Identifying key gaps allowed us to make recommendations regarding minimum reporting requirements and consistency of definitions for BioMeT-based adherence data.
METHODS
We conducted a systematic review of studies published between 2014 and 2019, which deployed a BioMeT outside the clinical or laboratory setting for which a quantitative, nonsurrogate, sensor-based measurement of adherence was reported. After systematically screening the manuscripts for eligibility, we extracted details regarding study design, participants, the BioMeT or BioMeTs used, and the definition and units of adherence. The primary definitions of adherence were categorized as a continuous variable based on duration (highest resolution), a continuous variable based on the number of measurements completed, or a categorical variable (lowest resolution).
RESULTS
Our PubMed search terms identified 940 manuscripts; 100 (10.6%) met our eligibility criteria and contained descriptions of 110 BioMeTs. During literature screening, we found that 30% (53/177) of the studies that used a BioMeT outside of the clinical or laboratory setting failed to report a sensor-based, nonsurrogate, quantitative measurement of adherence. We identified 37 unique definitions of adherence reported for the 110 BioMeTs and observed that uniformity of adherence definitions was associated with the resolution of the data reported. When adherence was reported as a continuous time-based variable, the same definition of adherence was adopted for 92% (46/50) of the tools. However, when adherence data were simplified to a categorical variable, we observed 25 unique definitions of adherence reported for 37 tools.
CONCLUSIONS
We recommend that quantitative, nonsurrogate, sensor-based adherence data be reported for all BioMeTs when feasible; a clear description of the sensor or sensors used to capture adherence data, the algorithm or algorithms that convert sample-level measurements to a metric of adherence, and the analytic validation data demonstrating that BioMeT-generated adherence is an accurate and reliable measurement of actual use be provided when available; and primary adherence data be reported as a continuous variable followed by categorical definitions if needed, and that the categories adopted are supported by clinical validation data and/or consistent with previous reports.
Topics: Biometry; Cimetidine; Data Collection; Humans; Research Design; Technology
PubMed: 35436221
DOI: 10.2196/33537 -
Journal of Healthcare Engineering 2022Hypertensive disorders of pregnancy (HDP) can cause serious prenatal and postnatal complications and is a threat to maternal and fetal health. To offer guidance for... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Hypertensive disorders of pregnancy (HDP) can cause serious prenatal and postnatal complications and is a threat to maternal and fetal health. To offer guidance for clinical decisions, we systematically reviewed the effects of misoprostol on induction of labour in HDP patients.
METHODS
PubMed, Web of Science, Embase, CNKI, and Wanfang databases were searched for relevant literature from 2010 to 2020. Subsequently, a meta-analysis was performed to compare the effective rate of induction of labour and reducing postpartum hemorrhage (PPH) between the intervention group ( = 544, misoprostol) and the control group ( = 543, oxytocin).
RESULTS
A total of 10 studies with 1087 patients were included. The 10 studies compared the effective rate of induction of labour between the two groups and confirmed that the effective rate in the intervention group was significantly higher than that in the control group (OR = 4.37; 95% CI: 2.73, 7.00). Seven studies compared PPH between the groups and showed that it was significantly reduced in the intervention group compared to the control group (SMD = -1.32; 95% CI: -2.05, -0.59; < 0.0001).
CONCLUSION
Misoprostol has a high effective rate of induction of labour in HDP patients and is an effective uterotonic agent in reducing PPH. This meta-analysis provides clinicians with meaningful information to help them make evidence-based decisions.
Topics: Female; Humans; Hypertension, Pregnancy-Induced; Labor, Induced; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy
PubMed: 35432818
DOI: 10.1155/2022/8448690