anurajms/meta_analysis huggingface dataset:
primary outcome:
Pharmacotherapy for hypertension‐induced left ventricular hypertrophy
All‐cause mortality.Cardiovascular events (myocardial infarction (fatal or non‐fatal), stroke (fatal or non‐fatal), or atrial fibrillation).Total serious adverse events. Serious adverse events were defined according to the International Conference on Harmonisation (ICH) Guidelines as events that at any dose result in death, are life‐threatening, require inpatient hospitalisation or prolongation of existing hospitalisation, result in persistent or significant disability, or are a congenital anomaly/birth defect, and any important medical event that may have jeopardised the participant or requires intervention to prevent it (ICH‐GCP 1997). These events were not required to have a causal relationship with the antihypertensive treatment.
primary outcome:
Hybrid repair versus conventional open repair for aortic arch dissection
Dissection‐related mortality and all‐cause mortality at 30 days and 12 months (Grade V)Neurological deficit (defined by global, focal and spinal events, Grade I to IV)Cardiac injury (defined by myocardial ischaemia, low cardiac output syndrome, arrhythmia, pericardial effusion, Grade I to IV)Respiratory compromise (defined by parenchymal and pleural complications, Grade I to IV)Renal ischaemia (defined by RIFLE classification Bellomo 2004, Grade I to IV)
primary outcome:
Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts
Graft patency
primary outcome:
Stem cell therapy for dilated cardiomyopathy
All‐cause mortality.Safety, as indicated by periprocedural complications occurring at the time of bone marrow aspiration or administration of SCT or control.Safety, as documented adverse events (AE) (including tumorigenesis) within 30 days of treatment.
primary outcome:
Graduated compression stockings for the initial treatment of varicose veins in people without venous ulceration 
Change in symptoms: such as aching and itching, reported by participants.Physiological measures used to monitor the impact of the intervention on varicose vein status: such as venous pressure at the ankle.
primary outcome:
Cilostazol for intermittent claudication
Initial claudication distance (ICD) (the distance walked on a treadmill before the onset of calf pain)Health‐related quality of life (QoL), including general and disease‐specific QoL, measured by a validated questionnaire
primary outcome:
Retroperitoneal versus transperitoneal approach for elective open abdominal aortic aneurysm repair
Mortality: we analyzed in‐hospital mortality, 30‐day and late mortality separately.Complications: we included hematoma, abdominal wall hernia and chronic wound pain.
primary outcome:
Endovascular thrombectomy and intra‐arterial interventions for acute ischaemic stroke
Favourable functional outcome at the end of the scheduled follow‐up period defined as a modified Rankin Scale (mRS) score of 0 to 2. Given that some prefer a definition of 'favourable outcome' as a score of 0 to 1 (NINDS 1995), we also sought data on the number of participants in each individual mRS category. If the mRS score was not reported, we used the trial's definition of functional outcome. Eighteen of the included trials (i.e. all but one trial: AUST 2005) reported their outcome at 90 days.
primary outcome:
Slow versus fast subcutaneous heparin injections for prevention of bruising and site pain intensity
Pain intensity at injection site (measured at injection site by any scale, including visual analogue scale (VAS), numerical rating, McGill scales, descriptive or other pain scales)Size of the bruise at the injection site (measured by diameter at the widest point; or area measured by millimetric measuring papers)Incidence of bruising at the injection site (the number of bruises larger than 2 mm2)
primary outcome:
Hybrid repair versus conventional open repair for thoracic aortic arch aneurysms
Aneurysm‐related mortality at 30 daysAneurysm‐related mortality at 12 monthsNeurological deficit (stroke or paraplegia)Cardiovascular event (myocardial ischaemia, heart failure, low cardiac output syndrome, arrhythmia, pericardial effusion)Respiratory compromise (parenchymal and pleural complications)
primary outcome:
Beta‐blockers and inhibitors of the renin‐angiotensin aldosterone system for chronic heart failure with preserved ejection fraction
Cardiovascular mortality.Heart failure hospitalisation (number of participants with at least one hospitalisation, analysed as risk ratios (RR), and time to first event, analysed as hazard ratios (HR)).Hyperkalaemia.
primary outcome:
Anticoagulation versus placebo for heart failure in sinus rhythm
All‐cause deathStroke
primary outcome:
Vasodilators for primary Raynaud's phenomenon
Frequency of attacksSeverity of attacks or severity of symptoms during attacks measured on validated scales (e.g. pain and numbness on visual analogue scales or Likert scales; cold sensitivity as Cold Intolerance Severity Score [CISS])Duration of attacksQuality of life scores (measured by Health Assessment Questionnaires [HAQs], Short Form‐36 [SF‐36], or QuickDASH Outcome Measure)Adverse events (including withdrawals)
primary outcome:
Fludrocortisone for orthostatic hypotension
BP outcomes: change between pre‐ and post‐treatment systolic BP and diastolic BP in the upright (standing or tilt) position, two to three minutes after standing or tilting was our preferred BP measurement after at least three weeks of treatment. However, we accepted any BP measurement method, including the pre‐ to post‐treatment change in the drop in systolic BP and diastolic BP after moving from supine to upright, or from sitting to upright, and measurements taken outside the two to three minute range (that is, any time between one and five minutes).
primary outcome:
Exercise‐based cardiac rehabilitation for adults after heart valve surgery
All‐cause mortality.Cardiovascular mortality.All‐cause hospitalisation.Health‐related quality of life assessed by generic or disease‐specific validated instruments (e.g. Short Form‐36, EuroQoL Group Quality of Life Questionnaire based on 5 dimensions (EQ‐5D) ‐ generic measures, HeartQoL ‐ heart disease‐specific measure).
primary outcome:
Endoluminal interventions versus surgical interventions for stenosis in vein grafts following infrainguinal bypass
Primary patency (defined as a patent graft without the need for re‐intervention, as assessed by angiography or ultrasonography) at 30 days, at one year, and longer when possiblePrimary assisted patency (defined as the need for revision or further revascularisation interventions to prevent impending occlusion or progression of stenosis, as assessed by angiography or ultrasonography) at 30 days, at one year, and longer when possibleAll‐cause mortality (at 30 days, at one year, and longer when possible)
primary outcome:
Thrombolytic therapy for pulmonary embolism
Death from all causesRecurrence of pulmonary emboliHaemorrhagic eventsMajor haemorrhagic events: a decreased haemoglobin concentration > 2 G/dL; retroperitoneal or intracranial bleeding; transfusion of two or more units of blood, which may or may not lead to discontinuation of anticoagulant treatmentMinor haemorrhagic events: other bleeding events not meeting the criteria for major bleeding
primary outcome:
Mobile phone‐based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults
Objective measures of adherence to treatment (low‐density lipoprotein cholesterol (LDL‐C), total cholesterol (TC) and high‐density lipoprotein cholesterol (HDL‐C), for the effect of statins; blood pressure for antihypertensive drugs; heart rate for the effect of atenolol; urinary 11‐dehydrothromboxane B2 for the antiplatelet effects of aspirin).Combined CVD events (fatal or non‐fatal events).Adverse effects including self‐reported road traffic accidents.
primary outcome:
Antibiotics for secondary prevention of coronary heart disease
All‐cause mortality.Serious adverse event. We defined a serious adverse event as any untoward medical occurrence that resulted in death; was life‐threatening; required hospitalisation or prolongation of existing hospitalisation; resulted in persistent or significant disability; or jeopardised the patient (ICH‐GCP 1997). None of the trials specifically assessed serious adverse events according to this definition by ICH‐GCP. Instead, the trials either reported composites of several specific serious adverse events or one specific serious adverse event.Quality of life measured on any valid continuous scale. None of the trials assessed quality of life.
primary outcome:
Surgical and radiological interventions for treating symptomatic extracranial cervical artery dissection
Ipsilateral stroke (for vertebral dissection, an ipsilateral event is defined as a recurrent event in the vertebrobasilar territory). The World Health Organization (WHO) defines stroke as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin" (Hatano 1976).Disability (defined according to the modified Rankin Scale (mRS) UK‐TIA Study Group 1988):mRS 0,1 and 2 are judged as no or minor disability*;mRS 3, 4 and 5 as major disability;mRS 6 are dead.
primary outcome:
Long‐term effects of weight‐reducing drugs in people with hypertension
Total mortalityCardiovascular morbidityAdverse events (withdrawals due to adverse events, adverse events related to a particular anti‐obesity drug)
primary outcome:
Blood pressure targets in adults with hypertension
All‐cause mortality plus cardiovascular and non‐cardiovascular mortality separately.Total serious adverse events (total serious morbidity and mortality).Cardiovascular serious adverse events: myocardial infarction, stroke, congestive heart failure, end‐stage renal failure. A composite of total cardiovascular events was not possible because it was not reported consistently in the different trials. All other serious adverse events.
primary outcome:
Trypanocidal drugs for late‐stage, symptomatic Chagas disease (Trypanosoma cruzi infection)
Lowering or disappearance of parasitaemia or anti‐T cruzi antibodies, which was considered to have been achieved if one or more of the following were fulfilled.Clearance or reduction of the mean antibody titres to T cruzi after treatment in comparison to the pretreatment results after a follow‐up period of at least 18 months. Mean anti‐T cruzi antibodies demonstrated by any of the following: haemagglutination, indirect immunofluorescence, and/or ELISA.Clearance of parasitaemia demonstrated by a negative xenodiagnosis, blood culture, and/or molecular biology assays 12 months after treatment.Pathological demonstration of tissue parasites (if a biopsy or necropsy was available).
primary outcome:
Angioplasty versus stenting for iliac artery lesions
Technical success of the procedure (ability to restore more than 50% of the lumen)Incidence of complications:Immediate (< 72 hours): e.g. dissection, thrombosis, infection, distal embolisationDelayed (> 72 hours): e.g. worsening of disease, pseudoaneurysm formationSymptomatic improvement: improvement in the stage of PAD according to Rutherford's criteria (Rutherford 1997)Patency of the treated vessel as assessed by duplex sonography, computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
primary outcome:
Inotropic agents and vasodilator strategies for the treatment of cardiogenic shock or low cardiac output syndrome
All‐cause mortality (short‐term: up to 1 month after treatment; long‐term: more than 1 month after treatment)
primary outcome:
Ivabradine as adjuvant treatment for chronic heart failure
Mortality from cardiovascular causes (as defined by trial authors).Quality of life (QoL) measured using validated scales, e.g. the Short Form Health Survey (SF‐36) (Ware 1992).Time to first hospitalisation for heart failure during follow‐up.Number of days spent in hospital due to heart failure during follow‐up.
primary outcome:
Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension
All‐cause mortalityTotal cardiovascular events:fatal or non‐fatal myocardial infarctionfatal or non‐fatal strokefatal congestive heart failurehospitalizations for congestive heart failureEnd‐stage renal disease (ESRD)Withdrawal due to adverse effects (WDAE)Fatal or non‐fatal serious adverse events (SAEs)Adverse events (AEs)
primary outcome:
Electromechanical‐assisted training for walking after stroke
a score of 3 on the ambulation item of the Barthel Index (Wade 1988); ora score of 6 or 7 for the walking item of the Functional Independence Measure (Hamilton 1994); ora 'yes' response to the item 'walking inside, with an aid if necessary (but with no standby help)' or 'yes' to 'walking on uneven ground' in the Rivermead Mobility Index (Collen 1991).
primary outcome:
PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease
Composite endpoint of CVD, defined as urgent coronary revascularisation, unstable angina pectoris, non‐fatal and fatal myocardial infarction (MI), non‐fatal and fatal stroke, and CHD death.All‐cause mortality.MI.Stroke.
primary outcome:
Pentoxifylline for intermittent claudication
pain‐free walking distance (PFWD) or initial claudication distance (ICD), which is the distance walked on a treadmill before the onset of pain; andtotal walking distance (TWD) or absolute claudication distance (ACD), which is the maximum or absolute distance walked on a treadmill.
primary outcome:
Antiplatelet and anticoagulant agents for secondary prevention of stroke and other thromboembolic events in people with antiphospholipid syndrome
Any thromboembolic event, including death or any arterial or venous thrombosisMajor bleeding
primary outcome:
Vena caval filters for the prevention of pulmonary embolism
PE (fatal and non‐fatal) as demonstrated by computer tomography (CT), pulmonary angiography or ventilation‐perfusion lung scanMortality
primary outcome:
Atherectomy for peripheral arterial disease
Primary vessel patency, as assessed by ankle brachial index (ABI), arterial doppler ultrasound or angiography at six months and one year, and as data available in the studiesAll‐cause mortality at six months and one year, and as data available in the studiesFatal and non‐fatal cardiovascular events at six months and one year, and as data available in the studies
primary outcome:
Motor imagery for gait rehabilitation after stroke
Continuous variable: walking speed, measured by biomechanical analysis or walking tests, or both, considering both preferable/comfortable walking speed and fastest walking speed.Dichotomous variable: dependence on personal assistance. According to Mehrholz and colleagues, dependence was defined "as the inability to walk indoors (with or without a gait aid) without personal assistance or supervision" (Mehrholz 2017). If reported, we used data from functional scales related to walking to define the level of dependence. We considered the following scales and scores (Mehrholz 2017):Motor Assessment Scale (MAS) (Carr 1985), score of 2 or less for the walking item;Functional Independence Measure (Hamilton 1994), score of 5 or less for the walking item;Barthel Index (Collin 1988), score of 3 (independent, but may use any aid) or less for the ambulation item;Rivermead Mobility Index (Collen 1991), an answer of 'no' to the 'walking inside with an aid if necessary' item; andFunctional Ambulation Category (FAC) (Holden 1984), score of 2 or less.
primary outcome:
Presurgery exercise‐based conditioning interventions (prehabilitation) in adults undergoing lower limb surgery for peripheral arterial disease
30‐day mortality: defined as all‐cause death occurring within 30 days of the surgical procedurePostoperative complicationsNon‐fatal cardiovascular events including myocardial infarction, heart failure, or strokePulmonary complications: including hypoxia, atelectasis, pneumonia, and respiratory failureHaemorrhageSurgical site infection (SSI)Any other complications not specified aboveReadmission within 30 days of the surgical procedureMajor adverse limb events (MALE), including amputations or major re‐interventionAny other cause related to surgery
primary outcome:
Alcohol intake reduction for controlling hypertension
Overall mortality.Cardiovascular mortality.Serious adverse events. According to the International Conference on Harmonisation Guidelines (ICH 1995) that defines serious adverse events as any event that leads to death, that was life‐threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability, or is a congenital anomaly/birth defect.Cardiovascular events: including myocardial infarction, stroke, sudden death, hospitalisation or death from congestive heart failure and other significant vascular events such as ruptured aneurysms (does not include angina, transient Ischaemic attacks, surgical or other procedures or accelerated hypertension).Decrease in blood pressure.Proportion of subjects with SBP < 140 mmHg and DBP < 90 mmHg.
primary outcome:
Time course for blood pressure lowering of beta‐blockers with partial agonist activity
End point hourly systolic and diastolic BP, measured using a 24‐hour ambulatory BP monitoring device.
primary outcome:
Citicoline for treating people with acute ischemic stroke
All‐cause mortality (at 90 days).Degree of disability or dependence in daily activities according to the modified Rankin scale (at 90 days) (Harrison 2013; McArthur 2014; van Swieten 1988). See Appendix 1.
primary outcome:
Modes of exercise training for intermittent claudication
Maximal treadmill walking distance or time (MWD/T)
primary outcome:
Setting and techniques for monitoring blood pressure during pregnancy
Systolic BP greater than or equal to 150 mmHg
primary outcome:
mHealth education interventions in heart failure
Heart‐failure knowledge using validated toolsSelf‐efficacy using validated toolsSelf‐care using validated toolsAdverse events
primary outcome:
Effect of alcohol on blood pressure
Change in resting seated systolic and diastolic blood pressures at three different time periods after alcohol intake: early (up to six hours); intermediate (7 to 12 hours); and late (≥ 13 hours)
primary outcome:
Surgery for small asymptomatic abdominal aortic aneurysms
Mortality: death rate during a specified period of time following randomisation.Direct hospital costs from trial data: all hospital costs using specific survey or standard costing manuals which included inpatient stays, surgery, and outpatient attendances including ultrasound surveillance.
primary outcome:
Mechanical assist devices for acute cardiogenic shock
Survival (measured to: discharge; 30 days; 1 year; end of follow‐up).Survival (measured to: transplant; unsupported cardiac function; end of follow‐up).
primary outcome:
Mental practice for treating upper extremity deficits in individuals with hemiparesis after stroke
Box and Block test (Mathiowetz 1985);Action Research Arm Test (Hsieh 1998);Wolf Motor Function Test (Wolf 2001); andMotor Activity Log (Uswatte 2006).
primary outcome:
A comparison of different antibiotic regimens for the treatment of infective endocarditis
All‐cause mortality (without the time points).Cure, defined as: disappearance of fever, sterilisation of blood cultures, and normalisation of inflammatory markers during treatment and in the subsequent four weeks (Baddour 2015; Hoen 2006).Adverse events including treatment‐related adverse events (TRAE) (Ioannidis 2004), at any time of the treatment. We defined TRAE as: "a response to a drug which is noxious and uninitiated and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiologic functions" (Nebeker 2004). We extracted the number of participants with at least one TRAE out of the total randomised in each study arm.
primary outcome:
Anti‐inflammatory therapy for preventing stroke and other vascular events after ischaemic stroke or transient ischaemic attack
all vascular events (stroke, MI, non‐fatal cardiac arrest, unstable angina requiring revascularisation, vascular death) at 90 days and at one year; however when follow‐up is completed at different time points and all other criteria are met, the studies will be included for analysis; andsafety of interventions (total adverse events (AEs), infections, serious AEs).
primary outcome:
Pharmacological, psychological and non‐invasive brain stimulation interventions for preventing depression after stroke
meeting the criteria for depression, dysthymia or minor depression as defined by the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders (DSM‐IIIR, DSM‐IV, DSM V; APA 1987; APA 1994; APA 2013) or similar standard diagnostic criteria;scoring above cut‐off points for a depressive disorder, as defined by symptom scores on standard mood rating scales.
primary outcome:
Pharmacological treatment for Buerger's disease
Ulcer healingPain: assessed using a validated pain score or scale, or quality of life (QoL) questionnaireRate of amputation: major amputation (defined as amputation of the lower or upper limb above the ankle or the wrist, respectively); and minor amputation (defined as amputation of a hand or foot or any part of)
primary outcome:
Interventions for sexual dysfunction following stroke
International Index of Erectile Function (IIEF) (Rosen 1997);Derogatis Interview for Sexual Functioning (DISF) and Derogatis Interview for Sexual Functioning Self‐Report (DISF‐SR) (Derogatis 1997);Changes in Sexual Functioning Short‐Form (CSFQ‐14) (Keller 2006);Sexual Function Questionnaire (SFQ) (Quirk 2002); andArizona Sexual Experience Scale (ASEX) (McGahuey 2000).Sexual Self‐Perception and Adjustment Questionnaire (SSPAQ) (Steinke 2013); andSexual Satisfaction Scale for Women (SSS‐W) (Meston 2005).
primary outcome:
Transverse versus vertical groin incision for femoral artery approach
Surgical site infection (superficial incisional infection, deep incisional infection or organ/space infection) (≤ 30 days; > 30 days)Grade 1: cellulitis involving the wound.Grade 2: infection involving the subcutaneous tissue.Grade 3: infection involving the vascular prosthesis.Lymphatic complications (e.g. lymphorrhea/lymphatic leakage, lymphocele) (≤ 30 days; > 30 days)Infection of the vascular graft (endoprosthesis/prosthesis) (early: ≤ 4 months; late: > 4 months)
primary outcome:
Low molecular weight heparin for prevention of microvascular occlusion in digital replantation
Success rate of replantation, defined as the survival rate of replanted digits judged by the physician clinically, by means of excluding necrotic digitsIncidence of compromised microcirculation requiring invasive interventions such as re‐exploration, re‐anastomosis, removal of nail, and incision
primary outcome:
Treatment of distal deep vein thrombosis
Recurrence of VTE: defined as DVT recurrence in the calf veins, or progression of DVT to proximal veins (e.g. popliteal or femoral vein) or PE, provided that these were objectively diagnosed with venography or ultrasonography for DVT and pulmonary angiography, computed tomography or V/Q scan for PE. We considered any episode of DVT after the first episode, including propagation of distal DVT, as recurrence.Major bleeding: defined as clinically overt and associated with a fall in haemoglobin level of 20 g/L or more; transfusion of two or more units of red cells; retroperitoneal, intracranial, occurred in a critical site, or contributed to death.
primary outcome:
Physical fitness training for stroke patients
Death: numbers of deaths from all causesDeath or dependence: composite outcome where dependence is classified as having a Barthel Index score of less than 20 or modified Rankin Scale score of 3, 4, or 5 (Lindley 1994).Disability: assessed by functional scales such as the Functional Independence Measure (Hamilton 1994); Barthel Index (Collin 1988); Rivermead Mobility Index (Collen 1991); Nottingham Extended Activities of Daily Living Scale (Wade 1992); Lawton Index of Activities of Daily Living (Lawton 1969); and the Stroke Impact Scale (Duncan 1999).
primary outcome:
Advance care planning for adults with heart failure
Concordance between participants' preferences and end‐of‐life care (measurement defined by trial authors, e.g. comparing end‐of‐life care that participants received with participant‐stated preferences) (yes/no).Participants' quality of life (e.g. Minnesota Living with Heart Failure Questionnaire (MLHFQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), the 36‐Item Short Form Health Survey (SF‐36), or other measurement scales, as defined by trial authors).Participants' satisfaction with care/treatment (measurement defined by trial authors) (yes/no).
primary outcome:
Carotid artery stenting versus endarterectomy for treatment of carotid artery stenosis
Primary outcome measure for evaluation of treatment safety was the combined outcome of death or any stroke occurring between randomisation and 30 days after treatment. For participants who did not undergo carotid revascularisation, this period was defined as the first 30 days after randomisation, or according to the definition used in the trial.Primary outcome measure for evaluation of combined safety and long‐term efficacy was the combined outcome of death or any stroke occurring between randomisation and 30 days after treatment, or ipsilateral stroke occurring thereafter until the end of follow‐up.*
primary outcome:
Anticoagulant treatment for subsegmental pulmonary embolism
Three‐month thromboembolic risk (recurrence defined as a new SSPE or a new event with minimal segmental defects, or both, diagnosed by CTPA)Major bleeding defined as fatal or clinically overt bleeding resulting in a fall in haemoglobin levels by 2 g/L or more or bleeding into critical anatomical sites (retroperitoneal, intraocular, pericardial, atraumatic intra‐articular, subdural haematoma, intraspinal haemorrhage) or leading to transfusion of ≥ 2 U of blood or red cells (White 2008)All‐cause mortality
primary outcome:
First‐line combination therapy versus first‐line monotherapy for primary hypertension
Total mortality.Total serious adverse events, defined according to the International Conference on Harmonisation Guidelines (ICH 1995), as any event that leads to death, was life‐threatening, required hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability, or that was a congenital anomaly/birth defect. Total cardiovascular events including total myocardial infarction, stroke, sudden death, hospitalisation or death from congestive heart failure, and other significant vascular events such as ruptured aneurysms (not including angina, transient ischaemic attacks, surgical or other procedures, or accelerated hypertension).Cardiovascular mortality.
primary outcome:
Dressings and topical agents for arterial leg ulcers
Time to complete ulcer healing/proportion of ulcers completely healed in trial period: the complete healing of an ulcer is a definitive endpoint which can be measured, and is likely to be the outcome of greatest interest to participants and, therefore, should be the primary outcome measure of any treatment.Change in ulcer area over time: although the primary outcome of interest is the complete ulcer healing rate (defined as the number of participants achieving complete healing), some trials report changes in ulcer area over time. These are less valid indicators of effectiveness, as the rate of decrease of ulcer area may vary during the healing process without resulting in complete ulcer healing. In addition, expressing outcomes as either a percentage of initial ulcer area healed, or absolute area healed, may lead to bias, favouring either the small or large‐ulcer group where there are different ulcer sizes in the treatment groups at baseline. We used both percentage and absolute healing rates where reported, and attempted to describe the direction of any potential bias due to poor baseline comparability.
primary outcome:
Motor neuroprosthesis for promoting recovery of function after stroke
Independence in ADL, e.g. Functional Independence Measure (FIM) (Hamilton 1994), Barthel Index (BI) (Quinn 2011), Motor Assessment Scale (MAS) (Dean 1992).Activities involving limbs, e.g. Jebsen Taylor Hand Function Test (Stern 1992), Wolf Motor Function Test (WMFT) (Wolf 2001), 9‐Hole Peg Test (9HPT) (Heller 1987), Box & Blocks Test (BBT) (Mathiowetz 1985), Motor Activity Log (MAL) (Uswatte 2005), Timed Up and Go test (TUG) (Podsiadlo 1991), Rivermead Mobility Index (Collen 1991), Functional Ambulation Categories (FAC) (Holden 1984), Dynamic Gait Index (Jonsdottir 2007), modified Emory Functional Ambulation Profile (mEFAP) (Baer 2001; Wolf 1979), walking speed.
primary outcome:
Endovascular versus open repair of asymptomatic popliteal artery aneurysm
Primary patency rate at one and four years. According to the Trans‐Atlantic Inter‐Society Consensus (TASC) document, primary patency indicates uninterrupted patency following initial graft deployment (Dormandy 2000).Assisted primary patency rate at one and four years. This conveys the cases in which a revision or a revascularisation method is applied to prevent impending occlusion or progression of stenosis (Dormandy 2000).
primary outcome:
Non‐vitamin K antagonist oral anticoagulants (NOACs) post‐percutaneous coronary intervention: a network meta‐analysis
Death from cardiovascular causesMyocardial infarctionStrokeMajor bleeding, as defined by the Thrombolysis In Myocardial Infarction (TIMI) criteria (Mehran 2011)
primary outcome:
Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis in people with low surgical risk
All‐cause mortalityStrokeRehospitalisation (number of participants)
primary outcome:
Beta‐blockers for suspected or diagnosed acute myocardial infarction
All‐cause mortality.Serious adverse events. We defined a serious adverse event as any untoward medical occurrence that: resulted in death; was life‐threatening; required hospitalisation or prolongation of existing hospitalisation; resulted in persistent or significant disability; or jeopardised the participant according to the International Conference on Harmonization ‐ Good Clinical Practice (ICH‐GCP Guidelines) (ICH‐GCP 1997). None of the trials specifically assessed serious adverse events according to the definition by ICH‐GCP. Instead, the trials either reported composites of several specific serious adverse events or one specific serious adverse event.Major adverse cardiovascular events (MACE), defined as a composite outcome consisting of cardiovascular mortality (defined by trialists) and non‐fatal myocardial infarction during follow‐up (defined by trialists). Additionally, we assessed cardiovascular mortality and myocardial infarction during follow‐up separately as secondary outcomes (see below).
primary outcome:
Positive airway pressure therapy for the treatment of central sleep apnoea associated with heart failure
All‐cause mortalityCardiovascular (cardiac‐related) mortalityAll‐cause rehospitalisationsCardiac‐related rehospitalisation: defined as total number of rehospitalisationsHealth‐related quality of life as assessed by validated questionnairesAdverse events (PAP device‐related and non‐device‐related): defined as total number of adverse events
primary outcome:
Cognitive rehabilitation for attention deficits following stroke
The primary outcome was measures of global attentional functions, and the secondary outcomes were measures of the individual domains of attention, functional abilities in activities of daily living (ADL), mood, and quality of life. We assessed the outcomes immediately after treatment and at follow‐up. We defined 'long‐term' follow‐up as more than three months after the intervention. We did not include studies in which the outcome was related exclusively to any single activity of daily living (e.g. driving a car).
primary outcome:
Combined proximal descending aortic endografting plus distal bare metal stenting (PETTICOAT technique) versus conventional proximal descending aortic stent graft repair for complicated type B aortic dissections
Thoracic and abdominal aortic remodelling at 12 months (complete false lumen thrombosis, partial false lumen thrombosis). This can be assessed by any imaging technique, such as computed tomography angiography (CTA) or magnetic resonance angiography (MRA), as reported by the study authors.Dissection‐related mortality and all‐cause mortality at 30 days and 12 monthsEndoleak (type I, type II, type III, and type IV). In TEVAR, type Ia (antegrade perfusion of the false lumen) and type II are most important endoleaks. Type II refers to perfusion of the false lumen via the overstented left subclavian artery and posterior intercostal arteries. Type III refers to blood flow from module disconnection. Type IV is caused by endograft porosity and is no longer observed with more recent technology. Retrograde flow from distal entry tears must not be considered as endoleaks (Grabenwöger 2012).Thoracic and abdominal aortic expansion at 12 months (diameter increase > 5 mm or volume increase > 10%) (Diehm 2013; Famularo 2017)
primary outcome:
Perioperative beta‐blockers for preventing surgery‐related mortality and morbidity in adults undergoing non‐cardiac surgery
Early all‐cause mortality
primary outcome:
Perioperative beta‐blockers for preventing surgery‐related mortality and morbidity in adults undergoing cardiac surgery
Early all‐cause mortality
primary outcome:
Compression therapy for treating post‐thrombotic syndrome
Severity of PTS: as defined in each study provided they included a systematic clinical history and scoring of physical examinations. This is necessary because some trials only report changes in symptoms over time which provides a less valid indicator of effectiveness, as symptoms may vary.Adverse effects (discomfort, skin damage, pain, arterial leg ulceration, and recurrence of thrombosis).
primary outcome:
Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation
All‐cause mortalityAdverse effects: withdrawals from taking the study drug caused by adverse events.Adverse effects: proarrhythmia, including any of the following: sudden death, any new symptomatic arrhythmia (including symptomatic bradycardia), aggravation of existing arrhythmias (i.e. rapid atrial fibrillation) and new appearance on electrocardiogram (ECG) of QRS or QT widening that led to stopping treatment (Friedman 1998).Stroke, all types.
primary outcome:
Interventions for visual field defects in people with stroke
Where possible, we assessed the outcome at the end of the intervention period and at a follow‐up point (ideally six months after the intervention had finished, but we accepted any follow‐up point after the intervention period had finished, documenting the time point).
primary outcome:
Stem cell transplantation for ischemic stroke
Efficacy (neurologic impairment or functional outcome – disability or dependency, or both) at longer‐term follow‐up, assessed using clinical outcome measures or validated international scales, for example the National Institutes of Health Stroke Scale (NIHSS), the modified Rankin Scale (mRS), or the Barthel Index (BI). We set six months as the minimum follow‐up period.
primary outcome:
Prostacyclin for pulmonary arterial hypertension
Change in WHO or New York Heart Association (NYHA) functional class (Badesch 2009)Six‐minute walk distance (6MWD) test (Badesch 2009)Mortality
primary outcome:
Non‐invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary oedema
Hospital mortality
primary outcome:
Epidural analgesia for adults undergoing cardiac surgery with or without cardiopulmonary bypass
Risk of mortality (0 to 30 days, six months, and one year)
primary outcome:
Exercise‐based cardiac rehabilitation for adult patients with an implantable cardioverter defibrillator
All‐cause mortality.Serious adverse events, defined as any adverse event that results in death, is life threatening, requires hospitalisation, or results in persistent or significant disability or incapacity (ICH‐GCP 2015).Health‐related quality of life using generic or disease‐specific validated instruments, e.g. Short Form‐36 (SF‐36) (Ware 1992), EuroQual (Brooks 1996) and Minnesota Living with Heart Failure Questionnaire (Rector 1992).
primary outcome:
Thoracic endovascular repair (TEVAR) versus open surgery for blunt traumatic thoracic aortic injury
Mortality at 30 days, and at one year.
primary outcome:
Drug‐eluting balloon angioplasty versus uncoated balloon angioplasty for the treatment of in‐stent restenosis of the femoropopliteal arteries
Amputation‐free survival, defined as the probability of being alive without loss of the affected lower extremityVessel patency, both primary and secondary, measured by late lumen loss, target lesion revascularization (TLR), and rate of binary restenosis, defined as 50% or greater narrowing of the vessel by duplex ultrasound or angiographyDeath
primary outcome:
Clinically‐indicated replacement versus routine replacement of peripheral venous catheters
Catheter‐related blood stream infection (CRBSI, defined as a positive blood culture from a peripheral vein; clinical signs of infection; no other apparent source for the bloodstream infection except the IV catheter; and colonised IV catheter tip culture with the same organism as identified in the blood)Thrombophlebitis (using any definition identified by the trial author)All‐cause bloodstream infection (BSI, defined as a any positive blood culture drawn from a peripheral vein while an IV catheter is in situ or for 48 hours after removal)Cost (in terms of materials and labour associated with IV catheter‐related insertion)
primary outcome:
Disease management interventions for heart failure
Mortality due to heart failure (where this is reported separately from all cardiac causes)All‐cause mortalityReadmissions due to heart failure (where this is reported separately from all cardiac related readmissions)All‐cause readmissionsAdverse effects
primary outcome:
Angioplasty versus stenting for infrapopliteal arterial lesions in chronic limb‐threatening ischaemia
Technical success defined as absence of residual stenosis < 30% and absence of flow‐limiting dissection on final catheter angiogramProcedural complications, including death as a direct result of the procedure, vascular injury requiring vascular repair by surgical or non‐surgical techniques, arterial dissection, major bleeding, stroke, myocardial infarction (MI), renal failure, retroperitoneal bleed, embolisation resulting in partial or total arterial occlusion, unplanned tibial or pedal bypass, major infection, compartment syndrome, acute renal failure, access site infection, groin haematoma, pseudoaneurysm, and arteriovenous fistulaPrimary patency defined as < 50% loss of luminal diameter at the treated site (determined by computerised tomography (CT) angiogram, magnetic resonance (MR) angiogram, or Doppler ultrasound) without re‐intervention in the interimSecondary patency reflecting the fate of initial and subsequent PTA procedures combined, and determined by CT/MR angiogram or Doppler ultrasound as either the absence of a haemodynamically significant re‐stenosis or > 50% re‐stenosis
primary outcome:
Implantable cardiac defibrillators for people with non‐ischaemic cardiomyopathy
All‐cause mortality.Cardiovascular mortality.Sudden cardiac death (SCD).Adverse events of using CRT‐D or ICD (adverse events included serious device infection, pneumothorax, haemothorax, inappropriate shocks, lead displacement, dissection and tamponade, lead‐failure/fracture).
primary outcome:
Ezetimibe for the prevention of cardiovascular disease and all‐cause mortality events
Major adverse cardiovascular events (MACE), defined as a composite outcome of cardiovascular death, non‐fatal myocardial infarction (MI), non‐fatal stroke, hospitalisation for unstable angina, or coronary revascularisation procedures.All‐cause mortality
primary outcome:
First‐line drugs inhibiting the renin angiotensin system versus other first‐line antihypertensive drug classes for hypertension
All‐cause death.All‐cause serious morbidity (non‐fatal serious adverse events).Total CV events:fatal and non‐fatal MI;fatal and non‐fatal stroke;fatal and non‐fatal congestive heart failure (CHF) requiring hospitalizations.Renal outcomes:ESRF (defined as a requirement for maintenance dialysis).
primary outcome:
Stem cell therapy for treatment of thromboangiitis obliterans (Buerger's disease)
Rate of amputation: major amputation (defined as amputation of the lower or upper limb above the ankle or the wrist, respectively); and minor amputation (defined as amputation of a hand or foot or any part of)Ulcer healingPain: assessed using a validated pain score or scale, or quality of life questionnaireAdverse effects such as local or systemic inflammatory responses evaluated using clinical (erythema, local pain, wound infection) and biological (C‐reactive protein, fibrinogen, white blood cell count) assessments; cardiovascular abnormalities (e.g. arrhythmias); immunological manifestations (e.g. anaphylactic reaction, graft‐versus‐host disease); thromboembolic complications (e.g. disseminated intravascular coagulation); donor‐to‐recipient transmission of bacterial, viral, fungal, or prion pathogens (microbiological contamination); and the development of benign or malignant neoplasms
primary outcome:
Gamma aminobutyric acid (GABA) receptor agonists for acute stroke
We assessed the following outcomes, measured at three‐month follow‐up.
primary outcome:
Percutaneous vascular interventions versus intravenous thrombolytic treatment for acute ischaemic stroke
Functional outcome at the end of the scheduled follow‐up period, categorised by the modified Rankin Scale (mRS): good outcome: scores 0 to 2 (i.e. functional independence); poor outcome: scores 3 to 6 (i.e. functional dependency or death).Given that some trials use the term 'favourable outcome', to denote mRS scores of 0 or 1, we also sought data on the number of participants in each individual mRS category. If the mRS score was not reported, we used the trial's own definition of good or poor functional outcome.
primary outcome:
Very early versus delayed mobilisation after stroke
Death or a poor outcome: the number of participants who died or had a poor outcome at the end of scheduled follow‐up (in preferred order, this was defined as: remained dependent (modified Rankin Score (mRS) 3 to 5, or Barthel score < 15, or equivalent), or required admission to institutional care. We defined institutional care as care provided in a residential home, nursing home, or hospital at follow‐up.
primary outcome:
Antihypertensive drug therapy for mild to moderate hypertension during pregnancy
Severe hypertension: defined whenever possible as either systolic blood pressure 170 mmHg or more, or diastolic blood pressure 110 mmHg or more. Trials where the definition of severe hypertension was not clear, or where the cut‐off was up to 10 mmHg lower were also included and were clearly documented.Proteinuria/pre‐eclampsia: defined whenever possible as new proteinuria (1+ or more or 300 mg/24 hours).Total reported fetal or neonatal death (including miscarriage): fetal deaths included miscarriage (fetal losses before viability, usually taken as 20 or 24 weeks) and stillbirths (after 24 weeks, or however defined). Perinatal deaths are stillbirths plus deaths in the first week of life. Neonatal deaths are deaths in the first 28 days.Small‐for‐gestational age: low birthweight for gestational age, below the third, fifth or 10th percentile, using the most severe reported.Preterm birth: all births before 37 completed weeks.
primary outcome:
Exercise‐based cardiac rehabilitation for people with implantable ventricular assist devices
Mortality: all‐cause and cardiovascularRehospitalisation: all‐cause and cardiovascular eventsSerious adverse events: defined as participants who could not complete the study due to device‐ and non‐device‐related adverse eventsHeart transplantation
primary outcome:
Electromechanical and robot‐assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke
The primary outcome was activities of daily living. We preferred the Barthel Index (Wade 1987), and the Functional Independence Measure (Hamilton 1994) as primary outcome measures (scales were regarded as continuously scaled, with higher scores indicating a good outcome), if they were available. However, we accepted other scales that measured activities of daily living.
primary outcome:
Mechanical versus manual chest compressions for cardiac arrest
The primary outcome for this review was survival to hospital discharge with good neurological function, equivalent to a Cerebral Performance Category (CPC) one or two (Jennett 1975), as measured by any validated scale.
primary outcome:
Endovascular coiling versus neurosurgical clipping for people with aneurysmal subarachnoid haemorrhage
Poor outcome: death or dependence in daily activities (defined as modified Rankin scale 3 to 6 or Glasgow Outcome Scale (GOS) 1 to 3).
primary outcome:
Surgery versus thrombolysis for initial management of acute limb ischaemia
Limb salvage (i.e. avoidance of a major amputation)
primary outcome:
Activity monitors for increasing physical activity in adult stroke survivors
Steps per day. Steps per day is relevant to people with stroke because it is associated with the Activities and Participation domains of the International Classification of Functioning (Eng 2007).Time spent in moderate‐to‐vigorous intensity physical activity (MVPA) at the end of the intervention period (short‐term), three months post‐intervention (medium‐term), and 12 months post‐intervention (long‐term). We had planned to measure time in MVPA in minutes per day and in percentage of waking hours. We had planned to include two methods of calculating MVPA with devices:using metabolic equivalents (METS), with MVPA defined as 3 METS or greater, where 1 MET was defined as the energy cost of sitting quietly (Haskell 2007);using activity count cutoff points: for example, 1952 counts per minute or greater (using the equations from Freedson and colleagues; Freedson 1998).
primary outcome:
Blood pressure‐lowering treatment for preventing recurrent stroke, major vascular events, and dementia in patients with a history of stroke or transient ischaemic attack
Recurrent stroke of any type (fatal and non‐fatal).
primary outcome:
Continuation versus discontinuation of antiplatelet therapy for bleeding and ischaemic events in adults undergoing non‐cardiac surgery
All‐cause mortality at longest follow‐up (up to six months)All‐cause mortality (up to 30 days)
primary outcome:
Antiplatelet and anticoagulant agents for primary prevention of thrombosis in individuals with antiphospholipid antibodies
Any acute arterial or venous thrombosis diagnosed based on the APS Sapporo classification criteria (Wilson 1999), or updated Sydney classification criteria (Miyakis 2006), which would be confirmed by objectively validated methods, including (but not limited to) deep vein thrombosis, pulmonary embolism, myocardial infarction, ischaemic stroke, transient ischaemic attack, peripheral thromboembolism.Bleeding based on definitions of minor or major bleeding (Schulman 2005).Total mortality.
primary outcome:
Mirror therapy for improving motor function after stroke
Upper limb and hand motor function: Action Research Arm Test (Lyle 1981), Wolf Motor Function Test (Wolf 2001), Motor Assessment Scale ‐ upper limb and hand function or both (Carr 1985), Manual Function Test (Miyamoto 2009), Box and Bock Test (Mathiowetz 1985).Lower limb motor function: Motor Assessment Scale ‐ Items 4 or 5 (or both) (Carr 1985), Berg Balance Scale (Berg 1992).Global motor function: Motor Assessment Scale (Carr 1985), Rivermead Motor Assessment Scale (Collen 1991).
primary outcome:
Remote ischaemic conditioning for preventing and treating ischaemic stroke
Ischaemic stroke or recurrent ischaemic stroke at completion of follow‐upDeath or dependency (e.g. Barthel Index (BI) score ≤ 60, modified Rankin Scale (mRS) grade 3 to 6, defined by the trial author) at completion of follow‐up