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The use of knee mega-prosthesis for the management of distal femoral fractures: A systematic review.Injury Aug 2020Distal femur fractures (DFFs) are unusual and difficult to deal, especially in elderly patients. A consensus about a gold-standard treatment has not been reached yet....
INTRODUCTION
Distal femur fractures (DFFs) are unusual and difficult to deal, especially in elderly patients. A consensus about a gold-standard treatment has not been reached yet. Available options include both conservative and surgical management. In elderly patients a prosthetic replacement could be a valid treatment option. Literature is lacking about the use of mega-prosthesis in this type of fractures. The purpose of the present systematic review is to examine which fracture, both acute and chronic, involving distal femur should be treated by using a mega-prosthesis.
MATERIALS AND METHODS
Studies were identified by searching electronic databases. All studies that enrolled people of any age affected by a DFFs treated by using a megaprosthesis were included. Primary outcomes of the present reviews were: ROM, functional assessment and complications. Two review authors independently selected eligible trials. Disagreements at any stage were resolved by consensus or a third party adjudication. Descriptive statics was used to summarize the data.
RESULTS
Thirteen article were finally included in the review. One hundred-four patients were treated with knee megaprosthesis. Three categories of patients were identified: 29 patients were affected by supracondylar femur fracture; 51 patients occurred with a periprosthetic fracture; 24 patients suffered a non-union of a previous supracondylar fracture. The follow-up varied between 6 months to 58 months. All studies showed good results in terms of improving quality of life, resuming activities of daily living (ADLs), early mobilization, ROM, shorter hospital stay. Although not frequent, the only reported complications were infection and aseptic loosening.
DISCUSSION
The present review showed that the use of knee megaprosthetic implants could represent a valid treatment option aiming to reduce patients' immobilitazion and hospital stay. Good clinical outcomes with low rate of complications were reported by all included studies. Literature is lacking about long-term outcomes and complications. Moreover studies comparing knee prostheses and other types of surgical treatment (intramedullary nails, plate fixation system) are needed.
CONCLUSIONS
Megaprosthesis represent a viable treatment option in patients affected by DFFs (either acute, periprostethic or non-union) because they allow immediate weight-bearing, shorter hospital stay, a fast recovery of knee function and ADLs.
Topics: Activities of Daily Living; Aged; Femoral Fractures; Fracture Fixation, Internal; Humans; Knee Prosthesis; Periprosthetic Fractures; Quality of Life; Retrospective Studies; Treatment Outcome
PubMed: 31526601
DOI: 10.1016/j.injury.2019.08.011 -
Obesity Reviews : An Official Journal... Jun 2019This systematic review of systematic reviews investigated the effectiveness of lifestyle weight management interventions for postnatal women. We systematically reviewed...
This systematic review of systematic reviews investigated the effectiveness of lifestyle weight management interventions for postnatal women. We systematically reviewed Medline (PubMed), Embase, CINAHL Plus, The Cochrane Library, and Scopus from 2000 until January 2018, to identify systematic reviews of randomized controlled trials that evaluated the effectiveness of behavioural lifestyle interventions for weight management in postnatal women. Results were summarized both descriptively and statistically using a mega meta-analysis of data from randomized controlled trials included in previous systematic reviews. Nine systematic reviews met our inclusion criteria. Overall the reviews concluded that lifestyle interventions involving physical activity and/or dietary changes resulted in a reduction in postnatal weight. Results from the overall mega meta-analysis confirmed this finding with a mean difference of -1.7 kg (95% CI, -2.3 to -1.1). Findings for subgroup analyses gave mean differences of -1.9 kg (95% CI, -2.9 to -1.0) for combined diet and physical activity interventions, -1.6 kg (95% CI, -2.1 to -1.2) for physical activity-only interventions, and -9.3 kg (95% CI, -16.5 to -2.1) for diet-only interventions (one study). Heterogeneity varied from 0% to 68%. Interventions involving lifestyle interventions appeared to be effective in reducing weight in postnatal women, although these findings should be interpreted with some caution due to statistical heterogeneity.
Topics: Diet; Exercise; Female; Health Behavior; Humans; Life Style; Postpartum Period; Randomized Controlled Trials as Topic; Systematic Reviews as Topic; Weight Reduction Programs
PubMed: 30941875
DOI: 10.1111/obr.12834 -
BMC Complementary and Alternative... Mar 2019This systematic review aimed at summarizing and evaluating the evidence of randomized controlled trials (RCTs) using acupuncture to improve endometrial receptivity (ER). (Meta-Analysis)
Meta-Analysis
BACKGROUND
This systematic review aimed at summarizing and evaluating the evidence of randomized controlled trials (RCTs) using acupuncture to improve endometrial receptivity (ER).
METHODS
We searched 12 databases electronically through August 2018 without language restrictions. We included RCTs of women of infertility due to low ER, and excluded infertility caused by other reasons or non-RCTs. Two independent reviewers extracted the characteristics of studies and resolved the differences through consensus. Data were pooled and expressed as standard mean difference (SMD) or mean difference (MD) for continuous outcomes and risk ratio (RR) for dichotomous outcomes, with 95% confidence interval (CI).
RESULTS
We found very low to moderate level of evidence that acupuncture may improve pregnancy rate (RR = 1.23 95%CI[1.13, 1.34] P < 0.00001) and embryo transfer rate (RR = 2.04 95%CI[1.13, 3.70] P = 0.02), increase trilinear endometrium (RR = 1.47 95%CI [1.27, 1.70] P < 0.00001), thicken endometrium (SMD = 0.41 95% CI [0.11, 0.72] P = 0.008), reduce resistive index (RI) (MD = -0.08 95% CI [- 0.15, - 0.02] P = 0.01), pulse index (PI) (SMD = -2.39 95% CI [- 3.85, - 0.93] P = 0.001) and peak systolic velocity/ end-diastolic blood velocity (S/D) (SMD = -0.60 95% CI [- 0.89, - 0.30] P < 0.0001), compared with medication, sham acupuncture or physiotherapy. Acupuncture was statistically significant as a treatment approach.
CONCLUSION
The efficacy and safety of acupuncture on key outcomes in women with low ER is statistically significant, but the level of most evidence was very low or low. More large-scale, long-term RCTs with rigorous methodologies are needed.
Topics: Acupuncture Therapy; Endometrium; Female; Humans; Infertility, Female; Pregnancy
PubMed: 30866920
DOI: 10.1186/s12906-019-2472-1 -
Journal of Cardiothoracic and Vascular... Feb 2018A careful choice of perioperative care strategies is pivotal to improve survival in cardiac surgery. However, there is no general agreement or particular attention to... (Review)
Review
OBJECTIVE
A careful choice of perioperative care strategies is pivotal to improve survival in cardiac surgery. However, there is no general agreement or particular attention to which nonsurgical interventions can reduce mortality in this setting. The authors sought to address this issue with a consensus-based approach.
DESIGN
A systematic review of the literature followed by a consensus-based voting process.
SETTING
A web-based international consensus conference.
PARTICIPANTS
More than 400 physicians from 52 countries participated in this web-based consensus conference.
INTERVENTIONS
The authors identified all studies published in peer-reviewed journals that reported on interventions with a statistically significant effect on mortality in the setting of cardiac surgery through a systematic Medline/PubMed search and contacts with experts. These studies were discussed during a consensus meeting and those considered eligible for inclusion in this study were voted on by clinicians worldwide.
MEASUREMENTS AND MAIN RESULTS
Eleven interventions finally were selected: 10 were shown to reduce mortality (aspirin, glycemic control, high-volume surgeons, prophylactic intra-aortic balloon pump, levosimendan, leuko-depleted red blood cells transfusion, noninvasive ventilation, tranexamic acid, vacuum-assisted closure, and volatile agents), whereas 1 (aprotinin) increased mortality. A significant difference in the percentages of agreement among different countries and a variable gap between agreement and clinical practice were found for most of the interventions.
CONCLUSIONS
This updated consensus process identified 11 nonsurgical interventions with possible survival implications for patients undergoing cardiac surgery. This list of interventions may help cardiac anesthesiologists and intensivists worldwide in their daily clinical practice and can contribute to direct future research in the field.
Topics: Cardiac Surgical Procedures; Congresses as Topic; Consensus; Consensus Development Conferences as Topic; Humans; Internet; Mortality; Perioperative Care; Postoperative Complications; Randomized Controlled Trials as Topic
PubMed: 29122431
DOI: 10.1053/j.jvca.2017.06.017 -
The Cochrane Database of Systematic... Aug 2017Cardiovascular disease, which includes coronary artery disease, stroke and peripheral vascular disease, is a leading cause of death worldwide. Homocysteine is an amino... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cardiovascular disease, which includes coronary artery disease, stroke and peripheral vascular disease, is a leading cause of death worldwide. Homocysteine is an amino acid with biological functions in methionine metabolism. A postulated risk factor for cardiovascular disease is an elevated circulating total homocysteine level. The impact of homocysteine-lowering interventions, given to patients in the form of vitamins B6, B9 or B12 supplements, on cardiovascular events has been investigated. This is an update of a review previously published in 2009, 2013, and 2015.
OBJECTIVES
To determine whether homocysteine-lowering interventions, provided to patients with and without pre-existing cardiovascular disease are effective in preventing cardiovascular events, as well as reducing all-cause mortality, and to evaluate their safety.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 5), MEDLINE (1946 to 1 June 2017), Embase (1980 to 2017 week 22) and LILACS (1986 to 1 June 2017). We also searched Web of Science (1970 to 1 June 2017). We handsearched the reference lists of included papers. We also contacted researchers in the field. There was no language restriction in the search.
SELECTION CRITERIA
We included randomised controlled trials assessing the effects of homocysteine-lowering interventions for preventing cardiovascular events with a follow-up period of one year or longer. We considered myocardial infarction and stroke as the primary outcomes. We excluded studies in patients with end-stage renal disease.
DATA COLLECTION AND ANALYSIS
We performed study selection, 'Risk of bias' assessment and data extraction in duplicate. We estimated risk ratios (RR) for dichotomous outcomes. We calculated the number needed to treat for an additional beneficial outcome (NNTB). We measured statistical heterogeneity using the I statistic. We used a random-effects model. We conducted trial sequential analyses, Bayes factor, and fragility indices where appropriate.
MAIN RESULTS
In this third update, we identified three new randomised controlled trials, for a total of 15 randomised controlled trials involving 71,422 participants. Nine trials (60%) had low risk of bias, length of follow-up ranged from one to 7.3 years. Compared with placebo, there were no differences in effects of homocysteine-lowering interventions on myocardial infarction (homocysteine-lowering = 7.1% versus placebo = 6.0%; RR 1.02, 95% confidence interval (CI) 0.95 to 1.10, I = 0%, 12 trials; N = 46,699; Bayes factor 1.04, high-quality evidence), death from any cause (homocysteine-lowering = 11.7% versus placebo = 12.3%, RR 1.01, 95% CI 0.96 to 1.06, I = 0%, 11 trials, N = 44,817; Bayes factor = 1.05, high-quality evidence), or serious adverse events (homocysteine-lowering = 8.3% versus comparator = 8.5%, RR 1.07, 95% CI 1.00 to 1.14, I = 0%, eight trials, N = 35,788; high-quality evidence). Compared with placebo, homocysteine-lowering interventions were associated with reduced stroke outcome (homocysteine-lowering = 4.3% versus comparator = 5.1%, RR 0.90, 95% CI 0.82 to 0.99, I = 8%, 10 trials, N = 44,224; high-quality evidence). Compared with low doses, there were uncertain effects of high doses of homocysteine-lowering interventions on stroke (high = 10.8% versus low = 11.2%, RR 0.90, 95% CI 0.66 to 1.22, I = 72%, two trials, N = 3929; very low-quality evidence).We found no evidence of publication bias.
AUTHORS' CONCLUSIONS
In this third update of the Cochrane review, there were no differences in effects of homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination comparing with placebo on myocardial infarction, death from any cause or adverse events. In terms of stroke, this review found a small difference in effect favouring to homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination comparing with placebo.There were uncertain effects of enalapril plus folic acid compared with enalapril on stroke; approximately 143 (95% CI 85 to 428) people would need to be treated for 5.4 years to prevent 1 stroke, this evidence emerged from one mega-trial.Trial sequential analyses showed that additional trials are unlikely to increase the certainty about the findings of this issue regarding homocysteine-lowering interventions versus placebo. There is a need for additional trials comparing homocysteine-lowering interventions combined with antihypertensive medication versus antihypertensive medication, and homocysteine-lowering interventions at high doses versus homocysteine-lowering interventions at low doses. Potential trials should be large and co-operative.
Topics: Angina Pectoris; Cardiovascular Diseases; Cause of Death; Folic Acid; Humans; Hyperhomocysteinemia; Myocardial Infarction; Randomized Controlled Trials as Topic; Risk Factors; Stroke; Vitamin B 12; Vitamin B 6; Vitamin B Complex
PubMed: 28816346
DOI: 10.1002/14651858.CD006612.pub5 -
The Cochrane Database of Systematic... Jun 2017Pressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are localised areas of injury to the skin or the underlying tissue, or both. Dressings... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are localised areas of injury to the skin or the underlying tissue, or both. Dressings are widely used to treat pressure ulcers and promote healing, and there are many options to choose from including alginate, hydrocolloid and protease-modulating dressings. Topical agents have also been used as alternatives to dressings in order to promote healing.A clear and current overview of all the evidence is required to facilitate decision-making regarding the use of dressings or topical agents for the treatment of pressure ulcers. Such a review would ideally help people with pressure ulcers and health professionals assess the best treatment options. This review is a network meta-analysis (NMA) which assesses the probability of complete ulcer healing associated with alternative dressings and topical agents.
OBJECTIVES
To assess the effects of dressings and topical agents for healing pressure ulcers in any care setting. We aimed to examine this evidence base as a whole, determining probabilities that each treatment is the best, with full assessment of uncertainty and evidence quality.
SEARCH METHODS
In July 2016 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses, guidelines and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
Published or unpublished randomised controlled trials (RCTs) comparing the effects of at least one of the following interventions with any other intervention in the treatment of pressure ulcers (Stage 2 or above): any dressing, or any topical agent applied directly to an open pressure ulcer and left in situ. We excluded from this review dressings attached to external devices such as negative pressure wound therapies, skin grafts, growth factor treatments, platelet gels and larval therapy.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed study selection, risk of bias assessment and data extraction. We conducted network meta-analysis using frequentist mega-regression methods for the efficacy outcome, probability of complete healing. We modelled the relative effectiveness of any two treatments as a function of each treatment relative to the reference treatment (saline gauze). We assumed that treatment effects were similar within dressings classes (e.g. hydrocolloid, foam). We present estimates of effect with their 95% confidence intervals for individual treatments compared with every other, and we report ranking probabilities for each intervention (probability of being the best, second best, etc treatment). We assessed the certainty (quality) of the body of evidence using GRADE for each network comparison and for the network as whole.
MAIN RESULTS
We included 51 studies (2947 participants) in this review and carried out NMA in a network of linked interventions for the sole outcome of probability of complete healing. The network included 21 different interventions (13 dressings, 6 topical agents and 2 supplementary linking interventions) and was informed by 39 studies in 2127 participants, of whom 783 had completely healed wounds.We judged the network to be sparse: overall, there were relatively few participants, with few events, both for the number of interventions and the number of mixed treatment contrasts; most studies were small or very small. The consequence of this sparseness is high imprecision in the evidence, and this, coupled with the (mainly) high risk of bias in the studies informing the network, means that we judged the vast majority of the evidence to be of low or very low certainty. We have no confidence in the findings regarding the rank order of interventions in this review (very low-certainty evidence), but we report here a summary of results for some comparisons of interventions compared with saline gauze. We present here only the findings from evidence which we did not consider to be very low certainty, but these reported results should still be interpreted in the context of the very low certainty of the network as a whole.It is not clear whether regimens involving protease-modulating dressings increase the probability of pressure ulcer healing compared with saline gauze (risk ratio (RR) 1.65, 95% confidence interval (CI) 0.92 to 2.94) (moderate-certainty evidence: low risk of bias, downgraded for imprecision). This risk ratio of 1.65 corresponds to an absolute difference of 102 more people healed with protease modulating dressings per 1000 people treated than with saline gauze alone (95% CI 13 fewer to 302 more). It is unclear whether the following interventions increase the probability of healing compared with saline gauze (low-certainty evidence): collagenase ointment (RR 2.12, 95% CI 1.06 to 4.22); foam dressings (RR 1.52, 95% CI 1.03 to 2.26); basic wound contact dressings (RR 1.30, 95% CI 0.65 to 2.58) and polyvinylpyrrolidone plus zinc oxide (RR 1.31, 95% CI 0.37 to 4.62); the latter two interventions both had confidence intervals consistent with both a clinically important benefit and a clinically important harm, and the former two interventions each had high risk of bias as well as imprecision.
AUTHORS' CONCLUSIONS
A network meta-analysis (NMA) of data from 39 studies (evaluating 21 dressings and topical agents for pressure ulcers) is sparse and the evidence is of low or very low certainty (due mainly to risk of bias and imprecision). Consequently we are unable to determine which dressings or topical agents are the most likely to heal pressure ulcers, and it is generally unclear whether the treatments examined are more effective than saline gauze.More research is needed to determine whether particular dressings or topical agents improve the probability of healing of pressure ulcers. The NMA is uninformative regarding which interventions might best be included in a large trial, and it may be that research is directed towards prevention, leaving clinicians to decide which treatment to use on the basis of wound symptoms, clinical experience, patient preference and cost.
Topics: Alginates; Bandages; Bandages, Hydrocolloid; Collagenases; Dermatologic Agents; Egg White; Gels; Glucuronic Acid; Hexuronic Acids; Humans; Network Meta-Analysis; Ointments; Pharmaceutic Aids; Phenytoin; Povidone; Pressure Ulcer; Randomized Controlled Trials as Topic; Wound Healing; Zinc Oxide
PubMed: 28639707
DOI: 10.1002/14651858.CD011947.pub2 -
AIDS Research and Treatment 2017Although tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) and zidovudine (ZDV)/lamivudine (3TC)/efavirenz (EFV) are used as preferred first line regimen, their... (Review)
Review
BACKGROUND
Although tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) and zidovudine (ZDV)/lamivudine (3TC)/efavirenz (EFV) are used as preferred first line regimen, their head-to-head comparison in terms of their efficacy and tolerability was limited. This review aimed to synthesize the best available evidence on the comparative efficacy and tolerability of the two regimens.
METHODS
Seven sites and databases in addition to Google search until August 20, 2016, were searched. Only randomized clinical trials conducted on adult population were included in this study. Our primary outcome was viral load suppression while secondary outcomes were death and tolerability. Undetectable viral load is defined as <50 Human Immunodeficiency Virus (HIV) ribonucleic acid (RNA) copies/ml. Joanna Briggs institute meta-analysis of statistics assessment and review instrument (JBI-MAStARI) and critical appraisal and data extraction tool were applied for critical assessment and data extraction, respectively. We performed a random effect meta-analysis to pool the relative risk (RR) for viral load suppression (<50 HIV RNA copies/ml and <400 HIV RNA copies/ml), tolerability, and death.
RESULT
Data was extracted from four articles, which included a total of 2381 participants. We found superior viral load suppression among tenofovir (TDF) arm compared to zidovudine (ZDV) arm. Tenofovir arm achieves viral load <50 HIV RNA copies/ml (RR = 1.12, 95% confidence interval (CI) [1.04, 1.21], = 0%) higher than zidovudine arm. Similarly TDF arm is superior in viral load suppression to <400 HIV RNA copies/ml (RR = 1.19, 95% CI [1.11, 1.27], = 0%). Moreover, TDF based regimens were more likely to be tolerated than ZDV based regimens (4 trials, 2381 participants (RR = 1.06, 95% CI [1.02, 1.10], = 51%)). However, forest plot of death shows that it was not significant (RR = 0.91, 95% CI [0.51, 1.62]).
CONCLUSION
The use of TDF/FTC/EFV as first line regimen for naïve HIV-1 infected adult patient showed superior viral load suppression and tolerability as compared to ZDV/3TC/EFV. In order to compare the death outcome of both ZDV/3TC/EFV and TDF/FTC/EFV further research is needed.
PubMed: 28638661
DOI: 10.1155/2017/5792925 -
BMC Cardiovascular Disorders Jun 2017Enthusiasts for telehealth extol its potential for supporting heart failure management. But randomised trials have been slow to recruit and produced conflicting... (Review)
Review
BACKGROUND
Enthusiasts for telehealth extol its potential for supporting heart failure management. But randomised trials have been slow to recruit and produced conflicting findings; real-world roll-out has been slow. We sought to inform policy by making sense of a complex literature on heart failure and its remote management.
METHODS
Through database searching and citation tracking, we identified 7 systematic reviews of systematic reviews, 32 systematic reviews (including 17 meta-analyses and 8 qualitative reviews); six mega-trials and over 60 additional relevant empirical studies and commentaries. We synthesised these using Boell's hermeneutic methodology for systematic review, which emphasises the quest for understanding.
RESULTS
Heart failure is a complex and serious condition with frequent co-morbidity and diverse manifestations including severe tiredness. Patients are often frightened, bewildered, socially isolated and variably able to self-manage. Remote monitoring technologies are many and varied; they create new forms of knowledge and new possibilities for care but require fundamental changes to clinical roles and service models and place substantial burdens on patients, carers and staff. The policy innovation of remote biomarker monitoring enabling timely adjustment of medication, mediated by "activated" patients, is based on a modernist vision of efficient, rational, technology-mediated and guideline-driven ("cold") care. It contrasts with relationship-based ("warm") care valued by some clinicians and by patients who are older, sicker and less technically savvy. Limited uptake of telehealth can be analysed in terms of key tensions: between tidy, "textbook" heart failure and the reality of multiple comorbidities; between basic and intensive telehealth; between activated, well-supported patients and vulnerable, unsupported ones; between "cold" and "warm" telehealth; and between fixed and agile care programmes.
CONCLUSION
The limited adoption of telehealth for heart failure has complex clinical, professional and institutional causes, which are unlikely to be elucidated by adding more randomised trials of technology-on versus technology-off to an already-crowded literature. An alternative approach is proposed, based on naturalistic study designs, application of social and organisational theory, and co-design of new service models based on socio-technical principles. Conventional systematic reviews (whose goal is synthesising data) can be usefully supplemented by hermeneutic reviews (whose goal is deepening understanding).
Topics: Attitude of Health Personnel; Comorbidity; Cost of Illness; Evidence-Based Medicine; Health Knowledge, Attitudes, Practice; Heart Failure; Hermeneutics; Humans; Patient Participation; Policy Making; Predictive Value of Tests; Process Assessment, Health Care; Risk Factors; Self Care; Telemedicine; Treatment Outcome
PubMed: 28615004
DOI: 10.1186/s12872-017-0594-2 -
The Cochrane Database of Systematic... Oct 2014Each year about two million pregnant women are infected with preventable syphilis infection, mostly in developing countries. Despite the expansion of antenatal syphilis... (Review)
Review
BACKGROUND
Each year about two million pregnant women are infected with preventable syphilis infection, mostly in developing countries. Despite the expansion of antenatal syphilis screening programmes over the past few decades, syphilis continues to be a major public health concern in developing countries. Point-of-care syphilis testing may be a useful strategy to substantially prevent syphilis-associated perinatal mortality and other negative consequences in resource-poor settings. However, the evidence on effectiveness has been generated mostly from observational study designs or has been reported as a mixed-intervention effect.
OBJECTIVES
To assess the effectiveness of antenatal syphilis screening in improving the uptake of screening tests and treatment, and reducing perinatal mortality.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2014) and the reference lists of retrieved studies.
SELECTION CRITERIA
Randomised (individual and cluster) controlled trials comparing different screening tests conducted during routine antenatal check-ups versus no screening test. Cross-over trials and quasi-randomised experimental study designs were not eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked for accuracy.
MAIN RESULTS
We included two cluster-randomised controlled trials (three reports). Both trials assessed point-of-care syphilis testing with conventional testing methods and together involved a total of 8493 pregnant women. Data from these trials were not amenable to meta-analysis as the measure of effectiveness was assessed in a non-comparable way.One trial randomised 14 antenatal clinics (including 7700 pregnant women) and was carried out at in Ulaanbaatar, Mongolia. The trial assessed one-stop syphilis testing using a rapid treponemal test, and was judged to have unclear methods of random sequence generation, allocation concealment, selective reporting, and other bias and low risk of bias for incomplete outcome data. Blinding was not reported and was assessed as high risk. The point-of-care testing provided screening, test results and treatment within the same day. The trial appears to have adjusted their results to account for clustering. We entered the data into RevMan using the generic inverse variance method. The incidence of congenital syphilis was lower in the clusters receiving on-site screening (adjusted odds ratio (AOR) 0.09, 95% confidence interval (CI) 0.01 to 0.71) and the proportion of women tested for syphilis was higher in the clusters receiving on-site screening at both the first antenatal visit and at the third trimester visit (OR 989.80, 95% CI 16.27 to 60233.05; OR 617.88, 95% CI 13.44 to 28399.01). Adequate treatment and partner treatment was higher with the on-site screening (AOR 10.44, 95% CI 1.00 to 108.99; AOR 18.17, 95% CI 3.23 to 101.20) and more syphilis cases were detected at first and third trimester visits with the on-site screening (AOR 2.45, 95% CI 1.44 to 4.18; AOR 6.27, 95% CI 1.47 to 26.69). Perinatal mortality, incidence of HIV/AIDS, obstacles in uptake of screening, any other adverse effects, or healthcare resource usage were not reported in this trial.The second trial divided clinics into seven matched pairs (including 7618 pregnant women, although results were only presented for the positive cases (793 women)), and within each pair one clinic was randomised to receive the on-site screening and the other to continue routine laboratory testing. The trial was conducted in primary healthcare clinics in KwaZulu-Natal, South Africa. Random sequence generation were judged to be at low risk of bias, but allocation concealment and incomplete outcome data were judged to be high risk. Other bias and selective reporting bias remain unclear. Blinding was not reported and was assessed as high risk of bias. This trial assessed the primary outcome of this review (perinatal mortality) and the secondary outcomes (adverse outcomes; adequate treatment; syphilis prevalence) in the subset of women (793 women) who tested positive for syphilis. Only one outcome, adequate treatment, was adjusted to account for cluster design. However, not enough information was provided to include this in an analysis using the generic inverse variance method. Where possible, results have therefore been presented in forest plots (perinatal mortality; adequate treatment), as if the data are from a parallel randomised controlled trial. These results should therefore be interpreted with caution.The trial reported on perinatal mortality in women with positive test results and showed that on-site screening using a rapid plasma reagin test had no clear evidence of an effect on perinatal mortality reduction (odds ratio (OR) 0.63; 95% CI 0.27 to 1.48; 18/549 (3.3%) versus 8/157 (5.1%)). After loss to follow up, 396/618 (64.1%) women with positive test results received adequate treatment (two or more doses of 2.4 mega units of benzathine penicillin) in the intervention cluster versus 120/175 (68.6%) in the control (OR 0.82; 95% CI 0.57 to 1.17). It was not possible to include any other data on reported outcomes in forest plots (adverse outcomes; syphilis prevalence). Incidence of congenital syphilis, proportion of women test for syphilis, incidence of HIV/AIDS, obstacles in uptake of screening, partner treatment, or healthcare resource usage were not reported in this trial.
AUTHORS' CONCLUSIONS
This review included evidence from two cluster-randomised trials at high or unclear risk of bias for most of the 'Risk of bias' domains. Data were not combined in meta-analysis because the trials used non-comparable measures of effectiveness.Point-of-care syphilis testing showed some promising results for syphilis detection and treatment rates and for use in different settings. In Mongolia point-of-care testing was found to be effective in increasing the proportion of pregnant women tested for syphilis and treatment provided, reducing congenital syphilis, and improving access to treatment for both women and their partners. In contrast, in rural South Africa, among women with positive test results, there was no clear evidence of an effect of point-of-care syphilis testing in increasing adequate syphilis treatment rates, and reducing perinatal mortality, but point-of-care testing was found to reduce delay in seeking treatment.More trials are therefore warranted to determine the effectiveness of available testing strategies for improving syphilis-associated adverse outcomes in pregnant women and neonates, especially in high-risk regions.
Topics: Female; Humans; Point-of-Care Systems; Pregnancy; Pregnancy Complications, Infectious; Prenatal Diagnosis; Randomized Controlled Trials as Topic; Syphilis; Syphilis, Congenital
PubMed: 25352226
DOI: 10.1002/14651858.CD010385.pub2 -
Diabetes & Metabolic Syndrome 2013Recently a hot debate was raised to answer if intensive glycemic control aimed to reduce HbA1c to less than 6.5% is better than conventional therapy in terms of future... (Comparative Study)
Comparative Study Review
BACKGROUND
Recently a hot debate was raised to answer if intensive glycemic control aimed to reduce HbA1c to less than 6.5% is better than conventional therapy in terms of future outcomes. A lot of studies were conducted to explore that but few mega trials were conducted.
OBJECTIVE
To evaluate the effect and safety of both intensive and conventional insulin therapy in patients with type 2 diabetes.
METHODOLOGY
Traditional systematic review was conducted; criteria for studies selection were formatted. Studies selected were criticized.
RESULTS
Three mega trials (3) randomized 23,182 participants with type 2 diabetes (11,591 to intensive glycemic control and 11,591 to conventional glycemic control) were included. Only diabetic nephropathy was noted to be delayed in onset or progression by intensive insulin therapy.
CONCLUSION
There are no benefits from intensive glycemic therapy (target HbA1c<6.4%) versus conventional glycemic therapy (target HbA1c>6.4%) except for decrease the rate of new onset or progression of nephropathy.
Topics: Aged; Blood Glucose; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Diabetic Nephropathies; Disease Progression; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Insulin; Male; Middle Aged; Randomized Controlled Trials as Topic
PubMed: 23517797
DOI: 10.1016/j.dsx.2013.02.008