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The Cochrane Database of Systematic... Dec 2021Endometriosis is a condition characterised by the presence of ectopic deposits of endometrial-like tissue outside the uterus, usually in the pelvis. The impact of... (Review)
Review
BACKGROUND
Endometriosis is a condition characterised by the presence of ectopic deposits of endometrial-like tissue outside the uterus, usually in the pelvis. The impact of laparoscopic treatment on overall pain is uncertain and a significant proportion of women will require further surgery. Therefore, adjuvant medical therapies following surgery, such as the levonorgestrel-releasing intrauterine device (LNG-IUD), have been considered to reduce recurrence of symptoms. OBJECTIVES: To determine the effectiveness and safety of post-operative LNG-IUD in women with symptomatic endometriosis.
SEARCH METHODS
We searched the following databases from inception to January 2021: The Specialised Register of the Cochrane Gynaecology and Fertility Group, CENTRAL (which now includes records from two trial registries), MEDLINE, Embase, PsycINFO, LILACS and Epistemonikos. We handsearched citation lists of relevant publications, review articles, abstracts of scientific meetings and included studies. We contacted experts in the field for information about any additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing women undergoing surgical treatment of endometriosis with uterine preservation who were assigned to LNG-IUD insertion, versus control conditions including expectant management, post-operative insertion of placebo (inert intrauterine device), or other medical treatment such as gonadotrophin-releasing hormone agonist (GnRH-a) drugs.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies for inclusion, and extracted data to allow for an intention-to-treat analysis. For dichotomous data, we calculated the risk ratio (RR) and 95% confidence interval (CI) using the Mantel-Haenszel fixed-effect method. For continuous data, we calculated the mean difference (MD) and 95% CI using the inverse variance fixed-effect method.
MAIN RESULTS
Four RCTs were included, with a total of 157 women. Two studies are ongoing. The GRADE certainty of evidence was very low to low. The certainty of evidence was graded down primarily for serious risk of bias and imprecision. LNG-IUD versus expectant management Overall pain: No studies reported on the primary outcome of overall pain. Dysmenorrhoea: We are uncertain whether LNG-IUD improves dysmenorrhoea at 12 months. Data on this outcome were reported on by two RCTs; meta-analysis was not possible (RCT 1: delta of median visual analogue scale (VAS) 81 versus 50, P = 0.006, n = 55; RCT 2: fall in VAS by 50 (35 to 65) versus 30 (25 to 40), P = 0.021, n = 40; low-certainty evidence). Quality of life: We are uncertain whether LNG-IUD improves quality of life at 12 months. One trial demonstrated a change in total quality of life score with postoperative LNG-IUD from baseline (mean 61.2 (standard deviation (SD) 14.8) to 12 months (mean 70.3 (SD 16.2) compared to expectant management (baseline 55.1 (SD 17.0) to 57.0 (SD 33.2) at 12 months) (n = 55, P = 0.014, very low-certainty evidence). Patient satisfaction: Two studies found higher rates of satisfaction with LNG-IUD compared to expectant management; however, combining the studies in meta-analysis was not possible (n = 95, very low-certainty evidence). One study found 75% (15/20) of those given post-operative LNG-IUD were "satisfied" or "very satisfied", compared to 50% (10/20) of those in the expectant management group (RR 1.5, 95% CI 0.90-2.49, 1 RCT, n=40, very low-certainty evidence). The second study found that fewer were "very satisfied" in the expectant management group when compared to LNG, but there were no data to include in a meta-analysis. Adverse events: One study found a significantly higher proportion of women reporting melasma (n = 55, P = 0.015, very low-certainty evidence) and bloating (n = 55, P = 0.021, very low-certainty evidence) following post-operative LNG-IUD. There were no differences in other reported adverse events, such as weight gain, acne, and headaches. LNG-IUD versus GnRH-a Overall pain: No studies reported on the primary outcome of overall pain. Chronic pelvic pain: We are uncertain whether LNG-IUD improves chronic pelvic pain at 12 months when compared to GnRH-a (VAS pain scale) (MD -2.0, 95% CI -20.2 to 16.2, 1 RCT, n = 40, very low-certainty evidence). Dysmenorrhoea: We are uncertain whether LNG-IUD improves dysmenorrhoea at six months when compared to GnRH-a (measured as a reduction in VAS pain score) (MD 1.70, 95%.CI -0.14 to 3.54, 1 RCT, n = 18, very low-certainty evidence). Adverse events: One study suggested that vasomotor symptoms were the most common adverse events reported with patients receiving GnRH-a, and irregular bleeding in those receiving LNG-IUD (n = 40, very low-certainty evidence) AUTHORS' CONCLUSIONS: Post-operative LNG-IUD is widely used to reduce endometriosis-related pain and to improve operative outcomes. This review demonstrates that there is no high-quality evidence to support this practice. This review highlights the need for further studies with large sample sizes to assess the effectiveness of post-operative adjuvant hormonal IUD on the core endometriosis outcomes (overall pain, most troublesome symptom, and quality of life).
Topics: Dysmenorrhea; Endometriosis; Endometrium; Female; Humans; Intrauterine Devices, Medicated; Levonorgestrel
PubMed: 34928503
DOI: 10.1002/14651858.CD005072.pub4 -
Journal of Clinical Neuroscience :... Sep 2022In the surgical approach to treat deep-seated intracranial lesions, endoscopes can be used to assist microsurgical operations and improve outcomes. This technique is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In the surgical approach to treat deep-seated intracranial lesions, endoscopes can be used to assist microsurgical operations and improve outcomes. This technique is often called endoscope-assisted microneurosurgery (EAM). This systematic review and meta-analysis aimed to evaluate the feasibility, safety, and effectiveness of EAM.
METHODS
We performed a meta-analysis of relevant articles identified using PubMed, Embase, and the Cochrane Central Register to assess the efficacy of EAM according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. Primary outcomes were repositioning of the definitive clip, better surgical field, the overall and endoscope-related complication rates, mortality, and the rate of follow up.
RESULTS
A total of 10 studies of 1,432 patients with 1,717 aneurysms treated with EAM were included. EAM led to repositioning of the definitive clip in 13% (95% CI, 9%-17%; I = 72.61%; p < 0.001); 77% of aneurysms treated with endoscopically assisted vision and information had a better outcome than that with standard surgery (95% CI, 52%-95%; I = 97.63%; p < 0.001). There was an overall complication rate of 6% (95% CI, 1%-13%; I = 91.39%; p < 0.001). The incidence of endoscope-related complications was 0% (95% CI, 0%-1%; I = 64%; p < 0.001). The mortality was 0% (95% CI, 0-1%; I = 0.0%); and 94% of patients had an excellent to good recovery and good outcome (95% CI, 88%-98%; I = 88.42%; p < 0.001).
CONCLUSIONS
Our comprehensive study showed that EAM for intracranial aneurysms is feasible, the safety of the surgery is good, and the patients have a good prognosis, Therefore, we think EAM can be more widely adopted in the future.
Topics: Endoscopes; Humans; Intracranial Aneurysm; Microsurgery; Surgical Instruments; Treatment Outcome
PubMed: 35816766
DOI: 10.1016/j.jocn.2022.06.029 -
JMIR MHealth and UHealth Mar 2021There is increasing interest in reusing person-generated wearable device data for research purposes, which raises concerns about data quality. However, the amount of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
There is increasing interest in reusing person-generated wearable device data for research purposes, which raises concerns about data quality. However, the amount of literature on data quality challenges, specifically those for person-generated wearable device data, is sparse.
OBJECTIVE
This study aims to systematically review the literature on factors affecting the quality of person-generated wearable device data and their associated intrinsic data quality challenges for research.
METHODS
The literature was searched in the PubMed, Association for Computing Machinery, Institute of Electrical and Electronics Engineers, and Google Scholar databases by using search terms related to wearable devices and data quality. By using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, studies were reviewed to identify factors affecting the quality of wearable device data. Studies were eligible if they included content on the data quality of wearable devices, such as fitness trackers and sleep monitors. Both research-grade and consumer-grade wearable devices were included in the review. Relevant content was annotated and iteratively categorized into semantically similar factors until a consensus was reached. If any data quality challenges were mentioned in the study, those contents were extracted and categorized as well.
RESULTS
A total of 19 papers were included in this review. We identified three high-level factors that affect data quality-device- and technical-related factors, user-related factors, and data governance-related factors. Device- and technical-related factors include problems with hardware, software, and the connectivity of the device; user-related factors include device nonwear and user error; and data governance-related factors include a lack of standardization. The identified factors can potentially lead to intrinsic data quality challenges, such as incomplete, incorrect, and heterogeneous data. Although missing and incorrect data are widely known data quality challenges for wearable devices, the heterogeneity of data is another aspect of data quality that should be considered for wearable devices. Heterogeneity in wearable device data exists at three levels: heterogeneity in data generated by a single person using a single device (within-person heterogeneity); heterogeneity in data generated by multiple people who use the same brand, model, and version of a device (between-person heterogeneity); and heterogeneity in data generated from multiple people using different devices (between-person heterogeneity), which would apply especially to data collected under a bring-your-own-device policy.
CONCLUSIONS
Our study identifies potential intrinsic data quality challenges that could occur when analyzing wearable device data for research and three major contributing factors for these challenges. As poor data quality can compromise the reliability and accuracy of research results, further investigation is needed on how to address the data quality challenges of wearable devices.
Topics: Fitness Trackers; Humans; Reproducibility of Results; Wearable Electronic Devices
PubMed: 33739294
DOI: 10.2196/20738 -
Applied Ergonomics Sep 2023While the biomechanical effects of exoskeletons are well studied, research about potential side-effects and adverse events are limited. The aim of this systematic review... (Review)
Review
INTRODUCTION
While the biomechanical effects of exoskeletons are well studied, research about potential side-effects and adverse events are limited. The aim of this systematic review was to provide an overview of the side-effects and adverse events on shoulder- and back-support exoskeletons during work tasks.
METHODS
Four in-field studies and 32 laboratory studies were included in this review, reporting on n = 18 shoulder exoskeletons, n = 9 back exoskeletons, n = 1 full body with a supernumerary arm, and n = 1 combination of shoulder and back exoskeleton.
RESULTS
The most frequent side-effect reported is discomfort (n = 30), followed by a limited usability of the exoskeleton (n = 16). Other identified side-effects and adverse events were changes in muscle activity, mobility, task performance, balance and posture, neurovascular supply, gait parameters and precision. An incorrect fit of the exoskeleton and the decreased degrees of freedom are most often reported as causes of these side-effects. Two studies did not find any side-effects. This review also showed that there are differences in the occurrence of side-effects in gender, age, and physical fitness. Most studies (89%) were conducted in a laboratory setting. Most studies (97%) measured short-term effects only. Psychological and social side-effects or adverse events were not reported. Side-effects and adverse events for active exoskeletons were understudied (n = 4).
CONCLUSION
It was concluded that the evidence for side-effects and adverse events is limited. If available, it mainly consists of reports of mild discomfort and limited usability. Generalisation is limited because studies were conducted in lab settings and measured short term only, and most participants were young male workers.
Topics: Humans; Male; Shoulder; Exoskeleton Device; Upper Extremity; Posture; Task Performance and Analysis; Biomechanical Phenomena; Electromyography
PubMed: 37146320
DOI: 10.1016/j.apergo.2023.104042 -
The Cochrane Database of Systematic... Feb 2022Sitting can be viewed as a therapeutic intervention and an important part of a person's recovery process; but the risk of ulceration must be mitigated. Interventions for... (Review)
Review
BACKGROUND
Sitting can be viewed as a therapeutic intervention and an important part of a person's recovery process; but the risk of ulceration must be mitigated. Interventions for ulcer prevention in those at risk from prolonged sitting include the use of specialist cushions and surfaces, especially for wheelchair users. Whilst there is interest in the effects of different pressure redistributing cushions for wheelchairs, the benefits of pressure redistributing static chairs, compared with standard chairs, for pressure ulcer development in at-risk people are not clear.
OBJECTIVES
To assess the effects of pressure redistributing static chairs on the prevention of pressure ulcers in health, rehabilitation and social care settings, and places of residence in which people may spend their day.
SEARCH METHODS
In June 2021 we searched the following electronic databases to identify reports of relevant randomised clinical trials: the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase and EBSCO CINAHL Plus (Cumulative Index to Nursing and Allied Health Literature). We also searched clinical trials registers for ongoing and unpublished studies, and reference lists of relevant systematic reviews, meta-analyses and health technology reports. There were no restrictions by language, date of publication or study setting.
SELECTION CRITERIA
We sought to include published or unpublished randomised controlled trials that assessed pressure redistributing static chairs in the prevention or management of pressure ulcers.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed study selection. We planned that two review authors would also assess the risk of bias, extract study data and assess the certainty of evidence according to GRADE methodology.
MAIN RESULTS
We did not identify any studies that met the review eligibility criteria, nor any registered studies investigating the role of pressure redistributing static chairs in the prevention or management of pressure ulcers.
AUTHORS' CONCLUSIONS
Currently, there is no randomised evidence that supports or refutes the role of pressure redistributing static chairs in the prevention or management of pressure ulcers. This is a priority area and there is a need to explore this intervention with rigorous and robust research.
Topics: Bedding and Linens; Beds; Bias; Humans; Pressure Ulcer
PubMed: 35174477
DOI: 10.1002/14651858.CD013644.pub2 -
Clinical and Experimental Dental... Feb 2023To summarize the available evidence on the efficacy of power-driven interdental cleaning tools (PDICTs) as an adjunct to tooth brushing compared to tooth brushing alone... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To summarize the available evidence on the efficacy of power-driven interdental cleaning tools (PDICTs) as an adjunct to tooth brushing compared to tooth brushing alone or tooth brushing combined with any other non-PDICT in terms of interproximal plaque and gingival bleeding reduction in gingivitis patients.
MATERIAL AND METHODS
A systematic literature search was performed in three databases until March 20, 2022 with the following main eligibility criteria: (1) randomized controlled clinical trials (RCTs) with (2) at least 28 days of follow-up in (3) gingivitis patients. Interproximal plaque and bleeding values were defined as the primary outcome variables and used for pair-wise meta-analyses.
RESULTS
Sixteen RCTs were identified including data from 1258 participants at the final evaluation. Eight studies each investigated the effect of either a liquid-based or mechanical PDICT; one of these studies tested additionally a combined liquid-based and mechanical PDICT. Tooth brushing combined with a liquid-based PDICT compared to tooth brushing alone did not result in better interproximal plaque values but in significantly lower interproximal bleeding values. Tooth brushing combined with either a liquid-based PDICT or with a mechanical PDICT compared to tooth brushing and flossing achieved comparable interproximal plaque and bleeding values. The majority of studies reporting on patient compliance/preference favored the use of a PDICT, and except for a single study, which was reporting soft tissue trauma in two subjects from improper use of a mechanical PDICT, none of the studies reported adverse events.
CONCLUSIONS
Daily use of PDICT as an adjunct to tooth brushing significantly reduces interproximal bleeding. This effect appears comparable to that of flossing, while PDICT may achieve higher patient acceptance/compliance.
Topics: Humans; Dental Devices, Home Care; Toothbrushing; Gingivitis; Dental Plaque; Gingiva
PubMed: 36562267
DOI: 10.1002/cre2.691 -
ESC Heart Failure Apr 2023This systematic review evaluated the clinical effectiveness and safety of subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients at an increased risk of... (Review)
Review
This systematic review evaluated the clinical effectiveness and safety of subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients at an increased risk of sudden cardiac death and with an ICD indication for primary or secondary prevention. A systematic literature search was conducted in four databases (Medline via Ovid, Embase, the Cochrane Library, and HTA-INAHTA). Randomized controlled trials (RCTs) and controlled observational studies with ≥100 S-ICD patients and a low to moderate risk of bias were eligible for inclusion. The studies' quality and the available evidence's strength were assessed using the Cochrane risk of bias tool, the ROBINS-I tool, and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. One RCT, a post hoc analysis of the RCT (n = 849) and four controlled observational studies (n = 7149) were included. The quality of the available evidence was graded as low to very low, except for the primary composite endpoint of the RCT, which was rated as moderate quality. After 4 years, the RCT showed that S-ICD was non-inferior to TV-ICD regarding the composite endpoint of inappropriate shocks and device-related complications (68 [15.1%] vs. 68 [15.7%], hazard ratio [HR] 0.99, 95% confidence interval [CI] [0.71, 1.39], non-inferiority margin 1.45, P = 0.001). The RCT and two observational studies reported statistically significantly fewer lead complications in S-ICD patients (after 4 years: 1.4% vs. 6.6%, HR 0.24, 95% CI [0.10, 0.54]; after 3 years: 0.3% vs. 2.3%, P = 0.03; and after 5 years: 0.8% vs. 11.5%, P = 0.03). Identified evidence about appropriate and inappropriate shocks was inconclusive: The RCT detected statistically significantly more appropriate shocks in patients with S-ICD (83 [19.2%] vs. 57 [11.5%], HR 1.52, 95% CI [1.08, 2.12], P = 0.02), whereas one observational study showed a statistically significantly lower rate in the S-ICD group (9.9%, 95% CI [7.0, 13.9], vs. 13.9%, 95% CI [10.8, 17.8], P = 0.003). Regarding inappropriate shocks, one observational study reported statistically significantly higher rates in the S-ICD cohort (11.9% vs. 7.5%, P = 0.007), whereas the RCT and two other observational studies did not detect a statistically significant difference between the treatment groups (P > 0.05). None of the included studies showed a statistically significant difference in overall mortality and shock efficacy between patients with S-ICD and TV-ICD (P > 0.05). The available evidence is insufficient to show the superiority of S-ICD compared with TV-ICD, hindering the widespread use of the technology. Results of the recently completed ATLAS trial are to be awaited, and the anticipated role of the S-ICD needs to be clearly formulated.
Topics: Humans; Defibrillators, Implantable; Death, Sudden, Cardiac; Treatment Outcome; Observational Studies as Topic
PubMed: 36444868
DOI: 10.1002/ehf2.14249 -
BMC Oral Health Mar 2023This systematic review aims to examine the existing original studies to determine the effectiveness of occlusal splints (OSs) in the management of orofacial myalgia and...
BACKGROUND
This systematic review aims to examine the existing original studies to determine the effectiveness of occlusal splints (OSs) in the management of orofacial myalgia and myofascial pain (MP) in comparison with no treatment or other interventions.
MATERIALS AND METHODS
Based on the inclusion and exclusion criteria of this systematic review, randomized controlled trials were qualified, in which the effectiveness of occlusal splint therapy in the management of muscle pain was examined in comparison with no treatment or other interventions. This systematic review was conducted according to the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020. The authors searched three databases (PubMed, CINAHL (The Cumulative Index to Nursing and Allied Health Literature) and Scopus) for English publications published between January 1, 2010, and June 1, 2022. The last database search was carried out on June 4, 2022. Data were extracted from the included studies and assessed for risk of bias using the revised Cochrane risk-of-bias tool for randomized trials.
RESULTS
Thirteen studies were identified for inclusion in this review. In total, 589 patients were diagnosed with orofacial muscle pain who underwent education and various forms of therapy including different types of OSs, light emitting diode therapy, acupuncture, low-level laser therapy, device-supported sensorimotor training, Kinesio Taping, myofunctional therapy, and physical therapy. All studies included demonstrated a high risk of bias.
CONCLUSIONS
There is insufficient evidence regarding whether OS therapy in the treatment of orofacial myalgia and MP offers an advantage over other forms of interventions or no treatment. Further reliable clinical studies in this area are needed to improve the quality of research, which should be performed with larger groups of blinded respondents and controls.
CLINICAL RELEVANCE
Due to the large-scale nature of orofacial muscle pain, it is assumed that each dental clinician will meet patients with orofacial muscle pain repeatedly in daily practice; hence, the review of the effectiveness of OSs in the management of orofacial myalgia and MP is necessary.
Topics: Humans; Myalgia; Occlusal Splints; Facial Pain
PubMed: 36978070
DOI: 10.1186/s12903-023-02897-0 -
Urology Aug 2022The purpose of this study was to determine long-term survival of inflatable penile prosthesis (PP) and identify potential factors that may influence device survival. We... (Meta-Analysis)
Meta-Analysis Review
The purpose of this study was to determine long-term survival of inflatable penile prosthesis (PP) and identify potential factors that may influence device survival. We performed a systematic review of Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies of men treated with inflatable PP with at least 5 years of device survival data. We performed a random effects meta-analysis to estimate device survival at 1, 3, 5, 10, 15, and 20 years of follow-up. The robustness of the meta-analysis results was evaluated in a 1-study removed sensitivity analysis and sources of heterogeneity among studies were investigated with subgroup analysis. In 12 studies (20,161 patients; median age 57 years), PP device survival was 93.3% at 1 year, 91.0% at 3 years, 87.2% at 5 years, 76.8% at 10 years, 63.7% at 15 years, and 52.9% at 20 years. The results of the meta-analysis were not significantly influenced by single study effects in a 1-study removed sensitivity analysis. In a subgroup analysis, 5-year device survival rates were 90.6% vs 82.1% (P = .01) comparing newer vs older studies; no other patient or study design characteristic was statistically associated with device survival rates. In conclusion, the median device survival time of an inflatable PP is approximately 20 years. The factors responsible for improved device survival in newer studies remain unclear and warrant further study.
Topics: Erectile Dysfunction; Humans; Male; Middle Aged; Penile Implantation; Penile Prosthesis; Prosthesis Design; Prosthesis Failure; Survival Rate
PubMed: 35421510
DOI: 10.1016/j.urology.2022.03.026 -
Cells Oct 2022This systematic review aimed to analyze the development and functionality of microfluidic concentration gradient generators (CGGs) for toxicological evaluation of... (Review)
Review
This systematic review aimed to analyze the development and functionality of microfluidic concentration gradient generators (CGGs) for toxicological evaluation of different biological organisms. We searched articles using the keywords: concentration gradient generator, toxicity, and microfluidic device. Only 33 of the 352 articles found were included and examined regarding the fabrication of the microdevices, the characteristics of the CGG, the biological model, and the desired results. The main fabrication method was soft lithography, using polydimethylsiloxane (PDMS) material (91%) and SU-8 as the mold (58.3%). New technologies were applied to minimize shear and bubble problems, reduce costs, and accelerate prototyping. The Christmas tree CGG design and its variations were the most reported in the studies, as well as the convective method of generation (61%). Biological models included bacteria and nematodes for antibiotic screening, microalgae for pollutant toxicity, tumor and normal cells for, primarily, chemotherapy screening, and Zebrafish embryos for drug and metal developmental toxicity. The toxic effects of each concentration generated were evaluated mostly with imaging and microscopy techniques. This study showed an advantage of CGGs over other techniques and their applicability for several biological models. Even with soft lithography, PDMS, and Christmas tree being more popular in their respective categories, current studies aim to apply new technologies and intricate architectures to improve testing effectiveness and reduce common microfluidics problems, allowing for high applicability of toxicity tests in different medical and environmental models.
Topics: Animals; Anti-Bacterial Agents; Dimethylpolysiloxanes; Environmental Pollutants; Lab-On-A-Chip Devices; Zebrafish
PubMed: 36231063
DOI: 10.3390/cells11193101