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Resolution of pain crisis by five hours (post hoc change), as defined by:freedom from parenteral opioid use for five hours;pain relief as assessed by visual analogue pain scale score of 6 cm or lower (on 0‐to‐10 scale);ability to walk;participant and family decision, with physician consensus, that the remaining pain could be managed at home.Duration of initial pain crisis until resolution with iNOFrequency of pain crises in the follow‐up period | Provide primary outcome for the study
Inhaled nitric oxide for treating pain crises in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Total treatment failure at day 28 (PCR‐adjusted and unadjusted)Total treatment failure at day 42 (PCR‐adjusted and unadjusted) | Provide primary outcome for the study
Pyronaridine‐artesunate for treating uncomplicated Plasmodium falciparum malaria | You are a research assistant. Based on the question please provide appropriate answers |
As primary outcome we evaluated on‐study mortality defined as deaths occurring up to 30 days after the active study period. This is due to the qualitatively low number of studies reporting long follow‐up time periods. Long‐term follow‐up is prone to be less precise when it comes to recording the number of deaths, hence on‐study mortality is more appropriate as a primary outcome measure. | Provide primary outcome for the study
Intravenous iron versus oral iron versus no iron with or without erythropoiesis‐ stimulating agents (ESA) for cancer patients with anaemia: a systematic review and network meta‐analysis | You are a research assistant. Based on the question please provide appropriate answers |
Response to ECP treatment (defined as either classical response rates (i.e. number of people in complete or partial remission) or percentage of achieved reduction in either NIH score (Filipovich 2005; Jagasia 2009; Jagasia 2015; Schoemans 2018), scales of Akpek and Lee (Akpek 2001; Lee 2003), or steroid‐tapering under therapy with ECP (defined as number of people with at least 25% reduction in steroid dose). | Provide primary outcome for the study
Extracorporeal photopheresis versus alternative treatment for chronic graft‐versus‐host disease after haematopoietic stem cell transplantation in children and adolescents | You are a research assistant. Based on the question please provide appropriate answers |
Malaria incidence: measured as a count per person unit time of 1. infections or 2. new infections, following treatment to avoid measuring pre‐existing infections. Infection was defined as any symptom, including fever, with confirmed parasitaemia (by blood smear microscopy or rapid diagnostic test (RDT)).Malaria parasite prevalence: the proportion of surveyed people with confirmed parasitaemia. | Provide primary outcome for the study
Indoor residual spraying for preventing malaria in communities using insecticide‐treated nets | You are a research assistant. Based on the question please provide appropriate answers |
Urinary protein or albumin excretion (over 24 hours or first morning void (FMV))Serum creatinineElectrolyte levels | Provide primary outcome for the study
Angiotensin‐converting enzyme (ACE) inhibitors for proteinuria and microalbuminuria in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Maternal death (any cause, within 42 days following delivery)Post‐partum haemorrhage (women with total blood loss 500 mL or more within 24 hours after birth, and severe PPH defined as a blood loss of 1000 mL or more within the same timeframe) (WHO 2012).Infant death (within one year of birth) | Provide primary outcome for the study
Maternal and foetal outcomes following natural vaginal versus caesarean section (c‐section) delivery in women with bleeding disorders and carriers | You are a research assistant. Based on the question please provide appropriate answers |
Reproductive outcomes in women and their partners who are carriers of thalassaemia, sickle cell disease, cystic fibrosis or Tay‐Sachs disease identified during or after pregnancynumber of infants born with genetic conditionsnumber of infants born with congenital anomaliesnumber of infants born with low birth weightnumber of infants born prematurelyDecisions about future conception and pregnancy in women and their partners who are carriers for thalassaemia, sickle cell disease, cystic fibrosis or Tay‐Sachs diseasenumber of women or couples who would make use of prenatal diagnosisnumber of women or couples who would make use of prenatal diagnosis and consider termination of pregnancy if the child is affectednumber of women or couples who would consider PGT and IVFnumber of women or couples who would conceive using donated gametesnumber of women or couples who would consider adoptionnumber of women or couples who would refrain from having any childrenNumber of women or couples who make an informed choice measured by tools such as the Multidimensional Measure of Informed Choice (MMIC) | Provide primary outcome for the study
Preconception risk assessment for thalassaemia, sickle cell disease, cystic fibrosis and Tay‐Sachs disease | You are a research assistant. Based on the question please provide appropriate answers |
Measures of longitudinal growth (growth velocity z score, height z score) | Provide primary outcome for the study
Recombinant growth hormone therapy for X‐linked hypophosphatemia in children | You are a research assistant. Based on the question please provide appropriate answers |
Parasitaemia prevalence, as measured by microscopy, malaria RDT, or molecular method, such as polymerase chain reaction (PCR).Parasitaemia incidence (e.g. incidence of infection through active surveillance as measured in a cohort).Confirmed malaria illness incidence, defined as febrile illness with diagnostically confirmed parasitaemia (WHO 2015c) (e.g. incidence of confirmed clinical infection as measured in passive or routine surveillance data collected at health facilities). | Provide primary outcome for the study
Mass drug administration for malaria | You are a research assistant. Based on the question please provide appropriate answers |
Functional tests12‐minute walk test (12MWT)3‐minute stair climb (3MSC)other validated measures of functionality used by trial authors (i.e. 6‐minute walk test (6MWT)) | Provide primary outcome for the study
Enzyme replacement therapy with galsulfase for mucopolysaccharidosis type VI | You are a research assistant. Based on the question please provide appropriate answers |
Overall survivalQuality of life measured using reliable and valid instrumentsTreatment‐related mortalityNumber of participants with adverse events and serious adverse events, including:Cytokine release syndrome, neurotoxicity and the use of tocilizumab and/or corticosteroids for treatment of cytokine release syndrome and/or neurotoxicityCytopenias (anaemia, leukopenia, neutropenia, thrombocytopenia and any prolonged cytopenias)Infections | Provide primary outcome for the study
Chimeric antigen receptor (CAR) T‐cell therapy for people with relapsed or refractory diffuse large B‐cell lymphoma | You are a research assistant. Based on the question please provide appropriate answers |
Stable complete remission (defined as no reported relapse during follow‐up)Complete remission (defined as a negative inhibitor test and a normal FVIII level) | Provide primary outcome for the study
Rituximab for eradicating inhibitors in people with acquired haemophilia A | You are a research assistant. Based on the question please provide appropriate answers |
Number of joint bleeding episodes or joint bleeding frequency during the trialOrthopedic joint score or clinical joint functionQoL on validated scales (disease‐specific where possible) | Provide primary outcome for the study
Clotting factor concentrates for preventing bleeding and bleeding‐related complications in previously treated individuals with haemophilia A or B | You are a research assistant. Based on the question please provide appropriate answers |
Clinical malaria (fever plus asexual parasitaemia) | Provide primary outcome for the study
Intermittent preventive treatment for malaria in infants | You are a research assistant. Based on the question please provide appropriate answers |
Event‐free survival (event is defined as either β‐thalassaemia manifestations, need for resumption of blood transfusions, or adverse effects of the transplant procedure like graft failure, grade III/IV acute GVHD, or chronic GVHD) the interval from time of randomisation or trial entry to the first occurrence of event or to death of any cause.Quality of life (assessed by validated instruments and scales). | Provide primary outcome for the study
Hematopoietic stem cell transplantation for people with β‐thalassaemia | You are a research assistant. Based on the question please provide appropriate answers |
Frequency of complete haematological response (complete response (CR), defined as normalisation of haemoglobin concentration, reticulocyte count, and indirect (or unconjugated] bilirubin level) at months two, six and 12.Frequency of adverse events at two, six and 12 months. | Provide primary outcome for the study
Disease‐modifying treatments for primary autoimmune haemolytic anaemia | You are a research assistant. Based on the question please provide appropriate answers |
Number of participants developing Streptococcus pneumoniae infection, confirmed with culturesDeaths | Provide primary outcome for the study
Prophylactic antibiotics for preventing pneumococcal infection in children with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Total treatment failure at day 28 (polymerase chain reaction (PCR)‐adjusted and unadjusted).Total treatment failure at day 42 (PCR‐adjusted and unadjusted). | Provide primary outcome for the study
Atovaquone‐proguanil for treating uncomplicated Plasmodium falciparum malaria | You are a research assistant. Based on the question please provide appropriate answers |
Complete leg ulcer closure (defined as 100% epithelization or skin closure without drainage)Time to ulcer closureChange in ulcer size (surface area or volume) | Provide primary outcome for the study
Interventions for treating leg ulcers in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Blood phenylalanine and tyrosine concentrationsWeight gain and any other indices of nutritional status or growthMeasures of intelligence and neuropsychological performance | Provide primary outcome for the study
Tyrosine supplementation for phenylketonuria | You are a research assistant. Based on the question please provide appropriate answers |
Efficacy: polymerase chain reaction (PCR)‐adjusted and unadjusted treatment failure on day 28 (WHO 2009).Safety: serious adverse events and drug‐related serious adverse events (ICH 2016).Tolerability: adverse events and drug‐related adverse events (ICH 2016).Tolerability of drug administration: drug‐related gastrointestinal adverse events (drug‐related vomiting, drug‐related gastrointestinal disorders, and a composite endpoint of these two) (ICH 2016). | Provide primary outcome for the study
Paediatric formulations of artemisinin‐based combination therapies for treating uncomplicated malaria in children | You are a research assistant. Based on the question please provide appropriate answers |
Event‐free survival (individuals alive and free of SCD symptoms)Change in mean life expectancy of individuals with SCD attributable to gene therapy | Provide primary outcome for the study
Gene therapy for sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Frequency, severity or duration of painful crises (as judged by validated pain scales, analgesia use and hospital utilisation) (change or absolute values)Frequency of severe complications of SCD including sequestration crisis, acute sickle chest syndrome and leg ulcers (change or absolute values)Frequency of hospital admissions from severe complications of SCD including painful crises, sequestration crises, acute sickle chest syndrome and leg ulcers (change or absolute values) | Provide primary outcome for the study
Phytomedicines (medicines derived from plants) for sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Remission or no response (Hay 2012)complete remission: negative inhibitor titer, FVIII recovery over 66% of expected, and FVIII recovery lasting longer than six hourspartial remission: negative inhibitor titer, but persistently abnormal recovery or half‐life; responding clinically to FVIII replacement without an anamnestic increase in inhibitor titerfailure: failure of the inhibitor to decline by 20% over any six‐month period; or failure to achieve tolerance or partial response; or withdrawal from the trial for any reason before tolerance was achievedrelapse: inhibitor recurrence during the 12‐month follow‐up period on prophylaxis after tolerance was achieved, as evidenced by recurrent positive Bethesda titer or a decline in FVIII recovery or half‐life below trial limits | Provide primary outcome for the study
Rituximab for treating inhibitors in people with inherited severe hemophilia | You are a research assistant. Based on the question please provide appropriate answers |
Incidence of clinical diagnosis of any type of stroke (by clinical symptoms and signs, magnetic resonance imaging (MRI) scan, computed tomography imaging (CT) scan or autopsy)Deaths from any cause in each treatment groupTransfusion‐related complications (e.g. alloimmunisation, infection from blood product, procedural complications, transfusion reactions, reduced immunocompetency, iron overload (measured by serum ferritin, liver iron or quantitative MRI)) | Provide primary outcome for the study
Blood transfusion for preventing primary and secondary stroke in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Blood phenylalanine concentrationMeasures of neuropsychological performanceMeasures of intelligence | Provide primary outcome for the study
Dietary interventions for phenylketonuria | You are a research assistant. Based on the question please provide appropriate answers |
Improvement in health‐related quality of life as defined by participant questionnaires (all self‐completed).Common adverse effects of the treatments, presented as proportions of participants. | Provide primary outcome for the study
Interventions for mycosis fungoides | You are a research assistant. Based on the question please provide appropriate answers |
Event‐free survival (individuals alive and free of SCD symptoms) | Provide primary outcome for the study
Hematopoietic stem cell transplantation for people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Perioperative mortality (all cause)Serious complications related to:SCD (e.g. acute chest syndrome, painful crisis, neurological complication, renal complication)surgery (e.g. fall in haemoglobin level)infectiontransfusion (e.g. serious transfusion reactions, other serious transfusion complications) | Provide primary outcome for the study
Preoperative blood transfusions for sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
All‐cause mortalityLack of improvement (as defined by trial authors)Adverse eventsserious adverse eventsnon‐serious adverse events | Provide primary outcome for the study
Interventions for treating intrahepatic cholestasis in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Final heightheight (cm)height SDSheight SDS relative to expected height based on mid‐parental heightAdverse effects (such as but not limited to benign intracranial hypertension, slipped capital femoral epiphyses, effects on glucose metabolism in both non‐diabetic as well as diabetic patients and incidence of malignant disease, haemorrhagic stroke or cardiovascular events)Satisfaction (measured by validated questionnaires e.g. (Leiberman 1993; Rubin 2011))participantsparents or caregivers | Provide primary outcome for the study
Growth hormone therapy for people with thalassaemia | You are a research assistant. Based on the question please provide appropriate answers |
Serum 25‐hydroxyvitamin D (25(OH)D) level (reported as absolute change from baseline)BMD measured by dual energy X‐ray absorptiometry (DEXA) and reported as per cent (%) change from baselineat lumbar spineat hipsat forearmtotal bodyAdverse events (e.g. nausea, drowsiness, vomiting, loss of appetite, constipation, confusion, cardiac arrhthymias, renal failure, coma) | Provide primary outcome for the study
Vitamin D supplementation for sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Bleeding episode(s) (bleeding frequency, number of bleeding episodes per year, or as reported in the trial)Factor VIII or IX supplementation requirement (frequency as reported in the trials)Serious adverse events (resulting in death or life threatening complications, inpatient hospitalisation, significant or permanent disability, or one that requires additional intervention to prevent permanent damage or disability)Evidence of clotting factor antibody developmentEvidence of organ toxicityEvidence of tumour development | Provide primary outcome for the study
Gene therapy for haemophilia | You are a research assistant. Based on the question please provide appropriate answers |
Proportion of participants developing new or progressive SCI lesions on MRIAll‐cause mortalitySerious adverse events (SAEs) associated with different therapies or SCD | Provide primary outcome for the study
Interventions for preventing silent cerebral infarcts in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Pain relief *Pain intensity (as assessed by visual analogue pain scale score (VAS) or other validated assessment tools for measuring pain intensity during the use of TENS)Frequency of pain episodes | Provide primary outcome for the study
Transcutaneous electrical nerve stimulation (TENS) for pain management in sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Proportion of infants exposed to one or more red blood cell (RBC) transfusionsNecrotising enterocolitis (NEC) (Bell's stage II or higher, or stage not reported)Any neurodevelopmental impairment at 18 to 22 months' corrected age (in children examined)Bayley‐II Mental Development Index (MDI) at 18 to 24 months' corrected age | Provide primary outcome for the study
Early erythropoiesis‐stimulating agents in preterm or low birth weight infants | You are a research assistant. Based on the question please provide appropriate answers |
Use of one or more red blood cell transfusions. | Provide primary outcome for the study
Late erythropoiesis‐stimulating agents to prevent red blood cell transfusion in preterm or low birth weight infants | You are a research assistant. Based on the question please provide appropriate answers |
Chest painintensity (expressed as scores obtained through any validated patient‐reported outcomes instrument either generic or SCD specific)duration from time of start of symptomsFeverMortality | Provide primary outcome for the study
Blood transfusions for treating acute chest syndrome in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Haemoglobin concentration (g/L), measured at the end of follow‐upOverall quality of life, taken at the end of follow‐up, as measured by a quantitative quality‐of‐life measurement scale | Provide primary outcome for the study
Intravenous iron therapy for non‐anaemic, iron‐deficient adults | You are a research assistant. Based on the question please provide appropriate answers |
Resolution or reduction in the severity of the condition (as measured by)decayed, missing, filled teeth (DMFT) index, radiographic changes, salivary acid or streptococcus mutans levels for dental cariesgingival or plaque indices, probing depth, bone level for periodontal diseaseschange in teeth or jaw positions, cephalometric analysis, malocclusion indices (in case of malocclusions and craniofacial deformities)visual analogue scale, dichotomy scale or Likert scale for pain assessmentany other relevant measure reported | Provide primary outcome for the study
Treatment of dental complications in sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Painpresence and level of painuse of analgesia during the first two weeks (doses of opioids will be converted into morphine equivalents to facilitate comparisons)weak opioids, e.g. codeine and tramadolstrong opioids, e.g. morphine and pethidineacetaminophen and non‐steroidal anti‐inflammatory drugs (NSAIDs) (open or selective Cox 2‐inhibitors)other analgesicsDeath and cause of deathAdverse events, the events will be classified as: immediate (less than 24 hours post‐intervention); early (one to eight days after intervention); and long‐term (more than eight days after intervention). Our definition of immediate, early, and long term is arbitrary.prevalence and timing of joint looseningbone fractureinfectionsintra‐operative bleedingcomplications of SCD during hospital admission (e.g. painful crises, acute chest syndrome and stroke)related to analgesia | Provide primary outcome for the study
Treatment for avascular necrosis of bone in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
All‐cause mortality (up to 24 hours, and up to 30 days)Major bleeding within 24 hours and within seven days as defined by the study, or by the following (based on Schulman 2010).Fatal bleeding.Intracranial/intraspinal/pericardial/intraocular/retroperitoneal, into a non‐operated joint, or intramuscular causing compartment syndrome.Surgical/invasive procedure site bleeding requiring a second intervention or reoperation.Surgical/invasive procedure site bleeding that causes a haematoma or haemarthrosis of sufficient size to delay mobilisation or wound healing.Surgical/invasive procedure site bleeding that is unexpected and prolonged or causes haemodynamic instability (as defined by the study) and is associated with a 20‐g/L drop in haemoglobin (Hb), or requiring two or more units of whole blood/red cells within 24 hours of bleeding.Extrasurgical/invasive procedure site bleeding associated with a 20‐g/L drop in Hb, or requiring two or more units of whole blood/red cells within 48 hours of bleeding. | Provide primary outcome for the study
Prophylactic plasma transfusion for patients without inherited bleeding disorders or anticoagulant use undergoing non‐cardiac surgery or invasive procedures | You are a research assistant. Based on the question please provide appropriate answers |
We included all trials fitting the inclusion criteria mentioned above, irrespective of reported outcomes. We estimated the relative ranking of the competing interventions according to each of the following outcomes.*The Grades are referring to the severity of AEs according to the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1 refers to mild AEs; Grade 5 to death related to AEs | Provide primary outcome for the study
Multiple drug combinations of bortezomib, lenalidomide, and thalidomide for first‐line treatment in adults with transplant‐ineligible multiple myeloma: a network meta‐analysis | You are a research assistant. Based on the question please provide appropriate answers |
Participant‐reported pain relief of 50% or greater at 6, 12, 24, 48 hours and at the end of treatment.Participant‐reported pain relief of 30% or greater at 6, 12, 24, 48 hours and at the end of treatment.Patient global impression of change (PGIC) very much improved.Patient global impression of change (PGIC) much or very much improved. | Provide primary outcome for the study
Pharmacological interventions for painful sickle cell vaso‐occlusive crises in adults | You are a research assistant. Based on the question please provide appropriate answers |
Change in carotid intima‐media thicknessChange in serum LDL cholesterol levelChange in measures of growth and maturation, e.g. age of onset of puberty | Provide primary outcome for the study
Statins for children with familial hypercholesterolemia | You are a research assistant. Based on the question please provide appropriate answers |
Number of people with new diagnoses of chronic chest complicationschronic sickle lung diseasepulmonary hypertension (using a cut off of TRV 2.5 m/s to define pulmonary hypertension)Deathsfrom any causefrom chronic chest complications (chronic sickle lung disease and pulmonary hypertension)Transfusion‐related complications (up to 30 days post transfusion) including:alloimmunisationinfection from blood productsprocedural complications (such as device malfunction)iron overload (measured by serum ferritin, liver iron, or non‐invasive imaging)transfusion reactions | Provide primary outcome for the study
Regular long‐term red blood cell transfusions for managing chronic chest complications in sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Time to resolution of signs and symptoms of active infection | Provide primary outcome for the study
Antibiotics for treating osteomyelitis in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Frequency of transfusion (post splenectomy or discharge)Occurence of serious adverse events (resulting in death or life threatening complications, inpatient hospitalisation, significant or permanent disability, or one that necessitates an additional intervention to prevent further damage)Quality of life (as assessed by validated instruments or scales) | Provide primary outcome for the study
Splenectomy for people with thalassaemia major or intermedia | You are a research assistant. Based on the question please provide appropriate answers |
Change in frequency of vaso‐occlusive painful crises as measured bypain diary of days with significant painnumber of painful days (where the pain is strong enough to require analgesics)Quality of life (measured using a validated scale)Length of hospital stay | Provide primary outcome for the study
Magnesium for treating sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Number of postoperative bleeding episodes requiring intervention*Side effects or other adverse events | Provide primary outcome for the study
Antifibrinolytic therapy for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing minor oral surgery or dental extractions | You are a research assistant. Based on the question please provide appropriate answers |
Volume of blood required (red blood cell units)Frequency of blood transfusionMean Hb level | Provide primary outcome for the study
Hydroxyurea (hydroxycarbamide) for transfusion‐dependent β‐thalassaemia | You are a research assistant. Based on the question please provide appropriate answers |
Maternal mortalityPost‐partum haemorrhage (PPH) (defined as excessive bleeding occurring within six weeks after delivery and also judged on the basis of any intervention required (e.g. transfusion, surgery))Infant mortality | Provide primary outcome for the study
Desmopressin acetate (DDAVP) for preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders | You are a research assistant. Based on the question please provide appropriate answers |
We predefined overall survival (OS) as the primary efficacy outcome. As this outcome was reported in one trial only, but mortality was reported in six trials, we also evaluated mortality. | Provide primary outcome for the study
Aerobic physical exercise for adult patients with haematological malignancies | You are a research assistant. Based on the question please provide appropriate answers |
All‐cause mortalitySafety of MSC infusion – acute toxicity, ectopic tissue formation or oncogenesis | Provide primary outcome for the study
Mesenchymal stromal cells as treatment or prophylaxis for acute or chronic graft‐versus‐host disease in haematopoietic stem cell transplant (HSCT) recipients with a haematological condition | You are a research assistant. Based on the question please provide appropriate answers |
Thirty‐day mortality from any cause (all‐cause mortality). If all‐cause mortality was not available at 30 days, we used the time point reported by the study and documented it. | Provide primary outcome for the study
Early discontinuation of antibiotics for febrile neutropenia versus continuation until neutropenia resolution in people with cancer | You are a research assistant. Based on the question please provide appropriate answers |
Mortality (all causes) (principal primary outcome for therapeutic intervention usage)The number of participants suffering arterial and/or venous thromboembolic events (principal primary outcome for prophylactic intervention usage) | Provide primary outcome for the study
Pro‐coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia | You are a research assistant. Based on the question please provide appropriate answers |
Acute morbidity from salmonella infection (e.g. vaso‐occlusive, hyperhaemolytic, sequestration and aplastic crises; septicaemia; pneumonia; meningitis;osteomyelitis; acute chest syndrome)Mortality from salmonella infection | Provide primary outcome for the study
Vaccines for preventing invasive salmonella infections in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Child mortality from all causes. | Provide primary outcome for the study
Insecticide‐treated nets for preventing malaria | You are a research assistant. Based on the question please provide appropriate answers |
Number of deathsNumber of sickle pain crises (requirement for opiate treatment or self‐reported patient scales)Number of serious complications of sickle cell disease including stroke, acute chest syndrome and acute splenic sequestration | Provide primary outcome for the study
Drugs for preventing red blood cell dehydration in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Mortality (all‐causes, secondary to bleeding, secondary to thromboembolism and secondary to infection) within 30 days and 90 days of surgery.Number of participants with major procedure‐related bleeding within seven days of surgery, defined as:surgical site bleeding requiring a second intervention or reoperation or surgical site bleeding that causes a haematoma or haemarthrosis of sufficient size to delay mobilisation or wound healing;bleeding of sufficient size to cause delayed wound healing, or wound infection or surgical site bleeding that was unexpected and prolonged or caused haemodynamic instability (as defined by the study) that was associated with a 20 g/L drop in haemoglobin (Hb);bleeding that required two or more units of whole blood/red cells within 24 hours of the bleeding;bleeding defined by the study with no further details. | Provide primary outcome for the study
Prophylactic platelet transfusions prior to surgery for people with a low platelet count | You are a research assistant. Based on the question please provide appropriate answers |
Mortality from Hib infectionsOverall mortalityAcute morbidity from Hib infections (e.g. vaso‐occlusive, hyperhaemolytic and sequestration crises, septicaemia, meningitis, pneumonia, acute chest syndrome, epiglottitis, cellulitis, arthritis, osteomyelitis, pericarditis). | Provide primary outcome for the study
Conjugate Haemophilus influenzae type b vaccines for sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Overall survival (OS) defined as time from random treatment assignment to death from any cause or to last follow‐up | Provide primary outcome for the study
Effects of all‐trans retinoic acid (ATRA) in addition to chemotherapy for adults with acute myeloid leukaemia (AML) (non‐acute promyelocytic leukaemia (non‐APL)) | You are a research assistant. Based on the question please provide appropriate answers |
The number of participants with at least one bleeding episode (WHO Grade 1 to 4, or WHO Grade 2 to 4)The total number of days on which bleeding occurred or the total number of bleeding episodes per participant (WHO Grade 1 to 4, or WHO Grade 2 to 4)The number of participants with at least one episode of severe or life‐threatening bleedingTime to first bleeding episode from the start of the study (WHO Grade 1 to 4, or WHO Grade 2 to 4) | Provide primary outcome for the study
Comparison of a therapeutic‐only versus prophylactic platelet transfusion policy for people with congenital or acquired bone marrow failure disorders | You are a research assistant. Based on the question please provide appropriate answers |
Folate concentration (using serum or plasma folate or erythrocyte folate)Hemoglobin concentration (grams per decilitre (g/dL))Adverse effects of the intervention, including but not limited to:increased incidence of priapism;the risk of masking cobalamin deficiency with consequent neuropsychiatric manifestations (nanogram per litre (ng/L));any other side effects (e.g. twin pregnancy, etc.), including SCD‐related morbidities (e.g. pain, acute splenic sequestration, strokes, priapism, recurrent infections). | Provide primary outcome for the study
Folate supplementation in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Clinical malaria: confirmed through blood smears or rapid diagnostic tests (P. falciparum or P. vivax);malaria parasitaemia (malaria infection incidence): confirmed through thick or thin blood smears, mRDTs, or polymerase chain reaction (PCR) (P. falciparum or P. vivax). | Provide primary outcome for the study
Mosquito repellents for malaria prevention | You are a research assistant. Based on the question please provide appropriate answers |
Overall survival (OS) (measured as mortality)Progression‐free survival (PFS)Skeletal‐related events (SRE): number of participants experiencing pathological fractures (vertebral and non‐vertebral), total skeletal‐related events (SREs) (as defined by individual authors; these included vertebral fractures, non‐vertebral fractures and osteolytic lesions) | Provide primary outcome for the study
Bisphosphonates in multiple myeloma: an updated network meta‐analysis | You are a research assistant. Based on the question please provide appropriate answers |
Overall survival (OS), defined as the time interval from random treatment assignment to death from any cause, or to last follow‐up.Number and severity of bleeding episodes, including the number of patients with at least one: a) bleeding episode of any severity; and b) severe/life‐threatening bleeding episode (as defined in the individual trials). | Provide primary outcome for the study
Thrombopoietin receptor agonists for prevention and treatment of chemotherapy‐induced thrombocytopenia in patients with solid tumours | You are a research assistant. Based on the question please provide appropriate answers |
DeathEpisodes of ASS (in individuals who either had a partial splenectomy or conservative management) | Provide primary outcome for the study
Splenectomy versus conservative management for acute sequestration crises in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Hematological assessment ‐ hemoglobin concentration and platelet countsVisceral assessment ‐ liver and spleen volumes by volumetric computer tomography (CT) or magnetic resonance imaging (MRI) or ultrasoundMortality and morbidityoverall mortalitytransplant‐related mortalitytransplant‐related morbidity | Provide primary outcome for the study
Hematopoietic stem cell transplantation for Gaucher disease | You are a research assistant. Based on the question please provide appropriate answers |
All‐cause death until discharge.Presence of cardiac dysrhythmias within one week of EBT.Number of infants with total serum calcium levels less than 8 mg/dL (2 mmol/L) or ionised calcium levels less than 4.4 mg/dL (1.1 mmol/L) within one week of EBT. | Provide primary outcome for the study
Prophylactic intravenous calcium therapy for exchange blood transfusion in the newborn | You are a research assistant. Based on the question please provide appropriate answers |
Overall survival (OS), defined as the time interval from random treatment assignment/entry into the study to death from any cause or to last follow‐up.Mortality during study | Provide primary outcome for the study
Thrombopoietin mimetics for patients with myelodysplastic syndromes | You are a research assistant. Based on the question please provide appropriate answers |
Major procedure‐related bleeding within 24 hours of the procedure (as defined by 24 hours after removal of lumbar puncture needle or catheter in the case of epidural anaesthesia). For example: spinal haematoma; intraventricular, intracerebral or subarachnoid haemorrhage; or major bleeding (not further defined), as reported by individual studies.Serious adverse events:transfusion‐related complications within 24 hours of the procedure (including transfusion‐related acute lung injury (TRALI), transfusion‐transmitted infection, transfusion‐associated circulatory overload (TACO), transfusion‐associated dyspnoea (TAD), acute transfusion reactions);venous and arterial thromboembolism (including deep vein thrombosis; pulmonary embolism; stroke; myocardial infarction) (up to 30 days);lumbar puncture (LP)‐related or epidural anaesthetic‐related complications within seven days of the procedure (infection, headache, cerebral herniation, neurological symptoms such as radicular pain or numbness, back pain). | Provide primary outcome for the study
Plasma transfusions prior to lumbar punctures and epidural catheters for people with abnormal coagulation | You are a research assistant. Based on the question please provide appropriate answers |
Overall bleeding events (per month), as defined by study authors | Provide primary outcome for the study
Bypassing agent prophylaxis in people with hemophilia A or B with inhibitors | You are a research assistant. Based on the question please provide appropriate answers |
The primary endpoint is the time to occurrence of a secondary malignant neoplasm (secondary malignant neoplasm‐free survival). This is an adverse event. | Provide primary outcome for the study
Optimisation of chemotherapy and radiotherapy for untreated Hodgkin lymphoma patients with respect to second malignant neoplasms, overall and progression‐free survival: individual participant data analysis | You are a research assistant. Based on the question please provide appropriate answers |
Overall mortality measured at any point in time | Provide primary outcome for the study
Deferasirox for managing iron overload in people with thalassaemia | You are a research assistant. Based on the question please provide appropriate answers |
Duration of pain crisis | Provide primary outcome for the study
Fluid replacement therapy for acute episodes of pain in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Number, type, and severity of bleeding episodes. Bleeding was measured at up to 48 hours, 48 hours to 7 days, and more than 7 days.All‐cause mortality. Mortality was measured at up to 4 weeks, 4 to 12 weeks, and more than 12 weeks. Of particular interest were deaths from platelet transfusion‐related complications such as bleeding, infection, thromboembolism, or transfusion reactions. | Provide primary outcome for the study
Pathogen‐reduced platelets for the prevention of bleeding | You are a research assistant. Based on the question please provide appropriate answers |
As primary outcomes we chose overall survival (OS) and progression‐free survival (PFS). The definition of OS was time from randomisation until death as a result of any cause (Cheson 2007a).PFS was defined as the time from randomisation until disease progression, relapse or death as a result of any cause. PFS was provided by GHSG HD14, HD 2000 and EORTC 20012. However, we also accepted other definitions that addressed progression in the process of the disease such as freedom from treatment failure (FFTF) and event‐free survival (EFS). Freedom from treatment failure was defined as the time from randomisation until progression during treatment, lack of complete response at the end of treatment, relapse and death from any cause (GHSG HD9). The definition of EFS was time from randomisation to evidence of severe toxicity causing definite treatment discontinuation, progressive lymphoma, cardiorespiratory failure, secondary leukaemia, death due to any cause, whichever occurred first (GSM‐HD 2008). Within the review, data coming under these definitions were discussed as results of PFS. | Provide primary outcome for the study
Comparison of first‐line chemotherapy including escalated BEACOPP versus chemotherapy including ABVD for people with early unfavourable or advanced stage Hodgkin lymphoma | You are a research assistant. Based on the question please provide appropriate answers |
We evaluated overall survival (OS) as the primary endpoint. The preferred definition of OS was "time from entry onto the clinical trial until death as a result of any cause" (Cheson 2007).PatientsFive trials with 1388 patients reported OS (CALGB 7751; EORTC‐GELA H9‐F; Mexico B2H031; MSKCC trial #90‐44; UK NCRI Rapid). In the UK NCRI Rapid trial, 12% of the patients in the chemotherapy plus radiotherapy arm did not receive treatment as randomised: 26 did not receive radiotherapy. Five of the eight patients who died in the chemotherapy plus radiotherapy arm received no radiotherapy. These patients were included in the published analysis. In the MSKCC trial #90‐44 trial, 11 patients randomised to radiotherapy never received radiotherapy. Because this affects the results and no per‐protocol results were available for both trials, we excluded the trials from the meta‐analysis for a sensitivity analysis and performed subgroup analyses without these trials as well (three trials with 816 patients).ResultsThe addition of radiotherapy to chemotherapy has probably little or no difference on OS (hazard ratio (HR) = 0.48; 95% confidence interval (CI) 0.22 to 1.06; P = 0.07, see Analysis 1.1), with a moderate grade of heterogeneity between trials (I2 = 52%). One reason for the heterogeneity could be the results of the UK NCRI Rapid and MSKCC trial #90‐44 trials. In the UK NCRI Rapid trial 28 of 420 patients did not receive treatment as randomised: two received radiotherapy in the chemotherapy alone arm and 26 did not receive radiotherapy in the chemotherapy plus radiotherapy arm. Five of the eight patients who died in the chemotherapy plus radiotherapy arm received no radiotherapy. These patients were included in the published analysis of the trial. In the MSKCC trial #90‐44 trial, 11 patients randomised to the chemotherapy plus radiotherapy arm never received radiotherapy (six refused, fo ur progressed on chemotherapy prior to receiving radiotherapy, one never received radiotherapy because of bleomycin‐ induced toxicity to radiotherapy).In a sensitivity analysis without UK NCRI Rapid and MSKCC trial #90‐44, the addition of radiotherapy to chemotherapy significantly improved OS (HR 0.31; 95% CI 0.19 to 0.52; P < 0.00001). We found no evidence of heterogeneity across the trials in the meta‐analysis (P value of the homogeneity test = 0.72; I² = 0%), see Figure 3.Subgroup analysesThe subgroup analyses showed no statistically significant differences between the subgroups examined (early favourable or unfavourable disease, bulky or non‐bulky disease, timing and type of radiation therapy, type of chemotherapy). See Analysis 1.2; Analysis 1.3; Analysis 1.4; Analysis 1.5; Analysis 1.6.The P value for the intention‐to‐teat (ITT)‐analysis is P = 0.78, so there are no statistically significant differences between the subgroups in the performed sensitivity analysis, see Analysis 1.7.Subgroup analyses withoutUK NCRI RapidandMSKCC trial #90‐44The subgroup analyses without UK NCRI Rapid and MSKCC trial #90‐44 showed no statistically significant differences between the subgroups examined (early favourable or unfavourable disease, bulky or non‐bulky disease, timing of radiotherapy, type of radiotherapy and type of chemotherapy. See Analysis 2.2; Analysis 2.3; Analysis 2.4; Analysis 2.5; Analysis 2.6.There are no statistically significant subgroup differences in the ITT‐analysis as well (P = 0.42), see Analysis 2.7.PatientsOnly one trial with 276 patients reported OS (HD6), therefore we did not perform subgroup analyses. In this trial, 41 of 399 patients did not receive therapy as randomised, therefore a sensitivity analysis without the HD6 trial could no be performed for the same reasons.ResultsThe use of chemotherapy alone significantly improved OS (HR 2.12; 95% CI 1.03 to 4.37; P = 0.04), see Analysis 11.1. | Provide primary outcome for the study
Chemotherapy alone versus chemotherapy plus radiotherapy for adults with early stage Hodgkin lymphoma | You are a research assistant. Based on the question please provide appropriate answers |
early‐onset is when HIT develops within 24 hours of heparin administration;delayed‐onset is when HIT is diagnosed after the discontinuation of heparin. | Provide primary outcome for the study
Unfractionated heparin versus low molecular weight heparins for avoiding heparin‐induced thrombocytopenia in postoperative patients | You are a research assistant. Based on the question please provide appropriate answers |
Bleed frequency (number of major bleeds reported per year, month, or week)Adverse events (e.g. bleed following exercise, worsening of symptoms)Quality of life (e.g. assessed through self‐administered questionnaires such as the 'Hemo‐QOL and SF‐36') | Provide primary outcome for the study
Exercise for haemophilia | You are a research assistant. Based on the question please provide appropriate answers |
2. Number of days to become afebrile**This has been re‐classified from a secondary outcome. | Provide primary outcome for the study
Antibiotics for treating community‐acquired pneumonia in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Frequency of blood transfusion measured by the volume transfused per kg per year (units transfused per kg per year (if sufficient data available) or other similar measures)Transfusion‐free interval (in months)Haemoglobin level (in g/dl or equivalent at intervals after commencing the intervention (e.g. every three to six months) | Provide primary outcome for the study
Hydroxyurea for reducing blood transfusion in non‐transfusion dependent beta thalassaemias | You are a research assistant. Based on the question please provide appropriate answers |
Number of participants with at least one bleeding episodeNumber of participants with at least one severe or life‐threatening bleeding episodeNumber of days bleeding occurred per participant | Provide primary outcome for the study
Alternative agents to prophylactic platelet transfusion for preventing bleeding in people with thrombocytopenia due to chronic bone marrow failure: a meta‐analysis and systematic review | You are a research assistant. Based on the question please provide appropriate answers |
Fracture reductionnumbers of breaksfrequency of breaks (rates)Change in BMD as assessed by DEXA | Provide primary outcome for the study
Bisphosphonate therapy for osteogenesis imperfecta | You are a research assistant. Based on the question please provide appropriate answers |
Patient and caregiver understanding of SCD and related complications (e.g. the 'Sickle Cell Disease Knowledge Questionnaire' (Armstrong 1993), the 'Illness Perception Questionnaire')Patient or caregiver (or both) ‐ reported signs and symptoms leading to self‐managementUtilization of health servicesnumber of acute hospitalizations (admission to hospital in‐patient services for an acute event)average length of hospital stayhospital appointments (scheduled, unscheduled and missed)primary care appointments (scheduled, unscheduled and missed) | Provide primary outcome for the study
Interventions for patients and caregivers to improve knowledge of sickle cell disease and recognition of its related complications | You are a research assistant. Based on the question please provide appropriate answers |
Overall survival (OS): time from date of randomisation to date of death (from any cause)Progression‐free survival (PFS): time from date of randomisation to date of progression or death (from any cause) | Provide primary outcome for the study
Bortezomib for the treatment of multiple myeloma | You are a research assistant. Based on the question please provide appropriate answers |
Number, site and severity of bleeding (i.e. any bleeding, clinically significant bleeding, life‐threatening bleeding)Thromboembolism (venous and arterial) | Provide primary outcome for the study
Antifibrinolytics (lysine analogues) for the prevention of bleeding in people with haematological disorders | You are a research assistant. Based on the question please provide appropriate answers |
ACT use (defined as the percentage of patients with fever/confirmed malaria who received an ACT on the day that the fever started or on the following day; Global Fund).Two studies reported data on ACT use (Kangwana 2011; Talisuna 2012; Table 3). In the first study (Kangwana 2011), ACT subsidy programmes increased ACT usage in children under five years of age by 25 percentage points (95% CI 14.1 to 35.9 percentage points; high certainty evidence). This suggests that in practice, among febrile children under five years of age with an ACT usage rate of 5% without a subsidy, subsidy programmes would increase usage by between 19% and 41%. In the second study (Talisuna 2012), ACT subsidy programmes resulted in a ten‐fold increase (95% CI 5.0 to 18.9) in ACT usage in children under five years of age and a six‐fold increase (95% CI 4.2 to 8.4) in ACT usage in all age groups (very low certainty evidence). | Provide primary outcome for the study
Subsidising artemisinin‐based combination therapy in the private retail sector | You are a research assistant. Based on the question please provide appropriate answers |
Clinical malaria: uncomplicated malaria, defined as a history of fever with parasitological confirmation (WHO 2010). We included cases of severe malaria if they were not reported separately.Severe malaria: cerebral malaria or acute Plasmodium falciparum malaria with signs of severity, or evidence of vital organ dysfunction, or both (WHO 2010). If it had been defined differently, we extracted the outcome as reported in the trial and used the trial authors' definitions.Death from any cause. | Provide primary outcome for the study
Oral iron supplements for children in malaria‐endemic areas | You are a research assistant. Based on the question please provide appropriate answers |
Overall survival (OS) was the primary outcome due to its relevance to patients with MDS and its importance as an indicator of the benefits of an intervention. OS was defined as the time interval from random treatment assignment or entry into a study to death from any cause or to last follow‐up.Five trials analysed overall survival (OS) (Greenberg 1993; Mantovani 1996; Ossenkoppele 1999; Verbeek 1999; Zwierzina 2005). Balleari 2006 and Taieb 1998 did not assess this outcome.Only one trial (Ossenkoppele 1999) reported of "longer median overall survival in the filgrastim arm" with no statistical significant difference (P = 0.22). Ossenkoppele included 33 patients in the G‐CSF arm, 31 in the control arm. (hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.44 to 1.47; P = 0.48) (see Analysis 1.1).Our meta‐analysis included both studies with 149 participants and showed no evidence for a difference between both arms (HR 0.88, 95% CI 0.62 to 1.26, P = 0.49) (see Analysis 2.1). Sensitivity analysis using the random‐effects model did not lead to differing results (HR 0.88, 95% CI 0.62 to 1.26, see Analysis 2.13). | Provide primary outcome for the study
Granulocyte and granulocyte‐macrophage colony stimulating factors for newly diagnosed patients with myelodysplastic syndromes | You are a research assistant. Based on the question please provide appropriate answers |
Number of painful sickle cell disease crisesPainintensity (expressed as scores obtained through any validated patient reported outcomes instrument either generic or sickle cell disease specific)durationThe requirement for opiate treatment during hospitalisation, Accident & Emergency Department visits or on discharge to home.dosetypefrequency | Provide primary outcome for the study
Piracetam for reducing the incidence of painful sickle cell disease crises | You are a research assistant. Based on the question please provide appropriate answers |
We evaluated quality of life as the primary efficacy endpoint. It had to be measured with reliable and validated instruments. | Provide primary outcome for the study
Meditation for adults with haematological malignancies | You are a research assistant. Based on the question please provide appropriate answers |
Mortality: before discharge from initial hospital or before a defined period of follow‐up (28 days, 12 months, or 18 months postnatal age, or a combination).ROP, grade 3 or more prior to discharge home (ICCRP 2005).Severe adverse findings at ultrasound (grades 3 to 4 IVH (Papile 1983), hydrocephalus, cortical atrophy, or periventricular leukomalacia) during first hospitalisation (Pinto‐Martin 1995).CLD requiring additional oxygen at 36 weeks' postmenstrual age or prior to discharge home (Shennan 1988).NEC, stage 2 or greater (Bell 1978).Cerebral palsy by physician assessment.Developmental delay (developmental quotient more than two standard deviations below the mean on validated assessment tool of cognitive function (e.g. Bayley Score of Infant Development).Blindness (visual acuity less than 20/200 in best eye).Deafness (hearing loss requiring amplification or cochlear implantation). | Provide primary outcome for the study
Washed versus unwashed red blood cells for transfusion for the prevention of morbidity and mortality in preterm infants | You are a research assistant. Based on the question please provide appropriate answers |
Remission (partial, complete), relapse rate, event‐free and overall survival, and adverse effects for each lymphoma type and treatment option separately.Adverse effects of antibody therapy mentioned in the included studies, such as: immunosuppression (febrile neutropenia or use of antibiotics or infection), prolonged B‐cell depletion (longer than six months), progressive multi‐focal leukoencephalopathy, infusion reactions, skin changes, pulmonary toxicity, renal failure (due to acute cell lysis), hepatotoxicity, cardiac toxicity, seizures. | Provide primary outcome for the study
Antibody therapies for lymphoma in children | You are a research assistant. Based on the question please provide appropriate answers |
Overall survivalAll cause mortality (including infection‐related, treatment‐related, or on‐trial mortality)Infection‐related mortality | Provide primary outcome for the study
Prophylactic antibiotics or G(M)‐CSF for the prevention of infections and improvement of survival in cancer patients receiving myelotoxic chemotherapy | You are a research assistant. Based on the question please provide appropriate answers |
PainIntensity (expressed as scores obtained through any validated patient‐reported outcomes instrument, either generic or SCD specific)DurationThe requirement for opiate treatmentDoseTypeFrequency | Provide primary outcome for the study
Low‐molecular‐weight heparins for managing vaso‐occlusive crises in people with sickle cell disease | You are a research assistant. Based on the question please provide appropriate answers |
Early cessation of bleeding measured bychanges on any subjective or objective pain and mobility scale orby the volume of haematoma assessed radiologically at any point in the first 48 hours | Provide primary outcome for the study
Recombinant factor VIIa concentrate versus plasma‐derived concentrates for treating acute bleeding episodes in people with haemophilia and inhibitors | You are a research assistant. Based on the question please provide appropriate answers |
Major procedure‐related bleeding within 24 hours of the procedure.All‐cause mortality up to 30 days after the procedure. | Provide primary outcome for the study
Comparison of different platelet transfusion thresholds prior to insertion of central lines in patients with thrombocytopenia | You are a research assistant. Based on the question please provide appropriate answers |
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