anurajms/meta_analysis huggingface dataset:
primary outcome:
Professional interventions for general practitioners on the management of musculoskeletal conditions
Rates of diagnosis and diagnostic accuracyRates of appropriate clinical assessment/examinationUse of relevant clinical assessment and shared decision support tools (e.g. pain assessment score tools)Ordering of tests/investigations to confirm a diagnosis or exclude other conditions (e.g. x‐rays, MRIs, bone scans, ultrasound scans, bone mineral density (BMD) scans, blood tests)Prescribing of medication (e.g. non‐steroidal anti‐inflammatory medications for symptomatic pain relief, osteoporosis medication for treatment)Provision of medical interventions/procedures (e.g. minor surgery, joint injections, ultrasound treatment)Referral rates to other services (e.g. physiotherapy, occupational therapy, secondary‐care specialist clinics)Symptom burden and health statusMarkers of disease control (e.g. pain scores)Symptom days/scoresFunctional health status (e.g. disability scores)Quality of life, morbidity, mortalitySchool/work days lostPatient behaviour and utilisation of health careMedication adherenceConsultation lengthPatient repeat visits with same musculoskeletal complaintEmergency Department visitsPatient sickness certificationHospitalisationsHealth service and societal costsCost effectiveness (for example, incremental cost‐effectiveness ratios (ICERs), incremental cost per quality‐adjusted life year (QALY) and cost‐benefit ratios)Cost utility
primary outcome:
Transition of care for adolescents from paediatric services to adult health services
Disease‐specific patient outcomes or status, using validated measures, for example, glycated haemoglobin (HbA1c), lung function, disease‐specific patient‐reported outcomes (PROMs).
primary outcome:
Interventions to optimise prescribing for older people in care homes
adverse drug events;hospital admissions;mortality.
primary outcome:
Interactive telemedicine: effects on professional practice and health care outcomes
Mortality.Disease‐specific and general measures of health status using validated measures (to include both clinical measures that are used to monitor patients' response to treatment and questionnaire assessed quality of life measures).Healthcare resource use.Costs.
primary outcome:
Alternative versus standard packages of antenatal care for low‐risk pregnancy
For all outcomes, where data included results from cluster‐randomised trials, the risk ratio has been adjusted to take account of the cluster‐design effect.
primary outcome:
Medical day hospital care for older people versus alternative forms of care
death;the need for institutional care;dependency;global 'poor outcome' comprising death or one of the following (in order of preference): resident in institutional care, severe dependency at end of follow up, or deterioration in physical function during follow up; this outcome was included in anticipation of incomplete data sets.
primary outcome:
Chronic disease management programmes for adults with asthma
Throughout the text, we use the term outcome in its broad sense to refer to the notion of dependent variable. Under that term, we considered clinically relevant effect measures (such as patient outcomes), process of care and intermediate measures, as well as structure indicators. These were based and adapted from a consensus of clinically relevant outcomes of an asthma patient management model (Clark 1994). Indicators relating to the implementation of CDM programmes, per se, were not considered. We divided our outcomes into two main groups: organisational and patient level outcomes. The list of possible outcomes, as well as the 10 outcomes selected as primary outcomes (specified in brackets) that were considered in the analyses, are shown below. We included 7 of these 10 primary outcomes in the summary of findings Table for the main comparison, based on their clinical importance: quality of life, hospitalisation, emergency or unscheduled visits, asthma exacerbations, self‐efficacy, asthma severity, and days off school or work absences.
primary outcome:
In‐service training for health professionals to improve care of seriously ill newborns and children in low‐income countries
We included studies only if they reported objectively measured health professional (in practice) performance outcomes (e.g. clinical assessment/diagnosis, recognition and management/referral of seriously ill newborn/child, prescribing practices).
primary outcome:
Case management approaches to home support for people with dementia
Outcome measures related either to patients or to patient‐carer dyads. We do not include studies which focus exclusively on carer outcomes. For the analysis, outcomes were grouped into 3/3 ‐ 4; 4 ‐ 6/6; 10 ‐ 12/12; 18; 24; 36 months. In the Discussion section, we further define short‐term outcomes as those measured at less than 12 months, medium‐term as equal to or greater than 12 months but less than 18 months, and longer‐term as greater than or equal to 18 months.
primary outcome:
Dental auxiliaries for dental care traditionally provided by dentists
Performance in history taking, diagnosis and treatment planning.Performance in technical procedures.Performance in oral health education and other health promotion measures.
primary outcome:
Task shifting from doctors to non‐doctors for initiation and maintenance of antiretroviral therapy
Quality of care: Death after being considered eligible for treatment, or during treatment
primary outcome:
Computerized advice on drug dosage to improve prescribing practice
All outcome measures included were patient‐oriented outcomes.We excluded the outcomes for which reporting was incomplete (e.g. no numerical values reported, no measure of dispersion) and excluded studies whose only relevant outcomes were death or adverse effects requiring monitoring and which did not explicitly report such outcomes as primary.For serum concentrations, we also considered peak, trough and steady‐state concentrations. The measurement of drug levels in the blood, called therapeutic drug monitoring (TDM), is required for some drugs to ensure that the participants maintain the concentration of drug within the established therapeutic range (drug effective without toxicity). Blood for peak level is collected at the drug's highest concentration within the dosing period. Trough levels (occasionally called residual levels) are measured just prior to administration of the next dose, and are the lowest concentration in the dosing interval. Most therapeutic drugs have a narrow trough to peak difference (therapeutic range), and, therefore, only trough levels are needed to detect blood levels that are too low or too high. Peak levels are needed for some drugs, especially aminoglycoside antibiotics: a concentration below the therapeutic range will not resolve the bacterial infection so high peak concentrations are necessary for optimal efficacy; however, too high a level can cause damage such as nephrotoxicity so it is important that the trough concentration be allowed to fall in order to avoid accumulation. The steady‐state concentration is defined as the point at which the amount of drug administered (drug intake) and the amount of drug excreted (drug elimination) reach an equilibrium. The goal of TDM is to optimize the drug dose so that the participant's drug concentrations remain within the therapeutic range.
primary outcome:
Nutritional screening for improving professional practice for patient outcomes in hospital and primary care settings
Patient outcomes: mortality, morbidity (e.g. wound infection), health related quality of life (measured by validated generic or condition specific instruments).
primary outcome:
Managerial supervision to improve primary health care in low‐ and middle‐income countries
Service quality measures, including changes in provider practice, adherence to guidelines or service coverage.
primary outcome:
Dressings and topical agents containing hyaluronic acid for chronic wound healing
Complete wound healing. We considered the proportion of ulcers healed during follow‐up, as presented by the trial authors.Time to complete wound healing, correctly analysed using survival, time‐to‐event approaches, ideally with adjustment for relevant covariate such as the baseline size.Adverse events (e.g. the presence of wound infection and signs and symptoms of clinical infection).
primary outcome:
Anti‐vascular endothelial growth factor for diabetic macular oedema: a network meta‐analysis
We considered that mean continuous best‐corrected visual acuity (BCVA) was the preferred outcome measure in trials on DMO at the time of this update. We also recognised a need for longer‐term results, as people with DMO are followed for several years and tend to stabilise during the second year of treatment.Therefore, the primary outcome for this update was change in BCVA (logarithm of the minimum angle of resolution (logMAR: lower is better)), measured using ETDRS charts, between baseline and 24 months.
primary outcome:
Fenofibrate for diabetic retinopathy
Progression of diabetic retinopathy
primary outcome:
Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes
Prosthesis use: use of prosthesis achieved after rehabilitation including walking freely or need of a support (walking stick, walker or crutches).Adverse events: such as falls (an unintentional loss of balance resulting in the individual coming to rest on the ground) and stump pain.
primary outcome:
Anti‐vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy
As the main aim of this review was to look at outcomes and complications following vitrectomy, we excluded studies that did not report any postoperative outcomes.
primary outcome:
Blood pressure control for diabetic retinopathy
Incidence of retinopathy, defined as mild non‐proliferative or more severe diabetic retinopathy, i.e. a retinopathy score on the Early Treatment Diabetic Retinopathy Study (ETDRS) final scale of 35 or greater based on evaluation of stereoscopic color fundus photographs of eyes of participants who did not have retinopathy at baseline (ETDRS10 1991).Progression of retinopathy, defined as a two‐step or greater progression from baseline on the ETDRS final scale based on evaluation of stereoscopic color fundus photographs of eyes of participants who had diabetic retinopathy at baseline (ETDRS10 1991).
primary outcome:
Anti‐vascular endothelial growth factor for proliferative diabetic retinopathy
loss of 3 or more lines of vision on the ETDRS visual acuity charts;gain of 3 or more lines of vision on the ETDRS visual acuity charts.corrected visual acuity measured on a continuous scale (logarithm of the minimum angle of resolution (logMAR) visual acuity or ETDRS letters).
primary outcome:
Parathyroidectomy for adults with primary hyperparathyroidism
Cure of PHPTDefined as improvement of hypercalcaemia and elevated PTH levels to normal laboratory reference valuesMeasured at six months or later after randomisationMorbidity related to PHPTFor example, improvement or lack of progression of established osteoporosis or osteopenia after parathyroidectomy, lack of progression or development of kidney dysfunction or nephrolithiasis/urolithiasis, improvement or lack of progression of cognitive dysfunction, improvement or lack of worsening of cardiovascular diseaseMeasured at six months or later after randomisationSerious adverse eventsFor example, postoperative bleeding requiring prolonged hospitalisation or surgical drainage insertion, hypocalcaemia, local haematoma, voice change from injury to recurrent laryngeal nerve, infectionMeasured at any time after randomisation
primary outcome:
Antenatal dietary supplementation with myo‐inositol for preventing gestational diabetes
Studies that met the above inclusion criteria were included regardless of whether they reported on the following outcomes for the review.
primary outcome:
Pharmacological interventions for prevention of weight gain in people with schizophrenia
We aimed to report binary outcomes recording clear and clinically meaningful degrees of change (e.g. global impression of much improved, or more than 50% improvement on a rating scale* ‐ as defined within the studies) before any others. Thereafter, we will list other binary outcomes and then those that are continuous.* For types of scales we extracted data from, please see (Data extraction and management).
primary outcome:
Rituximab for thyroid‐associated ophthalmopathy
The primary outcome for this review was improvement in thyroid‐associated CAS after treatment.CAS is a validated scoring system, designed to distinguish inflammatory from non‐inflammatory TAO, with a high predictive value for the outcome of immunosuppressive treatment in TAO patients (Mourits 1997). It is based on the classical signs of acute inflammation (pain, redness, swelling, and impaired function). After the first clinical examination, a score out of seven is given. After two consecutive clinical examinations, an activity score can be determined, ranging from nought to 10 points, including three points that rely on assessing the changes in the disease status.
primary outcome:
Recombinant human thyrotropin (rhTSH)‐aided radioiodine treatment for non‐toxic multinodular goitre
Health‐related quality of lifeHypothyroidismAdverse events
primary outcome:
Through‐knee versus above‐knee amputation for vascular and non‐vascular major lower limb amputations
Limb‐fitted and not limb‐fitted: measured as whether patients are referred for limb fitting and are successfully fitted with a prosthetic limb, or are not fitted with a prosthetic limbUncomplicated primary wound healing (30 days)
primary outcome:
Continuous glucose monitoring systems for monitoring cystic fibrosis‐related diabetes
QoL (measured by a validated disease‐specific tool, e.g. CFQ‐QOL (Yohannes 2011))Treatment‐related adverse outcomes (e.g. hypoglycaemia (defined as ≤ 3.8 mmol/L), contact dermatitis, etc.)Proportion of time within a normal* blood sugar profile (any range falling between 3.5 mmol/L to 8.0 mmol/L accepted) (Battelino 2019)
primary outcome:
Nutritional supplementation for nonalcohol‐related fatty liver disease: a network meta‐analysis
All‐cause mortality at maximal follow‐upHealth‐related quality of life, as defined in the included trials, based on a validated scale such as the EuroQoL Group Quality of Life Questionnaire based on 5 dimensions (EQ‐5D) or the 36‐Item Short Form Health Survey (SF‐36) at maximal follow‐up (EuroQol 2018; Optum 2018)Serious adverse events (during or within six months after cessation of intervention). We defined a serious adverse event as any event that would increase mortality; is life‐threatening; requires hospitalisation; results in persistent or significant disability; is a congenital anomaly/birth defect; or is any important medical event that might jeopardise the person or require intervention for prevention (ICH‐GCP 1997). However, none of the trial authors defined serious adverse events. Therefore, we used the list provided by trial authors for serious adverse events (as indicated in the protocol)Proportion of trial participants with one or more serious adverse eventNumber of serious adverse events reported per participant
primary outcome:
Lifestyle modifications for nonalcohol‐related fatty liver disease: a network meta‐analysis
All‐cause mortality at maximum follow‐up (time to death)Health‐related quality of life, as defined in the included trials, using a validated scale such as the EQ‐5D or 36‐Item Short Form Health Survey (SF‐36; (EuroQol 2018; RAND 2021)) at maximum follow‐upSerious adverse events (during or within six months after cessation of intervention). We defined a serious adverse event as any event that would increase mortality; is life‐threatening; requires hospitalisation; results in persistent or significant disability; is a congenital anomaly/birth defect; or any important medical event that might jeopardise the person or require intervention to prevent it (ICH‐GCP 1997). However, none of the trial authors defined serious adverse events. We therefore used the list provided by trial authors for serious adverse events (as indicated in the protocol).Proportion of trial participants with one or more serious adverse eventsNumber of serious adverse events per participant
primary outcome:
Interventions for weight loss in people with chronic kidney disease who are overweight or obese
Death (any cause)Cardiovascular eventsAnthropometric measures (weight loss, body weight, BMI, waist circumference, waist‐to‐hip ratio, and body composition)
primary outcome:
Interventions for preventing type 2 diabetes in adults with mental disorders in low‐ and middle‐income countries
Our primary outcome is prevention of diabetes, measured as a difference between study arms in the number of participants who developed type 2 diabetes during the study period. A clinical diagnosis of diabetes may be confirmed in the presence of symptoms by various parameters such as HbA1c, fasting blood sugar, random blood sugar or, in unclear cases, 2‐hour plasma glucose following an oral glucose tolerance test (OGTT). We accepted diagnoses made using any of these parameters using cut‐offs consistent with those current at the time of the study, as described in national and international guidance such as WHO (e.g. WHO 2006), National Institute of Health and Care Excellence (NICE) (e.g. NICE 2015), Diabetes UK (e.g. Diabetes UK 2018), American Diabetes Association (e.g. ADA 2017). Current cut‐offs are as follows: HbA1c ≥ 48 mmol/mol, a fasting blood glucose ≥ 7 mmol/L or a random blood glucose ≥ 11.1 mmol/L; and for OGTT 2‐hour glucose ≥ 11.1 mmol/L (ADA 2017).  Conversion to prediabetes was not included as part of this outcome.As the primary adverse outcome, we report drop‐out from care: the number of participants who dropped out of treatment for any reason after randomization.
primary outcome:
Psychological interventions for treating foot ulcers, and preventing their recurrence, in people with diabetes
the proportion of wounds completely healed (frequency of complete healing by group);time to complete wound healing (survival data: study‐level data reported as a hazard ratio (HR) with standard error (SE)).time to recurrence (survival data: study‐level data reported as an HR with SE);number of recurrences.short‐term (up to 12 weeks following treatment);medium‐term (more than 12 weeks and up to six months after the end of treatment);long‐term follow‐up (longer than six months and less than 12 months after the end of treatment).
primary outcome:
Antiandrogen or estradiol treatment or both during hormone therapy in transitioning transgender women
Quality of life (QoL) as measured by validated generic instruments, e.g. Quality of Life Inventory (QOLI) (Frisch 2005); or specific instruments, e.g. for body image, the Body Image Quality of Life Inventory (BIQLI) (Cash 2004); or for sexual life the Sexual Satisfaction Scale for Women (SSS‐W) (Meston 2005).Satisfaction with change of male to female body characteristics, as measured with validated instrumentsAdverse events specific to hormone therapy, including serious adverse events
primary outcome:
Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus
All‐cause mortalityIncidence of T2DMSerious adverse events
primary outcome:
(Ultra‐)long‐acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus
Diabetes‐related complications.Hypoglycaemic episodes.Health‐related quality of life.
primary outcome:
Minimally invasive parathyroidectomy guided by intraoperative parathyroid hormone monitoring (IOPTH) and preoperative imaging versus bilateral neck exploration for primary hyperparathyroidism in adults
Success rate.Total incidence of perioperative adverse events.
primary outcome:
Nutritional interventions for treating foot ulcers in people with diabetes
time to complete healing;absolute or percentage change in ulcer area, or volume, or individual parameters of ulcer dimensions over time i.e. changes in wound length, width and depth reported as separate measures (change from protocol, see Differences between protocol and review);proportion of ulcers healed at the completion of the study period; andhealing rate at completion of the study.
primary outcome:
Metformin monotherapy for adults with type 2 diabetes mellitus
All‐cause mortality.Serious adverse events.Health‐related quality of life.
primary outcome:
Non‐nutritive sweeteners for diabetes mellitus
HbA1cBody weightAdverse events
primary outcome:
Zinc supplementation for the promotion of growth and prevention of infections in infants less than six months of age
Infant mortality defined as the number of infant deaths (one year of age or younger) among those infants enrolled in the trials.*Growth measured as mean length; change in length; mean weight; change in weight; mean head circumference; change in head circumference; Weight for Age Z‐scores (WAZ); change in WAZ; Length for Age Z‐scores (LAZ); change in LAZ; Weight for Length Z‐scores (WLZ); change in WLZ; incidence of stunting, wasting or underweight children.Incidence of diarrhoea (defined as three or more loose stools in a 24‐hour period).
primary outcome:
Resveratrol for adults with type 2 diabetes mellitus
All‐cause mortalityDiabetes‐related complicationsAdverse events
primary outcome:
Metformin for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus
All‐cause mortality.Incidence of type 2 diabetes (T2DM).Serious adverse events.
primary outcome:
Oxandrolone for growth hormone‐treated girls aged up to 18 years with Turner syndrome
Improvement in final adult height.Health‐related quality of life.Adverse events.
primary outcome:
Thyroxine replacement for subfertile women with euthyroid autoimmune thyroid disease or subclinical hypothyroidism
Live birth rate per woman randomised (live birth was defined by The International Glossary on Infertility and Fertility Care as the birth of a baby after 22 completed weeks of gestational age as long as it showed signs of life) (Zegers‐Hochschild 2017).Adverse events: including direct adverse effects of thyroxine (e.g. allergic reactions, hyperthyroidism), maternal pregnancy complications (e.g. preterm delivery, pre‐eclampsia (preterm delivery defined as delivery of foetus after 22 weeks' and before 37 weeks' gestation)), and foetal complications during pregnancy (e.g. intrauterine growth restriction).
primary outcome:
Metformin and second‐ or third‐generation sulphonylurea combination therapy for adults with type 2 diabetes mellitus
All‐cause mortalityHealth‐related quality of lifeSerious adverse events
primary outcome:
Transperitoneal versus retroperitoneal laparoscopic adrenalectomy for adrenal tumours in adults
All‐cause mortalityEarly and late morbidity
primary outcome:
Alpha‐glucosidase inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus
All‐cause mortalityIncidence of T2DMSerious adverse events
primary outcome:
Sliding scale insulin for non‐critically ill hospitalised adults with diabetes mellitus
All‐cause mortality.Diabetes‐related mortality.Hypoglycaemic episodes.
primary outcome:
Tocilizumab for thyroid eye disease
Change in TED as defined by investigators, at three months (range two to six months) and 12 months (range six to 18 months) post treatment. This may include classification scores such as CAS, EUGOGO, NOSPECS and VISA.
primary outcome:
Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus
Complete wound healingTime to wound healing within a specific time period, correctly analysed using survival, time‐to‐event, approaches, ideally with adjustment for relevant covariates such as size of wound at baseline (start of trial). We assumed that the period of time in which healing could occur was the duration of the trial, unless otherwise stated.Number of wounds completely healed during follow‐up (frequency of complete healing).AmputationMajor amputation (defined as any amputation above the ankle joint).Minor amputation (defined as any amputation below the level of the ankle joint).
primary outcome:
Monotherapy laser photocoagulation for diabetic macular oedema
Improvement or worsening of best‐corrected visual acuity (BCVA) defined as gain or loss of 3 lines (0.3 logMAR or 15 ETDRS letters) of BCVA, recorded at 12 months (plus or minus six months) and then yearly.
primary outcome:
Metformin for women who are overweight or obese during pregnancy for improving maternal and infant outcomes
Large‐for‐gestational‐age infant, defined as birthweight ≥ 90th percentile for gestational age and infant sex
primary outcome:
Anti‐vascular endothelial growth factor combined with intravitreal steroids for diabetic macular oedema
We excluded studies with follow‐up of less than six months.
primary outcome:
Different lasers and techniques for proliferative diabetic retinopathy
The primary outcome was best‐corrected visual acuity (BCVA). Specifically we used the proportion of people who lost or gained at least 15 ETDRS letters (equivalent to 3 ETDRS lines) as measured on a LogMAR chart at the one‐ and five‐year time point.
primary outcome:
Planned birth at or near term for improving health outcomes for pregnant women with pre‐existing diabetes and their infants
For this review, we adapted the core outcome set agreed by consensus between review authors of the Cochrane Pregnancy and Childbirth systematic reviews for prevention and treatment of gestational diabetes mellitus and pre‐existing diabetes. The core outcome set was adapted to ensure that the outcome measures included were appropriate for this research question.
primary outcome:
Diet, physical activity or both for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus
All‐cause mortalityIncidence of T2DMSerious adverse events
primary outcome:
Insulin for the treatment of women with gestational diabetes
These outcomes were identified from published Cochrane reviews of gestational diabetes, revised and selected by a group of Cochrane authors of systematic reviews related to the treatment of women with gestational diabetes. The outcomes were identified as being important to the mother, the infant and health service provision and included both short‐ and long‐term outcomes.
primary outcome:
Oral anti‐diabetic agents for women with established diabetes/impaired glucose tolerance or previous gestational diabetes planning pregnancy, or pregnant women with pre‐existing diabetes
For this update, we used the standard outcome set agreed by consensus between review authors of Cochrane Pregnancy and Childbirth systematic reviews for prevention and treatment of gestational diabetes and pre‐existing diabetes.
primary outcome:
Psychological interventions for diabetes‐related distress in adults with type 2 diabetes mellitus
Diabetes‐related distress (DRD)Health‐related quality of lifeAdverse events
primary outcome:
Preconception care for diabetic women for improving maternal and infant health
For this update, we modified, as appropriate, the standard outcome set agreed by consensus between review authors of Cochrane Pregnancy and Childbirth systematic reviews for prevention and treatment of gestational diabetes mellitus (GDM) and pre‐existing diabetes.
primary outcome:
Phototherapy for treating foot ulcers in people with diabetes
Complete wound healing. A range of different methods of measuring and reporting this outcome are used in studies. We reported the authors' definitions of complete wound healing where possible. We considered RCTs that reported one or more of the following outcomes to provide the most relevant and rigorous measures of wound healing:time to complete wound healing (unit: weeks or days; correctly analysed using survival, time‐to‐event approaches, or mean time to healing if it was clear that all wounds were healed during follow‐up);proportion of wounds completely healed during follow‐up.Number of adverse events: all adverse events, treatment‐related adverse events, and any specific adverse events reported in the trials.
primary outcome:
Topical antimicrobial agents for treating foot ulcers in people with diabetes
Complete ulcer healing. We included this outcome (complete epithelialisation of the ulcer), seeking the following as measures:time to complete ulcer healing (correctly analysed using survival, time‐to‐event approaches, ideally with adjustment for relevant covariates, such as baseline size);the proportion of people with an ulcer that completely healed.Resolution of infection. We accepted the investigators' assessment of resolution of infection, e.g. diminution or disappearance of clinical findings such as erythema (redness), warmth, pain or tenderness, induration (swelling), or purulent secretions (Table 1).Incidence of infection. We accepted the investigators' assessment of the development of infection in a diabetic foot wound, e.g. by the appearance of new clinical findings, such as erythema (redness), warmth, pain or tenderness, induration (swelling), or purulent secretions (Table 1) (Lipsky 2012b).
primary outcome:
Glucose targets for preventing diabetic kidney disease and its progression
Doubling of SCrESKD (GFR < 15 mL/min for 3 months or longer, treated with dialysis, transplantation or symptomatic management)Death (any cause, cardiovascular, sudden) or nonfatal myocardial infarction or stroke
primary outcome:
Dipeptidyl‐peptidase (DPP)‐4 inhibitors and glucagon‐like peptide (GLP)‐1 analogues for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk for the development of type 2 diabetes mellitus
All‐cause mortality.Incidence of T2DM.Serious adverse events.
primary outcome:
Lifestyle interventions for the treatment of women with gestational diabetes
The following standardised outcomes have been developed through a process involving authors of Cochrane reviews for treatment interventions for women with gestational diabetes mellitus (GDM).
primary outcome:
Supportive interventions for enhancing dietary intake in malnourished or nutritionally at‐risk adults
Nutritional intake (actual or percentage change in macro‐ and micronutrient intake)Health‐related quality of life (evaluated by validated scores) and patient satisfactionMorbidity/complications (number of participants with medical complications)
primary outcome:
Drug interventions for the treatment of obesity in children and adolescents
Body mass index (BMI) and bodyweight.Adverse events.
primary outcome:
Insulin secretagogues for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus
All‐cause mortalityIncidence of T2DMSerious adverse events
primary outcome:
Short‐acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus
All‐cause mortality.Macrovascular and microvascular complications.Severe hypoglycaemic episodes.
primary outcome:
Fortification of staple foods with zinc for improving zinc status and other health outcomes in the general population
The primary outcomes across all populations in this review were zinc deficiency, serum plasma zinc concentrations, and undernutrition.
primary outcome:
Continuous subcutaneous insulin infusion versus multiple daily injections of insulin for pregnant women with diabetes
For this update, we used the core outcome set agreed by consensus between review authors of Cochrane Pregnancy and Childbirth systematic reviews for prevention and treatment of gestational diabetes mellitus (GDM) and pre‐existing diabetes.
primary outcome:
Autologous platelet‐rich plasma for treating chronic wounds
Proportion of chronic wounds completely healed (defined as 100% epithelialisation or skin closure without drainage).
primary outcome:
Different intensities of glycaemic control for pregnant women with pre‐existing diabetes
In one trial of 22 women and babies (Sacks 2006), no significant differences in caesarean sections were seen between very tight and tight‐moderate glycaemic control (risk ratio (RR) 0.92, 95% confidence interval) CI 0.49 to 1.73; evidence graded very low;Analysis 1.1). In the same trial, there were no perinatal deaths or instances of serious perinatal morbidity (both outcomes: evidence graded low; Analysis 1.2; Analysis 1.3). In this trial, two babies in the very tight control group had congenital fetal anomalies compared with none in the tight‐moderate glycaemic control group (RR 3.57, 95% CI 0.19 to 66.61; Analysis 1.4).Neither trial reported the other primary outcome of pre‐eclampsia.No significant differences between the tight and moderate glycaemic control target groups were seen for pre‐eclampsia (RR 5.29, 95% CI 0.23 to 122.91; evidence graded very low;Analysis 2.1) or caesarean sections (RR 1.21, 95% CI 0.22 to 6.50; evidence graded very low;Analysis 2.2) in these two arms of the Farrag 1987 trial. (evidence graded very low) . In this trial, no perinatal deaths were reported (evidence graded very low).This trial did not report on the outcomes of congenital fetal abnormalities or serious perinatal morbidities.In Farrag 1987, significantly fewer women in the tight‐moderate group compared with the loose glycaemic target group had pre‐eclampsia (RR 0.11, 95% CI 0.01 to 0.99; evidence graded low;Analysis 3.1) and caesarean sections (RR 0.28, 95% CI 0.10 to 0.78; evidence graded low;Analysis 3.2).Two neonatal deaths were reported in the loose glycaemic control target group, giving no significant differences between the tight‐moderate and loose groups in Farrag 1987 (RR 0.07, 95% CI 0.00 to 1.37; evidence graded very low;Analysis 3.3).This trial did not report on the outcomes of maternal hyperglycaemia requiring treatment, congenital fetal abnormalities or serious perinatal morbidities.
primary outcome:
Self management interventions for type 2 diabetes in adult people with severe mental illness
Self care behaviours.Diabetes‐related complications.Adverse events.
primary outcome:
Sodium‐glucose cotransporter (SGLT) 2 inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus
All‐cause mortality.Incidence of T2DM.Serious adverse events.
primary outcome:
Radioiodine therapy versus antithyroid medications for Graves' disease
Health‐related quality of life.                                        Development and worsening of Graves' ophthalmopathy.Adverse events other than development or worsening of Graves' ophthalmopathy.
primary outcome:
Skin grafting and tissue replacement for treating foot ulcers in people with diabetes
Incidence of complete closure of the foot ulcer (healing rate).Time to complete closure of the foot ulcer.Total incidence of lower limb amputations (major and minor amputations with a minimum of one toe removed, defined as amputation above or below the ankle joint, respectively).
primary outcome:
Subcutaneous rapid‐acting insulin analogues for diabetic ketoacidosis
Time to resolution of DKA.All‐cause mortality.Hypoglycaemic episodes.
primary outcome:
Intensive versus conventional glycaemic control for treating diabetic foot ulcers
Number of ulcers healed.Time to complete ulcer healing.Change in ulcer severity reported as a change in an ulcer grading score using a well‐defined validated ulcer grading scale e.g. University of Texas Wound Classification System (UTWCS) that measures the depth, presence of infection and ischemia of an ulcer (Armstrong 1998).Incidence of amputation related to foot ulcers (identified on International Classification of Disease (ICD) codes (NCCH 2006).
primary outcome:
Parent‐only interventions for childhood overweight or obesity in children aged 5 to 11 years
Changes in body mass index (BMI) and body weight.Adverse events.
primary outcome:
Thyroid surgery for Graves’ disease and Graves’ ophthalmopathy
Rate of recurrent hyperthyroidism.Adverse events.
primary outcome:
Growth factors for treating diabetic foot ulcers
Complete wound healing (defined as 100% epithelialisation or skin closure without drainage).Lower limb amputation (minimum of one toe).Time to complete healing of the diabetic foot ulcer.
primary outcome:
Aromatase inhibitors for short stature in male children and adolescents
Final or near‐final height.Health‐related quality of life.Adverse events.
primary outcome:
Systemic antibiotics for treating diabetic foot infections
Clinical resolution of the infection, defined as the resolution of all acute signs and symptoms related to the infection, or improvement such that additional antimicrobial therapy of any kind was not required (Lipsky 2007). This outcome was not initially defined in the protocol, as it was integrated in the 'time to resolution of the infection' outcome. We later decided to separate these two outcomes in order not to lose important information (see Differences between protocol and review).Time to resolution of the infection, defined as the time needed to reach clinical resolution of the infection (as defined above).Adverse effects of treatment (allergic reactions, organ toxicity, intolerance, etc.).Serious infections or complications of infection (for example, septicaemia, septic shock or amputation ‐ major amputation is defined as an amputation above the ankle and minor amputation as an amputation limited to the foot).
primary outcome:
Complex interventions for preventing diabetic foot ulceration
incidence of foot ulceration;rates of amputation (partial or total).
primary outcome:
Total or near‐total thyroidectomy versus subtotal thyroidectomy for multinodular non‐toxic goitre in adults
All‐cause mortality.Goitre recurrence and re‐intervention due to goitre recurrence.Adverse events.
primary outcome:
Hyperbaric oxygen therapy for chronic wounds
proportion of ulcers healed;proportion of people undergoing major amputation (defined as amputation of the lower or upper extremity above the ankle or the wrist, respectively).proportion of ulcers healed.proportion of ulcers healed.proportion of ulcers healed.proportion of people undergoing major amputation (defined as amputation of the lower or upper extremity above the ankle or the wrist, respectively).
primary outcome:
Topical non‐steroidal anti‐inflammatory agents for diabetic cystoid macular oedema
The primary outcome for this review was 2 or more lines improvement of visual acuity from baseline (Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen or LogMAR equivalent) at three months of treatment.
primary outcome:
Calcimimetics for secondary hyperparathyroidism in chronic kidney disease patients
All‐cause mortalityCardiovascular mortalityParathyroidectomyFracturesAdverse events (hypocalcaemia, hypercalcaemia, nausea, vomiting, upper respiratory tract infection, dyspnoea, muscle weakness, headache, paraesthesia, abdominal pain, diarrhoea)
primary outcome:
Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus
Macrovascular complications (nonfatal and fatal myocardial infarction, stroke).Microvascular complications (manifestation and progression of retinopathy, nephropathy, neuropathy, and endstage renal disease).Severe hypoglycaemic episodes.
primary outcome:
Transtheoretical model stages of change for dietary and physical exercise modification in weight loss management for overweight and obese adults
Sustained weight loss (changes in weight or BMI at one to five years and above).Short‐term weight loss (changes in weight or BMI at less than 12 months).Health‐related quality of life.
primary outcome:
Vitamin D supplementation for prevention of mortality in adults
All‐cause mortality.Adverse events: depending on the availability of data, we attempted to classify adverse events as serious and non‐serious. A serious adverse event was defined as any untoward medical occurrence that was life threatening; resulted in death, or in persistent or significant disability or incapacity; or was a congenital anomaly/birth defect; or any medical event that might have jeopardised the participant or required intervention to prevent it (ICH‐GCP 1997). All other adverse events (i.e. medical occurrences not necessarily having a causal relationship to the treatment but causing a dose reduction or discontinuation of treatment) were considered as non‐serious.
primary outcome:
Blue‐light filtering spectacle lenses for visual performance, sleep, and macular health in adults
the change in visual fatigue or discomfort, measured using a questionnaire or visual analogue scale; andthe change in CFF, measured in Hertz (Hz).
primary outcome:
Laser‐assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery
The primary outcome was intraoperative complications in the operated eye.
primary outcome:
Antibiotics versus placebo for acute bacterial conjunctivitis
We considered the following outcome measures.
primary outcome:
Device‐modified trabeculectomy for glaucoma
Change in IOP, measured as a mean decrease from baseline (immediate preoperative IOP) at one year after the intervention when IOP had been measured using Goldmann tonometry, TonoPen, or another standard device. When the change in IOP was not available and baseline IOP distributions were similar in the two surgery groups, we would not compare postoperative IOP as a surrogate to estimate the effect of device‐modified trabeculectomy as we had mean postoperative IOP as a separate outcome for our review.Mean postoperative IOP at one year after the intervention when IOP had been measured using Goldmann tonometry, TonoPen, or another standard device.
primary outcome:
Lens extraction versus laser peripheral iridotomy for acute primary angle closure
We analyzed critical outcomes at 18 to 24 months postintervention and all other outcomes at any other follow‐up time point reported in the included studies (see Differences between protocol and review). We have included a summary of findings table, and report the following outcomes listed according to priority.
primary outcome:
Interventions for acute non‐arteritic central retinal artery occlusion
We included studies in which the study design, participants, interventions, and comparators met our inclusion criteria irrespective of whether our prespecified outcome data were reported.
primary outcome:
Trifocal intraocular lenses versus bifocal intraocular lenses after cataract extraction among participants with presbyopia
Mean uncorrected (without the aid of spectacles or contact lenses) distance visual acuity measured by logarithm of the minimum angle of resolution (LogMAR) chart at one‐year follow‐up.
primary outcome:
Iridotomy to slow progression of visual field loss in angle‐closure glaucoma
Proportion of participants with any progression of visual field loss at one year. We planned to assess progression of visual field loss using criteria as defined in the included studies measured using any validated tool, such as automated Humphrey Field Analyzer, Heidelberg Edge Perimeter, or Oculus. We also planned to consider other time points during follow‐up as reported in the included studies and to assess this outcome for studies involving participants with PAC or PACG.
primary outcome:
Early vitrectomy for exogenous endophthalmitis following surgery
We defined the primary outcome as the proportion of people at three months postintervention that had an improvement of 10 letters or more on a standard ETDRS chart, at a distance of four metres.
primary outcome:
Adjunctive steroid therapy versus antibiotics alone for acute endophthalmitis after intraocular procedure
The primary outcome of the review was complete resolution of endophthalmitis one month after the initiation of therapy. We considered complete resolution as resolution of associated symptoms or hypopyon, or both, but we also accepted definitions used by the investigators of the included trials. We based our primary analysis on one‐month outcomes to evaluate whether using steroids as adjunctive therapy provides any benefit in the short term. We also compared outcomes at three, six, and 12 months whenever data were available.
primary outcome:
Tocilizumab for giant cell arteritis
Proportion of participants with sustained remission (as defined by the study investigators) at short term and long term.
primary outcome:
Immediate sequential bilateral surgery versus delayed sequential bilateral surgery for cataracts
Adverse events related to bilateral cataract surgery: (e.g. the proportion of people with severe or sight‐threatening endophthalmitis as a bilateral complication of cataract surgery, refractive surprise, or other intra‐ and postoperative complications).Severe endophthalmitis: symptoms associated with endophthalmitis, such as pain or loss of vision, due to aqueous or vitreous infection, with an onset between three days and six weeks postoperatively (Endophthalmitis Study Group 2007), according to the definition in the Endophthalmitis Vitrectomy Study (Doft 2008).Refraction: the proportion of eyes in which the achieved spherical equivalent refraction was NOT within 0.5 dioptre and NOT within 1.0 dioptre of target refraction, measured one to three months after surgery.Intraoperative and postoperative complications: the proportion of complications (other than bilateral endophthalmitis) that occurred intraoperatively (e.g. capsular rupture, haemorrhage), or postoperatively (e.g. corneal oedema, retinal detachment, cystoid macula oedema), from the procedure to three months' follow‐up.Cost‐effectiveness or economic evaluations: total cost per participant, cost per quality‐adjusted life year (QALY), or both, over the reported time horizon. If reported, total costs were split into cost categories and over years (if the time horizon exceeded one year). We reported the costs in the currency and year stated in the studies. However, to make the outcomes more comparable, costs were also reported in one common currency (2017 USD). Because costs in different years are less comparable as a result of inflation, we reported costs for one common year. Any costs incurred in another year were converted to a common year (2017) using the consumer price index as reported and advised by the Organisation for Economic Co‐operation and Development (OECD). Then, we converted the non‐USD currency to 2017 USD (manual calculation) using the Purchasing Power Parity for Gross Domestic Product (PPP for GDP) as reported by the OECD.
primary outcome:
Topical pharmacologic interventions versus placebo for epidemic keratoconjunctivitis
Symptom resolutionMean time (days) from initiation of treatment until symptoms of tearing and discomfort had resolved. Symptoms of discomfort include pain, itching, foreign body sensation, and photophobia.Proportion of participants with subjective resolution of symptoms by day 7 after initiation of treatment.Sign resolutionMean time (days) from initiation of treatment until clinical signs had resolved. Examples of clinical signs are chemosis, hyperemia, bulbar conjunctival injection (redness), and subepithelial infiltrates (SEI).Proportion of participants with resolved signs by day 7 after initiation of treatment.
primary outcome:
Pneumatic retinopexy versus scleral buckle for repairing simple rhegmatogenous retinal detachments
Proportion of participants with successful reattachment of the retina after their initial surgery.Proportion of participants with recurrence of retinal detachment.Mean change in best‐corrected visual acuity (BCVA) from baseline.Proportion of eyes with visual acuity 20/40 or better.Number of surgical complications such as progression of cataract in phakic eyes, postoperative choroidal detachments, proliferative vitreoretinopathy, diplopia, macular pucker, increase in intraocular pressure, and others reported in the included studies.
primary outcome:
Fornix‐based versus limbal‐based conjunctival trabeculectomy flaps for glaucoma
The proportion of failed trabeculectomies at 24 months. Failure was defined as the need for repeat surgery or uncontrolled IOP (more than 22 mmHg) despite additional topical/systemic medications. Needling and 5‐FU injections were allowed only during the first six months postoperatively. Additional needling or 5‐FU injections were considered as failure.Mean postoperative IOP at 24 months.