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European Respiratory Review : An... Dec 2017Poor inhaler technique and inferior asthma outcomes are evident in older adults. Reviews comparing metered dose inhaler (MDI) and dry powder inhaler (DPI) techniques... (Review)
Review
Poor inhaler technique and inferior asthma outcomes are evident in older adults. Reviews comparing metered dose inhaler (MDI) and dry powder inhaler (DPI) techniques across older adults and younger cohorts are scarce. This systematic review aimed to determine whether differences exist between such cohorts with regards to the number and type of MDI and DPI errors made. A systematic literature search was conducted in Embase, Medline and PubMed from July 1 to December 31, 2016. Studies were selected in accordance with preset inclusion criteria, relevant data were extracted, and quality was assessed with validated checklists. 14 studies were identified. Evidence suggests a negative correlation between advancing age and correct technique across MDI and varying DPI devices when examined collectively. Differences appear to exist between older adult and younger cohorts prescribed MDIs in error types. There is evidence of age-associated differences in the number and type of inhaler technique errors. Further research is required to assess outcomes in individual DPIs, reproducibility and the effects of confounders.
Topics: Administration, Inhalation; Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Anti-Asthmatic Agents; Asthma; Child; Dry Powder Inhalers; Equipment Design; Health Knowledge, Attitudes, Practice; Humans; Lung; Metered Dose Inhalers; Middle Aged; Patient Education as Topic; Self Administration; Young Adult
PubMed: 29212836
DOI: 10.1183/16000617.0055-2017 -
European Journal of Physical and... Oct 2016Treadmill training is used in rehabilitation might improve gait parameters of patients with Parkinson Disease. Aim of this study was to assess the effectiveness of... (Review)
Review
INTRODUCTION
Treadmill training is used in rehabilitation might improve gait parameters of patients with Parkinson Disease. Aim of this study was to assess the effectiveness of treadmill training in improving the gait of patients with Parkinson Disease and the acceptability and safety of this type of therapy.
EVIDENCE ACQUISITION
We searched the Cochrane Movement Disorders Group Specialized Register (last searched September 2014), Cochrane Central Register of Controlled Trials (The Cochrane Library 2014, Issue 10), MEDLINE (1950 to September 2014), and EMBASE (1980 to September 2014). We also handsearched relevant conference proceedings, searched trials and research registers, and checked reference lists (last searched September 2014). We contacted trialists, experts and researchers in the field and manufacturers of commercial devices. We included all randomized controlled trials comparing treadmill training with no treadmill training in patients with Parkinson Disease. Two review authors independently selected trials for inclusion, assessed trial quality and extracted data.
EVIDENCE SYNTHESIS
Treadmill training improved gait speed (MD=0.09 m/s; 95% confidence interval (CI) 0.03 to 0.14; P=0.001; I2=24%; moderate quality of evidence), stride length (MD=0.05 meters; 95% CI 0.01 to 0.09; P=0.01; I2=0%; low quality of evidence), but walking distance (MD=48.9 meters; 95% CI -1.32 to 99.14; P=0.06; I2=91%; very low quality of evidence) and cadence did not improve (MD=2.16 steps/minute; 95% CI -0.13 to 4.46; P=0.07; I2=28%; low quality of evidence) at the end of study. Treadmill training did not increase the risk of patients dropping out from intervention (RD=-0.02; 95% CI -0.06 to 0.02; P=0.32; I2=13%; moderate quality of evidence) and adverse events were not reported.
CONCLUSIONS
This systematic review provides evidence from eighteen trials with moderate to low risk of bias that the use of treadmill training in patients with PD may improve clinically relevant gait parameters such as gait speed and stride length. This apparent benefit for patients is, however, not supported by all secondary variables (e.g. cadence and walking distance). The results must be interpreted with caution because the results were heterogeneous and it is not known how long improvements last and differences between the trials in terms of patient characteristics, duration and amount of training and types of treadmill training exists.
Topics: Aged; Disability Evaluation; Evidence-Based Medicine; Exercise Test; Exercise Therapy; Female; Gait; Gait Disorders, Neurologic; Humans; Male; Middle Aged; Parkinson Disease; Prognosis; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome; Walking Speed
PubMed: 26940123
DOI: No ID Found -
Annals of Palliative Medicine Oct 2021Riociguat therapy has been recommended for pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), and it might have therapeutic... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Riociguat therapy has been recommended for pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), and it might have therapeutic significance for other types of pulmonary hypertension (PH). Our purpose was to evaluate the specific impact of riociguat on all types of PH.
METHODS
We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing the safety and efficacy of riociguat treatment for PH through databases of the Cochrane Library, PubMed, Embase, and Web of Science from inception to the present. Duplicate publications, studies with no full text, incomplete information or inability to extract data, animal experiments and reviews, and systematic reviews were excluded. The software RevMan 5.4 was used for data synthesis.
RESULTS
There were 8 RCTs included in our study, involving 1,606 participants. For PAH and CTEPH patients, riociguat treatment extended 6-minute walk distance (6MWD) by 39.84 meters, decreased mean pulmonary arterial pressure (PAP) by 4.20 mmHg, lowered pulmonary vascular resistance (PVR) by 218.76 dynes/sec/cm-5, cut down right atrial pressure (RAP) by 0.9 mmHg, increased cardiac index (CI) by 0.49 L/min/m2, improved cardiac output (CO) by 0.89 L/min, reduced N-terminal pro-type B natriuretic peptide (NT-proBNP) by 436.21 pg/mL, and decreased adverse events and clinical worsening as compared with placebo. For other types of PH including PH due to left heart disease and PH due to lung disease, riociguat was reported as having improved CI by 0.42 L/min/m2 and CO was increased by 0.92 L/min compared with placebo. Other efficacy outcomes and safety outcomes did not attain statistical difference in other types of PH.
CONCLUSIONS
For PAH and CTEPH, riociguat treatment is safe and effective, but for other types of PH, it can only improve some hemodynamic parameters.
Topics: Chronic Disease; Humans; Hypertension, Pulmonary; Pyrazoles; Pyrimidines
PubMed: 34763472
DOI: 10.21037/apm-21-2656 -
Scandinavian Journal of Medicine &... Dec 2023Hamstring strain injury (HSI) remains a performance, economic, and player availability burden in sport. High-speed running (HSR) is cited as a common mechanism for HSI.... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Hamstring strain injury (HSI) remains a performance, economic, and player availability burden in sport. High-speed running (HSR) is cited as a common mechanism for HSI. While evidence exists regarding the high physical demands on the hamstring muscles in HSR, meta-analytical synthesis of related activation and kinetic variables is lacking.
METHODS
A systematic search of Medline, Embase, Scopus, CINAHL, SportDiscus, and Cochrane library databases was conducted in accordance with the PRISMA 2020 guidelines. Studies reporting hamstring activation (electromyographic [EMG]) or hamstring muscle/related joint kinetics were included where healthy adult participants ran at or beyond 60% of maximum speed (activation studies) or 4 m per second (m/s) (kinetic studies).
RESULTS
A total of 96 studies met the inclusion criteria. Run intensities were categorized as "slow," "moderate," or "fast" in both activation and kinetic based studies with appropriate relative, and raw measures, respectively. Meta-analysis revealed pooled mean lateral hamstring muscle activation levels of 108.1% (95% CI: 84.4%-131.7%) of maximal voluntary isometric contraction (MVIC) during "fast" running. Meta-analysis found swing phase peak knee flexion internal moment and power at 2.2 Newton meters/kilogram (Nm/kg) (95% CI: 1.9-2.5) and 40.3 Watts/kilogram (W/kg) (95% CI: 31.4-49.2), respectively. Hip extension peak moment and power was estimated as 4.8 Nm/kg (95% CI: 3.9-5.7) and 33.1 W/kg (95% CI: 17.4-48.9), respectively.
CONCLUSIONS
As run intensity/speed increases, so do the activation and kinetic demands on the hamstrings. The presented data will enable clinicians to incorporate more objective measures into the design of injury prevention and return-to-play decision-making strategies.
Topics: Adult; Humans; Hamstring Muscles; Kinetics; Isometric Contraction; Muscle Strength; Running; Soft Tissue Injuries
PubMed: 37668346
DOI: 10.1111/sms.14478 -
Archives of Physical Medicine and... Apr 2016To systematically review the evidence to determine energy expenditure (EE) in volume of oxygen uptake (V̇O2) (mL/kg/min) and energy cost in oxygen uptake per meter... (Review)
Review
OBJECTIVES
To systematically review the evidence to determine energy expenditure (EE) in volume of oxygen uptake (V̇O2) (mL/kg/min) and energy cost in oxygen uptake per meter walked (V̇O2/walking speed; mL/kg/m) during walking poststroke and how it compares with healthy controls; and to determine how applicable current exercise prescription guidelines are to stroke survivors.
DATA SOURCES
Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and CINAHL were searched on October 9, 2014, using search terms related to stroke and EE. Additionally, we screened reference lists of eligible studies.
STUDY SELECTION
Two independent reviewers screened titles and abstracts of 2115 identified references. After screening the full text of 144 potentially eligible studies, we included 29 studies (stroke survivors: n=501, healthy controls: n=123), including participants with confirmed stroke and a measure of V̇O2 during walking using breath-by-breath analysis. Studies with (9 studies) and without (20 studies) a healthy control group were included.
DATA EXTRACTION
Two reviewers independently extracted data using a standard template, including patient characteristics, outcome data, and study methods.
DATA SYNTHESIS
Mean age of stroke survivors was 57 years (range, 40-67y). Poststroke EE was highly variable across studies and could not be pooled because of high heterogeneity. EE during steady-state overground walking at matched speeds was significantly higher in stroke survivors than healthy controls (mean difference in V̇O2, 4.06 mL/kg/min; 95% confidence interval [CI], 2.21-5.91; 1 study; n=26); there was no significant group difference at self-selected speeds. Energy cost during steady-state overground walking was higher in stroke survivors at both self-selected (mean difference, .47 mL/kg/m; 95% CI, .29-.66; 2 studies; n=38) and matched speeds compared with healthy controls (mean difference, .27 mL/kg/m; 95% CI, .03-.51; 1 study; n=26).
CONCLUSIONS
Stroke survivors expend more energy during walking than healthy controls. Low-intensity exercise as described in guidelines might be at a moderate intensity level for stroke survivors; there is a need for stroke-specific exercise guidelines.
Topics: Adult; Aged; Case-Control Studies; Energy Metabolism; Exercise Therapy; Female; Healthy Volunteers; Humans; Male; Middle Aged; Oxygen Consumption; Stroke; Stroke Rehabilitation; Survivors; Walking
PubMed: 26686877
DOI: 10.1016/j.apmr.2015.11.007 -
The Cochrane Database of Systematic... Oct 2014Interstitial lung disease (ILD) is characterised by reduced functional capacity, dyspnoea and exercise-induced hypoxia. Pulmonary rehabilitation, an intervention that... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Interstitial lung disease (ILD) is characterised by reduced functional capacity, dyspnoea and exercise-induced hypoxia. Pulmonary rehabilitation, an intervention that includes exercise training, is beneficial for people with other chronic lung conditions; however its effects in ILD have not been well characterised.
OBJECTIVES
• To determine whether pulmonary rehabilitation in patients with ILD has beneficial effects on exercise capacity, symptoms, quality of life and survival compared with no pulmonary rehabilitation in patients with ILD.• To assess the safety of pulmonary rehabilitation in patients with ILD.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 6), MEDLINE (Ovid), EMBASE (Ovid), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (EBSCO) and the Physiotherapy Evidence Database (PEDro) (all searched from inception to June 2014). We also searched the reference lists of relevant studies, international clinical trial registries and respiratory conference abstracts to look for qualifying studies.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials in which pulmonary rehabilitation was compared with no pulmonary rehabilitation or with other therapy in people with ILD of any origin were included.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials for inclusion, extracted data and assessed risk of bias. Study authors were contacted to provide missing data and information regarding adverse effects. A priori subgroup analyses were specified for participants with idiopathic pulmonary fibrosis (IPF) and participants with severe lung disease (low diffusing capacity or desaturation during exercise). We planned to subgroup according to training modality applied, but there were insufficient data.
MAIN RESULTS
Nine studies were included, six of which were published as abstracts. Five studies were included in the meta-analysis (86 participants who undertook pulmonary rehabilitation and 82 control participants). One study used a blinded assessor and intention-to-treat analysis. No adverse effects of pulmonary rehabilitation were reported. Pulmonary rehabilitation improved the six-minute walk distance with weighted mean difference (WMD) of 44.34 metres (95% confidence interval (CI) 26.04 to 62.64 metres) and improved oxygen consumption (VO2) peak with WMD of 1.24 mL/kg/min(-1) (95% CI 0.46 to 2.03 mL/kg/min(-1)). Improvements in six-minute walk distance and VO2 peak were also seen in the subgroup of participants with idiopathic pulmonary fibrosis (IPF) (WMD 35.63 metres, 95% CI 16.02 to 55.23 metres; WMD 1.46 mL/kg/min(-1), 95% CI 0.54 to 2.39 mL/kg/min(-1), respectively). Reduced dyspnoea (standardised mean difference (SMD) -0.66, 95% CI -1.05 to -0.28) following pulmonary rehabilitation was also seen in the IPF subgroup (SMD -0.68, 95% CI -1.12 to -0.25). Quality of life improved following pulmonary rehabilitation for all participants on a variety of measures (SMD 0.59, 95% CI 0.20 to 0.98) and for the subgroup of people with IPF (SMD 0.59, 95% CI 0.14 to 1.03). Two studies reported longer-term outcomes, with no significant effects of pulmonary rehabilitation on clinical variables or survival at three or six months. Available data were insufficient to allow examination of the impact of disease severity or exercise training modality.
AUTHORS' CONCLUSIONS
Pulmonary rehabilitation seems to be safe for people with ILD. Improvements in functional exercise capacity, dyspnoea and quality of life are seen immediately following pulmonary rehabilitation, with benefits also evident in IPF. Because of inadequate reporting of methods and small numbers of included participants, the quality of evidence was low to moderate. Little evidence was available regarding longer-term effects of pulmonary rehabilitation.
Topics: Exercise; Exercise Therapy; Exercise Tolerance; Humans; Lung Diseases, Interstitial; Randomized Controlled Trials as Topic; Walking
PubMed: 25284270
DOI: 10.1002/14651858.CD006322.pub3 -
The Cochrane Database of Systematic... Mar 2016Mucopolysaccharidosis type VI or Maroteaux-Lamy syndrome is a rare genetic disorder caused by the deficiency of arylsulphatase B. The resultant accumulation of dermatan... (Review)
Review
BACKGROUND
Mucopolysaccharidosis type VI or Maroteaux-Lamy syndrome is a rare genetic disorder caused by the deficiency of arylsulphatase B. The resultant accumulation of dermatan sulphate causes lysosomal damage.The clinical symptoms are related to skeletal dysplasia (i.e. short stature and degenerative joint disease). Other manifestations include cardiac disease, impaired pulmonary function, ophthalmological complications, hepatosplenomegaly, sinusitis, otitis, hearing loss and sleep apnea. Intellectual impairment is generally absent. Clinical manifestation is typically by two or three years of age; however, slowly progressive cases may not present until adulthood.Enzyme replacement therapy with galsulfase is considered a new approach for treating mucopolysaccharidosis type VI.
OBJECTIVES
To evaluate the effectiveness and safety of treating mucopolysaccharidosis VI by enzyme replacement therapy with galsulfase compared to other interventions, placebo or no intervention.
SEARCH METHODS
Eletronic searches were performed on the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register, in CENTRAL, MEDLINE, LILACS, the Journal of Inherited Metabolic Disease and ClinicalTrials.gov. Date of the last search of the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register: 05 February 2016.
SELECTION CRITERIA
Randomized and quasi-randomized controlled clinical studies of enzyme replacement therapy with galsulfase compared to other interventions or placebo.
DATA COLLECTION AND ANALYSIS
Two authors independently screened the studies, assessed the risk of bias and extracted data.
MAIN RESULTS
One study was included involving 39 participants who received either enzyme replacement therapy with galsulfase (recombinant human arylsulphatase B) or placebo. This small study was considered to be of overall unclear quality, since the authors did not report how both the allocation generation and concealment were performed.The key finding at 24 weeks in the 12-minute walk test was a statistically significant mean difference of 92.00 meters between the two groups in favour of the galsulfase group (95% confidence interval 11.00 to 172.00). While week 24 results for the three-minute stair climb demonstrated some improvement in the treatment group as compared to the placebo group, this was not significant, mean difference 5.70 (95% confidence interval -0.10 to 11.50).A significant decrease in the urinary glycosaminoglycan levels was observed in favour of the galsulfase group at 24 weeks, mean difference -227.00 (95% confidence interval -264.00 to -190.00).In general, the dose of galsulfase was well tolerated and there were no significant differences in relation to adverse events. These events include drug-related adverse events, serious and severe adverse events, those during infusion, drug-related adverse events during infusion, and deaths. More infusion-related reactions were observed in the galsulfase group and were managed with interruption or slowing of infusion rate or administration of antihistamines or corticosteroids drugs. No deaths occurred during the study.
AUTHORS' CONCLUSIONS
The results of one small study (based on 24-week randomised phase of the study and prior to the open-label extension) demonstrated that galsulfase is more effective than placebo in people with MPS VI, with significant improvements in the 12-minute walk test and a reduction in urinary glycosaminoglycans.There were no significant changes in cardiac or pulmonary functions, liver or spleen volume, overnight apnea-hypopnea, height and weight, quality of life and adverse effects.Further studies are needed to obtain more information on the long-term effectiveness and safety of enzyme replacement therapy with galsulfase.
Topics: Enzyme Replacement Therapy; Glycosaminoglycans; Humans; Mucopolysaccharidosis VI; N-Acetylgalactosamine-4-Sulfatase; Randomized Controlled Trials as Topic; Recombinant Proteins
PubMed: 26943923
DOI: 10.1002/14651858.CD009806.pub2 -
Circulation. Cardiovascular Quality and... Oct 2015About half of survivors with stroke experience severe and significant long-term disability. The purpose of this article is to review the state of the science and to make... (Review)
Review
BACKGROUND
About half of survivors with stroke experience severe and significant long-term disability. The purpose of this article is to review the state of the science and to make recommendations for measuring patient-centric outcomes in interventions for motor improvement in the chronic stroke phase.
METHODS AND RESULTS
A 9-member expert panel reviewed evidence to identify measures of upper and lower extremity function used to date as outcomes in trials with patients who experienced a stroke ≥6 months before assessment. Outcome measures were screened using StrokEDGE consensus panel recommendations, and evaluated for availability of a published minimal clinically important difference. Measures meeting these criteria were further evaluated with regard to their level of measurement, psychometric properties, and ability of minimal clinically important difference to capture gains associated with improved function and clinical relevance to patients, to arrive at recommendations. A systematic literature review yielded 115 clinical trials of upper and lower extremity function in chronic stroke that used a total of 34 outcome measures. Seven of these had published minimal clinically important differences and were recommended or highly recommended by StrokEDGE. Those are the Fugl-Meyer Upper Extremity and Lower Extremity scales, Wolf Motor Function Test, Action Research Arm Test, Ten-Meter and Six-Minute Walk Tests, and the Stroke Impact Scale. All had evidence for their psychometric performance, although the strength of evidence for validity varied, especially in populations with chronic stroke Fugl-Meyer Upper and Lower Extremity scales showing the strongest evidence for validity.
CONCLUSIONS
The panel recommends that the Fugl-Meyer Upper and Lower Extremity scales be used as primary outcomes in intervention trials targeting motor function in populations with chronic stroke. The other 6 measures are recommended as secondary outcomes.
Topics: Chronic Disease; Clinical Trials as Topic; Disability Evaluation; Early Medical Intervention; Expert Testimony; Humans; Lower Extremity; Outcome Assessment, Health Care; Recovery of Function; Research Design; Stroke; Upper Extremity
PubMed: 26515205
DOI: 10.1161/CIRCOUTCOMES.115.002098 -
International Journal of Environmental... Feb 2023An understanding of physical demands during official competitions is essential to achieving the highest performance in handball. The aim of this systematic review was to... (Review)
Review
An understanding of physical demands during official competitions is essential to achieving the highest performance in handball. The aim of this systematic review was to summarise the available scientific evidence associated with physical demands during official competitions in elite handball according to playing positions, competition level and gender. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, 17 studies were selected after a systematic search and selection process of three digital databases: PubMed, Web of Science and Sport Discus. The quality of the selected studies was evaluated using the Strengthening the Reporting of Observational Studies in Epidemiology checklist; the average score was 18.47 points. The sample consisted of 1175 handball players, of whom 1042 were men (88.68%) and 133 were women (11.32%). The results show that an elite handball player covered on average 3664.4 ± 1121.6 m during a match. The average running pace was 84.8 ± 17.2 m∙min. The total distance covered was largely greater in national competitions (4506.7 ± 647.9 m) compared with international competitions (2190.3 ± 1950.5 m) (effect size (ES) = 1.2); however, the running pace did not present any significant difference between the international or national level (ES = 0.06). In regard to gender, the total distance covered was moderately greater in female competitions (4549.1 ± 758.6 m) compared with male competitions (3332.6 ± 1257.7 m) (ES = 0.9), and the running pace was largely greater in female competitions (110.5 ± 7.2 m∙min) compared with male competitions (78.4 ± 19.7 m∙min) (ES = 1.6). In relation to playing position, backs and wings covered a moderately greater total distance (ES = 0.7 and 0.6) and slightly more meters per minute (ES = 0.4 and 0.2) than pivots. Moreover, the technical activity profile differed between playing positions. Backs performed moderately more throws than pivots and wings (ES = 1.2 and 0.9), pivots exhibited largely more body contact than backs and wings, and wings performed moderately more fast breaks (6.7 ± 3.0) than backs (2.2 ± 2.3) (ES = 1.8). Therefore, this research study provides practical applications for handball coaches and strength and conditioning professionals with respect to designing and implementing more individualised training programmes to maximise performance and reduce injury risk.
Topics: Humans; Male; Female; Athletic Performance; Anthropometry
PubMed: 36834047
DOI: 10.3390/ijerph20043353 -
Health Technology Assessment... Feb 2016In recent years, meters for continuous monitoring of interstitial fluid glucose have been introduced to help people with type 1 diabetes mellitus (T1DM) to achieve... (Review)
Review
Integrated sensor-augmented pump therapy systems [the MiniMed® Paradigm™ Veo system and the Vibe™ and G4® PLATINUM CGM (continuous glucose monitoring) system] for managing blood glucose levels in type 1 diabetes: a systematic review and economic evaluation.
BACKGROUND
In recent years, meters for continuous monitoring of interstitial fluid glucose have been introduced to help people with type 1 diabetes mellitus (T1DM) to achieve better control of their disease.
OBJECTIVE
The objective of this project was to summarise the evidence on the clinical effectiveness and cost-effectiveness of the MiniMed(®) Paradigm™ Veo system (Medtronic Inc., Northridge, CA, USA) and the Vibe™ (Animas(®) Corporation, West Chester, PA, USA) and G4(®) PLATINUM CGM (continuous glucose monitoring) system (Dexcom Inc., San Diego, CA, USA) in comparison with multiple daily insulin injections (MDIs) or continuous subcutaneous insulin infusion (CSII), both with either self-monitoring of blood glucose (SMBG) or CGM, for the management of T1DM in adults and children.
DATA SOURCES
A systematic review was conducted in accordance with the principles of the Centre for Reviews and Dissemination guidance and the National Institute for Health and Care Excellence Diagnostic Assessment Programme manual. We searched 14 databases, three trial registries and two conference proceedings from study inception up to September 2014. In addition, reference lists of relevant systematic reviews were checked. In the absence of randomised controlled trials directly comparing Veo or an integrated CSII + CGM system, such as Vibe, with comparator interventions, indirect treatment comparisons were performed if possible.
METHODS
A commercially available cost-effectiveness model, the IMS Centre for Outcomes Research and Effectiveness diabetes model version 8.5 (IMS Health, Danbury, CT, USA), was used for this assessment. This model is an internet-based, interactive simulation model that predicts the long-term health outcomes and costs associated with the management of T1DM and type 2 diabetes. The model consists of 15 submodels designed to simulate diabetes-related complications, non-specific mortality and costs over time. As the model simulates individual patients over time, it updates risk factors and complications to account for disease progression.
RESULTS
Fifty-four publications resulting from 19 studies were included in the review. Overall, the evidence suggests that the Veo system reduces hypoglycaemic events more than other treatments, without any differences in other outcomes, including glycated haemoglobin (HbA1c) levels. We also found significant results in favour of the integrated CSII + CGM system over MDIs with SMBG with regard to HbA1c levels and quality of life. However, the evidence base was poor. The quality of the included studies was generally low, often with only one study comparing treatments in a specific population at a specific follow-up time. In particular, there was only one study comparing Veo with an integrated CSII + CGM system and only one study comparing Veo with a CSII + SMBG system in a mixed population. Cost-effectiveness analyses indicated that MDI + SMBG is the option most likely to be cost-effective, given the current threshold of £30,000 per quality-adjusted life-year gained, whereas integrated CSII + CGM systems and Veo are dominated and extendedly dominated, respectively, by stand-alone, non-integrated CSII with CGM. Scenario analyses did not alter these conclusions. No cost-effectiveness modelling was conducted for children or pregnant women.
CONCLUSIONS
The Veo system does appear to be better than the other systems considered at reducing hypoglycaemic events. However, in adults, it is unlikely to be cost-effective. Integrated systems are also generally unlikely to be cost-effective given that stand-alone systems are cheaper and, possibly, no less effective. However, evidence in this regard is generally lacking, in particular for children. Future trials in specific child, adolescent and adult populations should include longer term follow-up and ratings on the European Quality of Life-5 Dimensions scale at various time points with a view to informing improved cost-effectiveness modelling.
STUDY REGISTRATION
PROSPERO Registration Number CRD42014013764.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Blood Glucose; Blood Glucose Self-Monitoring; Cost-Benefit Analysis; Diabetes Complications; Diabetes Mellitus, Type 1; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Insulin; Quality of Life; Technology Assessment, Biomedical
PubMed: 26933827
DOI: 10.3310/hta20170