anurajms/meta_analysis huggingface dataset:
primary outcome:
Controlled hypotension versus normotensive resuscitation strategy for people with ruptured abdominal aortic aneurysm
30‐day mortality (short term, due to haemorrhagic shock, myocardial infarction, or renal insufficiency).Presence of coagulopathy (defined as International Normalised Ratio (INR) greater than 1 to 3).Blood transfusion (measured by units or volume).
primary outcome:
Extracorporeal shock wave therapy for the healing and management of venous leg ulcers
time to complete wound healing;proportion of index ulcers completely healed;adverse effects, including participant‐reported pain from intervention (measured using a visual analogue scale, such as a numeric box scale (NBS).
primary outcome:
Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease
Net adverse clinical events (NACE), defined as a composite of cardiac death, stroke, myocardial infarction (MI), target lesion revascularisation, and bleeding, or as defined by trialists.Cardiac death.MyocardiaI infarction (MI).Success of the procedure, defined as completion of procedure without cross‐over to another access site, or as defined by trialists (not prespecified).
primary outcome:
First‐line drugs for hypertension
Total mortality (death from all causes)Total stroke (fatal and non‐fatal strokes)Total coronary heart disease (CHD; fatal and non‐fatal myocardial infarction, and sudden or rapid cardiac death).Total cardiovascular events (total stroke, total CHD, hospitalization or death from congestive heart failure and other significant vascular deaths, such as ruptured aneurysms. It does not include angina, transient ischemic attacks, surgical or other procedures, or accelerated hypertension).
primary outcome:
Supervised exercise therapy versus home‐based exercise therapy versus walking advice for intermittent claudication
Maximal treadmill walking distance or time (MWD/T)
primary outcome:
Perioperative beta‐blockers for preventing surgery‐related mortality and morbidity
All‐cause mortality, defined as death due to any cause occurring 30 days postoperatively or before hospital discharge (whichever occurs later).
primary outcome:
Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation
The composite endpoint of all strokes (both ischaemic and haemorrhagic) and other systemic embolic events.
primary outcome:
Fluvastatin for lowering lipids
LDL cholesterol.
primary outcome:
Treatment for superficial thrombophlebitis of the leg
symptomatic VTE (i.e. the combined of symptomatic PE and symptomatic DVT).major bleeding.
primary outcome:
Graft type for femoro‐popliteal bypass surgery
Primary patency, defined as continuous patency of the graft without need for further intervention (including primary assisted patency if performed during the primary procedure)
primary outcome:
Pulmonary artery perfusion versus no perfusion during cardiopulmonary bypass for open heart surgery in adults
All‐cause mortality (at maximum follow‐up)Pulmonary events: numbers of participants with reduced postoperative oxygenation values (specified as a decrease in the PaO2/FiO2 ratio, or an increase in the OI), prolonged mechanical ventilation (> three hours), pneumonia, and/or ARDS
primary outcome:
Exercise‐based cardiac rehabilitation for adults with stable angina
All‐cause mortalityMorbidity (myocardial infarction (MI); revascularisation (CABG or PCI); or all‐cause hospital admissions)Health‐related quality of life (HRQL) assessed using validated instruments (e.g. 36‐Item Short Form Health Survey (SF‐36), EQ‐5D)Exercise capacity assessed by validated outcome measure (e.g. VO2peak, 6‐minute walk test)Cardiovascular‐related hospital admissions
primary outcome:
Antibiotic therapy for preventing infections in people with acute stroke
case fatality (mRS 6); and'poor functional outcome' (death or dependency; preferably mRS ≥ 3)
primary outcome:
Prostanoids for critical limb ischaemia
Cardiovascular mortality (e.g. due to myocardial infarction, stroke, arrhythmia or variation form the normal rhythm of the heartbeat, sudden death)Total amputations (major plus minor)Quality of life (measured according to a validated quality of life questionnaire)Adverse events of treatment
primary outcome:
Home versus in‐patient treatment for deep vein thrombosis
Recurrence of VTE: PE or recurrence of DVT (depending on length of follow‐up)Venous gangreneHeparin complications: major and minor bleeding (the former defined as bleeding within the abdomen, cranium, or eye, or requiring transfusion, or causing a fall in haemoglobin ≥ 2 g/dL)Death
primary outcome:
Exercise for intermittent claudication
Treadmill walking distance (time to onset of pain or pain‐free walking distance and maximum walking time or maximum walking distance)
primary outcome:
Secondary prevention of recurrent venous thromboembolism after initial oral anticoagulation therapy in patients with unprovoked venous thromboembolism
VTE‐related mortalityRecurrence rate of symptomatic, objectively confirmed VTE (DVT or PE) during follow‐upMajor bleeding: A major bleeding episode is defined as clinically overt bleeding that is associated with at least one of a fall in haemoglobin levels of 20 g/L or more; transfusion of at least 2 units of packed red blood cells; involvement of the intracranial or retroperitoneal space or a body cavity; or death (International Society on Thrombosis and Haemostasis (ISTH) definition) (Schulman 2005); or as defined by the investigators in each trial
primary outcome:
Clopidogrel plus aspirin versus aspirin alone for preventing cardiovascular events
Cardiovascular mortality.All‐cause mortality.Fatal and non‐fatal myocardial infarction.Fatal and non‐fatal ischaemic stroke.Adverse events (i.e. renal failure, thrombotic thrombocytopenic purpura (TTP), neutropenia, low platelets, gastric complaints, diarrhoea, skin rash).
primary outcome:
Calcium channel blockers for primary and secondary Raynaud's phenomenon
We considered outcomes for trials one week or longer in duration. Outcome measurements included the following.
primary outcome:
Thrombolysis for acute upper extremity deep vein thrombosis
Proportion of participants with severe bleeding (defined by trialists)Proportion of participants with pulmonary embolism (defined by trialists)All‐cause mortality
primary outcome:
Pentasaccharides for the treatment of deep vein thrombosis
Main efficacy outcome:Any VTE: incidence of symptomatic, recurrent VTE during a six‐month study period. We defined symptomatic, recurrent VTE as objectively documented DVT or pulmonary embolism.Main harm outcome:Major and clinically relevant bleeding. Major bleeding (as defined by the International Society on Thrombosis and Haemostasis) (Schulman 2005):fatal bleeding;symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra‐articular or pericardial bleeding, or intramuscular bleeding progressing to compartment syndrome;bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells;any combination of points 1 to 3.
primary outcome:
Virtual reality for stroke rehabilitation
Upper limb function and activity:arm function and activity: including assessments such as the Fugl Meyer, Motor Assessment Scale (upper limb), Action Research Arm Test, Wolf Motor Function Test, Box and Block Test, Jebsen Taylor Hand Function Testhand function: grip strength
primary outcome:
Direct oral anticoagulants versus warfarin for preventing stroke and systemic embolic events among atrial fibrillation patients with chronic kidney disease
Composite of all strokes and systemic embolic eventsAll strokes: sudden focal neurologic deficit caused by cerebrovascular thrombosis, and categorised as ischaemic, haemorrhagic, or unspecificSystemic embolic events: acute vascular occlusion of an extremity or organMajor bleeding: reduction in haemoglobin of at least 20 g/L, and transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ.
primary outcome:
Adenosine versus intravenous calcium channel antagonists for supraventricular tachycardia
Reversion to sinus rhythmMajor adverse events (defined as cardiac arrest, prolonged hypotension, symptomatic bradycardia requiring treatment, and acute cardiac failure)
primary outcome:
Compression therapy for prevention of post‐thrombotic syndrome
Incidence of PTS up to two years (Definitions used for PTS in each trial paper were accepted, provided they included a systematic clinical history and scoring of physical examinations.)
primary outcome:
Interventions for treating tuberculous pericarditis
Deaths from all causes.
primary outcome:
Drug‐eluting stents versus bare‐metal stents for acute coronary syndrome
All‐cause mortality.Serious adverse events, defined as any untoward medical occurrence that resulted in death, was life‐threatening, was persistent, or led to significant disability, prolonged hospitalisation, or any medical event that had jeopardised the participant or required intervention to prevent it (ICH‐GCP 1997).Major cardiovascular event, defined as a composite outcome consisting of cardiovascular mortality and myocardial infarction.Quality of life measured on any valid scale, such as the Seattle Angina Questionnaire or 36‐Item Short Form Health Survey (SF‐36) (Ware 1992; Wyrwich 2004).
primary outcome:
Treadmill training and body weight support for walking after stroke
Motor Assessment Scale (Carr 1985), a score of two or less;Functional Independence Measure (Hamilton 1994), a score of five or less for the walking item;Barthel Index (Collin 1988), a score of three (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 (Holden 1984), a score of two or less.independent walking speed measured over a short distance (e.g. six to 10 metres); andindependent walking endurance measured over a long distance (e.g. Six‐Minute Walk Test) expressed as a total distance walked.
primary outcome:
Pharmacotherapy for hypertension in adults aged 18 to 59 years
All‐cause mortality (death from all causes).
primary outcome:
Blood pressure targets for hypertension in older adults
All‐cause mortalityStroke (fatal and non‐fatal, excluding transient ischaemic attack)Institutionalisation (i.e. nursing home admission)Cardiovascular serious adverse events, including: cerebrovascular disease (infarction, haemorrhage, transient ischaemic attack), cardiac disease (myocardial infarction, new treatment for angina or congestive heart failure, sudden death), vascular disease (enlarging or rupturing or dissecting aneurysms of the aorta, treatment for occlusive arterial disease) and renal failure (acute or chronic doubling of serum creatinine or dialysis)
primary outcome:
Low molecular weight heparin for prevention of venous thromboembolism in patients with lower‐limb immobilization
DVT ‐ confirmed by venography or ultrasonographyPE ‐ confirmed by a ventilation‐perfusion scan, a CT scan, or angiographySymptomatic VTE ‐ symptomatic DVT, PE, or combination
primary outcome:
Vitamin K antagonists versus low‐molecular‐weight heparin for the long term treatment of symptomatic venous thromboembolism
Incidence of recurrent symptomatic VTE during three months of allocated treatmentOccurrence of major bleeding complications during three months of allocated treatmentMortality during three months of allocated treatmentExtension of an intraluminal filling defect on a venogram.New intraluminal filling defect.Extension of non‐visualisation of proximal veins in the presence of a sudden cut‐off defect on a venogram seen on at least two projections.New intraluminal filling defect.Extension of an existing defect.Sudden cut‐off of vessels > 2.5 mm in diameter on a pulmonary angiogram.
primary outcome:
Occupational therapy for adults with problems in activities of daily living after stroke
Performance in personal ADL at the end of scheduled follow‐up. Measures of ADL included Barthel Index or Functional Independence Measure (FIM).Death or a poor outcome at the end of follow‐up*. We defined this as the combined outcome of being dead or:having deteriorated, characterised by experiencing a deterioration in ability to perform personal activities of daily living (i.e. experiencing a drop in ADL score); orbeing dependent, characterised by lying above or below a predefined cut‐off point on a given ADL scale; orrequiring institutional care at the end of scheduled follow‐up.
primary outcome:
Early supported discharge services for people with acute stroke
The main focus of the analysis was on the patient outcomes of: death, physical dependency (i.e. dependent on help for transfers, mobility, washing, dressing or toileting), and place of residence (home, residential home, nursing home, hospital).The primary patient outcome was the composite end‐point of death or long‐term dependency recorded at the end of scheduled follow‐up.We also analysed death or requiring institutional care (residential home, nursing home, hospital) at the end of scheduled follow‐up, and death at the end of scheduled follow‐up.The main resource outcome was the length of the index hospital stay. We planned to record other resource outcomes (i.e. readmission to hospital, number of readmissions, number of readmission days, cost of in‐patient stay, total cost of service interventions), but in the end were limited to length of the index hospital stay, readmission to hospital, and total cost of service interventions.
primary outcome:
Psychological interventions for acute pain after open heart surgery
Number of participants with self‐reported pain intensity reduction of at least 50% from baseline.Number of participants below 30/100 mm on the visual analogue scale (VAS) in self‐reported postoperative pain intensity.Participant‐reported postoperative pain intensity measured on continuous or categorical scales, or other participant‐reported pain intensity scales or questionnaires with satisfactory reliability and validity.
primary outcome:
Niacin for primary and secondary prevention of cardiovascular events
Overall mortality
primary outcome:
Growth factors for angiogenesis in peripheral arterial disease
Limb amputationDeathSevere complications/adverse events (e.g. stroke, myocardial infarction, neoplasia)
primary outcome:
Circuit class therapy for improving mobility after stroke
In this update the primary outcome of interest was walking capacity as measured using the Six Minute Walk Test (distance walked in six minutes: 6mWT). This is a clinically‐sensitive measure with demonstrated functional benefit for the person with stroke.Ten studies (835 participants, 64% of total sample) measured walking capacity using the 6mWT (Blennerhassett 2004; Dean 2000; Dean 2012; English 2015; Kim 2016a; Moore 2015; Mudge 2009a; Pang 2005; Van de Port 2012; Verma 2011). Meta‐analysis demonstrated that overall CCT was superior to the comparison intervention (MD 60.86, 95% CI 44.55 to 77.17; I2 = 27%, Analysis 1.1). Subgroup analysis between trials with participants who were early versus late after stroke onset showed a greater mean difference (improvement) for the later group but failed to reach a significant difference between these subgroups (P = 0.14).Using the GRADE criteria based on the number of participants, the significant effect and relatively narrow CIs, we applied an overall rating of 'moderate', however we downgraded due to uncertain risk of bias across several studies.
primary outcome:
Laparoscopic surgery for elective abdominal aortic aneurysm repair
30‐day or in‐hospital mortality.Operative time (minutes).
primary outcome:
Complete versus culprit‐only revascularisation in ST elevation myocardial infarction with multi‐vessel disease
Long‐term all‐cause mortality: defined as death from any cause at one year or greater after the intervention.Long‐term cardiovascular mortality: defined as death from cardiovascular cause at one year or greater after the intervention.Long‐term non‐fatal myocardial infarction: spontaneous myocardial infarction measured at one year or greater after the intervention.Adverse events: acute kidney injury, stroke, and bleeding (defined as GUSTO (Global Utilization of Streptokinase and t‐PA for Occluded Coronary Arteries) severe or moderate and TIMI (Thrombolysis in Myocardial Infarction) major or minor) at 30 days (short‐term) and one year or later (long‐term) after the initial intervention.
primary outcome:
Nitric oxide donors (nitrates), L‐arginine, or nitric oxide synthase inhibitors for acute stroke
End‐of‐trial death or dependency, defined as modified Rankin Scale (mRS) > 2. The mRS is a 7‐level ordinal hierarchical scale ascribing a score to grades of disability from 0: no symptoms; 1: symptoms but independent; 2: mostly independent but needs some help; 3: moderate dependency but can walk; 4: dependency needing help for walking and bodily needs; 5: severe dependency and bedridden; and 6: death.
primary outcome:
Educational and behavioural interventions for anticoagulant therapy in patients with atrial fibrillation
The primary outcome measure was TTR, as defined by Rosendaal 1993 (INR 2.0 to 3.0).
primary outcome:
Blood pressure lowering efficacy of renin inhibitors for primary hypertension
1. Change from baseline of trough and/or peak systolic and diastolic blood pressure over a minimum time frame of three weeks.
primary outcome:
Low‐molecular‐weight heparins or heparinoids versus standard unfractionated heparin for acute ischaemic stroke
To be consistent with current methodological guidance from the Cochrane Stroke Group Editorial Board, we defined a primary outcome for this update of the review. In previous versions, we had defined 10 outcomes, and did not specify a single primary outcome. For this update, from the previous list of 10 outcomes, we chose 'the proportion of people who had died or needed help with daily activities at six months after randomisation' as the most clinically relevant of the 10 as the primary and we then classed the remaining nine as secondary outcomes.
primary outcome:
Exercise‐based cardiac rehabilitation in heart transplant recipients
Cardiovascular mortality.Hospital admissions (all‐cause and cardiovascular related).Reported adverse events (including those related to (i) exercise and (ii) transplantation treatments or drugs).
primary outcome:
Continuous chest compression versus interrupted chest compression for cardiopulmonary resuscitation of non‐asphyxial out‐of‐hospital cardiac arrest
Survival to hospital discharge.Survival to hospital admission, where a successful hospital admission was defined as a patient admitted to hospital with spontaneous circulation and measurable blood pressure, with or without vasopressors (Cummins 1991).
primary outcome:
Vitamin C supplementation for the primary prevention of cardiovascular disease
Major cardiovascular eventsCardiovascular mortalityAll‐cause mortalityNon‐fatal endpoints such as MI, CABG, PTCA, angina, or angiographically‐defined CHD, stroke, carotid endarterectomy, peripheral arterial disease (PAD)
primary outcome:
Risk scoring for the primary prevention of cardiovascular disease
CVD events (a composite of fatal and non‐fatal myocardial infarction and stroke)Change in risk factor levelsCholesterol: total cholesterol, low‐density lipoprotein (LDL) cholesterolBlood pressure: systolic blood pressure, diastolic blood pressureChange in multivariable CVD risk: a summary score or risk estimate that incorporates multiple and simultaneous changes in different CVD risk factor levelsInvestigator‐defined adverse events, including but not limited to physical or psychosocial events, including anxiety or depression
primary outcome:
Fixed‐dose combination therapy for the prevention of atherosclerotic cardiovascular diseases
Clinical outcomes including mortality (cardiovascular and all‐cause); non‐fatal ASCVD endpoints such as myocardial infarction, coronary artery bypass grafting (CABG), percutaneous transluminal coronary angioplasty (PTCA), angina or angiographically‐defined ischaemic heart disease, stroke, transient ischaemic attack (TIA), carotid endarterectomy, or peripheral arterial disease (PAD). The previous version of the review included the broader outcome of CVD, but we have narrowed this definition for this update to include only ASCVD.Investigator‐defined adverse events including the proportion of participants experiencing specific symptoms including: myalgias, cough, elevated liver enzymes, gastric irritation or dyspepsia.
primary outcome:
Eplerenone for hypertension
All‐cause mortalityCardiovascular mortalityNon‐cardiovascular mortalityNumber of patients experiencing at least one serious adverse eventFatal and non‐fatal, disabling strokeFatal and non‐fatal myocardial infarction
primary outcome:
Fixed dose subcutaneous low molecular weight heparins versus adjusted dose unfractionated heparin for the initial treatment of venous thromboembolism
Incidence of symptomatic recurrent venous thromboembolism (deep venous thrombosis or pulmonary embolism) during the initial treatment and during follow‐up.
primary outcome:
Ranolazine for stable angina pectoris
We considered effectiveness and safety outcome measures, and only measures taken at the longest follow‐up within each study. For the outcomes considered, we included only results measured with a follow‐up of at least one week. Studies were included irrespective of whether or not they assessed the outcomes listed below.
primary outcome:
Beta‐blockers for hypertension
Mortality.
primary outcome:
Pharmacological treatment of vascular risk factors for reducing mortality and cardiovascular events in patients with abdominal aortic aneurysm
All‐cause mortality.Cardiovascular mortality (fatal myocardial infarction (MI), fatal stroke, other vascular deaths).
primary outcome:
Stem cell therapy for chronic ischaemic heart disease and congestive heart failure
MortalityPeriprocedural adverse events (defined as occurring at the time of bone marrow aspiration or administration of cell therapy (or placebo), or documented adverse events within 30 days of treatment)
primary outcome:
Caregiver‐mediated exercises for improving outcomes after stroke
Patient: basic ADL measures, such as the Barthel index (BI) (Collin 1988; Mahoney 1965), Functional Independence Measure (FIM) (Dodds 1993), modified Rankin Scale (mRS) (De Haan 1995; Dromerick 2003); extended ADL measures, such as the Nottingham Extended Activities of Daily Living (NEADL) Index (Nouri 1987), or Frenchay Activities Index (FAI) (Wade 1985). When found, we combined scales with the same construct.Caregiver: measures of burden, for example Caregiver Strain Index (CSI) (Robinson 1983). When found, we combined scales with the same construct.
primary outcome:
Blood pressure‐lowering efficacy of reserpine for primary hypertension
The outcome of interest was changes in systolic and diastolic blood pressure from baseline at the three‐ to 12‐week interval in the treatment group compared with the control group.
primary outcome:
Interventions to improve adherence to lipid‐lowering medication
Indirect measures of adherence (e.g. pill count, prescription refill rate, electronic monitoring);Subjective measures of adherence (e.g. person's self‐report in diaries, interviews);Direct measures of adherence (tracer substances in blood or urine).
primary outcome:
Oxygen therapy for acute myocardial infarction
This review is primarily focused on clinically important outcomes. To facilitate the assessment of the clinical importance of outcomes we used the nine‐point scale suggested by GRADE (Guyatt 2008), which classifies the outcomes into three levels of importance. The outcomes included in the review are type I ("critical for decision‐making"‐ ratings 9, 8, 7) and also type 2 ("important but not critical for decision‐making"‐ ratings 6, 5, 4). We did not include the type 3 outcomes: ("not important for decision‐making, of lower importance to patients" ‐ ratings 3, 2, 1). We pre‐specified mortality as the primary outcome. We agreed the point on the GRADE scale for each outcome through discussion within the review team, where we easily reached a consensus. We showed our proposed classifications to cardiologist colleagues to see whether they agreed with them. Although there were one‐point differences in some of their assessments of the importance of particular outcomes, none of these affected the level of importance into which we classified an outcome.We classified the following outcomes as type I (the review group's consensus score is given in brackets).We classified the following outcomes as type 2 outcomes.We classified the following outcomes as type 3 outcomes.Although these outcomes may prove useful for helping understand the disease process, they currently have little implication for decision‐making or prognosis.We used standard direct measures for all types of outcomes. For the case of pain, when the direct measurement was not available we used the opiate dosage as a proxy for pain. This approach (response to treatment) is classically used when validating pain scales. We have included type 2 outcomes because they may be used to make clinical decisions or recommendations.
primary outcome:
Endovenous ablation therapy (laser or radiofrequency) or foam sclerotherapy versus conventional surgical repair for short saphenous varicose veins
Recanalisation or persistence of reflux at six weeks.Recurrence of reflux at one year.Clinical evidence of recurrence (i.e. presence of new visible varicose veins).Reintervention (due to technical failure).
primary outcome:
Efficacy and safety of ablation for people with non‐paroxysmal atrial fibrillation
Freedom from atrial arrhythmias (i.e. atrial fibrillation, atrial flutter, or atrial tachycardia) or recurrence of any atrial arrhythmiasParticipants needing cardioversionCardiac hospitalisation
primary outcome:
Fibrates for primary prevention of cardiovascular disease events
Combined outcome of major CVD events (CVD death, non‐fatal myocardial infarction, or non‐fatal stroke).
primary outcome:
Pharmacomechanical thrombectomy for iliofemoral deep vein thrombosis
Post‐thrombotic syndrome: (including venous ulceration rates, as defined by the Villalta scale; Prandoni 1992)Any improvement in venous patency (assessed by objective measures, such as venography, where pre‐ and post‐comparative data on the degree of restoration of the lumen were available)Major bleeding (as defined by the International Society on Thrombosis and Haemostasis (ISTH); Schulman 2005):Fatal bleedingSymptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra‐articular or pericardial, or intramuscular with compartment syndromeBleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cellsAny combination of points a to c
primary outcome:
Pharmacological interventions other than botulinum toxin for spasticity after stroke
Functional ability during activities of daily living.
primary outcome:
Antiplatelet versus anticoagulation treatment for patients with heart failure in sinus rhythm
All‐cause mortalityNon‐fatal cardiovascular events (non‐fatal stroke, myocardial infarction, pulmonary embolism, peripheral arterial embolism)
primary outcome:
Self management programmes for quality of life in people with stroke
Quality of life (QoL): health‐related, such as measured by the 36‐item Short Form (SF‐36) version 2, EuroQol (ED‐5D); or general, such as measured by the World Health Organization Quality of Life (WHOQOL)‐BREF.
primary outcome:
Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports
The correct placement of a functional TIVAP (success of primary implantation). The position of the catheter tip was checked by fluoroscopy and the functionality assessed by aspiration of blood as well as injection of heparinised saline solution during the procedure. Initial procedural failure could include the following: vein not found, vein too small, venous occlusion, inability to advance catheter, failure of venepuncture.
primary outcome:
Intravenous heparin during ruptured abdominal aortic aneurysmal repair
All‐cause mortality30‐day all‐cause mortality (and 6‐month all‐cause mortality)
primary outcome:
Drug‐eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs
Incidence of amputation.Amputation‐free survival, defined as the probability of being alive without an amputation.Amputation‐free rate, defined as the patency of the target vessels and freedom from amputation.Vessel patency (primary and secondary), as determined by delayed arterial lumen loss, target lesion revascularization, and binary restenosis rate measured with duplex ultrasound or angiography.Death.
primary outcome:
Pharmacological interventions for treating heart failure in patients with Chagas cardiomyopathy
All‐cause mortality;Cardiac mortality at 30 days;Time‐to‐heart decompensation;Disease‐free period (at 30, 60, and 90 days).
primary outcome:
Sulodexide for treating venous leg ulcers
Proportion of ulcers completely healed during follow up.Time to complete ulcer healing.Percentage, or absolute, change in ulcer size.
primary outcome:
Routine invasive strategies versus selective invasive strategies for unstable angina and non‐ST elevation myocardial infarction in the stent era
Death: all causes.Myocardial infarction (MI) (this endpoint only included non‐fatal MI in the review protocol, but the review includes fatal and non‐fatal MI).Death (all causes) or non‐fatal MI.Refractory angina.
primary outcome:
Implantable loop recorder versus conventional diagnostic workup for unexplained recurrent syncope
Short (i.e. within 30 days) and long‐term all‐cause mortality.Other adverse events (cardiopulmonary resuscitation, intensive care unit admittance, major trauma, acute myocardial infarction, pulmonary embolism, major bleeding, aortic dissection, ILR‐related adverse events requiring either explant or treatment).Quality of life during follow‐up (as defined in the single studies).
primary outcome:
Anticoagulants (extended duration) for prevention of venous thromboembolism following total hip or knee replacement or hip fracture repair
Symptomatic VTE (including DVT and PE)
primary outcome:
Pre‐hospital versus in‐hospital initiation of cooling for survival and neuroprotection after out‐of‐hospital cardiac arrest
Survival: we investigated short‐term survival (closest to 30 days) and long‐term survival (closest to six months).Neurological outcome: ideally we expected the outcome to be reported as best neurological outcome during hospital stay and in cerebral performance categories (CPC) (Cummins 1991; Jennett 1975). Good neurological outcome is usually considered if the CPC is 1 or 2. If authors grouped this outcome along with other categories or cut‐offs, or used other instruments for neurological outcome assessment, like the modified Rankin Scale, we accepted this for our meta‐analysis and planned to perform a sensitivity analysis based on the outcome definition.
primary outcome:
Blood pressure lowering efficacy of beta‐1 selective beta blockers for primary hypertension
Change in trough (13 hours to 26 hours after the dose) or peak (1 hour to 12 hours after the dose), or both, systolic and diastolic blood pressure compared to placebo. If blood pressure measurements were available at more than one time within the acceptable window, we used the mean differences (MD) of blood pressures taken in the 3 week to 12 week range.
primary outcome:
Antihypertensive pharmacotherapy for prevention of sudden cardiac death in hypertensive individuals
Sudden cardiac death.
primary outcome:
Interventions for helping people adhere to compression treatments for venous leg ulceration
venous ulcer healing (e.g. proportion of ulcers healed within trial period, as defined by the trial authors);time to complete healing;recurrence of venous ulcer (as reported in the trials);adherence to compression therapy, e.g. proportion reporting adherence to compression.
primary outcome:
Calcium channel blockers for primary Raynaud's phenomenon
Attack rates of Raynaud's phenomenonDuration of attacksSeverity scoresParticipant‐preference scores
primary outcome:
Sexual counselling for sexual problems in patients with cardiovascular disease
We included outcome measures from both patients with cardiac disease and their partners, where available.
primary outcome:
Oral aspirin for treating venous leg ulcers
Time to complete ulcer healing.Rate of changes in the area of the ulcer in the trial period.Proportion of ulcers healed in the trial period.Proportions of people with ulcers completely healed in the trial period.Major bleeding (haemorrhagic stroke, gastric bleeding, any bleeding requiring blood transfusion, any bleeding causing hospitalisation).
primary outcome:
Biphasic versus monophasic waveforms for transthoracic defibrillation in out‐of‐hospital cardiac arrest
Overall rate of return of spontaneous circulation (ROSC).
primary outcome:
Systematic versus opportunistic risk assessment for the primary prevention of cardiovascular disease
All‐cause mortalityCardiovascular mortalityNon‐fatal cardiovascular endpoints, including CHD, MI, CABG, PTCA, stroke, transitory ischaemic attack (TIA) and peripheral artery disease
primary outcome:
Warfarin initiation nomograms for venous thromboembolism
The proportion of patients with an INR of 2.0 to 3.0 on the fifth day of initial therapy with warfarin.
primary outcome:
Perioperative angiotensin‐converting enzyme inhibitors or angiotensin II type 1 receptor blockers for preventing mortality and morbidity in adults
All‐cause mortality and cardiac mortality (occurring 30 days postoperatively or before hospital discharge).Risk of acute myocardial infarction, defined as the presence of characteristic chest pain, an ST elevation, or increase in myocardial isoenzymes, occurring up to 30 days postoperatively or before discharge from hospital.Risk of myocardial ischaemia (defined as the presence of clinical symptoms and significant ST segment depression, occurring up to 30 days postoperatively or before hospital discharge).
primary outcome:
Colchicine for prevention of cardiovascular events
All‐cause mortalityMyocardial infarctionAdverse events (total, gastrointestinal, serious)
primary outcome:
A 'test and treat' strategy for elevated wound protease activity for healing in venous leg ulcers
Time to complete wound healing (correctly analysed using survival, time‐to‐event approaches). Ideally the outcome would be adjusted for appropriate covariates, e.g. baseline ulcer area/duration.Proportion of wounds completely healed during follow‐up (frequency of complete healing).
primary outcome:
Internet‐based interventions for the secondary prevention of coronary heart disease
Mortality (cardiovascular and overall)Non‐fatal re‐infarctionRevascularisationLipid levels (total cholesterol, high‐density lipoprotein (HDL), low‐density lipoprotein (LDL), and triglycerides)Blood pressure (systolic blood pressure and diastolic blood pressure)HRQOL
primary outcome:
Nurse‐led titration of angiotensin converting enzyme inhibitors, beta‐adrenergic blocking agents, and angiotensin receptor blockers for people with heart failure with reduced ejection fraction
All‐cause hospital admissionsHeart failure‐related hospital admissionsAll‐cause mortalityAll‐cause event‐free survival
primary outcome:
Amiodarone versus other pharmacological interventions for prevention of sudden cardiac death
Sudden cardiac death (as defined in the studies)All‐cause mortalityCardiac mortality (as defined in the studies)
primary outcome:
Aminophylline for bradyasystolic cardiac arrest in adults
Primary outcome.Secondary outcomes.Survival to hospital discharge, survival to hospital admission and return of spontaneous circulation were defined according to the Utstein style guidelines and templates (Jacobs 2004).
primary outcome:
Structured telephone support or non‐invasive telemonitoring for patients with heart failure
All‐cause mortality (total number of deaths at the end of study follow‐up in each arm of the study)All‐cause hospitalisations (calculated as the proportion of participants readmitted to hospital at least once during the period of follow‐up)Heart failure‐related hospitalisations (calculated as the proportion of participants readmitted to hospital at least once during the period of follow‐up due to heart failure)
primary outcome:
Fibrates for secondary prevention of cardiovascular disease and stroke
The primary outcome was the composite outcome of non‐fatal stroke (ischaemic or hemorrhagic stroke), non‐fatal MI, and vascular death. We included each participant only once in this composite outcome (for example if a participant had a non‐fatal event followed by a fatal event, it was counted as a fatal event only).
primary outcome:
Implantable defibrillators versus medical therapy for cardiac channelopathies
All‐cause (total) mortality.Fatal and non‐fatal cardiovascular events, including sudden cardiac death, survived sudden cardiac arrest, myocardial infarction, and stroke.Adverse events, including: ICD site, generator, or lead infection; inappropriate firing; ICD malfunction; lead extraction; pocket haematoma; pneumothorax; ICD removal; drug discontinuation due to adverse effects, toxicity, intolerance, or adverse reaction.
primary outcome:
Stent graft types for endovascular repair of thoracic aortic aneurysms
Short‐term mortality (30‐day or in‐hospital mortality, i.e. procedure‐related).
primary outcome:
Debridement for venous leg ulcers
The percentage (or number) of wounds completely debrided during the trial period.Time to complete debridement.Wound healing as measured by the time to complete healing or the number of wounds completely healed during the trial period.
primary outcome:
Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack
Composite endpoint of ischemic stroke (fatal or non‐fatal) or TIA events.Recurrent fatal or non‐fatal ischemic stroke.
primary outcome:
Blood pressure lowering efficacy of dual alpha and beta blockers for primary hypertension
Change in trough (13 to 26 hours after the dose), peak (1 to 12 hours after the dose) or both systolic and diastolic blood pressure compared to placebo. If blood pressure measurements were available at more than one time within the acceptable window, the weighted means of blood pressures taken in the 3 to 12 week range were used.
primary outcome:
Prophylactic lidocaine for myocardial infarction
All‐cause mortality.Cardiac mortality.Overall survival at 30 days after myocardial infarction (MI), which was defined as the proportion of survivors in a group. The proportion of persons in a specified group alive at the beginning of the time interval who survive to the end of the interval (Porta 2008).
primary outcome:
Buflomedil for acute ischaemic stroke
The primary outcome was death or disability/dependence at long‐term follow‐up (i.e. at least three months after stroke). Measures of disability or dependence included but were not limited to the Barthel Index (BI) and the modified Rankin Scale (mRS). We also reported short‐term death and disability/dependence, defined as within three months after stroke and usually measured immediately at the end of treatment.
primary outcome:
Negative pressure wound therapy for treating leg ulcers
The primary outcomes for this review were complete wound healing and adverse events.The median time to healing in the NPWT group was 28 days (95% CI 25.5 to 32.5) compared with 45 days (95% CI 36.2 to 53.8) in the standard care group. The study reported an adjusted hazard ratio of 3.2, 95% CI 1.7 to 6.2 (adjusted for ulcer area; smoking; infection signs; ulcer history; therapy) suggesting a higher hazard (chance) of healing with NPWT. GRADE assessment: low quality evidence (due to imprecision and indirectness):summary of findings Table for the main comparison.The study reported that all but one participant in each group healed ‐ as laid out in our Dealing with missing data section, we assumed that any participants for whom complete healing data were missing (n = 6) did not heal. This approach meant that 97% (29/30) of participants healed in both groups (RR 1.00, 95% CI 0.91 to 1.10; Analysis 1.1). The time period over which this proportion of healing occurred was not clear, but time‐to‐event data suggested that all or almost all participants were healed after 80 days from randomisation. GRADE assessment: low quality evidence (due to imprecision and indirectness):summary of findings Table for the main comparison.Twelve adverse events were reported in the NPWT group compared with seven in the standard care group. The methods of adverse events data collection were not reported, and it was not clear whether data were reported per participant. These data have not been analyzed further.
primary outcome:
Fresh frozen plasma for cardiovascular surgery
Short‐term mortality rate (30 days or in hospital).
primary outcome:
Psychosocial interventions for smoking cessation in patients with coronary heart disease
Abstinence by self‐report or validated (e.g. carbon monoxide) measurement at a minimum of 6 months. The outcome is dichotomous (non smoker versus smoker). We did not extract data on the number of cigarettes smoked per day, as there is little evidence that smoking reduction alters the risk of future cardiac events or mortality.
primary outcome:
Interventions for post‐stroke fatigue
Fatigue Severity Scale (FSS) (Krupp 1989);Visual Analogue Scale for fatigue severity (VAS‐f);self reported fatigue questionnaires;energy/fatigue scale from the Medical Outcomes Study (i.e. Short Form‐36 vitality subscale).A measure of fatigue designed specifically for stroke (e.g. a case definition of PSF) (Lynch 2007); a generic measure for fatigue that has been tested in stroke (e.g. Fatigue Assessment Scale, Profile of Mood States ‐ fatigue subscale, Short Form‐36 vitality scale, Multidimensional Fatigue Symptom Inventory, FSS, Functional Assessment of Chronic Illness Fatigue, Neurological Fatigue Index) (Mead 2007; Tyson 2014); a generic measure for fatigue that has not been previously tested in stroke.If the scales were in the same category according to the above criterion, we specified the main outcome measure from most commonly used scales (e.g. FSS) to less commonly used scales in the publications identified in this review.
primary outcome:
Psychological interventions for symptomatic management of non‐specific chest pain in patients with normal coronary anatomy
Pain intensity measured by categorical scales or visual analogue scales (VAS);Pain diaries (mean difference (MD) in pain scores or recorded frequency of exacerbation of pain).
primary outcome:
Motivational interviewing for improving recovery after stroke
Activities of daily living, using the following scales.Barthel Index (Mahoney 1965).Functional Independence Measure (Keith 1987).Modified Rankin Scale (van Swieten 1988).Katz Index of Activities of Daily Living (Katz 1970).Rehabilitation Activities Profile (van Bennekom 1995).
primary outcome:
Anti‐inflammatory treatment for carditis in acute rheumatic fever
Valvular lesions developing in participants with previously normal valves.Worsening of valvular lesions in participants with valves damaged during previous attacks of rheumatic fever.
primary outcome:
Blood pressure‐lowering efficacy of loop diuretics for primary hypertension
Change in systolic and diastolic blood pressure compared to placebo. If blood pressure measurements were available at more than one time during the 24‐hour period, we used the trough measurement. Peak level was defined as blood pressure measurement within 12 hours of the dose, and trough level was defined as blood pressure measurements between 12 and 24 hours. If blood pressure measurements were available at more than 1 week within the 3‐ to 12‐week window, the weighted means of blood pressure measurement was calculated and used as the best estimate of the treatment effect.
primary outcome:
Adenosine and verapamil for no‐reflow during primary percutaneous coronary intervention in people with acute myocardial infarction
All‐cause mortality at short term and at long term.Non‐fatal myocardial infarction at short term and at long term.
primary outcome:
Influenza vaccines for preventing cardiovascular disease
First‐time myocardial infarction.First‐time unstable angina.Death from cardiovascular causes.Myocardial infarction.Unstable angina.Death from cardiovascular causes.
primary outcome:
Intra‐aortic balloon pump counterpulsation (IABP) for myocardial infarction complicated by cardiogenic shock
All‐cause mortality (mortality distribution and rates within the commonly accepted limits, either to discharge, within 30 days, 6 months and 1 year)Non‐fatal cardiovascular events (reinfarction, reocclusion and subsequent re‐revascularization, stroke, recurrent ischaemia) (hierarchical lower ranked endpoint)
primary outcome:
Anaesthetic and sedative agents used for electrical cardioversion
Major adverse events including the following.Hypotension (defined as during the procedure; definitions such as > 20% decrease in systolic blood pressure, > 20 mmHg fall in systolic blood pressure to < 100 mmHg or the need for fluid intervention).Unintended apneic episode (definitions such as no spontaneous respiration for > 20 seconds or the need for manual ventilation).Patient awareness or recall of pain during the procedure.
primary outcome:
Interventions for improving community ambulation in individuals with stroke
In the Community Health Activities Model Program for Seniors (CHAMPS) (Stewart 2001), individuals are asked if they participate in a certain activity and, if they do, the number of hours per week is recorded.The Reintegration to Normal Living Index evaluates aspects of participation, including moving around indoors, in the community, work, recreation, and social activities. It is scored on a three or four‐point scale with 11 items in total. Inter‐rater reliability, construct validity, and responsiveness to change of the scores has been demonstrated in people with various diagnoses (Wood‐Dauphinee 1988).The London Handicap Scale (Harwood 1994a) consists of six dimensions (questions) related to participation with six response options each. Responses are weighted, leading to a score from 0 to 1, with 1 representing no difficulties with participation. Validity and reliability of the scale has been evaluated in stroke survivors (Harwood 1994b).The Stroke Impact Scale was developed specifically for stroke survivors and has undergone testing for reliability, validity, and sensitivity to change. There are eight domains, one of which is the participation domain. Each domain results in a score from 0 to 100, with 100 being the better score (Duncan 1999).SF‐36 is a generic measure of health‐related quality of life with eight subscales, one of which is the social function subscale (Ware 1992). Validity for use with stroke survivors has been evaluated. However, the social function subscale (0 to 100, with 100 representing a better score) did not correlate well with other measures of social function (Anderson 1996).
primary outcome:
Atorvastatin for lowering lipids
Placebo‐controlled RCTs: mean per cent change in LDL‐cholesterol from baseline of different doses of atorvastatin minus per cent change from baseline with placebo.Before‐and‐after trials: mean per cent change in LDL‐cholesterol from baseline of different doses of atorvastatin.