anurajms/meta_analysis huggingface dataset:
primary outcome:
Interventions to improve return to work in depressed people
The main outcome measure in this review was sickness absence, either measured as sickness absence days during the follow‐up period or employment status after a period of time, categorised as being 'off work' or 'at work.' Sickness absence data could be extracted from the employee attendance records, the files of a compensation board, or it could be self‐reported.
primary outcome:
Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff
contamination of skin or clothing, measured with any type of test material to visualise contamination (e.g. stains made visible with UV light) or harmless viruses or bacteria;infection with EVD, another viral haemorrhagic fever, or comparable highly infectious disease with serious consequences such as SARS, or COVID‐19;compliance with guidance on selection of type and use of PPE measured, for example, with an observation checklist.
primary outcome:
Workplace interventions for increasing standing or walking for decreasing musculoskeletal symptoms in sedentary workers
Musculoskeletal symptoms may be reported as pain on a scale (as listed below) or may be reported as 'discomfort' or 'trouble' on similar scales.Presence of musculoskeletal symptoms may be reported on a dichotomous scale (yes/no) by outcome measures such as the Nordic Musculoskeletal Questionnaire (Kuorinka 1987).Intensity of musculoskeletal symptoms may be reported on a visual analogue scale (or similar), a numerical rating scale, a Likert scale (Bond 1966; Harland 2015), or a McGill Pain Questionnaire (Melzack 1975).Impact of pain such as pain‐related disability.Disability may be assessed by outcome measures such as the Oswestry Disability Index, the Roland Morris Disability Questionnaire (Roland 2000), or the Neck Disability Index (Vernon 2008).
primary outcome:
Work‐break schedules for preventing musculoskeletal symptoms and disorders in healthy workers
Newly diagnosed musculoskeletal disordersMedical assessment by an occupational physicianScales assessing newly diagnosed musculoskeletal disorders referring to injuries that affect musculoskeletal, peripheral nervous and neurovascular systems caused or aggravated by occupational exposureParticipant‐reported musculoskeletal symptoms, including pain, discomfort and fatigueAssessing of pain, discomfort or fatigue by a visual analogue scale (VAS) or numeric rating scales (NRS)Productivity or work performanceAssessment of the level of work functioning, change in work productivity or work time loss as assessed by outcome measures such as the Health and Work Performance Questionnaire (Kessler 2003) or similar instruments
primary outcome:
Incentives for smoking cessation
The primary outcome for this review is long‐term smoking cessation. This could be measured as point prevalence, sustained or continuous abstinence; however, where multiple measures were used in one study we took the most stringent measure. For trials in mixed populations abstinence had to be assessed at a minimum of six months from the start of the intervention. For trials in pregnant women, we extracted smoking cessation outcomes at the closest follow‐up to end of pregnancy, and also at longest follow‐up post‐partum if reported. We did not require the minimum six‐month follow‐up period for pregnant smokers because of the time‐limited nature of pregnancy. Abstinence could be self‐reported or biochemically validated, but we preferred biochemically validated over self‐reported rates.We also looked at disbenefits and costs, where reported.
primary outcome:
Ergonomic interventions for preventing work‐related musculoskeletal disorders of the upper limb and neck among office workers
Number of workers with newly diagnosed or verified MSDs of the upper limb or neck, or both (incident cases).Presence or severity or intensity of complaints or symptoms of pain or discomfort in the upper limb or neck, or both, using a dichotomised scale (e.g. yes/no), Likert scale, visual analogue scale (VAS), or any similar scale measuring pain or discomfort.Work‐related function as measured by number of work days lost, loss of or change in job, work disability, and level of functioning. For the level of functioning, we included studies using validated outcome measures e.g. Disability of the Arm, Shoulder, and Hand (DASH) questionnaire (Kitis 2009), and Northwick Park Neck Pain Questionnaire (Leak 1994).
primary outcome:
Ergonomic interventions for preventing musculoskeletal disorders in dental care practitioners
Number of workers with newly diagnosed WMSD (incident cases)WMSDs refered to injuries that affected the musculoskeletal, peripheral nervous, and neurovascular systems, which were caused or aggravated by occupational exposure to ergonomic hazards (NIOSH 1997)Self‐reported complaints of pain related to the musculoskeletal systemThis could be measured using a dichotomy scale (yes or no), a Likert scale, a visual analogue scale (VAS), or any similar scaleWork functioning or disability, assessed in terms of level of functioning, limitation of movement, decrease in productivity, number of hours worked, total number of work days lost, loss or change of job, or work‐related disability, measured by outcome measures instruments, like the Oswestry Disability Index (ODI), Roland‐Morris Disability Questionnaire (RMDQ), Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH), Work Ability Index (WAI), or other similar instruments
primary outcome:
Closed‐system drug‐transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff
Measures of exposure to infusional hazardous drugs such as urine mutagenicity, chromosomal aberrations, sister chromatid exchanges, and micronuclei inductionEnvironmental contamination measured with surrogate outcomes for exposure: surface samples, splashes, leakage tests, or atmospheric contaminationShort‐term health outcomes such as skin rashesMedium‐term health outcomes such as infertility or miscarriageLong‐term health outcomes such as cancer (any type of cancer)
primary outcome:
Workplace lighting for improving alertness and mood in daytime workers
Alertness.Mood.
primary outcome:
Multidisciplinary biopsychosocial rehabilitation for subacute low back pain
PainBack‐specific disability/functional statusWork status (return‐to‐work, sick leave)
primary outcome:
Influenza vaccination for healthcare workers who care for people aged 60 or older living in long‐term care institutions
Cases of influenza in those aged 60 years or older confirmed by viral isolation or serological supporting evidence (or both), plus a list of likely respiratory symptoms.Lower respiratory tract infection.Admission to hospital for respiratory illness.Deaths caused by respiratory illness.Deaths from any cause
primary outcome:
Organisational interventions for improving wellbeing and reducing work‐related stress in teachers
Subjective measures: validated measures of work stress and wellbeing e.g. Maslach Burnout Inventory (Maslach 1996), Teacher Stress Inventory (Fimian 1988), Occupational Stress Inventory (Osipow 1998), Work Ability Index (Tuomi 1998), Minnesota Satisfaction Questionnaire (Weiss 1967), Organisational Climate Description Questionnaire (Hoy 1991), Organisational Health Inventory (Hoy 1991).Objective measures: teacher turnover (retention rates) and sickness absence.
primary outcome:
Exercises for mechanical neck disorders
A study was included if it used at least one of the four primary outcome measures of interest:We extracted information on adverse events and costs of care when available.We defined the duration of follow‐up as:
primary outcome:
Multidisciplinary biopsychosocial rehabilitation for chronic low back pain
PainBack‐specific disability or functional statusWork status (return to work, sick leave)
primary outcome:
Interventions for preventing the spread of infestation in close contacts of people with scabies
The primary outcome was the proportion of contacts (of index cases) who were diagnosed with scabies where the contacts of the index cases were advised to use some prophylactic treatment. The contacts of the index cases should have been examined for scabies within eight weeks of being recommended to use the prophylactic treatment. If contacts were examined more than eight weeks after using the prophylactic treatment, any positive diagnosis could have been due to an exposure to an index case during the intervening period; such diagnoses would bias the results. Diagnosis of scabies in contacts was based on the clinical opinion of a physician or other suitably‐qualified health professional, on the basis of the development of clinical symptoms suggestive of scabies and either positive physical examination findings or positive microscopy.
primary outcome:
Non‐pharmacological interventions for preventing venous insufficiency in a standing worker population
Clinical features of CVI including oedema and skin changes such as eczema, hyperdermatitis and venous ulcerationComplaints of CVI, which included at least oedema, itching, a tired or heavy feeling in the legs, or pain
primary outcome:
Supported employment for adults with severe mental illness
We grouped outcomes into short term (less than six months) medium term (six months to one year) and long term (over one year: a follow‐up duration of 12 months was also considered as long term)
primary outcome:
Physical conditioning as part of a return to work strategy to reduce sickness absence for workers with back pain
Work status outcomes were:1. time between intervention and return‐to‐work;2. return‐to‐work status in terms of 'at work' or ‘off work';3. time on light or modified duties.
primary outcome:
Therapeutic ultrasound for carpal tunnel syndrome
Short‐term overall improvement (any measure in which patients indicate the intensity of their complaints compared with baseline, for example global rating of improvement, satisfaction with treatment) (dichotomous outcome; three months or less)
primary outcome:
Training healthcare providers to respond to intimate partner violence against women
Healthcare providers’ attitudes/beliefs towards IPV, measured on a scale such as the Domestic Violence Assessment Instrument (Danley 2004) or similar tools used by study authors.Healthcare providers’ readiness to manage/respond to or support women survivors of IPV, measured on a scale such as the Physician Readiness to Manage Intimate partner violence Survey (PREMIS; Short 2006a) or similar tools.Healthcare providers’ knowledge or awareness of IPV, measured on a scale such as the PREMIS (Short 2006a) or similar tools.Referrals made to support agencies, social workers or other specialised services. These could have been self‐reported or documented by HCPs or by women survivors (or both) from medical records, or complete referrals measured by the use of referred services from the records of social workers or family/DV services.Provider response to IPV: safety planning, counselling or validation of survivors' feelings, or both. This could have been assessed by means of self‐report or documented by HCPs or by women survivors (or both) from medical records.Adverse outcomes for providers that may have included worsened attitudes, beliefs towards IPV or reduced readiness to manage IPV.
primary outcome:
Psychological interventions for depression and anxiety in patients with coronary heart disease, heart failure or atrial fibrillation
DepressionAnxiety
primary outcome:
Mobile phone text messaging for medication adherence in secondary prevention of cardiovascular disease
Medication adherence (self‐reported adherence, questionnaire, tablet counts, medication event monitoring systems, pharmacy prescription data).Fatal cardiovascular events (death caused by cardiovascular events), defined as the proportion of participants with fatal cardiovascular events.Non‐fatal cardiovascular events (coronary heart disease, revascularisation, stroke), defined as the proportion of participants with non‐fatal cardiovascular events.Combined CVD event (fatal or non‐fatal CVD events), defined as the proportion of participants with a combined CVD event.
primary outcome:
Prophylactic corticosteroids for cardiopulmonary bypass in adult cardiac surgery
all‐cause mortality (dichotomous outcome, during the index hospital admission, or within 30 days, at the longest follow‐up available);cardiac complications (dichotomous outcome, as defined by study authors, including cardiac compromise and fatal and non‐fatal myocardial infarction, defined as electrocardiogram (ECG) changes, echocardiological changes, disproportionate elevation of troponins); andpulmonary complications (dichotomous outcome, as defined by study authors, including pneumonia, embolism, reduced pulmonary function, prolonged ventilation, pleural effusion).
primary outcome:
Exercise‐based cardiac rehabilitation for adults with heart failure
All‐cause mortalityHeart failure mortalityNumber of participants who experienced an all‐cause hospital admissionNumber of participants who experienced a heart failure‐related hospital admissionHRQoL assessed by a validated outcome measure (e.g. 36‐item Short Form (SF‐36), Minnesota Living with Heart Failure (MLWHF) questionnaire)
primary outcome:
Home‐based versus centre‐based cardiac rehabilitation
Total mortality.Cardiac events:Re‐infarction;Total revascularisations (including CABG and percutaneous coronary intervention (PCI)); andCardiac associated hospitalisation.Exercise capacity assessed by validated outcome measure (e.g. peak oxygen [VO₂] uptake, 6‐minute walk test).Validated measures of HRQoL (e.g. Short Form Health Survey (SF‐36), Sickness Impact Profile, Nottingham Health Profile).Withdrawal from the intervention programme (measured as number of completers).
primary outcome:
Effects of interventions targeting the systemic inflammatory response to cardiac surgery on clinical outcomes in adults
To be included in the synthesis, trials had to measure biomarkers of the inflammatory response and clinical outcomes as listed below. Reporting one or more of the outcomes listed here in the review was not an inclusion criterion for the review. Where a published trial report did not appear to report one of these outcomes, we accessed the trial protocol and contacted the trial authors to ascertain whether the outcomes were measured but not reported. Relevant trials that measured these outcomes but did not report the data at all, or not in a usable format, were included in the review as part of the narrative. However, we excluded trials that did not measure or mention any data regarding the collection of the outcomes of interest.
primary outcome:
Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage
Death or dependence (measured on a standard rating scale, such as the modified Rankin Scale (mRS)) by day 90.
primary outcome:
Cerebrolysin for acute ischaemic stroke
All‐cause death, to be measured as the number of people who died from the start of tested treatment to the end of the follow‐up period.
primary outcome:
Pravastatin for lowering lipids
LDL cholesterol
primary outcome:
First‐line diuretics versus other classes of antihypertensive drugs for hypertension
Total mortality (death from all causes)Total serious adverse events (patients with at least one serious adverse event)Total number of people with at least one cardiovascular event including total stroke and total coronary heart disease (CHD) plus hospitalization or death from congestive heart failure and other significant vascular events such as ruptured aneurysms (does not include angina, transient ischemic attacks (TIAs), revascularization procedures or accelerated hypertension)Total stroke including fatal and non‐fatal strokesTotal CHD including fatal and non‐fatal myocardial infarction and sudden or rapid cardiac deathTotal congestive heart failure (death or hospitalization for heart failure)Total withdrawals due to adverse effects
primary outcome:
Physical exercise for the treatment of non‐ulcerated chronic venous insufficiency
Intensity of disease signs and symptoms, measured using a validated instrument such as the Venous Clinical Severity Score (see Table 2) (Rutherford 2000; Vasquez 2010)Ejection fraction, measured using air plethysmography or duplex ultrasonographyVenous refilling time, measured using plethysmographyIncidence of venous leg ulcer
primary outcome:
Risk of thromboembolism in patients with COVID‐19 who are using hormonal contraception
Venous thromboembolism during the study period.Arterial thromboembolism during the study period.
primary outcome:
Family presence during resuscitation
PTSD evaluation of the relatives measured short term (at 0 to 3 months) and long term (more than 3 months).
primary outcome:
Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of deep vein thrombosis
Recurrent VTE (clinically overt DVT confirmed by standard imaging techniques, including proximal leg vein ultrasound scan or D‐dimer test, or both; or clinically overt PE confirmed by computed tomography pulmonary angiography (CTPA) or ventilation/perfusion (V/Q) scan, or both)Recurrent DVT, confirmed by standard imaging techniques, including proximal leg vein ultrasound scan or D‐dimer testPE (fatal/non‐fatal), confirmed by CTPA or V/Q scan
primary outcome:
Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of pulmonary embolism
Recurrent PE, confirmed by standard imaging techniques (CTPA, V/Q scan, or pulmonary angiography)Recurrent venous thromboembolism (VTE, clinically overt DVT, confirmed by standard imaging techniques, including venography, impedance plethysmography, whole‐leg compression ultrasound, or proximal compression ultrasound; or clinically overt PE, confirmed by CTPA, V/Q scan, or pulmonary angiography)Clinically overt DVT, confirmed by standard imaging techniques (venography, impedance plethysmography, whole‐leg compression ultrasound, or proximal compression ultrasound).
primary outcome:
General versus loco‐regional anesthesia for endovascular aortic aneurysm repair
30‐day all‐cause perioperative mortalityLength of hospital stay, in daysLength of intensive care unit stay, in days
primary outcome:
Oral Class I and III antiarrhythmic drugs for maintaining sinus rhythm after catheter ablation of atrial fibrillation
Participants with recurrence of any ATa (AF, atrial flutter, or atrial tachycardia) lasting greater than 30 seconds.Adverse events, considered separately as the following individual outcomes:participants with a thromboembolic event (including transient ischaemic attack, ischaemic stroke, deep vein thrombosis, pulmonary embolism, and splanchnic vein thrombosis);participants with a myocardial infarction;participants with a new diagnosis of heart failure;participants who required hospitalisation one or more times for AF.
primary outcome:
Drugs to reduce bleeding and transfusion in major open vascular or endovascular surgery: a systematic review and network meta‐analysis
Red cell transfusions (units per participant*) at up to 30 days post surgeryAll‐cause mortality at up to 30 days; and between 31 and 90 days
primary outcome:
Endovascular therapy versus medical treatment for symptomatic intracranial artery stenosis
Short‐term death or stroke
primary outcome:
Antithrombotic treatment after stroke due to intracerebral haemorrhage
Composite outcome of all serious vascular events, commonly known as MACE (which we defined as ischaemic stroke, myocardial infarction, other major ischaemic event, ICH, major extracerebral haemorrhage, or vascular death) during the scheduled follow‐up period.We were unable to extract data on our primary outcome and some secondary outcomes (ischaemic stroke, myocardial infarction, vascular death, and cognitive status) from any of the RCTs, and we did not succeed in obtaining these outcomes from the corresponding authors.We found a significant reduction in the composite primary outcome of  major adverse cardiovascular events (MACE) with starting versus avoiding long‐term oral anticoagulation (26/172 versus 42/162; RR 0.61, 95% CI 0.40 to 0.94, P = 0.02; 2 published and 1 unpublished RCTs; 334 participants; moderate‐certainty evidence; Analysis 2.1).We did not find a significant difference in the composite primary outcome of MACE with starting versus avoiding long‐term oral antiplatelet therapy (54/268 versus 61/268; RR 0.89, 95% CI 0.64 to 1.22, P = 0.46; 1 published RCT; 536 participants; moderate‐certainty evidence; Analysis 3.1).We did not find a significant difference in the composite primary outcome of MACE with long‐term cilostazol versus aspirin (22/142 versus 17/146; RR 1.33, 95% CI 0.74 to 2.40), P = 0.34; 1 published RCT; 288 participants; low‐certainty evidence; Analysis 4.1).
primary outcome:
Intravenous immunoglobulin for the treatment of Kawasaki disease
Incidence of CAAs diagnosed by echocardiography or coronary angiography defined by absolute diameter, JMHW 1984, or Z‐scores.Incidence of any adverse effects after treatment initiation.
primary outcome:
Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures
Perioperative mortality, defined as death within one month after operation.
primary outcome:
Totally percutaneous versus surgical cut‐down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair
Short‐term mortality (30‐day or in‐hospital, i.e. procedure‐related)Failure of aneurysm exclusion (defined as no flow into the AAA sac on follow‐up imaging) 30 days after the procedureWound infection (30‐day or in‐hospital)
primary outcome:
Peroxisome proliferator‐activated receptor gamma agonists for preventing recurrent stroke and other vascular events in people with stroke or transient ischaemic attack
The number of participants with recurrent stroke, as defined in the original publications.The number of participants who experienced any adverse events, such as oedema, anaemia, or cardiac failure.
primary outcome:
Balneotherapy for chronic venous insufficiency
Disease severity signs and symptoms score, measured using any validated instrument, such as the Venous Clinical Severity Score (VCSS; Rutherford 2000; Table 1)Health‐related quality of life, measured using any validated instrument, such as the Chronic Venous Insufficiency Quality of Life Questionnaire 2 (CIVIQ2) or EuroQol Five‐Dimension Questionnaire (EQ‐5D; Brooks 1996; Launois 1996)Adverse effects of treatment, including palpitations, superficial thrombosis, infection or erysipelas and risk of falling
primary outcome:
High versus low blood pressure targets for cardiac surgery while on cardiopulmonary bypass
AKI within seven days after the surgery. AKI was defined as an abrupt kidney dysfunction within seven days after the surgery. If a study used the Risk, Injury, Failure, Loss and End‐stage kidney disease (RIFLE) criteria (Bellomo 2004), AKI was defined as 'R' or worse within seven days after the surgery. If a study used the Acute Kidney Injury Network (AKIN) (Mehta 2007), or Kidney Disease Improving Global Outcomes (KDIGO) criteria (KDIGO 2012), AKI was defined as stage I or worse of each criterion within seven days after the surgery. If a study did not use RIFLE, AKIN, or KDIGO criteria, AKI was defined by trial authors within seven days after the surgery. We defined the minimally important difference for AKI as a 20% decrease in relative risk (Azau 2014).Cognitive deterioration was defined as a decrease in cognition in any validated assessment scale, such as the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; Randolph 1998), from three to six months after the surgery (Annane 2018; Pandharipande 2013). If a study reported cognitive deterioration between three and six months after the surgery more than once, we included only the last timing as the outcome because a longer‐term cognitive deterioration has a more negative impact. We defined the minimally important difference for cognitive deterioration as a 50% decrease in relative risk (Cheng 2019).All‐cause mortality during the longest study period. We defined the minimally important difference for mortality as 1% in absolute risk (Landoni 2019).
primary outcome:
Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery
VTE (combined DVT or PE, symptomatic or asymptomatic, first episode or recurrent, fatal or non‐fatal). The diagnosis had to be confirmed by clinical examination and at least one additional objective diagnostic test. For DVT diagnosis from any site (e.g. lower limbs, abdominal) these tests included ultrasonography, angiography (e.g. computed tomography (CT), magnetic resonance imaging (MRI) or digital subtraction) and postmortem examination. For PE diagnosis, valid tests were angiography by any described method, ventilation‐perfusion scan or postmortem examination. If the participant had both DVT and PE events, we counted this as a single event of VTE for the analysis of this outcome.Major bleeding, defined by a decrease in haemoglobin concentration of 2 g/dL or more, a retroperitoneal or intracranial bleed, a transfusion of two or more units of blood, or fatal haemorrhagic events, as per the International Society on Thrombosis and Haemostasis (Schulman 2010)
primary outcome:
Prothrombin complex concentrate in cardiac surgery for the treatment of coagulopathic bleeding
Blood products transfused: defined as all products (whole blood, red blood cells, FFP, cryoprecipitate, platelets and fibrinogen concentrate) transfused in theatre and postoperatively, before and after the intervention or comparator, within 24 hours (mLs)Thrombotic events: defined as new venous and arterial thromboses within 30 daysMortality: defined as all‐cause mortality following cardiac surgery within 30 days
primary outcome:
Blood pressure targets for the treatment of people with hypertension and cardiovascular disease
Total mortality.Total serious adverse events.Total cardiovascular events including myocardial infarction, stroke, sudden death, hospitalization or death from CHF, and other significant vascular events such as ruptured aneurysms (excluding angina, TIA, surgical or other procedures, or accelerated hypertension). In practice, this was measured as total number of participants with at least one cardiovascular event, including fatal and non‐fatal cardiovascular events.Cardiovascular mortality.
primary outcome:
Pharmaceutical interventions for emotionalism after stroke
The proportion of participants achieving at least a 50% reduction in abnormal emotional behaviour at the end of treatment.Improved score on the Center for Neurologic Study ‐ Lability Scale (CNS‐LS) (Moore 1997).Improved score on the Testing Emotionalism After Recent Stroke – Questionnaire (TEARS‐Q) (Broomfield 2021).Clinician Interview‐Based Impression of Change (CIBIC) (Knopman 1994).Diminished tearfulness.
primary outcome:
Antifibrinolytic therapy for aneurysmal subarachnoid haemorrhage
The primary outcome measure was poor outcome (death, vegetative state, or (moderate) severe disability), assessed with either the Glasgow Outcome Scale or the Modified Rankin Scale, at the end of at least three months of follow‐up after SAH. Death from all causes, at a minimum follow‐up of at least three weeks, was our second primary outcome, since most studies only reported on case fatality.
primary outcome:
Interventions for perceptual disorders following stroke
Our primary outcome was performance in activities of daily living (ADL) immediately post‐intervention (‘immediate’ time point). We also planned to analyse ADL when measured at a follow‐up time point of three months after the intervention. We recognise that other follow‐up time points – for example, a longer (6‐ to 12‐month) follow‐up – are also important, but chose to focus on a short‐term (3‐month) follow‐up because: (1) based on experience in other reviews, we considered that trials were most likely to provide data for this time point (Hazelton 2022; Longley 2021; Pollock 2019b); and (2) synthesising data for this time point would enable us to explore whether any treatment effects observed immediately after treatment were maintained in the short term. We included any validated, standardised measure of ADL, such as the Barthel Index (Mahoney 1965), Functional Independence Measure (Keith 1987), Modified Rankin Scale (Rankin 1957), Katz Index of Activities of Daily Living (Katz 1983), Assessment of Motor and Process Skills (AMPS) (Fisher 1994), and Rehabilitation Activities Profile (Lankhorst 1996). Where trials provided data on more than one ADL outcome measurement instrument, we extracted and analysed the measure occurring earliest in the above list.
primary outcome:
Endovascular therapy versus medical treatment for spontaneous isolated dissection of the superior mesenteric artery
Endovascular intervention rate (at 12 months)Recurrent abdominal pain (measured by 10‐point visual analog scale (VAS), or 10‐point numerical rating scale (NRS), or other recognized scales at 12 months)
primary outcome:
Catheter‐directed therapies for the treatment of high risk (massive) and intermediate risk (submassive) acute pulmonary embolism
All‐cause mortalityTreatment‐associated major haemorrhage*Treatment‐associated minor haemorrhage*Adapted definitions from the Bleeding Academic Research Consortium (BARC) for cardiovascular trials (Mehran 2011)Major haemorrhage is defined as:overt bleeding plus haemoglobin drop of 5 g/dL or more (provided haemoglobin drop is related to the bleed);bleeding requiring surgical intervention for control (excluding skin/dental/nasal/haemorrhoid);bleeding requiring vasoactive drugs;bleeding causing intracranial haemorrhage (which does not include microbleeds or haemorrhagic transformation but does include intraspinal bleeds), confirmed by autopsy, imaging, or lumbar puncture;intraocular bleeding compromising vision; orfatal bleeding (death due to bleeding and no other cause). Fatal bleeding can be directly observed or confirmed by autopsy. The site of fatal bleeding is specified (intracranial, gastrointestinal, retroperitoneal, pulmonary, pericardial, genitourinary, or other). The time interval from the bleeding event to death should be considered to reflect likely bleeding causality.Minor haemorrhage is defined as any clinically overt signs of haemorrhage that require additional diagnostic studies or treatment by a healthcare professional but that do not meet the criteria for major haemorrhage listed above.Definitions from the International Society on Thrombosis and Haemostasis (ISTH), designed for the objective standardised evaluation of treatments for acute treatment of thromboembolism (therefore including APE) in people not undergoing surgery (Schulman 2005)Major bleeding is defined as:fatal bleeding;symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra‐articular, intrapericardial, or intramuscular with compartment syndrome; orbleeding causing a fall in haemoglobin level of 20 g/L or more, or leading to the transfusion of two or more units of whole blood or red cells.Clinically relevant non‐major bleeding in non‐surgical studies is defined as including any sign or symptom of haemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does:require medical intervention by a healthcare professional;lead to hospitalisation; orlead to increased level of care prompting a face‐to‐face evaluation (i.e. not just a telephone call or electronic communication; Kaatz 2015).
primary outcome:
Action observation for upper limb rehabilitation after stroke
Upper limb motor function, measured by the following.Arm functionMotor Assessment Scale (upper limb component)Frenchay Arm TestMotor Activity LogWolf Motor Function TestAction Research Arm TestFugl‐Meyer AssessmentHand functionMotor Assessment scale (hand component)Box and Block TestJebsen Test of Hand Function and Peg Test
primary outcome:
Patch angioplasty versus primary closure for carotid endarterectomy
Any stroke (fatal or non‐fatal; contralateral, ipsilateral or brainstem; haemorrhage or infarct) within 30 days of the operation and during long‐term follow‐upStroke ipsilateral to the endarterectomy site (fatal or non‐fatal; haemorrhage or infarct) within 30 days of the operation and during long‐term follow‐up
primary outcome:
Antiplatelet agents for the treatment of deep venous thrombosis
Recurrent VTE: including recurrent DVT and PE, first episode or recurrent, fatal or nonfatal. Both outcomes were diagnosed by clinical examination and a diagnostic assessment including ultrasonography, computed tomography or angiography.Major bleeding: defined by a decreased haemoglobin concentration of ≥ 2 g/dL, a retroperitoneal or intracranial bleed, a transfusion of ≥ 2 units of blood, or fatal haemorrhagic events, as defined by the International Society on Thrombosis and Haemostasis (Schulman 2005; Schulman 2010).PE (fatal/nonfatal): confirmed by computed tomography pulmonary angiography or ventilation/perfusion (V/Q) scan, or both.
primary outcome:
Type of anaesthesia for acute ischaemic stroke endovascular treatment
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). If the mRS score was not reported, we used the trial's own definition of functional outcome. If more than one functional outcome score was reported, we used the mRS as our main score of interest. If we identified both dichotomous and continuous variables related to independence, we reported them separately as independent outcomes (Wilson 2002).Neurological impairment assessed using clinical outcome measures or any validated international scales (e.g. the National Institutes of Health Stroke Scale (NIHSS)). If we identified both dichotomous and continuous variables related to neurological impairment, we reported them separately as independent outcomes (Brott 1989).
primary outcome:
Heparin versus 0.9% sodium chloride locking for prevention of occlusion in central venous catheters in adults
Occlusion of CVCs (defined as inability to infuse fluids through the catheter because of blockage)Duration (in days) of catheter patency
primary outcome:
Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia
All‐cause mortalityReduction in pain, as assessed by analgesic requirements or a pain analogue scaleIncidence of amputation (minor or major, where major amputation is above the ankle, and minor amputation is below the ankle or part of the foot)
primary outcome:
Routine or selective carotid artery shunting for carotid endarterectomy (and different methods of monitoring in selective shunting)
Death from any cause within 30 days of surgeryAll strokes (ischaemic and haemorrhagic) that occurred within 30 days of surgery. We did not include TIAs because these are less important to patients since they do not result in chronically impaired function. They are also more difficult to diagnose reliably, and so there is more potential for bias in their assessment (particularly if this is unblinded).
primary outcome:
Corticosteroids for the treatment of Kawasaki disease in children
Incidence of coronary artery abnormalities (measured via diameter or z‐scores; Boston scores (de Zorzi 1998)) per study group found at either cardiac angiography or echocardiography within three months of KD diagnosis. Coronary abnormality was defined using either the de Zorzi criteria (a coronary dimension that was 2.5 standard deviations (SDs) or greater above the mean for body surface area) (de Zorzi 1998); or the Japanese Ministry of Health criteria (Research Committee on Kawasaki Disease 1984), as follows.Lumen greater than 3 mm in children less than 5 years old;Lumen greater than 4 mm in children greater than 5 years old;Internal diameter of a segment measuring 1.5 times or greater that of an adjacent segment.Incidence of any serious adverse effects per study group that was attributable to the administration of corticosteroids at any point after treatment initiation. Known side effects of corticosteroids in other diseases include, for example, immunosuppression with resultant opportunistic infection and avascular necrosis of the femoral head.
primary outcome:
Percutaneous transluminal angioplasty and stenting for vertebral artery stenosis
30‐day post‐randomisation death/stroke;fatal/non‐fatal stroke in the territory of the treated vertebral artery stenosis after 30 days post‐randomisation to completion of follow‐up.
primary outcome:
Outpatient versus inpatient treatment for acute pulmonary embolism
Short‐term all‐cause mortality (from the date of randomisation to 10 and to 30 days).Long‐term all‐cause mortality (from the date of randomisation to 90 days).
primary outcome:
Endovascular versus conventional open surgical repair for thoracoabdominal aortic aneurysms
Prevention of aneurysm rupture (number of participants without aneurysm rupture up to 5 years from intervention)Aneurysm‐related mortality (30 days and 12 months)All‐cause mortality (5 years)Spinal cord ischaemia (paraplegia, paraparesis) (5 years)
primary outcome:
Occupational therapy for cognitive impairment in stroke patients
BADL, such as dressing, feeding, and bathing. We included both composite measures of BADL (e.g. Functional Independence Measure (FIM) (Stineman 1996), Barthel Index (BI) (Mahoney 1965; see Table 1 and Table 2), and measures of individual activities (e.g. dressing assessment).
primary outcome:
Angioplasty versus stenting for subclavian artery stenosis
vessel patency rate – i.e. restenosis or re‐occlusion rates, both primary and secondary, including time to restenosis or re‐occlusion as defined by an imaging modality. We planned to assess the vessel patency, restenosis or re‐occlusion rates by any major imaging modality, such as duplex ultrasound, magnetic resonance angiography, or computed tomography angiography.
primary outcome:
Ultrafiltration for acute heart failure
All‐cause mortality – up to and including 30 days from discharge, and longest available follow‐up.All‐cause rehospitalisation – up to and including 30 days from discharge, and longest available follow‐up.HF‐related rehospitalisation – up to and including 30 days from discharge, and longest available follow‐up.
primary outcome:
Oral antiplatelet therapy for acute ischaemic stroke
Death or dependence on help from other people for activities of daily living at least one month after their stroke (death or dependence at end of follow‐up). Many people regard this as the most important outcome since the aim of treatment should not only be to prevent death but also to prevent serious disability in survivors. The minimum interval of one month was used to allow time for recovery from the initial stroke.
primary outcome:
Calcium channel blockers versus other classes of drugs for hypertension
All‐cause mortalityMyocardial infarction (non‐fatal and fatal MI plus sudden or rapid death)Stroke (non‐fatal and fatal stroke)Congestive heart failureCardiovascular mortalityMajor cardiovascular events (MI, congestive heart failure, stroke, and cardiovascular mortality)
primary outcome:
Percutaneous thrombectomy or ultrasound‐accelerated thrombolysis for initial management of acute limb ischaemia
Primary patency: vessel patency at 6 months and 12 months after the intervention, as measured by image evaluation (Doppler ultrasound, tomography, or angiography)Amputation rate: number of participants undergoing major amputations (defined as amputation either above the ankle in the lower limb or above the wrist in the upper limb) at 12 and 24 months after the interventionMajor bleeding: defined as bleeding that causes a haemoglobin level drop of 3 g/dL or more, requires transfusion, requires surgical intervention for control, or requires vasoactive intravenous drugs; cardiac tamponade; intracranial haemorrhage; intraocular bleed compromising vision, type 3; or fatal bleeding, type 5. We used the Bleeding Academic Research Consortium (BARC) score for this definition (Mehran 2011).
primary outcome:
Propionyl‐L‐carnitine for intermittent claudication
MWD, or absolute claudication distance (ACD) ‐ the distance walked during a standardized test at which the participant stops walking due to muscular cramps (maximum distance walked). Another parameter used for this is peak walking time (PWT)
primary outcome:
Psychological and pharmacological interventions for depression in patients with coronary artery disease
Depression (measured either dimensionally or categorically) following the intervention, as assessed by validated self‐report questionnaires or standardised interviews. Depression may be quantified categorically as 'remitted' or 'response', the latter defined as a 50% or more reduction in severity from baseline.All‐cause mortality.Cardiovascular mortality.Non‐fatal cardiac events according to standardised criteria (e.g. WHO 1992 or subsequent iterations):myocardial infarction (MI);angina;heart failure;arrhythmia;stroke;Coronary revascularisation for CAD: coronary artery bypass graft (CABG) and/or percutaneous coronary intervention (PCI) or angioplasty.
primary outcome:
Endovascular versus open surgical repair for complicated chronic Type B aortic dissection
Mortality (all‐cause, dissection‐related, 30‐day)Neurological sequelae (stroke, spinal cord ischaemia/paresis‐paralysis, vertebral insufficiency)
primary outcome:
Injection sclerotherapy for varicose veins
Cosmetic appearance (assessed by any validated tool)Complications (including haematoma formation, skin pigmentation, ulceration and necrosis, superficial thrombophlebitis, thromboembolic complications (deep vein thrombosis and pulmonary embolism as defined by the authors of primary studies), and anaphylactic reaction)
primary outcome:
Environmental enrichment for stroke and other non‐progressive brain injury
Depression Anxiety Stress Scale‐21 (DASS) (Lovibond 1995);Hospital Anxiety and Depression Scale (HADS) (Zigmond 1983);Rosenberg Self‐Esteem Scale (Rosenberg 1965);Multidimensional Health Locus of Control (MHLC) (Wallston 1994)
primary outcome:
Renal denervation for resistant hypertension
Fatal and non‐fatal cardiovascular events, including but not limited to myocardial infarction, cerebrovascular accidents, and congestive heart failureAll‐cause mortalityAny hospitalisation and duration of hospital stay (if long‐term data are available)Quality of life (assessed using validated scales or any other instrument as reported by authors, such as the Short‐Form Health Survey (SF‐36)
primary outcome:
Interventions for altering blood pressure in people with acute subarachnoid haemorrhage
Death from all causes.Death (from all causes) or dependency (defined by trialists; measured on the modified Rankin Scale (mRS), or the extended Glasgow Outcome Scale (eGOS): we planned to perform a subgroup analysis of the various methods for measuring dependency as defined by trialists.
primary outcome:
Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery
independence at end of treatment. In stroke trials this is typically measured using the modified Rankin Scale (mRS), with a score of 0 to 2 conventionally considered to represent independence;disability score at the end of treatment. Measures included, but were not limited to, Barthel index (BI) or Functional Independence Measure (FIM). If FIM or Barthel was not measured, we included an outcome reported in the trial that reported a construct as similar as possible to FIM or Barthel. For the trials which reported the Stroke Impact Scale, we used the daily activities subscale as a measure of disability.
primary outcome:
Exercise‐based cardiac rehabilitation for coronary heart disease
All‐cause mortalityCardiovascular mortalityFatal MI and/or non‐fatal MIRevascularisation with CABGRevascularisation with PCIAll‐cause hospitalisationCardiovascular hospitalisation
primary outcome:
Beta‐blockers in patients without heart failure after myocardial infarction
All‐cause mortalityMajor cardiovascular event (MACE) defined as a composite outcome consisting of cardiovascular mortality (as defined by trialists) and non‐fatal myocardial infarction (as defined by trialists). Additionally, we assessed cardiovascular mortality and myocardial infarction separately as secondary outcomes (see later). We reported MACE (cardiovascular mortality + non‐fatal myocardial infarction) only if we were confident that there was no risk of double‐counting, and if the trialist had clearly defined and reported cardiovascular mortality and non‐fatal infarctionSerious adverse event defined as any untoward medical occurrence that was life‐threatening, resulted in death, or was persistent or led to significant disability; or prolonged hospitalisation or any medical event that had jeopardised the participant or required intervention to prevent it (ICH‐GCP 2015). Because we expected reporting of serious adverse events in many trials to be very heterogeneous and not done strictly according to recommendations regarding good clinical practice from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH‐GCP) (ICH‐GCP 2015), we planned to include the event as a serious adverse event if trial authors used the term ‘serious adverse event' without referring to ICH‐GCP. However, no trials specifically assessed serious adverse events according to the definition provided by ICH‐GCP. Instead, trials reported one specific serious adverse event, which was already included in one of the other outcomes in this review, or a composite of several different events without referring to the actual proportions of participants
primary outcome:
Dipeptidyl peptidase‐4 inhibitors, glucagon‐like peptide 1 receptor agonists and sodium‐glucose co‐transporter‐2 inhibitors for people with cardiovascular disease: a network meta‐analysis
Cardiovascular mortalityFatal or non‐fatal myocardial infarctionFatal or non‐fatal stroke
primary outcome:
Anticoagulants for acute ischaemic stroke
Death or dependency (i.e. people who were dead or were dependent on help from other people for their activities of daily living), at least one month after stroke. This minimum interval was used to allow time for recovery from the initial stroke. Comparable definitions of dependency were used in all of the trials assessed in this review
primary outcome:
Interrupted versus uninterrupted anticoagulation therapy for catheter ablation in adults with arrhythmias
Thromboembolic events (stroke or systemic embolism).Major bleeding, defined as bleeding requiring intervention (or as reported in included trials).
primary outcome:
Local versus general anaesthesia for carotid endarterectomy
The primary outcome was the proportion of participants who had a stroke of any kind (i.e. fatal or non‐fatal, contralateral or ipsilateral or brainstem, haemorrhage or infarction) within 30 days of surgery, and during long‐term follow‐up.
primary outcome:
Ultrasound guidance for arterial (other than femoral) catheterisation in adults
First‐attempt success rate (i.e. number of participants for whom the proposed method of catheterisation was successful on the first attempt).Pseudoaneurysm: total number of perioperative and postoperative pseudoaneurysms.
primary outcome:
Treatment for telangiectasias and reticular veins
Clinically‐ or photographically‐assessed resolution or improvement (or both) of telangiectasias: resolution or improvement were measured by clear diagnostic scales, e.g. vessel clearance < 20%, 20 to 40%, 40 to 60%, 60 to 80%, > 80% (Shamma 2005) or study definitionsAdverse events (including hyperpigmentation, matting, allergy, bruising, anaphylaxis, necrosis of the skin)