anurajms/meta_analysis huggingface dataset:
primary outcome:
HMG CoA reductase inhibitors (statins) for preventing acute kidney injury after surgical procedures requiring cardiac bypass
The primary outcome is the incidence of AKI after cardiac surgery.AKI is defined using the AKIN or RIFLE classification wherever provided. The Acute Kidney Injury Network (AKIN) (Mehta 2007) defines three stages of injury (1, 2 and 3) based on increasingly severe reductions of kidney function (Stage 1: increase in serum creatinine (SCr) ≥ 0.3 mg/dL, or 1.5‐ to 2‐fold increase from baseline; Stage 2: increase in SCr ≥ 150% to 200% from baseline; Stage 3: increase in SCr > 3‐fold from baseline, > 300% from baseline, ≥ 4.0 mg/dL, or initiation of RRT regardless of stage). The RIFLE criteria, proposed by the Acute Dialysis Quality Initiative group (Bellomo 2004) defines five levels of AKI (R isk, I njury, F ailure, L oss and End‐stage kidney disease) based on incremental reductions in kidney function.If AKI was not reported in the context of these criteria, efforts were made to classify patients.
primary outcome:
Transmyocardial laser revascularization versus medical therapy for refractory angina
Improvement of severity of angina as measured by the Canadian Cardiovascular Society (CCS) angina scale or New York Heart Association (NYHA) anginal class.One‐year mortality.Early postoperative mortality (deaths in the first month after surgery).
primary outcome:
Antiplatelet agents for preventing thrombosis after peripheral arterial bypass surgery
(1) Primary graft patency: patency rates after surgery with no further intervention, as determined by clinical examination, measurement of the ankle‐brachial pressure index (ABPI), duplex ultrasonography, angiography.
(2) Assisted primary patency: patency rates after intervention to improve blood flow in a graft which has not occluded.We analysed primary patency and primary assisted patency for all grafts and for venous or prosthetic (artificial) grafts separately.
primary outcome:
Effectiveness of the Valsalva Manoeuvre for reversion of supraventricular tachycardia
Reversion of SVT to a sinus rhythm.
primary outcome:
Beta‐adrenergic blockers for perioperative cardiac risk reduction in people undergoing vascular surgery
All‐cause mortality.Cardiovascular mortality.30‐day postoperative non‐fatal and fatal myocardial infarction.
primary outcome:
Statins for primary prevention of venous thromboembolism
The rate of VTE (DVT and PE)
primary outcome:
Biologics, colchicine, corticosteroids, immunosuppressants and interferon‐alpha for Neuro‐Behçet's Syndrome
Induction or maintenance of remission with disease activity considered as a dichotomous outcome, i.e. sustained‐remission rate and relapse‐free survival (RFS).Change of patient‐reported outcomes (PROs, e.g. Short Form 36, Behcet disease quality of life (Gilworth 2004), or any other PRO validated measures as reported in primary studies).Withdrawals due to serious adverse events (SAEs).Proportion of patients with at least one of the following adverse events (AEs):infections (pneumonia, fungal and opportunistic infections, tuberculosis reactivation);cardiac disorders;all cancers, including lymphomas and leukaemia;mental disorders;any other AE reported in the included studies.
primary outcome:
Balloon angioplasty, with and without stenting, versus medical therapy for hypertensive patients with renal artery stenosis
Systolic and diastolic blood pressureRenal function as assessed by serum creatinine, creatinine clearance or estimated glomerular filtration rate
primary outcome:
Blood pressure lowering efficacy of partial agonist beta blocker monotherapy for primary hypertension
Change in trough (13 to 26 hours after the dose) and/or peak (one to 12 hours after the dose) systolic and diastolic blood pressure compared to placebo. If blood pressure measurements were available at more than one time point, the weighted means of blood pressures taken in the three to 12‐week range were used.
primary outcome:
Rosuvastatin for lowering lipids
Placebo‐controlled RCTs: mean per cent change of LDL‐cholesterol from baseline of different doses of rosuvastatin minus per cent change from baseline with placebo.Placebo‐controlled RCTs: mean per cent change of non‐HDL‐cholesterol from baseline of different doses of rosuvastatin minus per cent change from baseline with placebo.Before‐and‐after trials: mean per cent change of LDL‐cholesterol from baseline of different doses of rosuvastatin.Before‐and‐after trials: mean per cent change of non‐HDL‐cholesterol from baseline of different doses of rosuvastatin.
primary outcome:
Interventions for deliberately altering blood pressure in acute stroke
Combined death or disability/dependency at end of trial (≥ one month after stroke). We defined death or dependency as the modified Rankin Scale (mRS) > 2 (or > 3 as available).
primary outcome:
Cardiopulmonary resuscitation (CPR) plus delayed defibrillation versus immediate defibrillation for out‐of‐hospital cardiac arrest
Survival to hospital discharge.
primary outcome:
Pre‐hospital versus in‐hospital thrombolysis for ST‐elevation myocardial infarction
All‐cause hospital mortality at one month (short term) and one year (mid term).
primary outcome:
Time course for blood pressure lowering of dihydropyridine calcium channel blockers
Endpoint hourly BP using a 24‐hour ABPM.
primary outcome:
Angiotensin converting enzyme (ACE) inhibitors versus angiotensin receptor blockers for primary hypertension
total mortality as death from all causes;cardiovascular mortality as coronary heart disease mortality (fatal MI, sudden or rapid cardiac death) and cerebrovascular mortality (fatal stroke) combined;cardiovascular morbidity as coronary heart disease morbidity (nonfatal MI) and cerebrovascular morbidity (nonfatal stroke) combined;total cardiovascular events as fatal and nonfatal MI, other coronary heart disease mortality, fatal and nonfatal stroke, fatal congestive heart failure and hospitalizations for congestive heart failure.
primary outcome:
Exercise for people with high cardiovascular risk
All‐cause mortality and CVD‐related mortalityIncidence of acute myocardial infarctionIncidence of stroke
primary outcome:
Heparin versus placebo for non‐ST elevation acute coronary syndromes
Death (all‐cause mortality).Myocardial infarction.Major hemorrhage (e.g. fall in hemoglobin level of >2 g/dL, requires transfusion, is intracranial, retroperitoneal, or intraocular, or causes death or cessation of the study treatment).
primary outcome:
Angioplasty versus bare metal stenting for superficial femoral artery lesions
Rates of restenosis (in trials with at least six months follow‐up and using techniques directly imaging the treatment site ‐ duplex ultrasound and angiography).
primary outcome:
Anticoagulation therapy versus placebo for pulmonary hypertension
Mortality.Six‐minute walk test.Haemorrhage from anticoagulant use (number of people experiencing one or more events): Bleeding requiring significant intervention will be regarded as a major bleed.
primary outcome:
Blood pressure‐lowering efficacy of monotherapy with thiazide diuretics for primary hypertension
Change in systolic and diastolic blood pressure compared with placebo. If blood pressure measurements were available at more than one time during the 24‐hour period, we used the trough measurement. We defined peak level as within 12 hours of the dose and trough level as between 12 and 24 hours. If several blood pressure measurements were available within the acceptable window, we used the weighted mean of all blood pressure measurements reported by the study authors during the 3 to 12‐week range as the best estimate of treatment effect.
primary outcome:
Trypanocidal drugs for chronic asymptomatic Trypanosoma cruzi infection
Any patient‐related outcomes regarding efficacy.
primary outcome:
Anticoagulants (heparin, low molecular weight heparin and oral anticoagulants) for intermittent claudication
maximum walking distance (absolute claudication distance), defined as the distance in metres, or time, walked until the patient stops as a result of claudication symptoms;pain‐free walking distance (initial claudication distance), defined as the distance in metres, or time, walked until the onset of claudication symptoms, i.e. pain, cramps or severe fatigue.
primary outcome:
Type of incision for below knee amputation
(1) Primary stump healing, defined as a painless, healed suture line enabling fitting of a prosthetic limb (if appropriate) and regaining of mobility(2) Post‐operative infection rate, including the specific incidence of methicillin‐resistant Staphylococcus aureus (MRSA) infection(3) Rate of reamputation at (a) same level; (b) higher level(4) Number of participants mobilising with a prosthetic limb
primary outcome:
Direct thrombin inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in people with non‐valvular atrial fibrillation
The composite outcome of vascular deaths and ischaemic events, including non‐fatal ischaemic strokes and transient ischaemic attacks (TIAs), non‐fatal systemic embolic events (SEE) and non‐fatal myocardial infarction (MI). Vascular death is defined as any death related to a vascular cause not including fatal haemorrhages or cardiovascular deaths (e.g. sudden arrhythmia, pump failure). Systemic embolism is defined as any event of acute non‐intracerebral or non‐coronary vascular origin including deep vein thrombosis (DVT) and pulmonary embolism (PE).The composite outcome of fatal or non‐fatal major bleeding events, including haemorrhagic strokes. We did not include minor bleeding events.
primary outcome:
Glycoprotein IIb‐IIIa inhibitors for acute ischaemic stroke
Death or dependency: the number of participants who died or remained severely disabled (modified Rankin Scale 3 to 6 or equivalent) at the end of the scheduled follow up, where follow up was performed three months or longer after the stroke.
primary outcome:
Antibiotic prophylaxis for preventing post solid organ transplant tuberculosis
Occurrence of TB of any organ (confirmed by cultures of relevant samples, histology, Ziehl‐Neelsen (acid‐fast bacilli) staining or PCR).
primary outcome:
Combined oral contraceptives: venous thrombosis
The primary outcome was fatal or non‐fatal first venous thrombosis event (DVT or pulmonary embolism).
primary outcome:
Blood pressure lowering efficacy of nonselective beta‐blockers for primary hypertension
Change in trough (13 to 26 hours after the dose) or peak (1 to 12 hours after the dose) (or both) SBP and DBP compared with placebo. If BP measurements were available at more than one time within the acceptable window, we used the weighted means of BPs taken in the three to 12 week range.
primary outcome:
First‐line beta‐blockers versus other antihypertensive medications for chronic type B aortic dissection
Total mortality rate was the primary outcome.
primary outcome:
Insulin for glycaemic control in acute ischaemic stroke
Death or dependency at the end of the scheduled follow‐up. Dependency is defined as being severely dependent on others in activities of daily living, or being significantly disabled; this corresponds to a Barthel Index score 60 or less, or a modified Rankin Scale grade 3 to 6 (Uyttenboogaart 2007).
primary outcome:
Endovascular repair of abdominal aortic aneurysm
Mortality and aneurysm‐related mortality rates: short term (30‐day or inhospital mortality), intermediate (up to four years from randomisation) and long term (beyond four years).Endograft‐related complications (e.g. endoleak, reintervention (defined as the rate of any secondary intervention after the primary repair ‐ EVAR or OSR)Major complications (e.g. those that altered management of the individual (myocardial infarction, stroke, renal failure, bowel ischaemia, pulmonary complications etc.)
primary outcome:
Antibiotics and antiseptics for venous leg ulcers
Time to complete wound healing (correctly analysed using survival, time‐to‐event approaches, ideally with adjustment for relevant covariates such as baseline ulcer area and duration).Proportion of ulcers healing during follow‐up (frequency of complete healing).Change (or rate of change) in wound size, with adjustment for baseline size.
primary outcome:
Intravascular brachytherapy for peripheral vascular disease
primary patency or restenosis;need for re‐intervention (including target lesion revascularisation and target vessel revascularisation).
primary outcome:
Treatment of hypertension in peripheral arterial disease
All‐cause mortalityCardiovascular deaths (stroke, myocardial infarction (MI), pulmonary embolism, peripheral arterial embolism)Non‐fatal cardiovascular events (stroke, MI, pulmonary embolism, peripheral arterial embolism)
primary outcome:
Immunosuppressive T‐cell antibody induction for heart transplant recipients
mortality;severe acute rejection ‐ proven by biopsy ‐ of level 3A or worse according to the classification of the ISHLT, which is equivalent to grade H2R in the recently revised classification (Stewart 2005). Grade H2R is defined according to the ISHLT classification as moderate rejection (that is, two or more foci with infiltrate and associated myocyte damage).
primary outcome:
Blood pressure targets for hypertension in people with diabetes mellitus
All‐cause mortality plus cardiovascular and non‐cardiovascular mortality separately.Total serious adverse events (total serious morbidity and mortality).Cardiovascular serious adverse events, including myocardial infarction, stroke, congestive heart failure, end‐stage renal failure.All other serious adverse events.
primary outcome:
Corticosteroids for viral myocarditis
Mortality;Clinical endpoint (defined as death rate combined with heart transplantation rate);Incidence of complications (severe arrhythmias, cardiac shock).
primary outcome:
Beta blockers for peripheral arterial disease
Primary outcome measures considered for this review were initial claudication distance in metres, time to claudication in minutes and maximal walking distance in metres and minutes (as assessed by treadmill).
primary outcome:
Nitrates for acute heart failure syndromes
Rapidity with which symptoms (for example dyspnoea, fatigue, self reported patient satisfaction score, global clinical status) are relieved.
primary outcome:
Once versus twice daily low molecular weight heparin for the initial treatment of venous thromboembolism
symptomatic recurrent VTE, i.e. DVT or PE, or both during the initial treatment and during follow up;major haemorrhagic episodes during initial treatment or within 48 hours after treatment cessation.a new constant intraluminal filling defect was found which was not present on the last available venogram, or extension of the thrombus on ultrasound,if the venogram was not diagnostic: either an abnormal 125I‐fibrinogen leg scan or abnormal impedance plethysmogram or ultrasound result that had been normal before the suspected recurrent episode (Büller 1991).a segmental defect was found on the perfusion lung scan unmatched on the previous ventilation scan or chest roentgenogram;a positive pulmonary angiography or spiral computed tomography (CT);pulmonary embolism at autopsy.
primary outcome:
Multidisciplinary rehabilitation following botulinum toxin and other focal intramuscular treatment for post‐stroke spasticity
passive function (e.g. Leeds Arm Spasticity Impact Scale (Bhakta 1996); Disability Assessment Scale (Brashear 2002); Arm Activity measure (Turner‐Stokes 2010b));active function of the upper limb (e.g. Motor Activity Log (MAL) (Van der Lee 2004); or Action Research Arm Test (ARAT) (Lyle 1981));active function of the lower limb with such mobility measures including tests of walking speed, balance and gait pattern (e.g. Timed Up And Go (TUAG) (Podsiadlo 1991); 10 m walk test (Green 2002)).
primary outcome:
Occupational therapy for care home residents with stroke
Performance in ADL at the end of scheduled follow‐up (e.g. Barthel ADL Index score (Mahoney 1965), Nottingham extended ADL Index score (Nouri 1987), Edmans ADL Index score (Edmans 1997)). When both personal ADL outcomes and extended ADL outcomes were available, we used personal ADL outcome data.Death or a poor outcome. We defined poor outcome as deterioration in ability to perform ADL (a drop in ADL score).
primary outcome:
Early versus delayed mobilisation for aneurysmal subarachnoid haemorrhage
Death from recurrent haemorrhage during the scheduled treatment period and the scheduled follow‐up period. We planned to classify recurrent haemorrhage into two categories:a probable recurrent haemorrhage defined as sudden deterioration leading to death without confirmation of rebleeding by CT, magnetic resonance imaging (MRI) or post mortem;a definite recurrent haemorrhage defined as sudden clinical deterioration with rebleeding confirmed by CT, MRI or post mortem.The proportion of recurrent haemorrhage.
primary outcome:
Continuous versus intermittent physiological monitoring for acute stroke
Death and disability (modified Rankin Scale (mRS) ≥ 3 or equivalent) at three months or longer, or at discharge if follow up was no longer availableDeath from any cause at discharge
primary outcome:
Flavonoids for treating venous leg ulcers
Total number of completely healed ulcers within the trial period.Change in ulcer surface area, however reported.Time for ulcers to achieve complete healing.
primary outcome:
Cholesterol‐reducing agents for aneurysmal subarachnoid haemorrhage
Unfavourable outcome (death, vegetative state, or severe disability (modified Rankin Scale (mRS) score 4 to 6) at six months post‐SAH).
primary outcome:
Non‐pharmacological interventions for preventing secondary vascular events after stroke or transient ischemic attack
A cluster of second stroke or MI or vascular death, whichever occurred first.
primary outcome:
Physical rehabilitation for older people in long‐term care
Function in activities of daily living (ADL) measured either with an independence scale (e.g. the Barthel Index (BI), the Functional Independence Measure (FIM)) or tests of ability in ADL, such as mobility or transfers (e.g. Timed Up and Go (TUG) test, 6‐metre walk test). Activities of daily living typically include eating, bathing, dressing, continence, personal care, mobility, and transfers.
primary outcome:
Hypothermia for neuroprotection in children after cardiopulmonary arrest
Best neurological outcome at hospital discharge and within the first year as assessed by the Paediatric Cerebral Performance Category score and other validated outcome scores for use in children (e.g. Vineland Adaptive Behaviour Scales)Survival up to six months and long‐term survival (long term defined as greater than one year)
primary outcome:
Wolbachia‐carrying Aedes mosquitoes for preventing dengue infection
We planned to assess the outcome measures at all time points up to the longest follow‐up. We planned to group the time points as short‐term (up to 12 months after final deployment) and long‐term (more than 12 months after final deployment). The outcomes listed are outcomes of interest and were not used as criteria for study inclusion.
primary outcome:
Vaccines for preventing herpes zoster in older adults
Cumulative incidence of herpes zoster, diagnosed according to the criteria (clinical or laboratory, or both) established by the primary studies.
primary outcome:
Antiplatelet agents for the treatment of adults with COVID‐19
We included studies evaluating antiplatelets for the treatment of COVID‐19 independently of reported outcomes.We evaluated core outcomes based on the Core Outcome Measures in Effectiveness Trials (COMET) Initiative for COVID‐19 patients (COMET 2021; Marshall 2020), and additional outcomes that have been prioritised by consumer representatives and the German guideline panel for therapy of hospitalised people with COVID‐19.We defined outcome sets for two populations. Those are: (i) hospitalised individuals with a confirmed diagnosis of COVID‐19 and moderate to severe disease, and (ii) ambulatory managed individuals with a confirmed diagnosis of SARS‐CoV‐2 infection and asymptomatic or mild disease, according to the WHO Clinical Progression Scale (Marshall 2020).
primary outcome:
Balanced crystalloid solutions versus 0.9% saline for treating acute diarrhoea and severe dehydration in children
Time in hospital (or hospital length of stay)Mortality (overall during hospitalization)
primary outcome:
Therapeutics for treating mpox in humans
The main review addresses patient‐important outcomes as determined by the WHO Clinical Management and Infection Prevention and Control guideline development group (GDG), described below. These are outcomes of interest, and we did not use them as criteria for study inclusion.
primary outcome:
Hyperimmune immunoglobulin for people with COVID‐19
We included these critical outcomes in the summary of findings tables for the most important comparisons.
primary outcome:
Remdesivir for the treatment of COVID‐19
We evaluated core outcomes based on the Core Outcome Measures in Effectiveness Trials (COMET) initiative for people with COVID‐19 (COMET 2020), and additional outcomes that have been prioritised by consumer representatives and the German guideline panel for therapy of people with SARS‐CoV‐2 infection.We defined outcome sets with primary and secondary outcomes for two populations:Primary outcomes were used to inform the summary of findings tables.
primary outcome:
Systemic corticosteroids for the treatment of COVID‐19: Equity‐related analyses and update on evidence
We evaluated core outcomes in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative for COVID‐19 patients (COMET 2020; Marshall 2020), and additional outcomes that have been prioritised by consumer representatives and the panel of the German 'National Treatment Guidance for Hospitalised COVID‐19 Patients' (Kluge 2022).We defined this outcome set for hospitalised individuals with a confirmed or suspected diagnosis of COVID‐19 and moderate to severe disease, according to the WHO clinical progression scale stage 4 to 9 (Marshall 2020); that is, all patients who were hospitalised because of symptomatic COVID‐19 treated with all different levels of respiratory support (no additional oxygen, low‐flow oxygen prongs or mask ('low‐flow oxygen' only hereafter), high‐flow oxygen or non‐invasive ventilation (NIV), invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO)), and individuals with a confirmed or suspected diagnosis of SARS‐CoV‐2 infection and asymptomatic or mild disease, according to the WHO clinical progression scale (Marshall 2020). Of note, readers may encounter respiratory support both as a baseline characteristic and as an outcome measure ‐ in the latter case we used changes in the level of support.
primary outcome:
Ivermectin for preventing and treating COVID‐19
We evaluated core outcomes in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative for COVID‐19 patients (COMET 2020; Marshall 2020), and additional outcomes that have been prioritized by consumer representatives and the German guideline panel for inpatient therapy of people with COVID‐19 (German AWMF Guideline 2021a) and for outpatient therapy (German AWMF Guideline 2021b). The current outcome set differed between previous protocols and reviews and the current review. Changes to the outcomes were necessary due to the risk of competing events associated with the original outcome set. We added outcomes for inpatients and outpatients that aim to simultaneously capture all participants of the population with clinical worsening and all participants with clinical improvement. This was possible by using composite outcomes, e.g. combining new need for invasive mechanical ventilation and death as clinical worsening for inpatients, and combining admission to hospital and death for outpatients. This adjusted outcome set should allow evidence on ivermectin to become more unambiguous and patient‐relevant.We analysed different outcomes for the use of ivermectin for treatment of people with COVID‐19 in inpatient and outpatient settings, and for the prevention of SARS‐CoV‐2 infection. If trials were eligible for inclusion regarding design, population, intervention, and comparator, but did not report outcomes of interest, they were not included for meta‐analysis. However, we summarized reported outcomes for all included trials in the Characteristics of included studies table.
primary outcome:
SARS‐CoV‐2‐neutralising monoclonal antibodies to prevent COVID‐19
We evaluated core outcomes as predefined by the Core Outcome Set for studies evaluating public health, primary and secondary care interventions for prevention of COVID‐19 transmission (COMET 2020; Marshall 2020).
primary outcome:
Janus kinase inhibitors for the treatment of COVID‐19
We evaluated core outcomes based on the Core Outcome Measures in Effectiveness Trials (COMET) Initiative for people with COVID‐19 (COMET 2020; Marshall 2020), and additional outcomes that have been prioritised by consumer representatives and the German guideline panel for therapy of hospitalised people with COVID‐19.We defined outcome sets with primary and secondary outcomes for two populations:Primary outcomes were used to inform the summary of findings Table 1.
primary outcome:
Inhaled corticosteroids for the treatment of COVID‐19
We evaluated core outcomes in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative for people with COVID‐19 (COMET 2020; Marshall 2020), and additional outcomes that have been prioritised by consumer representatives and the panel of the German "national treatment guidance for hospitalized COVID‐19 patients" (Kluge 2022).We defined this outcome set for hospitalised people with a confirmed diagnosis of COVID‐19 and moderate‐to‐severe disease, according to WHO clinical progression scale stage 4 to 9 (Marshall 2020) (i.e. all patients who were hospitalised because of symptomatic COVID‐19 treated with all different levels of respiratory support, such as no additional oxygen, low‐flow oxygen prongs or mask ('low‐flow oxygen'), high‐flow oxygen or non‐invasive ventilation, invasive mechanical ventilation inclusively extracorporeal membrane oxygenation) and people with a confirmed diagnosis of SARS‐CoV‐2 infection and asymptomatic or mild disease, according to the WHO clinical progression scale (Marshall 2020). Of note, the reader will encounter respiratory support both as baseline characteristic and as outcome measure – in the latter case changes in the level of support will be utilised.In review updates, we will also evaluate patient‐reported experience measures (PREMS), as suggested by the consumer editor. However, up to October 2021, the included studies did not report PREMS.
primary outcome:
Antibiotics for the treatment of COVID‐19
No study reported data for any primary outcome of this comparison.
primary outcome:
Colchicine for the treatment of COVID‐19
We evaluated core outcomes based on the Core Outcome Measures in Effectiveness Trials (COMET) Initiative for people with COVID‐19 (COMET 2021), and additional outcomes that have been prioritised by consumer representatives and the German guideline panel for hospitalised and non‐hospitalised therapy of people with COVID‐19.We defined outcome sets for two populations: hospitalised people with a confirmed diagnosis of COVID‐19 and moderate to severe disease, and non‐hospitalised managed people with a confirmed diagnosis of SARS‐CoV‐2 infection and asymptomatic or mild disease, according to WHO clinical progression scale (WHO 2020b). We separated outcomes into primary outcomes, the ones included in the summary of findings tables, and deemed most relevant for patients, and additional (i.e. secondary) outcomes.
primary outcome:
SARS‐CoV‐2‐neutralising monoclonal antibodies for treatment of COVID‐19
We evaluated core outcomes based on the Core Outcome Measures in Effectiveness Trials (COMET) Initiative for COVID‐19 patients and additional outcomes (COMET 2020; Marshall 2020).We stratified analyses by disease severity, thereby separating non‐hospitalised (asymptomatic or mild disease) and hospitalised individuals (moderate to severe disease) with COVID‐19 according to the WHO clinical progression scale (Marshall 2020; see Figure 1). At the later stage, reduction of viral replication may no longer be the main driver of the disease, instead, inflammation and coagulopathy may be more important (Marovich 2020).
primary outcome:
Impact of diagnostic strategies for tuberculosis using lateral flow urine lipoarabinomannan assay in people living with HIV
All‐cause mortality during study follow‐up time.Tuberculosis‐related mortality during study follow‐up time.
primary outcome:
Minimally invasive treatments for lower urinary tract symptoms in men with benign prostatic hyperplasia: a network meta‐analysis
Urological symptom scoresQuality of lifeMajor adverse events
primary outcome:
Effect of mass deworming with antihelminthics for soil‐transmitted helminths during pregnancy
Maternal anaemia in the third trimester of pregnancy (haemoglobin less than 11 g/dL)Preterm birth (birth before 37 weeks of gestation)Perinatal mortality (includes foetal death after 28 weeks of gestation and infant death that occurs at less than seven days of life)
primary outcome:
Topical microbicides for preventing sexually transmitted infections
Laboratory confirmed incidence of STIs (viral, bacterial, fungal, protozoan). We reported the laboratory methods used for measurement of the outcomes included.Serious adverse events, i.e. the proportion of participants who experience any adverse effect requiring hospitalisation or discontinuation of therapy, or both.
primary outcome:
Topical antibiotic prophylaxis to reduce respiratory tract infections and mortality in adults receiving mechanical ventilation
Overall mortality. We considered mortality at hospital discharge if this information was provided; otherwise we considered mortality in the ICU.Respiratory tract infections. We made no restriction on the type of RTI considered (pneumonia and tracheobronchitis, ventilator‐associated pneumonia (VAP), and infection‐related ventilator‐associated complication (IVAC)), nor on the RTI diagnostic criteria used. We considered both primary (diagnosed within 48 hours from admission) and acquired (diagnosed after 48 hours from admission) infections. In case both were reported, we considered data from the acquired group.
primary outcome:
Use of antimicrobial mouthwashes (gargling) and nasal sprays by healthcare workers to protect them when treating patients with suspected or confirmed COVID‐19 infection
Incidence of symptomatic or test‐positive COVID‐19 infection in HCWs.Significant adverse event: anosmia (or disturbance in sense of smell).
primary outcome:
Antimicrobial mouthwashes (gargling) and nasal sprays administered to patients with suspected or confirmed COVID‐19 infection to improve patient outcomes and to protect healthcare workers treating them
RECOVERY* outcomes in patients (www.recoverytrial.net):mortality;hospitalisation status;use of ventilation;use of renal dialysis or haemofiltration.Incidence of symptomatic or test‐positive COVID‐19 infection in HCWs.Significant adverse event: anosmia (or disturbance in sense of smell).
primary outcome:
Video calls for reducing social isolation and loneliness in older people: a rapid review
Self‐report measures of loneliness (i.e. scores on any self‐report questionnaire that is designed to quantify how lonely a person feels)Self‐report measures of social isolation (i.e. scores on any self‐report questionnaire that is designed to quantify the extent to which a person is socially isolated)
primary outcome:
Shortened treatment regimens versus the standard regimen for drug‐sensitive pulmonary tuberculosis
Relapse of tuberculosis, defined as clinical or bacteriologic recurrence within two years of completion of anti‐tuberculosis therapy
primary outcome:
Antibiotics for asymptomatic bacteriuria in pregnancy
Development of pyelonephritisPreterm birth less than 37 weeksBirthweight less than 2500 g
primary outcome:
Intra‐pleural fibrinolytic therapy versus placebo, or a different fibrinolytic agent, in the treatment of adult parapneumonic effusions and empyema
MortalityReferral for thoracic surgery (open or thorascopic)Overall treatment failure, including mortality, thoracic surgery or referral for further fibrinolytic therapySerious adverse events
primary outcome:
Rapid initiation of antiretroviral therapy for people living with HIV
All‐cause mortality rate.Virological suppression 12 months after a positive HIV test. According to the WHO, viral suppression refers to "a viral load below the detection threshold using viral assays" and defines viral failure as the inability to achieve a viral threshold below 1000 copies/mL (WHO 2016). However, there is inconsistency in the thresholds used in different settings and time periods to define viral suppression (AIDSinfo 2015; EACS 2017; NASCOP 2016; NDOHSA 2015). For this reason, we used the investigators' study definitions of virological suppression or undetectable viral load.
primary outcome:
Community‐based antibiotic delivery for possible serious bacterial infections in neonates in low‐ and middle‐income countries
Neonatal mortality ‐ the number of neonatal deaths from any cause among all neonates. For individually‐randomised and quasi‐randomised trials, neonatal morality was calculated as the number of neonatal deaths divided by the total number of neonates enrolled in the trial. For cluster‐randomised trials, neonatal mortality was calculated as the number of neonatal deaths divided by the total number of live births within each cluster during the trial period.Early neonatal mortality: from birth through six completed days of lifeLate neonatal mortality: between 7 and 27 completed days of lifeSepsis‐specific neonatal mortality ‐ the number of neonatal deaths secondary to PSBI among all neonates during the trial period. Similar calculation considerations applied to sepsis‐specific mortality as neonatal mortality.Early neonatal sepsis‐specific mortality: from birth through six completed days of lifeLate neonatal sepsis‐specific mortality: between 7 and 27 completed days of life
primary outcome:
Primary antifungal prophylaxis for cryptococcal disease in HIV‐positive people
All‐cause mortality: number of deaths from any cause/number randomized
primary outcome:
Early versus delayed antiretroviral treatment in HIV‐positive people with cryptococcal meningitis
All‐cause mortality
primary outcome:
Influenza vaccine for chronic obstructive pulmonary disease (COPD)
Exacerbations of COPD, defined as an increase in breathlessness, volume or purulence of sputum, or a combination. This was assessed in terms of both total numbers of exacerbations and participants with one or more exacerbations in the study period.Days of disability from respiratory illness, defined as days in bed, days off work, or days when the person was unable to undertake normal activitiesHospital admissionsMortality in the year following vaccination (All cause and respiratory‐related)
primary outcome:
Interventions for necrotizing soft tissue infections in adults
Mortality within 30 days.Proportion of participants who experience a serious adverse event.
primary outcome:
Interventions to increase influenza vaccination rates of those 60 years and older in the community
Uptake of vaccination against influenza in those aged 60 years or older.
primary outcome:
Osmotic therapies added to antibiotics for acute bacterial meningitis
All‐cause mortality.
primary outcome:
Antidepressants for depression in adults with HIV infection
Improvement in depression: (dichotomous: yes/no; or continuous) measured by rating scales such as the Beck Depression Inventory (Beck 1961), Patient Health Questionnaire (Spitzer 1999), Hamilton Depression Rating Scale (HAM‐D; Hamilton 1980), Montgomery‐Åsberg Depression Rating Scale (MADRS; Montgomery 1979), the Center for Epidemiologic Studies Depression Scale (CESD‐R; Eaton 2004) or Clinical Global Impression of Improvement (CGI‐I; Guy 1976).Study dropouts: rate/proportion after initiation of study intervention.
primary outcome:
Corticosteroids for pneumonia
All‐cause mortality within 30 days after randomisation. If not reported at day 30, we extracted the outcome closest to 30 days.
primary outcome:
Macrolides for treatment of Haemophilus ducreyi infection in sexually active adults
Clinical cure (proportion of participants with complete healing of ulcer and buboes after therapy). Syndromic and aetiological approaches.Clinical improvement (proportion of participants with decrease in the size of the ulcer or buboes after intervention). Syndromic and aetiological approaches.Microbiological cure (proportion of participants with eradication of H ducreyi after treatment, by in vitro cell culture or by polymerase chain reaction (PCR) test).Serious adverse event (proportion of participants who experience any adverse effect requiring hospitalization or discontinuation of therapy, or both).
primary outcome:
Interventions to increase tuberculosis case detection at primary healthcare or community‐level services
Tuberculosis cases detected (microbiologically confirmed) refers to tuberculosis patients with a positive result of either acid‐fast bacilli (AFB) sputum smear microscopy or GeneXpert MTB/RIF and/or mycobacterial culture (solid or liquid culture).
primary outcome:
Routine antibiotic prophylaxis after normal vaginal birth for reducing maternal infectious morbidity
Incidence of severe maternal infectious morbidity (including septicaemia, septic shock, laparotomy/hysterectomy for infection, maternal intensive care unit (ICU) admission, or organ failure) as reported by trial authors.Endometritis (with or without myometritis and with or without salpingitis causing maternal febrile morbidity), as reported by the trial authors.Urinary tract infection (fever or dysuria and positive urine culture).
primary outcome:
Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections
All‐cause mortality following randomisation up to a follow‐up time of 30 days.Setting‐specific treatment failure within 30 days of inclusion.
primary outcome:
Short‐course versus long‐course intravenous therapy with the same antibiotic for severe community‐acquired pneumonia in children aged two months to 59 months
Clinical cure: defined as improvement in symptoms, such as return of respiratory rate to the normal age‐specific range and disappearance of chest indrawing.Duration of hospital stay: defined as the duration for which the patient was admitted due to severe CAP. This duration is not outcome‐dependent and does not include time spent in the hospital for treatment for other conditions, if any.
primary outcome:
Intravenous immunoglobulin for the treatment of childhood encephalitis
Proportion of participants with significant disability (= 'poor outcome') at six months after treatment.Significant disability using any validated disability assessment scale such as (but not limited to) the Glasgow Outcome Scale Extended (score of 2 or less) (Beers 2012), Liverpool Outcome Score (score of 2 or less) (Lewthwaite 2010), or the modified Rankin Scale (score of 4 or more) (van Swieten 1988).Proportion of participants with at least one serious adverse event as defined in the trial.
primary outcome:
Probiotics for preventing urinary tract infection in people with neuropathic bladder
Symptomatic urinary tract infectionThe primary outcome measure was the number of symptomatic UTI according to defined clinical criteria, along with a positive quantitative urine culture. This is the most clinically significant outcome measure for populations at long‐term risk of recurrent UTI, such as people with neuropathic bladder.Symptoms of UTI in the general population include dysuria, frequency, urgency, voiding of small volumes, abrupt onset, suprapubic pain, and presence of pyuria (Stamm 1988). In SCI patients, relevant symptoms should be explained by other intercurrent pathology and include: temperature, autonomic dysreflexia, increased frequency of muscle spasms or spasticity, failure of usual control of urinary incontinence, and new abdominal discomfort (NIDRRCS 1992).Quantitative urine cultureNumbers of UTI confirmed by appropriate microbiological criteria. Bacteriuria on quantitative urine analysis of more than 100,000 organisms of a single species/mL was the accepted standard; however, the colony count may vary from 100 to 100,000 depending on the clinical setting (Stamm 1988). Therefore in some situations, such as a clean suprapubic tap, a colony count of less than 100,000 was acceptable.
primary outcome:
Isoniazid for preventing tuberculosis in HIV‐infected children
Active TB
primary outcome:
Antibiotics for persistent cough or wheeze following acute bronchiolitis in children
Number of participants who were not cured at follow‐up (up to six months) (i.e. wheeze/cough)Exacerbation rate (up to six months)Number of participants rehospitalised for a respiratory illness within six months of onset of illness
primary outcome:
Zinc supplementation for the treatment of measles in children
All‐cause mortality.
primary outcome:
Haemophilus influenzae oral vaccination for preventing acute exacerbations of chronic bronchitis and chronic obstructive pulmonary disease
Incidence of acute exacerbations of chronic bronchitis or COPD.Mortality.
primary outcome:
Antibiotics for acute bronchitis
Cough‐related outcomes including:time to resolution of cough;sputum production, defined as proportion of participants with or without sputum;proportions of participants with cough, night cough, productive cough.Global assessment of improvement by clinicians at follow‐up.General clinical outcomes including:severity of symptoms;activity limitations;abnormal lung examination at a designated follow‐up visit.
primary outcome:
Pre‐admission antibiotics for suspected cases of meningococcal disease
Mortality: death before reaching hospital, in hospital, or within a month of discharge or leaving the hospital.Lack of clinical improvement: as defined by individual trials.Morbidity: persistent neurological defects in the form of vision and hearing loss, speech disorders, persistent cognitive or intellectual impairment, and paralysis, or any other recorded persistent neurological defects.
primary outcome:
Nasal decontamination for the prevention of surgical site infection in Staphylococcus aureus carriers
The primary outcomes for this review were SSI and adverse events.Occurrence of postoperative SSI: the proportion of people who developed SSIs, as defined by the Centers for Disease Control and Prevention (CDC) (Mangram 1999); or by the study authors. We did not differentiate between superficial and deep‐incisional infection. The SSI outcome was measured in participants who were scheduled to undergo surgery. Whatever the organism implicated in the SSI we extracted any data on antibiotic resistance.Adverse events (e.g. burning localised to the area of application; itching, erythema, stinging and dryness localised to the area of application; cutaneous sensitisation reactions to mupirocin or the ointment base). These were included where reported as total number of individuals with adverse events in each intervention group.Konvalinka 2006: this study found no clear difference in SSI risk following use of mupirocin compared with placebo: RR 1.60, 95% CI 0.79 to 3.25 based on 18/130 (7 sternal and 11 leg) events in the mupirocin group and 11/127 (6 sternal and 5 leg) in the control group (Analysis 1.1). We considered this to be low‐certainty evidence due to imprecision (downgraded twice due to small numbers of events and wide confidence intervals which include the possibility of both benefit and harm for the intervention).Konvalinka 2006 reported information on adverse effects, noting that no adverse reactions were reported for either mupirocin or placebo. No GRADE assessment was possible.Yu 2011: it is uncertain whether there was a difference in the risk of SSIs following treatment with Anerdian compared with no treatment : RR 0.89, 95% CI 0.06 to 13.08 based on 1/18 events in the Anerdian group and 1/16 in the control group (Analysis 2.1). We considered these data to be very low certainty evidence due to imprecision (downgraded twice) and high risk of bias (downgraded once).It was not clear how adverse event data had been collected. The study summarised data on side effects of the use of Anerdian. Ten events of dry skin and itch and two events of nasal mucosa bleeding were reported in the treatment group. It was not clear that this was the total number of participants with events. We have not analysed data further. No GRADE assessment was possible.No data on other review outcomes were available.
primary outcome:
Surgical versus non‐surgical management for pleural empyema
Mortality.
primary outcome:
Effectiveness and safety of procalcitonin evaluation for reducing mortality in adults with sepsis, severe sepsis or septic shock
Mortality at up to 28 days, in the ICU, in hospital (from sepsis or all causes) and at longest follow‐up.Time receiving antimicrobial therapy (in days) or quantity (volume) of antimicrobial agents received.Change in antimicrobial regimen from a broad to a narrower spectrum.
primary outcome:
Dressings for the prevention of surgical site infection
Occurence of postoperative SSI as defined by the CDC criteria (Horan 2008), or the authors' definition of SSI. We did not differentiate between superficial and deep‐incisional infection.
primary outcome:
Antiviral agents for infectious mononucleosis (glandular fever)
Time to clinical recovery.Adverse events and side effects of medication: as reported in the original studies by patients and clinicians.
primary outcome:
One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates
Clinical efficacy: clearance of proven sepsis defined as negative blood or other body fluid cultures without the need for a change in antibiotics.Pharmacokinetic efficacy:Failure to reach adequate peak levels of at least 5 µg/ml. Peak level was defined as the level measured 0.5 to one hour after administration of any dose of gentamicin on any day during the study period.Failure to avoid toxic trough levels of > 2 µg/ml. The trough level was defined as the level measured within one hour prior to the administration of gentamicin on any day during the study period (except the initial dose).
primary outcome:
School‐based interventions for preventing HIV, sexually transmitted infections, and pregnancy in adolescents
Clinical/biological outcomes:Behavioural self‐reported outcomes:
primary outcome:
Topical antibiotics for preventing surgical site infection in wounds healing by primary intention
SSI, as defined by the CDC definition of SSI. In this definition infection must occur within 30 days of the procedure, therefore this time point was used as a cut‐off for this primary outcome measure. We also accepted the trial authors' definitions of infection.Proportion of patients with any relevant adverse effect within 30 days of the procedure, i.e. allergic contact dermatitis, anaphylaxis, or infections with patterns of antibiotic resistance.
primary outcome:
Fluid therapy for acute bacterial meningitis
DeathShort‐term (within the first four weeks of illness) and long‐term (persisting after the first four weeks of illness) neurological sequelae
primary outcome:
Antibiotics for ventilator‐associated pneumonia
All‐cause mortality (28‐day).Clinical cure. Resolution of pneumonia may be assessed subjectively by the clinician but must also be accompanied by a more objective indicator of improvement, for example, disappearance of infiltrates, repeat negative cultures, or decrease in the white blood cell count.
primary outcome:
HIV prevention advice for people with serious mental illness
For the purposes of this review we planned to divide outcomes into four time periods: i. immediate (within one week); ii. short term (one week to six months); iii. medium term (six months to one year); and iv. long term (more than one year).
primary outcome:
Interventions for men and women with their first episode of genital herpes
1. Duration of symptoms from onset of treatment: symptoms are defined by the trial authors. When several symptoms are reported, we included the longest duration.
2. Time to first recurrence.
3. Adverse events.
primary outcome:
Exercise prior to influenza vaccination for limiting influenza incidence and its related complications in adults
Incidence of influenza (as reported by primary studies).Complications related to influenza illness.Adverse effects of vaccination.