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International Journal of Chronic... 2021Almost half of the people with chronic obstructive pulmonary disease (COPD) do not adhere to the prescribed treatments and report anxiety and depression as... (Review)
Review
BACKGROUND
Almost half of the people with chronic obstructive pulmonary disease (COPD) do not adhere to the prescribed treatments and report anxiety and depression as comorbidities, resulting in higher rates of exacerbations, hospitalizations, and worse clinical outcomes.
OBJECTIVE
This systematic review provided a synthesis of studies about the relationships between anxiety, depression, and adherence in people affected by COPD.
METHODS
English language publications were searched in the PUBMED, SCOPUS, PsycInfo, Web of Science, PsycArticles, and Cochrane Library databases from December 2020 to March 2021, following PRISMA guidelines. The reference lists of eligible studies and other relevant systematic reviews were also searched. Data extraction and critical appraisal were undertaken by two reviewers working independently. The reference lists of eligible studies and other relevant systematic reviews were also searched. Data extraction and critical appraisal were undertaken by two reviewers working independently.
RESULTS
A total of 34 studies (23 quantitative and 2 qualitative studies, 9 reviews) were included. The relationship between depression and treatment adherence was significant and negative. Adherence to both rehabilitation, psychological, and antidepressant pharmacological treatments in depressed patients was linked to a decreased risk of hospitalization. Moreover, depressed patients compliant with an antidepressant were more likely to adherent to COPD maintenance inhalers. On the other hand, the associations between anxiety and adherence were poorly investigated and high heterogeneity characterized the studies, leading to a weak and variable relationship as well as too few interventions.
CONCLUSION
The systematic review highlights the variability in estimates of the relationship between depression, anxiety, and treatment adherence in COPD. It could be explained by methodological differences across the included studies. This suggests that standardization is critical to improving the precision of the estimates. Recommendations for future research include attention to causal inferences, an exploration of mechanisms to explain the relationships between both anxiety and depression and adherence in COPD, and a comprehensive, systematic approach.
Topics: Anxiety; Anxiety Disorders; Depression; Humans; Patient Compliance; Pulmonary Disease, Chronic Obstructive
PubMed: 34262270
DOI: 10.2147/COPD.S313841 -
The Cochrane Database of Systematic... Jan 2021Pulmonary rehabilitation is a proven, effective intervention for people with chronic respiratory diseases including chronic obstructive pulmonary disease (COPD),... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pulmonary rehabilitation is a proven, effective intervention for people with chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD) and bronchiectasis. However, relatively few people attend or complete a program, due to factors including a lack of programs, issues associated with travel and transport, and other health issues. Traditionally, pulmonary rehabilitation is delivered in-person on an outpatient basis at a hospital or other healthcare facility (referred to as centre-based pulmonary rehabilitation). Newer, alternative modes of pulmonary rehabilitation delivery include home-based models and the use of telehealth. Telerehabilitation is the delivery of rehabilitation services at a distance, using information and communication technology. To date, there has not been a comprehensive assessment of the clinical efficacy or safety of telerehabilitation, or its ability to improve uptake and access to rehabilitation services, for people with chronic respiratory disease.
OBJECTIVES
To determine the effectiveness and safety of telerehabilitation for people with chronic respiratory disease.
SEARCH METHODS
We searched the Cochrane Airways Trials Register, and the Cochrane Central Register of Controlled Trials; six databases including MEDLINE and Embase; and three trials registries, up to 30 November 2020. We checked reference lists of all included studies for additional references, and handsearched relevant respiratory journals and meeting abstracts.
SELECTION CRITERIA
All randomised controlled trials and controlled clinical trials of telerehabilitation for the delivery of pulmonary rehabilitation were eligible for inclusion. The telerehabilitation intervention was required to include exercise training, with at least 50% of the rehabilitation intervention being delivered by telerehabilitation.
DATA COLLECTION AND ANALYSIS
We used standard methods recommended by Cochrane. We assessed the risk of bias for all studies, and used the ROBINS-I tool to assess bias in non-randomised controlled clinical trials. We assessed the certainty of evidence with GRADE. Comparisons were telerehabilitation compared to traditional in-person (centre-based) pulmonary rehabilitation, and telerehabilitation compared to no rehabilitation. We analysed studies of telerehabilitation for maintenance rehabilitation separately from trials of telerehabilitation for initial primary pulmonary rehabilitation.
MAIN RESULTS
We included a total of 15 studies (32 reports) with 1904 participants, using five different models of telerehabilitation. Almost all (99%) participants had chronic obstructive pulmonary disease (COPD). Three studies were controlled clinical trials. For primary pulmonary rehabilitation, there was probably little or no difference between telerehabilitation and in-person pulmonary rehabilitation for exercise capacity measured as 6-Minute Walking Distance (6MWD) (mean difference (MD) 0.06 metres (m), 95% confidence interval (CI) -10.82 m to 10.94 m; 556 participants; four studies; moderate-certainty evidence). There may also be little or no difference for quality of life measured with the St George's Respiratory Questionnaire (SGRQ) total score (MD -1.26, 95% CI -3.97 to 1.45; 274 participants; two studies; low-certainty evidence), or for breathlessness on the Chronic Respiratory Questionnaire (CRQ) dyspnoea domain score (MD 0.13, 95% CI -0.13 to 0.40; 426 participants; three studies; low-certainty evidence). Participants were more likely to complete a program of telerehabilitation, with a 93% completion rate (95% CI 90% to 96%), compared to a 70% completion rate for in-person rehabilitation. When compared to no rehabilitation control, trials of primary telerehabilitation may increase exercise capacity on 6MWD (MD 22.17 m, 95% CI -38.89 m to 83.23 m; 94 participants; two studies; low-certainty evidence) and may also increase 6MWD when delivered as maintenance rehabilitation (MD 78.1 m, 95% CI 49.6 m to 106.6 m; 209 participants; two studies; low-certainty evidence). No adverse effects of telerehabilitation were noted over and above any reported for in-person rehabilitation or no rehabilitation.
AUTHORS' CONCLUSIONS
This review suggests that primary pulmonary rehabilitation, or maintenance rehabilitation, delivered via telerehabilitation for people with chronic respiratory disease achieves outcomes similar to those of traditional centre-based pulmonary rehabilitation, with no safety issues identified. However, the certainty of the evidence provided by this review is limited by the small number of studies, of varying telerehabilitation models, with relatively few participants. Future research should consider the clinical effect of telerehabilitation for individuals with chronic respiratory diseases other than COPD, the duration of benefit of telerehabilitation beyond the period of the intervention, and the economic cost of telerehabilitation.
Topics: Bias; Chronic Disease; Controlled Clinical Trials as Topic; Dyspnea; Exercise Tolerance; Humans; Internet; Non-Randomized Controlled Trials as Topic; Patient Compliance; Pulmonary Disease, Chronic Obstructive; Quality of Life; Randomized Controlled Trials as Topic; Respiration Disorders; Telephone; Telerehabilitation; Videoconferencing; Walk Test
PubMed: 33511633
DOI: 10.1002/14651858.CD013040.pub2 -
The Cochrane Database of Systematic... Mar 2014Combined oral contraceptive (COC) use has been associated with venous thrombosis (VT) (i.e., deep venous thrombosis and pulmonary embolism). The VT risk has been... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Combined oral contraceptive (COC) use has been associated with venous thrombosis (VT) (i.e., deep venous thrombosis and pulmonary embolism). The VT risk has been evaluated for many estrogen doses and progestagen types contained in COC but no comprehensive comparison involving commonly used COC is available.
OBJECTIVES
To provide a comprehensive overview of the risk of venous thrombosis in women using different combined oral contraceptives.
SEARCH METHODS
Electronic databases (Pubmed, Embase, Web of Science, Cochrane, CINAHL, Academic Search Premier and ScienceDirect) were searched in 22 April 2013 for eligible studies, without language restrictions.
SELECTION CRITERIA
We selected studies including healthy women taking COC with VT as outcome.
DATA COLLECTION AND ANALYSIS
The primary outcome of interest was a fatal or non-fatal first event of venous thrombosis with the main focus on deep venous thrombosis or pulmonary embolism. Publications with at least 10 events in total were eligible. The network meta-analysis was performed using an extension of frequentist random effects models for mixed multiple treatment comparisons. Unadjusted relative risks with 95% confidence intervals were reported.Two independent reviewers extracted data from selected studies.
MAIN RESULTS
3110 publications were retrieved through a search strategy; 25 publications reporting on 26 studies were included. Incidence of venous thrombosis in non-users from two included cohorts was 0.19 and 0.37 per 1 000 person years, in line with previously reported incidences of 0,16 per 1 000 person years. Use of combined oral contraceptives increased the risk of venous thrombosis compared with non-use (relative risk 3.5, 95% confidence interval 2.9 to 4.3). The relative risk of venous thrombosis for combined oral contraceptives with 30-35 μg ethinylestradiol and gestodene, desogestrel, cyproterone acetate, or drospirenone were similar and about 50-80% higher than for combined oral contraceptives with levonorgestrel. A dose related effect of ethinylestradiol was observed for gestodene, desogestrel, and levonorgestrel, with higher doses being associated with higher thrombosis risk.
AUTHORS' CONCLUSIONS
All combined oral contraceptives investigated in this analysis were associated with an increased risk of venous thrombosis. The effect size depended both on the progestogen used and the dose of ethinylestradiol. Risk of venous thrombosis for combined oral contraceptives with 30-35 μg ethinylestradiol and gestodene, desogestrel, cyproterone acetate and drospirenone were similar, and about 50-80% higher than with levonorgestrel. The combined oral contraceptive with the lowest possible dose of ethinylestradiol and good compliance should be prescribed-that is, 30 μg ethinylestradiol with levonorgestrel.
Topics: Androstenes; Contraceptives, Oral, Combined; Cyproterone; Desogestrel; Ethinyl Estradiol; Female; Humans; Levonorgestrel; Norpregnenes; Pulmonary Embolism; Randomized Controlled Trials as Topic; Venous Thrombosis
PubMed: 24590565
DOI: 10.1002/14651858.CD010813.pub2 -
International Journal of Cardiology May 2018Chronic Care Model (CCM) has been developed to improve patients' health care by restructuring health systems in a multidimensional manner. This systematic review aims to... (Review)
Review
BACKGROUND
Chronic Care Model (CCM) has been developed to improve patients' health care by restructuring health systems in a multidimensional manner. This systematic review aims to summarize and analyse programs specifically designed and conducted for the fulfilment of multiple CCM components. We have focused on programs targeting diabetes mellitus, hypertension and cardiovascular disease.
METHOD AND RESULTS
This review was based on a comprehensive literature search of articles in the PubMed database that reported clinical outcomes. We included a total of 25 eligible articles. Evidence of improvement in medical outcomes and the compliance of patients with medical treatment were reported in 18 and 14 studies, respectively. Two studies demonstrated a reduction of the medical burden in terms of health service utilization, and another two studies reported the effectiveness of the programs in reducing the risk of heart failure and other cardiovascular diseases. However, CCMs were still restricted by limited academic robustness and social constraints when they were implemented in primary care. Higher professional recognition, tighter system collaborations and increased financial support may be necessary to overcome the limitations of, and barriers to CCM implementation.
CONCLUSION
This review has identified the benefits of implementing CCM, and recommended suggestions for the future development of CCM.
Topics: Cardiovascular Diseases; Chronic Disease; Diabetes Mellitus; Disease Management; Humans; Hypertension; Primary Health Care
PubMed: 29544944
DOI: 10.1016/j.ijcard.2017.11.057 -
PLoS Medicine Jul 2018Incomplete adherence to tuberculosis (TB) treatment increases the risk of delayed culture conversion with continued transmission in the community, as well as treatment... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Incomplete adherence to tuberculosis (TB) treatment increases the risk of delayed culture conversion with continued transmission in the community, as well as treatment failure, relapse, and development or amplification of drug resistance. We conducted a systematic review and meta-analysis of adherence interventions, including directly observed therapy (DOT), to determine which approaches lead to improved TB treatment outcomes.
METHODS AND FINDINGS
We systematically reviewed Medline as well as the references of published review articles for relevant studies of adherence to multidrug treatment of both drug-susceptible and drug-resistant TB through February 3, 2018. We included randomized controlled trials (RCTs) as well as prospective and retrospective cohort studies (CSs) with an internal or external control group that evaluated any adherence intervention and conducted a meta-analysis of their impact on TB treatment outcomes. Our search identified 7,729 articles, of which 129 met the inclusion criteria for quantitative analysis. Seven adherence categories were identified, including DOT offered by different providers and at various locations, reminders and tracers, incentives and enablers, patient education, digital technologies (short message services [SMSs] via mobile phones and video-observed therapy [VOT]), staff education, and combinations of these interventions. When compared with DOT alone, self-administered therapy (SAT) was associated with lower rates of treatment success (CS: risk ratio [RR] 0.81, 95% CI 0.73-0.89; RCT: RR 0.94, 95% CI 0.89-0.98), adherence (CS: RR 0.83, 95% CI 0.75-0.93), and sputum smear conversion (RCT: RR 0.92, 95% CI 0.87-0.98) as well as higher rates of development of drug resistance (CS: RR 4.19, 95% CI 2.34-7.49). When compared to DOT provided by healthcare providers, DOT provided by family members was associated with a lower rate of adherence (CS: RR 0.86, 95% CI 0.79-0.94). DOT delivery in the community versus at the clinic was associated with a higher rate of treatment success (CS: RR 1.08, 95% CI 1.01-1.15) and sputum conversion at the end of two months (CS: RR 1.05, 95% CI 1.02-1.08) as well as lower rates of treatment failure (CS: RR 0.56, 95% CI 0.33-0.95) and loss to follow-up (CS: RR 0.63, 95% CI 0.40-0.98). Medication monitors improved adherence and treatment success and VOT was comparable with DOT. SMS reminders led to a higher treatment completion rate in one RCT and were associated with higher rates of cure and sputum conversion when used in combination with medication monitors. TB treatment outcomes improved when patient education, healthcare provider education, incentives and enablers, psychological interventions, reminders and tracers, or mobile digital technologies were employed. Our findings are limited by the heterogeneity of the included studies and lack of standardized research methodology on adherence interventions.
CONCLUSION
TB treatment outcomes are improved with the use of adherence interventions, such as patient education and counseling, incentives and enablers, psychological interventions, reminders and tracers, and digital health technologies. Trained healthcare providers as well as community delivery provides patient-centered DOT options that both enhance adherence and improve treatment outcomes as compared to unsupervised, SAT alone.
Topics: Adolescent; Adult; Antitubercular Agents; Attitude of Health Personnel; Cell Phone; Child; Child, Preschool; Directly Observed Therapy; Health Knowledge, Attitudes, Practice; Health Personnel; Humans; Infant; Infant, Newborn; Medication Adherence; Observational Studies as Topic; Patient Education as Topic; Randomized Controlled Trials as Topic; Risk Factors; Self Care; Telemedicine; Text Messaging; Treatment Outcome; Tuberculosis; Video Recording
PubMed: 29969463
DOI: 10.1371/journal.pmed.1002595 -
The Cochrane Database of Systematic... Sep 2013In some people with asthma, expiratory airflow limitation, premature closure of small airways, activity of inspiratory muscles at the end of expiration and reduced... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In some people with asthma, expiratory airflow limitation, premature closure of small airways, activity of inspiratory muscles at the end of expiration and reduced pulmonary compliance may lead to lung hyperinflation. With the increase in lung volume, chest wall geometry is modified, shortening the inspiratory muscles and leaving them at a sub-optimal position in their length-tension relationship. Thus, the capacity of these muscles to generate tension is reduced. An increase in cross-sectional area of the inspiratory muscles caused by hypertrophy could offset the functional weakening induced by hyperinflation. Previous studies have shown that inspiratory muscle training promotes diaphragm hypertrophy in healthy people and patients with chronic heart failure, and increases the proportion of type I fibres and the size of type II fibres of the external intercostal muscles in patients with chronic obstructive pulmonary disease. However, its effects on clinical outcomes in patients with asthma are unclear.
OBJECTIVES
To evaluate the efficacy of inspiratory muscle training with either an external resistive device or threshold loading in people with asthma.
SEARCH METHODS
We searched the Cochrane Airways Group Specialised Register of trials, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and reference lists of included studies. The latest search was performed in November 2012.
SELECTION CRITERIA
We included randomised controlled trials that involved the use of an external inspiratory muscle training device versus a control (sham or no inspiratory training device) in people with stable asthma.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by The Cochrane Collaboration.
MAIN RESULTS
We included five studies involving 113 adults. Participants in four studies had mild to moderate asthma and the fifth study included participants independent of their asthma severity. There were substantial differences between the studies, including the training protocol, duration of training sessions (10 to 30 minutes) and duration of the intervention (3 to 25 weeks). Three clinical trials were produced by the same research group. Risk of bias in the included studies was difficult to ascertain accurately due to poor reporting of methods.The included studies showed a statistically significant increase in inspiratory muscle strength, measured by maximal inspiratory pressure (PImax) (mean difference (MD) 13.34 cmH2O, 95% CI 4.70 to 21.98, 4 studies, 84 participants, low quality evidence). Our other primary outcome, exacerbations requiring a course of oral or inhaled corticosteroids or emergency department visits, was not reported. For the secondary outcomes, results from one trial showed no statistically significant difference between the inspiratory muscle training group and the control group for maximal expiratory pressure, peak expiratory flow rate, forced expiratory volume in one second, forced vital capacity, sensation of dyspnoea and use of beta2-agonist. There were no studies describing inspiratory muscle endurance, hospital admissions or days off work or school.
AUTHORS' CONCLUSIONS
There is no conclusive evidence in this review to support or refute inspiratory muscle training for asthma. The evidence was limited by the small number of trials with few participants together with the risk of bias. More well conducted randomised controlled trials are needed. Future trials should investigate the following outcomes: lung function, exacerbation rate, asthma symptoms, hospital admissions, use of medications and days off work or school. Inspiratory muscle training should also be assessed in people with more severe asthma and conducted in children with asthma.
Topics: Adult; Asthma; Breathing Exercises; Humans; Muscle Strength; Randomized Controlled Trials as Topic; Respiratory Muscles; Respiratory Therapy
PubMed: 24014205
DOI: 10.1002/14651858.CD003792.pub2 -
Intensive Care Medicine Dec 2016Veno-arterial extracorporeal life support (ECLS) is increasingly used in patients during cardiac arrest and cardiogenic shock, to support both cardiac and pulmonary... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Veno-arterial extracorporeal life support (ECLS) is increasingly used in patients during cardiac arrest and cardiogenic shock, to support both cardiac and pulmonary function. We performed a systematic review and meta-analysis of cohort studies comparing mortality in patients treated with and without ECLS support in the setting of refractory cardiac arrest and cardiogenic shock complicating acute myocardial infarction.
METHODS
We systematically searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed updated to December 2015. Thirteen studies were included of which nine included cardiac arrest patients (n = 3098) and four included patients with cardiogenic shock after acute myocardial infarction (n = 235). Data were pooled by a Mantel-Haenzel random effects model and heterogeneity was examined by the I statistic.
RESULTS
In cardiac arrest, the use of ECLS was associated with an absolute increase of 30 days survival of 13 % compared with patients in which ECLS was not used [95 % CI 6-20 %; p < 0.001; number needed to treat (NNT) 7.7] and a higher rate of favourable neurological outcome at 30 days (absolute risk difference 14 %; 95 % CI 7-20 %; p < 0.0001; NNT 7.1). Propensity matched analysis, including 5 studies and 438 patients (219 in both groups), showed similar results. In cardiogenic shock, ECLS showed a 33 % higher 30-day survival compared with IABP (95 % CI, 14-52 %; p < 0.001; NNT 13) but no difference when compared with TandemHeart/Impella (-3 %; 95 % CI -21 to 14 %; p = 0.70; NNH 33).
CONCLUSIONS
In cardiac arrest, the use of ECLS was associated with an increased survival rate as well as an increase in favourable neurological outcome. In the setting of cardiogenic shock there was an increased survival with ECLS compared with IABP.
Topics: Extracorporeal Membrane Oxygenation; Female; Heart Arrest; Humans; Male; Retrospective Studies; Shock, Cardiogenic; Treatment Outcome
PubMed: 27647331
DOI: 10.1007/s00134-016-4536-8 -
The Cochrane Database of Systematic... Feb 2014This is an update of a Cochrane Review first published in The Cochrane Library 2008, Issue 3.Upper abdominal surgical procedures are associated with a high risk of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an update of a Cochrane Review first published in The Cochrane Library 2008, Issue 3.Upper abdominal surgical procedures are associated with a high risk of postoperative pulmonary complications. The risk and severity of postoperative pulmonary complications can be reduced by the judicious use of therapeutic manoeuvres that increase lung volume. Our objective was to assess the effect of incentive spirometry compared to no therapy or physiotherapy, including coughing and deep breathing, on all-cause postoperative pulmonary complications and mortality in adult patients admitted to hospital for upper abdominal surgery.
OBJECTIVES
Our primary objective was to assess the effect of incentive spirometry (IS), compared to no such therapy or other therapy, on postoperative pulmonary complications and mortality in adults undergoing upper abdominal surgery.Our secondary objectives were to evaluate the effects of IS, compared to no therapy or other therapy, on other postoperative complications, adverse events, and spirometric parameters.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE, EMBASE, and LILACS (from inception to August 2013). There were no language restrictions. The date of the most recent search was 12 August 2013. The original search was performed in June 2006.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) of IS in adult patients admitted for any type of upper abdominal surgery, including patients undergoing laparoscopic procedures.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trial quality and extracted data.
MAIN RESULTS
We included 12 studies with a total of 1834 participants in this updated review. The methodological quality of the included studies was difficult to assess as it was poorly reported, so the predominant classification of bias was 'unclear'; the studies did not report on compliance with the prescribed therapy. We were able to include data from only 1160 patients in the meta-analysis. Four trials (152 patients) compared the effects of IS with no respiratory treatment. We found no statistically significant difference between the participants receiving IS and those who had no respiratory treatment for clinical complications (relative risk (RR) 0.59, 95% confidence interval (CI) 0.30 to 1.18). Two trials (194 patients) IS compared incentive spirometry with deep breathing exercises (DBE). We found no statistically significant differences between the participants receiving IS and those receiving DBE in the meta-analysis for respiratory failure (RR 0.67, 95% CI 0.04 to 10.50). Two trials (946 patients) compared IS with other chest physiotherapy. We found no statistically significant differences between the participants receiving IS compared to those receiving physiotherapy in the risk of developing a pulmonary condition or the type of complication. There was no evidence that IS is effective in the prevention of pulmonary complications.
AUTHORS' CONCLUSIONS
There is low quality evidence regarding the lack of effectiveness of incentive spirometry for prevention of postoperative pulmonary complications in patients after upper abdominal surgery. This review underlines the urgent need to conduct well-designed trials in this field. There is a case for large RCTs with high methodological rigour in order to define any benefit from the use of incentive spirometry regarding mortality.
Topics: Abdomen; Adult; Bronchial Diseases; Humans; Lung Diseases; Pneumonia; Postoperative Complications; Pulmonary Atelectasis; Randomized Controlled Trials as Topic; Respiratory Insufficiency; Respiratory Therapy; Spirometry; Tracheal Diseases
PubMed: 24510642
DOI: 10.1002/14651858.CD006058.pub3 -
The Cochrane Database of Systematic... Jun 2015Idiopathic scoliosis is a three-dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can... (Review)
Review
BACKGROUND
Idiopathic scoliosis is a three-dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased.
OBJECTIVES
To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues.
SEARCH METHODS
We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature.
SELECTION CRITERIA
Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by The Cochrane Collaboration.
MAIN RESULTS
We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized.There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) -2.10, 95% confidence interval (CI) -7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years).Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow-up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow-up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20).There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow-up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow-up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention-to-treat (ITT) analysis).There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow-up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression.Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10).
AUTHORS' CONCLUSIONS
Due to the important clinical differences among the studies, it was not possible to perform a meta-analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise-based' trials, prospective controlled cohort studies, prospective studies conducted according to pre-defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing.
Topics: Adolescent; Braces; Child; Cohort Studies; Disease Progression; Female; Humans; Male; Prospective Studies; Quality of Life; Randomized Controlled Trials as Topic; Scoliosis
PubMed: 26086959
DOI: 10.1002/14651858.CD006850.pub3 -
BMJ (Clinical Research Ed.) Sep 2013To provide a comprehensive overview of the risk of venous thrombosis in women using different combined oral contraceptives. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To provide a comprehensive overview of the risk of venous thrombosis in women using different combined oral contraceptives.
DESIGN
Systematic review and network meta-analysis.
DATA SOURCES
PubMed, Embase, Web of Science, Cochrane, Cumulative Index to Nursing and Allied Health Literature, Academic Search Premier, and ScienceDirect up to 22 April 2013.
REVIEW METHODS
Observational studies that assessed the effect of combined oral contraceptives on venous thrombosis in healthy women. The primary outcome of interest was a fatal or non-fatal first event of venous thrombosis with the main focus on deep venous thrombosis or pulmonary embolism. Publications with at least 10 events in total were eligible. The network meta-analysis was performed using an extension of frequentist random effects models for mixed multiple treatment comparisons. Unadjusted relative risks with 95% confidence intervals were reported. The requirement for crude numbers did not allow adjustment for potential confounding variables.
RESULTS
3110 publications were retrieved through a search strategy; 25 publications reporting on 26 studies were included. Incidence of venous thrombosis in non-users from two included cohorts was 1.9 and 3.7 per 10,000 woman years, in line with previously reported incidences of 1-6 per 10,000 woman years. Use of combined oral contraceptives increased the risk of venous thrombosis compared with non-use (relative risk 3.5, 95% confidence interval 2.9 to 4.3). The relative risk of venous thrombosis for combined oral contraceptives with 30-35 µg ethinylestradiol and gestodene, desogestrel, cyproterone acetate, or drospirenone were similar and about 50-80% higher than for combined oral contraceptives with levonorgestrel. A dose related effect of ethinylestradiol was observed for gestodene, desogestrel, and levonorgestrel, with higher doses being associated with higher thrombosis risk.
CONCLUSION
All combined oral contraceptives investigated in this analysis were associated with an increased risk of venous thrombosis. The effect size depended both on the progestogen used and the dose of ethinylestradiol.
Topics: Adult; Case-Control Studies; Confounding Factors, Epidemiologic; Contraceptives, Oral, Combined; Contraceptives, Oral, Hormonal; Dose-Response Relationship, Drug; Ethinyl Estradiol; Female; Humans; Medication Adherence; Progestins; Risk Assessment; Risk Factors; Venous Thrombosis
PubMed: 24030561
DOI: 10.1136/bmj.f5298