anurajms/meta_analysis huggingface dataset:
primary outcome:
Behavioral interventions for improving contraceptive use among women living with HIV
PregnancyContraception use, e.g. uptake of a new method or improved use or continuation of current method
primary outcome:
Corticosteroids for treating nerve damage in leprosy
Improvement in nerve function at one year.Sensory nerve function measured with graded nylon filaments or a ballpoint pen, compared to baseline measurement. In general, we considered improvement as determined and defined by the original authors. We adapted the scores as defined by Van Brakel et al. (Van Brakel 2005; Table 2). For testing with graded nylon filaments, sensory NFI was diagnosed if the monofilament threshold was increased from normal by three or more points for any sensory nerve. Normal thresholds used were 200 mg for the hand and 2 g for the foot. If the score for any nerve decreased by three or more points from the baseline score, the nerve was considered as improved. When a non‐graded test was used, such as the ballpoint pen test, a nerve was diagnosed as impaired if two or more test sites did not feel the stimulus. Improvement for any nerve was defined as two or more test sites feeling the stimulus, compared to the baseline measurement (Van Brakel 2003).Motor nerve function assessed with the modified MRC grading scale (Brandsma 1981; Table 3). Improvement was defined as at least one‐point improvement in score for any muscle compared to the initial score.
primary outcome:
Antiepileptic drugs for the primary and secondary prevention of seizures in viral encephalitis
Proportion of patients having a documented seizure during admission.Average number of seizures per patient during admission.Proportion of patients needing intensive care support for seizures during admission.Change in outcome score from admission to discharge (Glasgow Outcome Scale score, Modified Rankin Scale score,
Liverpool Outcome Score).Proportion of patients remaining seizure‐free throughout the course of the follow‐up period.
primary outcome:
Fixed‐dose combinations of drugs versus single‐drug formulations for treating pulmonary tuberculosis
A combined endpoint of treatment failure, relapse, or death.Treatment failure.Relapse.Death.
primary outcome:
Systemic antifungal therapy for tinea capitis in children
The proportion of participants with complete cure, i.e., clinical and mycological cure. We defined complete clinical cure as resolution of itching and clinical signs, such as redness, scaling, and oedema. We defined complete mycological cure as negative results on microscopy, no growth in culture or both.The frequency and type of adverse events.
primary outcome:
Corticosteroids for managing tuberculous meningitis
Death.Persisting disabling neurological deficit at the end of follow‐up.
primary outcome:
Early removal versus expectant management of central venous catheters in neonates with bloodstream infection
Mortality from study entry (due to all causes):before 28 days after birth;up to 44 weeks postmenstrual age; until one year corrected for preterm gestation;at latest follow‐up assessment.Neurodevelopmental outcomes assessed after 12 months postmenstrual age using validated tools: neurological evaluations, developmental scores and classifications of disability, including auditory and visual disability. We will define neurodevelopmental impairment as the presence of one or more of the following: non‐ambulant cerebral palsy, developmental delay (developmental quotient > two standard deviations below population mean), blindness (visual acuity less than 6/60) or deafness (any hearing impairment requiring or unimproved by amplification).
primary outcome:
Urinary alkalisation for symptomatic uncomplicated urinary tract infection in women
Early and late symptoms (at days 1 to 4 and days 5 to 10): dysuria, urinary frequency, and abdominal painAny adverse events: worsening of UTI, progression to complicated UTI, need for hospitalisation or intravenous antibiotics.
primary outcome:
Antihelminthics in helminth‐endemic areas: effects on HIV disease progression
Change in plasma viral load (log10copies viral RNA/mL).Change in CD4+ T‐cell count (cells/µL).
primary outcome:
Oral immunoglobulin for preventing necrotizing enterocolitis in preterm and low birth weight neonates
Diagnosis of definite NEC during the study period, defined as clinical evidence of gastrointestinal and systemic illness, confirmed by pneumatosis intestinalis, pneumoperitoneum, portal venous gas, surgery or postmortem.
primary outcome:
Antibiotics for preventing suppurative complications from undifferentiated acute respiratory infections in children under five years of age
otitis media;mastoiditis;quinsy;pneumonia;abscess;meningitis;rates of admission to hospital;death.
primary outcome:
Antithrombin III for critically ill patients
Overall mortality (longest follow‐up, regardless of the period of follow‐up)
primary outcome:
Frequency of dressing changes for central venous access devices on catheter‐related infections
Incidence of confirmed catheter‐related bloodstream infection (CRBSI) defined as bacteraemia or fungaemia in a patient with an intravascular catheter with at least one positive blood culture obtained from a peripheral vein, clinical manifestations of infection (i.e. fever, chills, and/or hypotension), and no apparent source for the bloodstream infection except the catheter. One of the following should be present for a positive diagnosis: a positive semi‐quantitative (> 15 colony forming units (CFU)/catheter segment) or quantitative (> 10³ CFU/catheter segment) culture from a catheter segment in which the same organism (species and antibiogram) is isolated from the catheter segment and peripheral blood (CDC 2002).Incidence of suspected CRBSI, as described by the trial investigator.All‐cause mortality.
primary outcome:
Ivermectin versus albendazole or thiabendazole for Strongyloides stercoralis infection
Elimination of infection or parasitological cure: defined as any parasitological exam negative during follow‐up period (more than two stool samples negative).
primary outcome:
Antifungal agents for preventing fungal infections in non‐neutropenic critically ill patients
Total (all‐cause) mortality.Proven invasive fungal infection. The criteria for proven IFI included a clinical illness consistent with the diagnosis and either histopathological evidence of IFI or a positive fungal culture from one or more sterile site specimens (including blood). Positive culture of Candida spp. from the respiratory tract, even in presence of systemic or respiratory signs of infections, was classified as colonization instead of IFI. Funguria (as indicated by a positive urine fungal culture), in the absence of a complicated urinary tract infection, and fungal oesophagitis were classified as superficial fungal infections.
primary outcome:
Semi‐recumbent position versus supine position for the prevention of ventilator‐associated pneumonia in adults requiring mechanical ventilation
Clinically suspected VAP, defined as a new, persistent or progressive radiographic infiltrate with at least two of the following criteria: fever (temperature > 38 ℃ or < 35 ℃); leucocytosis or leucopenia (leucocytes > 10 × 109/L or < 3 × 109/L); and a positive culture of tracheal secretion (CDC 1997).Microbiologically confirmed VAP, diagnosed according to the following: 103 cfu/mL in protected specimen brush cultures; 104 cfu/mL in bronchoalveolar lavage (El‐Ebiary 1993); and 105 cfu/mL in tracheobronchial aspirate (Meduri 1992).Composite of clinically suspected and clinically confirmed VAP.Intensive care unit (ICU) mortality.Hospital mortality.
primary outcome:
Linezolid versus vancomycin for skin and soft tissue infections
1. Clinical cure (resolution of symptoms and signs) and microbiological cure (eradication of bacteria on wound culture).Proportion of patients or infections healed. We defined healing as either the resolution of all clinical signs and symptoms of infection as assessed by laboratory test or defined by trialists, or microbiological cure (i.e. eradication of MRSA on wound culture).2. SSTI‐related and treatment‐related mortality.
primary outcome:
Adjuvant corticosteroids for reducing death in neonatal bacterial meningitis
Mortality.All‐cause death until hospital discharge.All‐cause death during first year of life.Presence of severe neurological deficits or developmental delay between one and two years of age (a neurological deficit was defined as a functional abnormality of a body area that is observed as the result of an abnormality in the function of the brain, spinal cord, muscles or nerves; developmental delay was defined as any significant lag in a child's physical or motor, cognitive, behavioural, emotional or social development, in comparison with other children of the same age and sex within similar environments; formal evaluation tools were used to assess neurological deficits and developmental delay). Examples of neurological deficits include mental retardation, cerebral palsy, epilepsy, blindness and behavioural disorders. We considered evaluation tools such as Bayley's Infant Scale or Griffith's Mental Development Scale (for neurodevelopmental deficits), the Gross Motor Functions Scale or the Movement Assessment Battery for Children (for cerebral palsy), the Sonken‐Silver visual acuity test (for blindness), distraction tests (for behavioural disorders) and electroencephalography (for epilepsy) ‐ all applied between one and two years of age. We also accepted other measures used by individual trialists to evaluate and document neurological deficits in their respective trials.Sensorineural hearing loss.Presence of sensorineural hearing loss at four to 10 weeks after discharge.Presence of sensorineural hearing at one year of age (this was to be assessed by clinical examination and audiometry at one year of age).Presence of sensorineural hearing loss at two years of age.
primary outcome:
Duration of treatment for asymptomatic bacteriuria during pregnancy
The primary outcome is maternal cure rate defined as the woman having negative culture (test of cure) following initial treatment for asymptomatic bacteriuria.No cureCure rates were similar whether women received a single dose or a short course of any antibiotic (average risk ratio (RR) 1.28, 95% confidence interval (CI) 0.87 to 1.88; women = 1502; studies = 13; I² = 56%; Analysis 1.1). There was no evidence of differences in cure rates for our subgroups of same antimicrobial agent or different microbial agent (Test for subgroup differences: Chi² = 0.55, (P = 0.46), I² = 0%) and moderate heterogeneity even with a random‐effects model (Heterogeneity: Tau² = 0.23; Chi² = 27.00, I² = 56%). We graded the evidence for the outcome of no cure as very low quality due to risk of bias in the contributing trials and wide CIs crossing the line of no effect.When assessing forest plots for publication bias, we found suggested asymmetry in the funnel plot for this outcome (Figure 3). However, the single outlier trial was extremely small, and so the source of asymmetry may well be a small‐study effect rather than publication bias. This trial also contribute very little to the overall pooled effect estimate (1.6%). We have not downgraded evidence for this outcome for publication bias.No cureAll trials reported bacteriological success of treatment by repeat cultures (Anderton 1983; Bailey 1983; Bailey 1986; Brumfitt 1982; Gerstner 87‐89; Lumbiganon 2009; Masterton 1985; Olsen 1989; Pregazzi 1987; Reeves 1975) The 'no cure' rate was similar for the one‐day and the four‐ to seven‐day treatment (average RR 1.34, 95% CI 0.85 to 2.12; women = 1286; studies = 10; Analysis 1.1). There was moderate heterogeneity for this outcome even with a random‐effects model (Heterogeneity: Tau² = 0.30; Chi² = 25.83, df = 9 (P = 0.002); I² = 65%).No cureThe three trials included in this outcome (216 women) reported bacteriological success of treatment by repeat cultures (Bayrak 2007; Estebanez 2009; Thoumsin 1990). There was no difference in the 'no cure' rate for the single‐dose treatment versus the short‐course treatment, but with wide CIs (RR 0.98, 95% CI 0.49 to 1.95; women = 216; studies = three; I² = 0%), Analysis 1.1.
primary outcome:
Steroids for symptom control in infectious mononucleosis
Overall improvement in health, measured by physical and psychological functional ability, time in hospital, time taken to return to normal activities, patient self report of health and relapse rates.Duration and severity of common symptoms, including fever, sore throat, swollen lymph glands, hepatic and splenic involvement, and fatigue, measured by subjective reports, validated scales, clinical findings and/or laboratory parameters.
primary outcome:
Prophylactic oral/topical non‐absorbed antifungal agents to prevent invasive fungal infection in very low birth weight infants
Confirmed invasive fungal infection as determined by:culture of fungus from a normally sterile site: cerebrospinal fluid, blood, urine, bone or joint, peritoneum, pleural space. Samples should have been collected using methods to minimise contamination with surface‐colonising organisms;findings on autopsy examination consistent with invasive fungal infection;findings on ophthalmological examination consistent with fungal ophthalmitis or retinitis;pathognomonic findings on renal ultrasound examination such as 'renal fungal balls'.Death prior to hospital discharge.Neurodevelopmental outcomes assessed beyond infancy (neurological evaluations, developmental scores, and classifications of disability, including auditory and visual disability, non‐ambulant cerebral palsy, developmental delay); and cognitive and educational outcomes at five years or older (intelligence quotient and/or indices of educational achievement measured using a validated tool including school examination results).
primary outcome:
Prophylactic systemic antifungal agents to prevent mortality and morbidity in very low birth weight infants
culture of fungus from a normally sterile site e.g. cerebrospinal fluid, blood, urine, bone or joint, peritoneum, pleural space;findings on autopsy examination consistent with invasive fungal infection;findings on ophthalmological examination consistent with fungal ophthalmitis or retinitis;pathognomonic findings on renal ultrasound examination such as 'renal fungal balls'.Kaufman 2005: RR 1.95 (95% CI 0.18 to 20.7); RD 0.02 (95% CI −0.06 to 0.11)Manzoni 2007b: RR 1.44 (95% CI 0.33 to 6.26); RD 0.01 (95% CI −0.04 to 0.11).Kaufman 2005: RR 0.98 (95% CI 0.34 to 2.77); RD 0.00 (95% CI −0.16 to 0.15);Manzoni 2007b: RR 1.44 (95% CI 0.33 to 6.26); RD 0.01 (95% CI −0.04 to 0.06).
primary outcome:
Prenatal education for congenital toxoplasmosis
Rate of congenital toxoplasmosis, defined by persistence of specific IgG antibodies beyond 11 months of age (Lebech 1996).Rate of toxoplasmosis seroconversion in pregnant women, defined by:an increase in specific IgG from paired sera in pregnant woman previously seronegative;a rising IgG titre, low IgG avidity, IgA antibodies, or a combination of these in pregnant women who were IgG and IgM positive at their first prenatal test (Gilbert 2002).seroconvertions for toxoplasmosis detected during the study did not differ between groups (risk ratio (RR) 1.70, 95% confidence interval (CI) 0.56 to 5.21; participants = 3949; one study) (Analysis 1.1): there were 13 cases out of 2591 pregnant women (0.5%) in the intervention group and four cases out of 1358 pregnant women (0.3%) in the control group (P = 0.35).The data above have not been adjusted for cluster design and so it is reasonable to assume the confidence intervals have been underestimated.
primary outcome:
Antibiotics for preventing lower respiratory tract infections in high‐risk children aged 12 years and under
Incidence of bacterial lower respiratory infections with serological (blood) or radiological confirmation, or both
primary outcome:
Heliox inhalation therapy for bronchiolitis in infants
In‐hospital mortality.Need for mechanical ventilation (invasive or not).Rate of endotracheal intubation.Rate of emergency department discharge.Length of treatment for respiratory distress.Length of paediatric intensive care unit (PICU) stay.Adverse effects.
primary outcome:
Corticosteroids for acute bacterial meningitis
MortalityHearing lossNeurological sequelae
primary outcome:
Post‐exposure passive immunisation for preventing rubella and congenital rubella syndrome
Cases of rubella. The diagnosis may have been made by detection or isolation of rubella virus in urine, respiratory secretions or blood; by rubella‐specific IgG seroconversion or a four‐fold or greater rise in titre; by serological detection of IgM to rubella in the presence of a compatible clinical illness and no recent vaccination; or by symptoms consistent with rubella (fever, a generalised maculopapular rash and one or more of arthralgia/arthritis, lymphadenopathy, conjunctivitis) in the absence of other diagnoses as judged by a medical professional.Cases of congenital rubella infection. The diagnosis may have been made by detection or isolation of rubella virus in the infant's urine, respiratory secretions or blood or in the products of conception; by serological detection of rubella‐specific IgM in the infant's serum; or by rising rubella‐specific IgG in the infant's serum in the first year of life.Cases of congenital rubella syndrome. A live or stillborn infant with any of the following compatible defects: cataracts, congenital glaucoma, congenital heart disease, hearing impairment, pigmentary retinopathy, microcephaly, mental retardation, purpura, hepatosplenomegaly, meningoencephalitis, radiolucent bone disease; and evidence of congenital rubella infection or maternal antepartum rubella infection.
primary outcome:
Beta2‐agonists for acute cough or a clinical diagnosis of acute bronchitis
Daily cough scores;The number of participants who were still coughing at the end of the trial;Adverse effects.
primary outcome:
Incentives and enablers to improve adherence in tuberculosis
Cured: a patient who was initially smear‐positive and who was smear negative in the last month of treatment and on at least one previous occasion;Completed treatment: a patient who completed the course of treatment as prescribed by the health worker;Successfully treated: a patient who was cured or who completed treatment (WHO 2009b).
primary outcome:
Short‐course versus prolonged‐course antibiotic therapy for hospital‐acquired pneumonia in critically ill adults
28‐day mortality.Recurrence of pneumonia (diagnosed on the basis of clinical and/or microbiological criteria).28‐day antibiotic‐free days.
primary outcome:
Surfactant therapy for bronchiolitis in critically ill infants
Mortality.Duration of mechanical ventilation (hours).Adverse effects (desaturation, change in heart rate, change in blood pressure and bronchospasm) or complications (pneumothorax) or both.
primary outcome:
Silver‐coated endotracheal tubes for prevention of ventilator‐associated pneumonia in critically ill patients
Risk rate of VAP;hospital mortality.
primary outcome:
Interventions for prevention of herpes simplex labialis (cold sores on the lips)
Incidence of HSL during use of the preventative intervention. We accepted both researcher‐diagnosed and participant‐reported recurrences.Adverse effects during use of the preventative intervention.
primary outcome:
Interventions for preventing recurrent urinary tract infection during pregnancy
Lenke 1983 found no differences in women who developed recurrent pyelonephritis (upper UTI) (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.31 to 2.53; one study, 167 women) (Analysis 1.1), or RUTI before birth (RR 0.30, 95% CI 0.06 to 1.38; one study, 167 women) (Analysis 1.2), and preterm birth (before 37 weeks) (RR 1.18, 95% CI 0.42 to 3.35; one study, 147 women) (Analysis 1.3) between nitrofurantoin and close surveillance and close surveillance only. Data on total mortality and small‐for‐gestational‐age babies were not reported.
primary outcome:
Vaccines for women for preventing neonatal tetanus
Neonatal tetanus cases.Neonatal mortality (deaths from neonatal tetanus; all causes).Serious harms. This includes outcomes related to the course of pregnancy (spontaneous abortion, fetal death, stillbirth, preterm birth, maternal death), to neonatal outcomes (congenital malformations, neonatal death) and to severe adverse events (e.g. neurological harms).
primary outcome:
Antibiotic prophylaxis during the second and third trimester to reduce adverse pregnancy outcomes and morbidity
Studies of antibiotic prophylaxis during the second or third trimester (ranging from 14 to 34 weeks of gestational age) in pregnant women reported the primary outcomes of interest as the following: preterm prelabour rupture of membranes, preterm delivery, postpartum endometritis, low birthweight and neonatal sepsis. Blood culture confirming sepsis was not reported in any of the studies.Antibiotic prophylaxis did not reduce the risk of preterm prelabour rupture of membranes (average risk ratio (RR) 0.31; 95% confidence interval (CI) 0.06 to 1.49 (one trial, 229 women) Analysis 1.1) or preterm delivery (average RR 0.88; 95% CI 0.72 to 1.09 (six trials, 3663 women) Analysis 1.2 all women; average RR 0.97; 95% CI 0.82 to 1.15 (four trials, 2905 women) Analysis 1.2.1 unselected women). However, preterm delivery was reduced in the subgroup of pregnant women with a previous preterm birth who had BV during the current pregnancy (average RR 0.64, 95% CI 0.47 to 0.88; one trial, 258 women, subgroup differences P = 0.08; Analysis 1.3.1), but there was no reduction in the subgroup of pregnant women with previous preterm birth without BV during the pregnancy (average RR 1.08; 95% CI 0.66 to 1.77 (two trials, 500 women) Analysis 1.3,2), or in the whole group of high‐risk women (average RR 0.89; 95% CI 0.58 to 1.36 (two trials, 758 women) Analysis 1.3), and a difference between these subgroups of high‐risk women was observed (Test for subgroup differences: Chi² = 3.11, df = 1 (P = 0.08), I² = 67.8%).A reduction in the risk of postpartum endometritis (RR 0.55; 95% CI 0.33 to 0.92 (one trial, 196 women)) was observed in high‐risk pregnant women (women with a history of preterm birth, low birthweight, stillbirth or early perinatal death) Analysis 1.4,2, and in all women (RR 0.53; 95% CI 0.35 to 0.82 (three trials, 627 women) Analysis 1.4), but not in unselected women (RR 0.51; 95% CI 0.24 to 1.08 (two trials, 431 women) Analysis 1.4.1. There was no difference in low birthweight in all women (average RR 0.86; 95% CI 0.53 to 1.39 (four trials; 978 women) (Analysis 1.5), or unselected pregnant women (average RR 1.07; 95% CI 0.71 to 1.63 (three trials; 725 women) Analysis 1.5.1, although a difference was observed in high‐risk women (average RR 0.57; 95% CI 0.37 to 0.88 (one trial; 253 women) Analysis 1.5.2 and a difference in subgroups observed (Test for subgroup differences: Chi² = 4.22, df = 1 (P = 0.04), I² = 76.3%). There was no difference in neonatal sepsis (RR 11.31; 95% CI 0.64 to 200.79) (one trial, 142 women) Analysis 1.6, and blood culture confirming sepsis was not reported in any of the studies.
primary outcome:
Impact of Haemophilus influenzae type B (Hib) and viral influenza vaccinations in pregnancy for improving maternal, neonatal and infant health outcomes
Mortality (perinatal, neonatal, infant, maternal).Any infection of the respiratory tract (upper or lower tract) among women, neonates and infants.Sepsis or other reported infections among women, neonates and infants.Mortality (perinatal, neonatal, infant, maternal)Any infection of the respiratory tract (upper or lower tract) among women, neonates and infantsSepsis or other reported infections among women, neonates and infants
primary outcome:
Antibiotic lock for the prevention of catheter‐related infection in neonates
Rates of confirmed catheter‐related infection.Rates of suspected catheter‐related infection.Combined rates of confirmed and suspected catheter‐related infection.CRBSI as defined by the Centers for Disease Control and Prevention (CDC) criteria for CRBSI that were relevant to infants, as listed in Appendix 1 (O'Grady 2002);as there is no consensus on the minimal number of factors required to satisfy a diagnosis of catheter‐related infection, for the purpose of this review, we accepted various definitions adopted by the author of each study, as long as the items included in their definitions were those contained in this set of diagnostic criteria. We accepted definitions that were not consistent with these diagnostic criteria, as long as the study authors justified their definitions with validated sources.CLABSI utilising LCBI or clinical sepsis, as listed in Appendix 1 (NHSN 2011; O'Grady 2011), or diagnosed at the discretion of the physician in‐charge as long as the diagnosis made could be justified with validated sources.
primary outcome:
Antibiotic prophylaxis for preventing meningitis in patients with basilar skull fractures
Frequency of meningitis: suspected clinically (fever, neck stiffness, deterioration of neurological status, headache) and confirmed by lumbar puncture (CSF analysis including biochemistry, Gram stains or bacteriological cultures (or both)).
primary outcome:
Adjunctive corticosteroids for Pneumocystis jiroveci pneumonia in patients with HIV infection
The main outcome measure of interest was overall mortality at one and three to four months of follow‐up.A secondary outcome measure was the need for mechanical ventilation.
primary outcome:
Leukotriene inhibitors for bronchiolitis in infants and young children
Length of hospital stay.All‐cause mortality.
primary outcome:
Azithromycin for acute lower respiratory tract infections
Clinical failure (persistence or deterioration of symptoms, death or relapse assessed at about 10 to 14 days after therapy started).
primary outcome:
Chlorhexidine skin or cord care for prevention of mortality and infections in neonates
All‐cause neonatal mortality.Incidence of infection (pneumonia, septicaemia, meningitis) in first 28 days (clinical signs/Integrated Management of Neonatal Childhood Illnesses (IMNCI)/WHO criteria/culture confirmed).Incidence of omphalitis.
primary outcome:
Comparison of routes for achieving parenteral access with a focus on the management of patients with Ebola virus disease
Success of route placement ('success'/'failure' as defined in the individual trial).
primary outcome:
Corticosteroids for parasitic eosinophilic meningitis
Resolution rates (complete disappearance of headache within two to four weeks after completion of the treatment).
primary outcome:
Routine blood cultures in the management of pyelonephritis in pregnancy for improving outcomes
Maternal sepsisPerinatal or neonatal mortality
primary outcome:
Skin preparation with alcohol versus alcohol followed by any antiseptic for preventing bacteraemia or contamination of blood for transfusion
Bacteraemia in the blood recipient (the presence of bacteria in the blood stream) as measured by blood culture.Blood product contamination (blood products include whole blood, platelets, red blood cells or any other product derived from the blood collection) at any time between collection and transfusion as detected most commonly by blood culture.
primary outcome:
Low dose versus high dose stavudine for treating people with HIV infection
Primary Outcomes:Secondary Outcomes:
primary outcome:
Macrolides for diffuse panbronchiolitis
Five‐year survival rate.Lung function: FEV1 (forced expiratory volume in one second); FVC (forced vital capacity); TGV (thoracic gas volume); RV/TLC (the ratio of residual volume to total lung capacity) and Gaw (airway conductance).Clinical response: improvement and duration of clinical signs and symptoms.
primary outcome:
Pneumococcal vaccination during pregnancy for preventing infant infection
pneumonia (diagnosed by clinical findings and radiological or laboratory findings);meningitis (diagnosed by clinical findings and laboratory findings);bacteremia/sepsis (diagnosed by clinical findings and laboratory findings);neonatal death (due to pneumococcal infection);otitis media (diagnosed by clinical findings and laboratory findings).at two to three months of age;by six to seven months of age.
primary outcome:
Adjunctive hyperbaric oxygen for necrotizing fasciitis
Mortaility during the presenting admission.
primary outcome:
Antibiotics for community‐acquired lower respiratory tract infections secondary to Mycoplasma pneumoniae in children
Proportions of participants who were not improved at follow‐up. We measured failure to improve according to the hierarchy listed below.
primary outcome:
Antibiotic regimens for management of intra‐amniotic infection
Maternal and neonatal mortality.Maternal and neonatal severe infection.Duration of maternal and neonatal hospital stay.
primary outcome:
Surfactant for meconium aspiration syndrome in term and late preterm infants
Mortality
primary outcome:
Vaginal chlorhexidine during labour to prevent early‐onset neonatal group B streptococcal infection
1. Early‐onset GBS disease (sepsis and/or meningitis), defined as a positive blood and/or cerebrospinal fluid (CSF) culture with GBS in an infant less than seven days of age with clinical signs consistent with a systemic infection.
2. GBS pneumonia within the first seven days of life. This was added in this update as a non‐prespecified outcome.Early onset GBS disease (sepsis and/or meningitis) within the first seven days of life (Outcome 01.01)Analysis 1.1Two studies (including 987 infants) reported on the outcome of early‐onset GBS infection following chlorhexidine vaginal disinfection. None of the studies reported a statistically significant difference for this outcome. When the studies were combined, there was no statistically significant difference in this outcome; risk ratio (RR) 2.32 (95% confidence interval (CI) 0.34 to 15.63). There was no substantial between‐study heterogeneity for RR (Chi² = 0.65; P = 0.42, I² = 0%).GBS pneumonia within the first seven days of life (Outcome 01.02)Analysis 1.2Two studies (including 987 infants) reported on the outcome of early‐onset GBS pneumonia following chlorhexidine vaginal disinfection. In one study (Adriaanse 1995a) there was no case of pneumonia in either group. The studies combined showed no statistically significant difference in this outcome; RR 0.35 (95% CI 0.01 to 8.60). Tests for heterogeneity not applicable for RR.
primary outcome:
Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery
Composite maternal postpartum infectious morbidity (including serious infectious complications such as sepsis (including septic shock), endomyometritis, wound infection, or death attributed to infection). Though not pre‐specified in the protocol, we stratified composite morbidity by whether 1 g or 2 g of cephalosporin were administered.
primary outcome:
Amantadine and rimantadine for influenza A in children and the elderly
Response to treatment (measured as cases on the specified day of treatment): fever on day three of treatment, cough on day seven of treatment, malaise on day six of treatment and conjunctivitis and eye symptoms on day five of treatment.Cases of influenza, studied in all prophylaxis comparisons, including those in which two antivirals (rimantadine and zanamivir) (Gravenstein 2005; Schilling 1998), and two different doses of rimantadine were compared (Monto 1995).Cases of side effects in children: diarrhoea, exanthema, malaise, muscular limb pain, headache, dyspnoea, dizziness, stimulation/insomnia, nausea, vomiting, arrhythmia, gastrointestinal (GI) symptoms, CNS symptoms, change in behaviour, hyperactivity and tinnitus.Cases of side effects in the elderly: headache, dizziness, stimulation/insomnia, nausea, vomiting, anxiety, confusion, fatigue, depression, impaired concentration, loss of appetite, rash or allergic reaction, seizures or clonic twitching, dry mouth, insomnia or sleeplessness, body weakness and debility.
primary outcome:
Antibiotics for meconium‐stained amniotic fluid in labour for preventing maternal and neonatal infections
Neonatal sepsis.
primary outcome:
Quantitative versus qualitative cultures of respiratory secretions for clinical outcomes in patients with ventilator‐associated pneumonia
Twenty‐eight day mortality.
primary outcome:
Strategies of testing for syphilis during pregnancy
Perinatal mortalityIncidence of congenital syphilis**Proportion of pregnant women tested for syphilis and treatment provided
primary outcome:
Antibiotics for community‐acquired pneumonia in adult outpatients
Test‐of‐clinical‐cure: clinical response: improvement of signs and symptoms, usually at a pre‐defined test‐of‐cure (TOC) visit. Where possible, we used duration of clinical signs and symptoms as outcome measures. We used a clinical definition of cure as the primary outcome since radiographic resolution lags behind clinical improvement (Macfarlane 1984).
primary outcome:
Antibiotics for bronchiolitis in children under two years of age
Duration of supplementary oxygen requirementOxygen saturationWheezeCrepitationsFever
primary outcome:
Prophylaxis for Pneumocystis pneumonia (PCP) in non‐HIV immunocompromised patients
Documented Pneumocystis infections, defined as documentation of Pneumocystis from a properly obtained specimen (bronchoalveolar lavage, induced sputum, or biopsy) in a patient with clinical manifestations compatible with PCP. Accepted methods for documentation included: staining techniques (methenamine silver, Wright‐Giemase, or other), immunofluorescence on clinical specimens or immunohistochemistry on tissue sections and polymerase chain reaction (PCR) (Mandel 2010).
primary outcome:
Acellular vaccines for preventing whooping cough in children
Whooping cough: 21 or more consecutive days of paroxysmal cough with confirmation of B. pertussis infection by culture, appropriate serology or contact with a household member who has culture‐confirmed pertussis. This case definition is recommended by the WHO for use in pertussis vaccine trials (WHO 1991).Pertussis disease: seven or more consecutive days of cough with confirmation of B. pertussis infection by culture or appropriate serology.
primary outcome:
Topical antifungal treatments for tinea cruris and tinea corporis
Rate of mycological cure ‐ defined as the follow‐up reporting of negative mycological testing at least two weeks from the start of treatment in each trial participant (negative microscopy findings, the absence of any growth of the dermatophytes in culture, or both).Clinical cure ‐ defined as the resolution of clinical signs and symptoms suggestive of dermatophyte infection, as judged by study investigators with trial participants. This was measured at least two weeks from the start of treatment.
primary outcome:
Structural and community‐level interventions for increasing condom use to prevent the transmission of HIV and other sexually transmitted infections
HIV incidence/prevalence.STI incidence/prevalence.
primary outcome:
Antibiotics for acute pyelonephritis in children
Duration of feverPersistent symptoms (e.g. UTI at 72 hours; inflammatory markers at 72 hours (ESR, WCC, CRP)Acute kidney parenchymal damage on DMSA scanLength of hospital stay for inpatientsPersistent bacteriuria after completion of antibioticsRecurrent UTIAdverse effects of treatment including minor (e.g. vomiting, discomfort from IV cannula) and major (e.g. anaphylaxis, hearing impairment)Economic costs of treatment (if data available).
primary outcome:
Humanized PA14 (a monoclonal CCR5 antibody) for treatment of people with HIV infection
Clinical laboratory results (including change of log10 HIV RNA viral load from baseline, maximum change in viral load following initiation of treatment, antiviral response which was defined as a ≧ 1.0 log10 copies/mL reduction in HIV RNA level at any time after treatment, change of CD4+ cell count from baseline, and other parameters following PRO 140 administration, etc.).Number of subjects with ≦ 400 copies/mL HIV RNA.Survival rates.
primary outcome:
Corticosteroids for dengue infection
Death
primary outcome:
Vaccines for post‐exposure prophylaxis against varicella (chickenpox) in children and adults
Prevention of varicella in contacts of a varicella case.Vaccine adverse events including local injection site adverse events, fever and systemic adverse events.
primary outcome:
Bronchodilators for bronchiolitis
Oxygen saturation, as this outcome often drives the clinical decision to hospitalize an infant with bronchiolitis. This outcome is objectively measured using pulse oximetry.
primary outcome:
Intrapartum antibiotics for known maternal Group B streptococcal colonization
There was no statistically significant effect of intrapartum antibiotics compared to no treatment on neonatal mortality from all causes (risk ratio (RR) 0.19, 95% confidence interval (CI) 0.01 to 3.82, one trial, 164 infants, test for heterogeneity not applicable) (seeAnalysis 1.1).There was no statistically significant effect of intrapartum antibiotics compared to no treatment on neonatal mortality from GBS infection (RR 0.31, 95% CI 0.01 to 7.50, one trial, 164 infants, test for heterogeneity not applicable) (seeAnalysis 1.2).There was no statistically significant effect of intrapartum antibiotics compared to no treatment on neonatal mortality from infections caused by bacteria other than GBS (RR 0.31, 95% CI 0.01 to 7.50, one trial, 164 infants, test for heterogeneity not applicable) (seeAnalysis 1.3).There was no statistically significant effect on neonatal mortality from all causes comparing intrapartum administration of ampicillin with penicillin (RR 3.03, 95% CI 0.12 to 73.98, one study 352 infants, test for heterogeneity not applicable). The one death was caused by a lethal congential heart condition and not due to an infection (seeAnalysis 2.1).
primary outcome:
Hormonal contraception for women exposed to HIV infection
HIV acquisition
primary outcome:
Post‐exposure passive immunisation for preventing measles
Cases of measles. The diagnosis may be made by detection or isolation of measles virus in urine or respiratory secretions; by detection of measles virus antigen in urine or respiratory secretions; by serological detection of immunoglobulin M (IgM) to measles in the absence of vaccination eight days to eight weeks prior to testing; by IgG seroconversion or by a fourfold or greater rise in titre to measles virus in the absence of vaccination eight days to eight weeks prior to testing; or by symptoms consistent with measles (fever, a red blotchy rash, conjunctivitis, runny nose and cough) or modified measles (prolonged incubation period, milder fever, cough, runny nose, conjunctivitis and sparse discrete rash of short duration).Mortality due to measles.
primary outcome:
Systemic corticosteroids for acute sinusitis
Proportion of participants with resolution or improvement of any patient‐related symptoms, including total change in clinical status, measured at two time points ‐ short‐term (two weeks or less) or long‐term (more than two weeks).
primary outcome:
Over‐the‐counter (OTC) medications to reduce cough as an adjunct to antibiotics for acute pneumonia in children and adults
Proportion of participants who were not cured or not substantially improved at follow‐up (failure to improve was measured according to the hierarchy listed below in Secondary outcomes).
primary outcome:
Intermittent versus daily therapy for treating tuberculosis in children
Cure as defined by the trial authors and including the following:
primary outcome:
Beta lactam antibiotic monotherapy versus beta lactam‐aminoglycoside antibiotic combination therapy for sepsis
All‐cause mortality by the end of the study follow‐up.
primary outcome:
Intranasal steroids for acute sinusitis
Proportion of participants with resolution or improvement of symptoms.
primary outcome:
Infection control strategies for preventing the transmission of meticillin‐resistant Staphylococcus aureus (MRSA) in nursing homes for older people
MRSA incidence.
primary outcome:
Antibiotic therapy for the treatment of methicillin‐resistant Staphylococcus aureus (MRSA) in non surgical wounds
All‐cause mortality (at maximal follow‐up, i.e. until the last visit of the patient or by other methods of follow‐up).Other serious adverse events, defined as any event that would increase mortality; is life‐threatening; requires inpatient hospitalisation; results in a persistent or significant disability; or any important medical event that might have jeopardised the patient or requires intervention to prevent it (ICH‐GCP 1996).Quality of life (as defined by study authors).
primary outcome:
Continuous negative extrathoracic pressure or continuous positive airway pressure compared to conventional ventilation for acute hypoxaemic respiratory failure in children
Mortality (both early and late, defined as less than and greater than 30 days after the diagnosis).Improvement in oxygenation (at 24‐hourly intervals up to one week) as measured by oxygenation index (mean airway pressure x fractional concentration of oxygen x 100)/arterial oxygen tension (PaO2)) and hypoxia score (arterial oxygen tension/fractional inspired oxygen concentration ratio (PaO2/FiO2)) or improvement in PaO2 with reduction of FiO2 after starting the therapy.Failure (use of any additional form of assisted ventilation).
primary outcome:
Combined and alternating paracetamol and ibuprofen therapy for febrile children
Measures of child discomfort, including stress scores; number of doses of medications given; and absences from daycare or school.Proportion of febrile children at one, four and six hours after administration of initial antipyretic.
primary outcome:
Antibiotics for preventing meningococcal infections
Mortality.Occurrence of meningococcal infection.
primary outcome:
Intravenous immunoglobulin for treating sepsis, severe sepsis and septic shock
All‐cause mortality at the end of the follow‐up periodShort‐term mortality: mortality measured at 30 days (30‐day mortality)Long‐term mortality: mortality measured at time periods greater than 30 days
primary outcome:
Optimal timing for intravascular administration set replacement
The rate of catheter‐related bloodstream infection, as defined by one of three criteria: bacteraemia or fungaemia with at least one positive blood culture from a peripheral vein, with no other identifiable source of infection other than the catheter, plus a positive semiquantitative (> 15 colony‐forming units (cfu)) or quantitative (>1 03 cfu) device culture, with the same organism (species and antibiogram) isolated from the device and blood (Maki 2006; O'Grady 2002); or two blood cultures (one drawn from the catheter and one from a peripheral vein) that grow the same organism, with the catheter colony count three‐fold the peripheral colony count, or with the catheter culture growing at least 2 hours before the peripheral culture; or two quantitative blood cultures drawn from two catheter lumens in which the colony counts differ three‐fold (Mermel 2009).The rate of infusate‐related bloodstream infection: isolation of the same organism from a quantitative culture of the infusate and from separate percutaneous blood cultures, with no other identifiable source of infection (O'Grady 2002).
primary outcome:
Antibiotics for preventing complications in children with measles
Incidence of pneumonia.
primary outcome:
Glucocorticoids for acute viral bronchiolitis in infants and young children
Rate of admission by days one and seven for outpatient studies.Length of stay (LOS) for inpatient studies.
primary outcome:
Antibiotics for community‐acquired pneumonia in children
Clinical cure. The definition of clinical cure is symptomatic and involves clinical recovery by the end of treatment.Treatment failure rates. The definition of treatment failure is the presence of any of the following: development of chest in‐drawing, convulsions, drowsiness or inability to drink at any time, respiratory rate above the age‐specific cut‐off point on completion of treatment, or oxygen saturation of less than 90% (measured by pulse oximetry) after completion of the treatment. Loss to follow‐up or withdrawal from the study at any time after recruitment indicated failure in the analysis.
primary outcome:
Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children
Hospitalisation for RSV infection.All‐cause mortality.
primary outcome:
De‐escalation of antimicrobial treatment for adults with sepsis, severe sepsis or septic shock
Mortality at day 28Mortality at hospital discharge or at the end of the follow‐up period
primary outcome:
Co‐formulated abacavir‐lamivudine‐zidovudine for initial treatment of HIV infection and AIDS
The primary outcome measure was suppression of viral activity, as defined by the authors.The secondary outcome measures included:
1‐ CD4 cell count
2‐ Severe adverse events
3‐ Clinical lipodystrophy manifestations
4‐ Total cholesterol
5‐ Triglyceride level
6‐ Treatment adherence
primary outcome:
Vaccines for preventing influenza in people with asthma
Protective effects of vaccination were measured during the influenza season (late benefits), while adverse effects caused by vaccination were measured in the first two weeks following vaccination (early adverse effects). We included the following outcomes measures under both categories:
primary outcome:
Extracorporeal membrane oxygenation for critically ill adults
All‐cause mortality at day 90 to one year
primary outcome:
Mental Health First Aid as a tool for improving mental health and well‐being
Mental health and well‐being, measured by a validated measure, for example the Strengths and Difficulties Questionnaire (SDQ).Mental health service usage, measured by objective service records. These may include clinic records, referrals to healthcare professionals, or the costs of service usage.Adverse effects of MHFA, for example, documented instances of inappropriate advice, delays in receiving treatment, and inappropriate service usage.
primary outcome:
Extracorporeal shock wave lithotripsy (ESWL) versus percutaneous nephrolithotomy (PCNL) or retrograde intrarenal surgery (RIRS) for kidney stones
Treatment success rate at three monthsQuality of life (QoL)Complications
primary outcome:
Magnetic seizure therapy for people with schizophrenia
We divided outcomes into short term (less than 6 months), medium term (7 to 12 months) and long term (over 1 year).We reported binary outcomes recording clear and clinically meaningful degrees of change (e.g. global impression of much improved, or more than 50% improvement on a rating scale ‐ as defined within the trials) before any others. Thereafter, we would list other binary outcomes and then those that were continuous.
primary outcome:
Digital technology for monitoring adherence to inhaled therapies in people with cystic fibrosis
Adherence to inhaled therapy treatment as measured by one or more of the following:percentage of the inhaled medication taken as prescribed;full adherence to the inhaled therapy as defined in the study protocol expressed as a binary outcome (yes or no). Where investigators have allowed a lower threshold than 100% for binary adherence (e.g. 80% or 90%), we will report this and combine data where possible;adherence measured using specific adherence instruments; MPR; medication adherence reporting scale (MARS) (Chan 2020);adherence rate as given by the technology itself (e.g. chipped or data‐tracking nebulisers);self‐reported adherence to inhaled therapies via a diary or a questionnaire.Treatment burden (mean change from baseline) using validated measures, such as the Cystic Fibrosis Questionnaire ‐ Revised (CFQ‐R) treatment burden domain score (Quittner 2009)Quality of life (QoL) using validated scales (e.g. CFQ‐R (Quittner 2009) or Cystic Fibrosis Quality of Life (CFQoL) (Gee 2000))
primary outcome:
Carnitine supplements for people with chronic kidney disease requiring dialysis
QoL: any validated scale used in the studies, such as the Short Form‐36 (SF‐36) scaleFatigue score*Adverse events: cardiovascular events*†, high blood pressure, seizures, gastrointestinal events, any self‐reported adverse events.