GEM/cochrane-simplification huggingface dataset:
Abstract: We included two studies with 362 pregnant women. Both studies compared ampicillin-sulbactam (N = 183) versus normal saline (N = 179) in pregnant women with MSAF. Prophylactic antibiotics appeared to have no statistically significant reduction in the incidence of neonatal sepsis (risk ratio (RR) 1.00, 95% CI 0.21 to 4.76), neonatal intensive care unit (NICU) admission (RR 0.83, 95% CI 0.39 to 1.78) and postpartum endometritis (RR 0.50, 95% CI 0.18 to 1.38). However, there was a significant decrease in the risk of chorioamnionitis (RR 0.36, 95% CI 0.21 to 0.62). No serious adverse effects were reported. Drug resistance, duration of mechanical ventilation and duration of admission to NICU/hospital were not reported. Most of the domains for risk of bias were at low risk of bias for one study and at unclear risk of bias for the other study. The quality of the evidence using GRADE was low for neonatal sepsis, postpartum endometritis, and neonatal mortality and morbidity prior to discharge (Neonatal intensive care admissions) and of moderate quality for chorioamnionitis. Current evidence indicates that compared to placebo, antibiotics for MSAF in labour may reduce chorioamnionitis. There was no evidence that antibiotics could reduce postpartum endometritis, neonatal sepsis and NICU admission. This systematic review identifies the need for more well-designed, adequately powered RCTs to assess the effect of prophylactic antibiotics in the incidence of maternal and neonatal complications.

Plain-language summary: Our review was based on two identified randomised controlled study (involving 362 women) and found that prophylactic antibiotics may reduce the risk of intra-amniotic infection in women with MSAF (moderate quality evidence). Antibiotics use did not clearly reduce neonatal sepsis (low quality evidence), NICU admission (low quality evidence) or postpartum endometritis (low quality evidence). Studies with much larger numbers of pregnant women with MSAF would be needed to examine these issues.
Abstract: One RCT and nine observational studies were included in the review. These ten studies identified 2,112 episodes of HIV transmission, 1,016 among treated couples and 1,096 among untreated couples. The rate ratio for the single randomised controlled trial was 0.04 [95% CI 0.00, 0.27]. All index partners in this study had CD4 cell counts at baseline of 350-550 cells/µL. Similarly, the summary rate ratio for the nine observational studies was 0.58 [95% CI 0.35, 0.96], with substantial heterogeneity (I2=64%). After excluding two studies with inadequate person-time data, we estimated a summary rate ratio of 0.36 [95% CI 0.17, 0.75] with substantial heterogeneity (I2=62%). We also performed subgroup analyses among the observational studies to see if the effect of ART on prevention of HIV differed by the index partner's CD4 cell count. Among couples in which the infected partner had ≥350 CD4 cells/µL, we estimated a rate ratio of 0.12 [95% CI 0.01, 1.99]. In this subgroup, there were 247 transmissions in untreated couples and 30 in treated couples. ART is a potent intervention for prevention of HIV in discordant couples in which the index partner has ≤550 CD4 cells/µL. A recent multicentre RCT confirms the suspected benefit seen in earlier observational studies and reported in more recent ones. Questions remain about durability of protection, the balance of benefits and adverse events associated with earlier therapy, long-term adherence and transmission of ART-resistant strains to partners. Resource limitations and implementation challenges must also be addressed. Counselling, support, and follow up, as well as mutual disclosure, may have a role in supporting adherence, so programmes should be designed with these components. In addition to ART provision, the operational aspects of delivering such programmes must be considered.

Plain-language summary: We found one randomised controlled trial and nine observational studies that examined this question. Overall we found that in couples in which the infected partner was being treated with antiretroviral drugs the uninfected partners had, at worst, more than 40% lower risk of being infected than in couples where the infected partner was not receiving treatment. Since the World Health Organization (WHO) already recommends antiretroviral treatment for all persons with ≤350 CD4 cells/µL, we also examined studies that had studied couples in which the infected partners had CD4 counts higher than this level. We found that there is strong evidence from the randomised controlled trial that in this group HIV was less likely to be transmitted to uninfected partners from treated infected partners than from untreated infected partners.
Abstract: Four cluster-randomised controlled studies met the inclusion criteria. All of them investigated complex interventions comprising educational approaches. Three studies offered education and training for nursing staff, one study offered multidisciplinary team meetings as main component of the intervention. There was one high-quality study, but overall the methodological quality of studies was moderate.  The studies revealed consistent results for the primary end point. All studies documented a decrease of the proportion of residents with antipsychotic drug use or a reduction in days with antipsychotic use per 100 days per resident, respectively. In summary, the reviewed evidence on psychosocial interventions targeting professionals is consistent with a reduction of antipsychotic medication prescription in care home residents. However, owing to heterogeneous approaches, summary effect sizes cannot be determined. There is evidence to support the effectiveness of psychosocial interventions for reducing antipsychotic medication in care home residents. However, the review was based on a small number of heterogeneous studies with important methodological shortcomings. The most recent and methodologically most rigorous study showed the most pronounced effect.

Plain-language summary: This review investigates whether psychosocial interventions aimed at reducing antipsychotic medication in care homes are effective. By psychosocial interventions, we mean programmes that consist of different non-pharmacological components including talking to the staff, residents, or both. We identified four randomised controlled trials for inclusion in the review. All studies examined, among other components, education targeted at nursing staff in care homes. The methodological quality of three studies was limited, one study showed high quality. In all studies the interventions led to a reduction of antipsychotic medication use, but the overall magnitude of the effect remains unclear.
Abstract: We included 10 trials involving 26,865 high vascular risk patients. The trials were generally of high quality. Aspirin was compared with ticlopidine in nine trials (7633 patients) and with clopidogrel in one trial (19,185 patients). Compared with aspirin, allocation to a thienopyridine produced a modest, just statistically significant, reduction in the odds of a serious vascular event (11.6% versus 12.5%; odds ratio (OR) 0.92, 95% confidence interval (CI) 0.85 to 0.99), corresponding to the avoidance of 10 (95% CI 0 to 20) serious vascular events per 1000 patients treated for about two years. However, the wide confidence interval includes the possibility of negligible additional benefit. Compared with aspirin, thienopyridines significantly reduced gastrointestinal adverse effects. However, thienopyridines increased the odds of skin rash and diarrhoea, ticlopidine more than clopidogrel. Allocation to ticlopidine, but not clopidogrel, significantly increased the odds of neutropenia. In patients with TIA/ischaemic stroke, the results were similar to those for all patients combined. The thienopyridine derivatives are at least as effective as aspirin in preventing serious vascular events in patients at high risk, and possibly somewhat more so. However, the size of any additional benefit is uncertain and could be negligible. Clopidogrel has a more favourable adverse effects profile than ticlopidine and so is the thienopyridine of choice. It should be used as an alternative to aspirin in patients genuinely intolerant of or allergic to aspirin.

Plain-language summary: This review of 10 trials comparing either clopidogrel or ticlopidine with aspirin in about 27,000 people found that clopidogrel and ticlopidine were at least as effective as aspirin for the prevention of stroke and heart attacks, and might be slightly more effective. In terms of adverse effects, compared with aspirin, clopidogrel and ticlopidine caused less stomach upset and less bleeding from the gut, but more diarrhoea and skin rash. Ticlopidine produced more of these last two adverse effects than clopidogrel when compared with aspirin. Ticlopidine can also cause suppression of the bone marrow production of blood cells, which can be a serious complication. Clopidogrel is therefore the thienopyridine of choice since it is safer and better tolerated. However, since it is substantially more expensive than aspirin and not clearly more effective, it should generally only be used instead of aspirin in patients who are unable to take aspirin.
Abstract: Seven studies, 482 participants, met the inclusion criteria. - Comparing antidepressant with placebo, no statistically significant results for dropouts. Selecting studies with low risk of bias, 325 participants, results favour placebo, RR 1.40 (Cl 95% 1.00 to 1.96). For severity of depression, results from two studies, 183 participants, favour antidepressants utilising Clinical Global Impression Scale RR 1.92 (CI 95% 1.26 to 2.94), while another study, 95 participants, utilising the Hamilton Depression Rating Scale, did not find a statistically significant difference RR 0.96 (CI 95% 0.54 to 1.71). For adverse events, result favour placebo, four studies, 311 participants, RR 2.90 (Cl 95% 1.23 to 6.86). For drug use, three studies, 211 participants, it was not possible to pool data because outcomes' measures were not comparable. Looking at singular studies, no statistically significant difference was seen. - Comparing different classes of antidepressants, the results favour tricyclics for severity of depression, two studies, 183 participants, RR 1.92 (Cl 95% 1.26 to 2.94) and favour placebo for adverse events, two studies, 172 participants, RR 3.11 (Cl 95% 1.06 to 9.12). There is low evidence, at the present, supporting the clinical use of antidepressants for the treatment of depressed opioid addicts in treatment with opioid agonists. There is a need of larger randomised studies investigating relevant outcomes, safety issues and reporting data to allow comparison of results.

Plain-language summary: Authors included seven randomised controlled studies that involved 482 participants in our review. The studies were conducted in outpatient settings over four to 16 weeks; six were in USA and one in Australia. The mean age of participants was 34 years and 62% were males. No clear difference was found in the number of dropouts from an opioid agonist maintenance program between people receiving antidepressants and those in the placebo groups. Neither was drug use different (two studies). Severity of depression was reduced with the use of antidepressants (two studies), including tricyclic antidepressants. Adverse events were important as more of the participants who received antidepressants withdrew from the studies for medical reasons compared with those participants on placebo (four studies). The differences between studies in clinical (participant characteristics, the medications used, services and treatments delivered) and methodological characteristics (study design and quality) made it difficult to draw confident conclusions about the efficacy and safety of antidepressants for the treatment of depression in people who are dependent on opioids.
Abstract: Seven treatment studies of 257 infants with suspected systemic bacterial infection and three prophylaxis studies comprising 359 neonates are analysed.   Treatment studies: There is no evidence that the addition of G-CSF or GM-CSF to antibiotic therapy in preterm infants with suspected systemic infection reduces immediate all cause mortality. No significant survival advantage was seen at 14 days from the start of therapy [typical RR 0.71 (95% CI 0.38,1.33); typical RD -0.05 (95% CI -0.14, 0.04)]. However all seven of the treatment studies were small, the largest recruiting only 60 infants.  The subgroup analysis of 97 infants from three treatment studies who, in addition to systemic infection, had clinically significant neutropenia (< 1.7 x 109/l) at trial entry, does show a significant reduction in mortality by day 14 [RR 0.34 (95% CI 0.12, 0.92); RD -0.18 (95% CI -0.33, -0.03); NNT 6 (95% CI 3-33)]. Prophylaxis studies have not demonstrated a significant reduction in mortality in neonates receiving GM-CSF [RR 0.59 (95% CI 0.24,1.44); RD -0.03 (95% CI -0.08,0.02)]. The identification of sepsis as the primary outcome of prophylaxis studies has been hampered by inadequately stringent definitions of systemic infection. However, data from one study suggest that prophylactic GM-CSF may provide protection against infection when given to preterm infants who are neutropenic or at high risk of developing postnatal neutropenia. There is currently insufficient evidence to support the introduction of either G-CSF or GM-CSF into neonatal practice, either as treatment of established systemic infection to reduce resulting mortality, or as prophylaxis to prevent systemic infection in high risk neonates. No toxicity of CSF use was reported in any study included in this review. The limited data suggesting that CSF treatment may reduce mortality when systemic infection is accompanied by severe neutropenia should be investigated further in adequately powered trials which recruit sufficient infants infected with organisms associated with a significant mortality risk.

Plain-language summary: The haemopoietic colony stimulating factors (CSFs), granulocyte-macrophage colony stimulating factor (GM-CSF) and granulocyte colony stimulating factor (G-CSF) are naturally occurring substances (cytokines) that can increase circulating white blood cells (neutrophils) and their ability to destroy bacteria. Common minor side effects are low grade fever and skeletal pain. The review authors identified seven treatment studies of 257 premature infants with suspected systemic bacterial infection. Adding G-CSF or GM-CSF to antibiotic therapy did not improve survival, overall. It may be, however, that infants who had clinically low neutrophils at the start of treatment did show some reduction in number of deaths by day 14 (taken from three studies). In three studies in which 359 low birthweight or premature neonates were treated preventatively (prophylaxis) no reduction in deaths was evident in those neonates receiving GM-CSF. GM-CSF was well tolerated with no adverse reactions in these small studies.
Abstract: Only one additional RCT met the eligibility criteria (24 participants) for this updated review. Although this was a feasibility study, not designed to investigate intervention effect, it suggested that TENS may improve bone pain on movement in a cancer population. The initial review identified two RCTs (64 participants) therefore this review now includes a total of three RCTs (88 participants). These studies were heterogenous with respect to study population, sample size, study design, methodological quality, mode of TENS, treatment duration, method of administration and outcome measures used. In one RCT, there were no significant differences between TENS and placebo in women with chronic pain secondary to breast cancer treatment. In the other RCT, there were no significant differences between acupuncture-type TENS and sham in palliative care patients; this study was underpowered. Despite the one additional RCT, the results of this updated systematic review remain inconclusive due to a lack of suitable RCTs. Large multi-centre RCTs are required to assess the value of TENS in the management of cancer-related pain in adults.

Plain-language summary: Only one new study met eligibility criteria for this review update, making at total of three included studies. TENS was given to 15 participants in one study, 41 participants in the other and 24 participants in the most recently included study. The newly included study suggested TENS might improve cancer bone pain on movement, but as a pilot study it was not designed to determine the impact of TENS on pain. The two studies in the previous review did not show that TENS significantly improved cancer pain. One study did not have sufficient participants to determine whether or not TENS had an effect. TENS was well tolerated in all three studies. There were significant differences in participants, treatments, procedures and symptom measurement tools used in the studies. In two of the studies some participants were able to identify when they received active TENS and when they received placebo. Consequently, there is insufficient evidence to judge whether TENS should be used in adults with cancer-related pain. Further research using well designed clinical trials is needed to improve knowledge in this field.
Abstract: We identified 15 studies for possible inclusion in the review. Five studies reporting results from a total of 354 participants (aged 5 to 50 years) were included in this review. All studies compared once-daily dosing with thrice-daily dosing. One cross-over trial had 26 participants who received the first-arm treatment but only 15 received the second arm. One study had a low risk of bias for all criteria assessed; the remaining included studies had a high risk of bias from blinding, but for other criteria were judged to have either an unclear or a low risk of bias. There was little or no difference between treatment groups in: forced expiratory volume in one second, mean difference (MD) 0.33 (95% confidence interval (CI) -2.81 to 3.48, moderate-quality evidence); forced vital capacity, MD 0.29 (95% CI -6.58 to 7.16, low-quality evidence); % weight for height, MD -0.82 (95% CI -3.77 to 2.13, low-quality evidence); body mass index, MD 0.00 (95% CI -0.42 to 0.42, low-quality evidence); or in the incidence of ototoxicity, relative risk 0.56 (95% CI 0.04 to 7.96, moderate-quality evidence). Once-daily treatment in children probably improved the percentage change in creatinine, MD -8.20 (95% CI -15.32 to -1.08, moderate-quality evidence), but showed no difference in adults, MD 3.25 (95% CI -1.82 to 8.33, moderate-quality evidence). The included trials did not report antibiotic resistance patterns or quality of life. Once- and three-times daily aminoglycoside antibiotics appear to be equally effective in the treatment of pulmonary exacerbations of cystic fibrosis. There is evidence of less nephrotoxicity in children.

Plain-language summary: This review includes five studies with a total of 354 children and adults. All the trials compared once-a-day dosing with three times-a-day dosing. The review found that when treating people with cystic fibrosis for pulmonary exacerbations, giving the antibiotics once per day was just as good at as giving them more frequently in terms of lung function and body mass index. The review also found that giving the antibiotics once per day appeared to be less toxic to the kidneys in children. There were no differences between the different treatment schedules for other outcomes that the studies measured. While once-daily treatment can be just as effective and more convenient than three-times daily treatment, we recommend further studies to look at the long-term safety of this treatment schedule. We judged that just one of the five studies carried a low risk that any design factors might affect the outcome results. In the remaining four studies, we thought that the fact that it was obvious whether the antibiotics were given once or three times a day could affect some outcome measures (e.g. lung function). Other risk factors were unclear or at low risk of bias. We assessed the evidence for lung function, body mass index and the evidence for side effects (e.g. toxicity) to be moderate to low quality.
Abstract: We included a total of five randomised studies (involving 805 women) evaluating different methods of analgesia for amniocentesis; there were no studies in women undergoing CVS. One RCT (N = 203) and one quasi-randomised study (N = 220) compared infiltrative local anaesthesia with no anaesthesia and found no statistical difference in experienced pain on the visual analogue scale (VAS) (mean differences (MD) -2.50 and 1.20; 95% confidence interval (CI) -6.98 to 1.98 and -2.67 to 5.07). One study (N = 200) compared light leg rubbing versus no intervention during amniocentesis and found no change in experienced anxiety (MD 0.2; 95% CI -0.63 to 1.03) or VAS pain score (MD 0.3; 95% CI -0.35 to 0.95) during amniocentesis. Another study with 62 patients did not find any benefit of using subfreezing temperature needle during amniocentesis in terms of decreased VAS pain score (MD -0.8; 95% CI -1.8 to 0.2). In addition, there was no difference between anticipated and actual pain (MD 0.4; 95% CI -0.82 to 1.62) (before/after comparison). There was also no difference in VAS pain scores in the study with 120 participants comparing lidocaine-prilocaine analgesic cream to placebo cream before amniocentesis (MD -0.6; 95% CI -1.44 to 0.24). In general, women who undergo amniocentesis could be informed that pain during procedure is minor and that there is currently insufficient evidence to support the use of local anaesthetics, leg rubbing or subfreezing the needle for pain reduction during procedure.

Plain-language summary: We identified five studies (involving a total of 805 women) that evaluated effectiveness of analgesia for pain during amniocentesis. Types of analgesia included local anaesthetics (either injected (two studies, 423 women) or applied topically (one study, 120 women)); use of a subfreezing (-14°C) needle (one study, 62 women); and leg rubbing (one study, 200 women). We found no studies evaluating analgesia during chorionic villus sampling. Each comparison failed to demonstrate positive affect on pain during amniocentesis. In general, women who undergo amniocentesis could be informed that pain during procedure is minor and that there is currently insufficient evidence to support the use of local anaesthetics, leg rubbing or subfreezing the needle for pain reduction during this procedure.