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PharmacoEconomics Nov 2017Clostridium difficile infection (CDI) is associated with high management costs, particularly in recurrent cases. Fidaxomicin treatment results in lower recurrence rates... (Comparative Study)
Comparative Study Review
BACKGROUND AND OBJECTIVE
Clostridium difficile infection (CDI) is associated with high management costs, particularly in recurrent cases. Fidaxomicin treatment results in lower recurrence rates than vancomycin and metronidazole, but has higher acquisition costs in Europe and the USA. This systematic literature review summarises economic evaluations (EEs) of fidaxomicin, vancomycin and metronidazole for treatment of CDI.
METHODS
Electronic databases (MEDLINE, Embase, Cochrane Library) and conference proceedings (ISPOR, ECCMID, ICAAC and IDWeek) were searched for publications reporting EEs of fidaxomicin, vancomycin and/or metronidazole in the treatment of CDI. Reference bibliographies of identified manuscripts were also reviewed. Cost-effectiveness was evaluated according to the overall population of patients with CDI, as well as in subgroups with severe CDI or recurrent CDI, or those at higher risk of recurrence or mortality.
RESULTS
Overall, 27 relevant EEs, conducted from the perspective of 12 different countries, were identified. Fidaxomicin was cost-effective versus vancomycin and/or metronidazole in 14 of 24 EEs (58.3%), vancomycin was cost-effective versus fidaxomicin and/or metronidazole in five of 27 EEs (18.5%) and metronidazole was cost-effective versus fidaxomicin and/or vancomycin in two of 13 EEs (15.4%). Fidaxomicin was cost-effective versus vancomycin in most of the EEs evaluating specific patient subgroups. Key cost-effectiveness drivers were cure rate, recurrence rate, time horizon, drug costs and length and cost of hospitalisation.
CONCLUSIONS
In most EEs, fidaxomicin was demonstrated to be cost-effective versus metronidazole and vancomycin in patients with CDI. These results have relevance to clinical practice, given the high budgetary impact of managing CDI and increasing restrictions on healthcare budgets.
OTHER
This analysis was initiated and funded by Astellas Pharma Inc.
Topics: Aminoglycosides; Anti-Bacterial Agents; Clostridium Infections; Cost-Benefit Analysis; Drug Costs; Fidaxomicin; Hospitalization; Humans; Metronidazole; Recurrence; Vancomycin
PubMed: 28875314
DOI: 10.1007/s40273-017-0540-2 -
Gastroenterology Report Aug 2017Mixed cryoglobulinemia (MC) has been associated with several viral infections, and chronic hepatitis C is recognized as a major cause. MC associated with hepatitis E... (Review)
Review
Mixed cryoglobulinemia (MC) has been associated with several viral infections, and chronic hepatitis C is recognized as a major cause. MC associated with hepatitis E virus (HEV) has been described and little is known about this rare association. The aim of this study is to perform a systematic review of MC associated with HEV, and examine the presence of a causal relationship. An experienced librarian conducted a search of databases from each database's inception to 12 December 2016 based on a priori criteria. The risk of bias was assessed, and Hill's criteria were applied to determine causality. Five publications met inclusion criteria, with a total of 15 cases. Three studies had low, one low to moderate and one moderate risk of bias. Median age was 43 years, and all patients came from Western Europe. Two patients were immunocompetent, while 13 were immunosuppressed, post solid organ transplant and had chronic hepatitis E. Renal involvement was observed in seven patients, mild to moderately severe cryoglobulinemic disease in one patient and severe cryoglobulinemic disease in three patients. One patient improved spontaneously, and another was treated with immunosuppressant reduction leading to viral clearance. Ten patients treated with peg-interferon or ribavirin for 3 months achieved loss of cryoglobulinemia and end-of-treatment response, but sustained virologic response was reported and achieved in two. Immunosuppressant achieved loss of cryoglobulinemia in three patients. One case of chronic renal failure, three cases of end-stage renal disease and one death were observed. Five of the nine Hill's criteria were fulfilled. MC has been described with HEV infection. A causal relationship between HEV infection and cryoglobulinemia is highly probable.
PubMed: 28852522
DOI: 10.1093/gastro/gox021 -
PloS One 2017Cervical cancer is a major public health problem. Even though readily preventable, it is the fourth leading cause of death in women globally. Women living with HIV are... (Review)
Review
BACKGROUND
Cervical cancer is a major public health problem. Even though readily preventable, it is the fourth leading cause of death in women globally. Women living with HIV are at increased risk of invasive cervical cancer, highlighting the need for access to screening and treatment for this population. Integration of services has been proposed as an effective way of improving access to cervical cancer screening especially in areas of high HIV prevalence as well as lower resourced settings. This paper presents the results of a systematic review of programs integrating cervical cancer and HIV services globally, including feasibility, acceptability, clinical outcomes and facilitators for service delivery.
METHODS
This is part of a larger systematic review on integration of services for HIV and non-communicable diseases. To be considered for inclusion studies had to report on programs to integrate cervical cancer and HIV services at the level of service delivery. We searched multiple databases including Global Health, Medline and Embase from inception until December 2015. Articles were screened independently by two reviewers for inclusion and data were extracted and assessed for risk of bias.
MAIN RESULTS
11,057 records were identified initially. 7,616 articles were screened by title and abstract for inclusion. A total of 21 papers reporting interventions integrating cervical cancer care and HIV services met the criteria for inclusion. All but one study described integration of cervical cancer screening services into existing HIV services. Most programs also offered treatment of minor lesions, a 'screen-and-treat' approach, with some also offering treatment of larger lesions within the same visit. Three distinct models of integration were identified. One model described integration within the same clinic through training of existing staff. Another model described integration through co-location of services, with the third model describing programs of integration through complex coordination across the care pathway. The studies suggested that integration of cervical cancer services with HIV services using all models was feasible and acceptable to patients. However, several barriers were reported, including high loss to follow up for further treatment, limited human-resources, and logistical and chain management support. Using visual screening methods can facilitate screening and treatment of minor to larger lesions in a single 'screen-and-treat' visit. Complex integration in a single-visit was shown to reduce loss to follow up. The use of existing health infrastructure and funding together with comprehensive staff training and supervision, community engagement and digital technology were some of the many other facilitators for integration reported across models.
CONCLUSIONS
This review shows that integration of cervical cancer screening and treatment with HIV services using different models of service delivery is feasible as well as acceptable to women living with HIV. However, the descriptive nature of most papers and lack of data on the effect on long-term outcomes for HIV or cervical cancer limits the inference on the effectiveness of the integrated programs. There is a need for strengthening of health systems across the care continuum and for high quality studies evaluating the effect of integration on HIV as well as on cervical cancer outcomes.
Topics: Female; HIV Infections; Humans; Uterine Cervical Neoplasms
PubMed: 28732037
DOI: 10.1371/journal.pone.0181156 -
Journal of the International AIDS... May 2017Substance use is an important risk factor for HIV, with both concentrated in certain vulnerable and marginalized populations. Although their management differs, there... (Review)
Review
INTRODUCTION
Substance use is an important risk factor for HIV, with both concentrated in certain vulnerable and marginalized populations. Although their management differs, there may be opportunities to integrate services for substance use and HIV. In this paper we systematically review evidence from studies that sought to integrate care for people living with HIV and substance use problems.
METHODS
Studies were included if they evaluated service integration for substance use and HIV. We searched multiple databases from inception until October 2015. Articles were screened independently by two reviewers and assessed for risk of bias.
RESULTS AND DISCUSSION
11,057 records were identified, with 7616 after removal of duplicates. After screening titles and abstracts, 51 met the inclusion criteria. Integration models were categorized by location (HIV, substance use and other facilities), level of integration from mirco (integrated care delivered to individuals) to macro (system level integrations) and degree of integration from least (screening and counselling only) to most (care for HIV, substance use and/or other illnesses at the same facility). Most reported descriptive or cohort studies; in four randomized control trials integrated activities improved patient outcomes. There is potential for integrating services at all facility types, including mobile health services. While services offering screening only can achieve synergies, there are benefits from delivering integrated treatment for HIV and substance use, including ease of referral to other mental health and social services.
CONCLUSIONS
Our review used a wide range of databases and conference archives to increase representation of papers from low- and middle-income countries. Limitations include the overrepresentation of studies from the United States, and the descriptive nature of the majority of papers. The evidence reviewed shows that greater integration offers important benefits in both patient and service outcomes but further research and outcome reporting is needed to better understand innovative and holistic care models at the complex intersection of substance use and HIV services.
Topics: Counseling; Delivery of Health Care, Integrated; HIV Infections; Humans; Substance-Related Disorders
PubMed: 28692211
DOI: 10.7448/IAS.20.1.21585 -
Health Policy and Planning Nov 2017Integration of services for patients with more than one diagnosed condition has intuitive appeal but it has been argued that the empirical evidence to support it is... (Review)
Review
Integration of services for patients with more than one diagnosed condition has intuitive appeal but it has been argued that the empirical evidence to support it is limited. We report the findings of a systematic review that sought to identify health system factors, extrinsic to the integration process, which either facilitated or hindered the integration of services for two common disorders, HIV and chronic non-communicable diseases. Findings were initially extracted and organized around a health system framework, followed by a thematic cross-cutting analysis and validation steps. Of the 150 articles included, 67% (n = 102) were from high-income countries. The articles explored integration with services for one or several chronic disorders, the most studied being alcohol or substance use disorders (47.7%), and mental health issues (29.5%). Four cross-cutting themes related to the health system were identified. The first and most common theme was the requirement for effective collaboration and coordination: formal and informal productive relationships throughout the system between providers and within teams, and between staff and patients. The second was the need for adequate and appropriately skilled and incentivized health workers-with the right expertise, training and operational support for the programme. The third was the need for supportive institutional structures and dedicated resources. The fourth was leadership in terms of political will, effective managerial oversight and organizational culture, indicating that actual implementation is as important as programme design. A fifth theme, outside the health system, but underpinning all aspects of the system operation, was that placing the patient at the centre of service delivery and responding holistically to their diverse needs. This was an important facilitator of integration. These findings confirm that integration processes in service delivery depend substantially for their success on characteristics of the health systems in which they are embedded.
Topics: Chronic Disease; Cooperative Behavior; Delivery of Health Care, Integrated; HIV Infections; Humans; Systems Integration
PubMed: 28666336
DOI: 10.1093/heapol/czw149 -
PloS One 2017Moderate correlation exists between the imaging quantification of brain white matter lesions and cognitive performance in people with multiple sclerosis (MS). This may... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Moderate correlation exists between the imaging quantification of brain white matter lesions and cognitive performance in people with multiple sclerosis (MS). This may reflect the greater importance of other features, including subvisible pathology, or methodological limitations of the primary literature.
OBJECTIVES
To summarise the cognitive clinico-radiological paradox and explore the potential methodological factors that could influence the assessment of this relationship.
METHODS
Systematic review and meta-analysis of primary research relating cognitive function to white matter lesion burden.
RESULTS
Fifty papers met eligibility criteria for review, and meta-analysis of overall results was possible in thirty-two (2050 participants). Aggregate correlation between cognition and T2 lesion burden was r = -0.30 (95% confidence interval: -0.34, -0.26). Wide methodological variability was seen, particularly related to key factors in the cognitive data capture and image analysis techniques.
CONCLUSIONS
Resolving the persistent clinico-radiological paradox will likely require simultaneous evaluation of multiple components of the complex pathology using optimum measurement techniques for both cognitive and MRI feature quantification. We recommend a consensus initiative to support common standards for image analysis in MS, enabling benchmarking while also supporting ongoing innovation.
Topics: Brain; Cognition; Humans; Image Processing, Computer-Assisted; Magnetic Resonance Imaging; Multiple Sclerosis; Neuropsychological Tests; Publication Bias; White Matter
PubMed: 28505177
DOI: 10.1371/journal.pone.0177727 -
British Journal of Sports Medicine Feb 2018To describe the electrocardiographic (ECG) and echocardiographic manifestations of the paediatric athlete's heart, and examine the impact of age, race and sex on cardiac... (Meta-Analysis)
Meta-Analysis Review
AIM
To describe the electrocardiographic (ECG) and echocardiographic manifestations of the paediatric athlete's heart, and examine the impact of age, race and sex on cardiac remodelling responses to competitive sport.
DESIGN
Systematic review with meta-analysis.
DATA SOURCES
Six electronic databases were searched to May 2016: MEDLINE, PubMed, EMBASE, Web of Science, CINAHL and SPORTDiscus.
INCLUSION CRITERIA
(1) Male and/or female competitive athletes, (2) participants aged 6-18 years, (3) original research article published in English language.
RESULTS
Data from 14 278 athletes and 1668 non-athletes were included for qualitative (43 articles) and quantitative synthesis (40 articles). Paediatric athletes demonstrated a greater prevalence of training-related and training-unrelated ECG changes than non-athletes. Athletes ≥14 years were 15.8 times more likely to have inferolateral T-wave inversion than athletes <14 years. Paediatric black athletes had significantly more training-related and training-unrelated ECG changes than Caucasian athletes. Age was a positive predictor of left ventricular (LV) internal diameter during diastole, interventricular septum thickness during diastole, relative wall thickness and LV mass. When age was accounted for, these parameters remained significantly larger in athletes than non-athletes. Paediatric black athletes presented larger posterior wall thickness during diastole (PWTd) than Caucasian athletes. Paediatric male athletes also presented larger PWTd than females.
CONCLUSIONS
The paediatric athlete's heart undergoes significant remodelling both before and during 'maturational years'. Paediatric athletes have a greater prevalence of training related and training-unrelated ECG changes than non-athletes, with age, race and sex mediating factors on cardiac electrical and LV structural remodelling.
Topics: Adaptation, Physiological; Adolescent; Age Factors; Athletes; Black People; Child; Echocardiography; Electrocardiography; Female; Heart; Humans; Male; Sex Factors; Ventricular Remodeling; White People
PubMed: 28363973
DOI: 10.1136/bjsports-2016-097052 -
The Cochrane Database of Systematic... Feb 2017System change interventions for smoking cessation are policies and practices designed by organizations to integrate the identification of smokers and the subsequent... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
System change interventions for smoking cessation are policies and practices designed by organizations to integrate the identification of smokers and the subsequent offering of evidence-based nicotine dependence treatments into usual care. Such strategies have the potential to improve the provision of smoking cessation support in healthcare settings, and cessation outcomes among those who use them.
OBJECTIVES
To assess the effectiveness of system change interventions within healthcare settings, for increasing smoking cessation or the provision of smoking cessation care, or both.
SEARCH METHODS
We searched databases including the Cochrane Tobacco Addiction Group Specialized Register, CENTRAL, MEDLINE, Embase, CINAHL, and PsycINFO in February 2016. We also searched clinical trial registries: WHO clinical trial registry, US National Institute of Health (NIH) clinical trial registry. We checked 'grey' literature, and handsearched bibliographies of relevant papers and publications.
SELECTION CRITERIA
Randomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs and interrupted time series studies that evaluated a system change intervention, which included identification of all smokers and subsequent offering of evidence-based nicotine dependence treatment.
DATA COLLECTION AND ANALYSIS
Using a standardized form, we extracted data from eligible studies on study settings, participants, interventions and outcomes of interest (both cessation and system-level outcomes). For cessation outcomes, we used the strictest available criteria to define abstinence. System-level outcomes included assessment and documentation of smoking status, provision of advice to quit or cessation counselling, referral and enrolment in quitline services, and prescribing of cessation medications. We assessed risks of bias according to the Cochrane Handbook and categorized each study as being at high, low or unclear risk of bias. We used a narrative synthesis to describe the effectiveness of the interventions on various outcomes, because of significant heterogeneity among studies.
MAIN RESULTS
We included seven cluster-randomized controlled studies in this review. We rated the quality of evidence as very low or low, depending on the outcome, according to the GRADE standard. Evidence of efficacy was equivocal for abstinence from smoking at the longest follow-up (four studies), and for the secondary outcome 'prescribing of smoking cessation medications' (two studies). Four studies evaluated changes in provision of smoking cessation counselling and three favoured the intervention. There were significant improvements in documentation of smoking status (one study), quitline referral (two studies) and quitline enrolment (two studies). Other secondary endpoints, such as asking about tobacco use (three studies) and advising to quit (three studies), also indicated some positive effects.
AUTHORS' CONCLUSIONS
The available evidence suggests that system change interventions for smoking cessation may not be effective in achieving increased cessation rates, but have been shown to improve process outcomes, such as documentation of smoking status, provision of cessation counselling and referral to smoking cessation services. However, as the available research is limited we are not able to draw strong conclusions. There is a need for additional high-quality research to explore the impact of system change interventions on both cessation and system-level outcomes.
Topics: Counseling; Health Facilities; Hotlines; Humans; Organizational Innovation; Organizational Policy; Randomized Controlled Trials as Topic; Smoking; Smoking Cessation; Tobacco Use Cessation Devices; Tobacco Use Disorder
PubMed: 28185257
DOI: 10.1002/14651858.CD010742.pub2 -
The Cochrane Database of Systematic... Feb 2017Exercise-based cardiac rehabilitation may benefit adults with atrial fibrillation or those who had been treated for atrial fibrillation. Atrial fibrillation is caused by... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Exercise-based cardiac rehabilitation may benefit adults with atrial fibrillation or those who had been treated for atrial fibrillation. Atrial fibrillation is caused by multiple micro re-entry circuits within the atrial tissue, which result in chaotic rapid activity in the atria.
OBJECTIVES
To assess the benefits and harms of exercise-based rehabilitation programmes, alone or with another intervention, compared with no-exercise training controls in adults who currently have AF, or have been treated for AF.
SEARCH METHODS
We searched the following electronic databases; CENTRAL and the Database of Abstracts of Reviews of Effectiveness (DARE) in the Cochrane Library, MEDLINE Ovid, Embase Ovid, PsycINFO Ovid, Web of Science Core Collection Thomson Reuters, CINAHL EBSCO, LILACS Bireme, and three clinical trial registers on 14 July 2016. We also checked the bibliographies of relevant systematic reviews identified by the searches. We imposed no language restrictions.
SELECTION CRITERIA
We included randomised controlled trials (RCT) that investigated exercise-based interventions compared with any type of no-exercise control. We included trials that included adults aged 18 years or older with atrial fibrillation, or post-treatment for atrial fibrillation.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data. We assessed the risk of bias using the domains outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed clinical and statistical heterogeneity by visual inspection of the forest plots, and by using standard Chi² and I² statistics. We performed meta-analyses using fixed-effect and random-effects models; we used standardised mean differences where different scales were used for the same outcome. We assessed the risk of random errors with trial sequential analysis (TSA) and used the GRADE methodology to rate the quality of evidence, reporting it in the 'Summary of findings' table.
MAIN RESULTS
We included six RCTs with a total of 421 patients with various types of atrial fibrillation. All trials were conducted between 2006 and 2016, and had short follow-up (eight weeks to six months). Risks of bias ranged from high risk to low risk.The exercise-based programmes in four trials consisted of both aerobic exercise and resistance training, in one trial consisted of Qi-gong (slow and graceful movements), and in another trial, consisted of inspiratory muscle training.For mortality, very low-quality evidence from six trials suggested no clear difference in deaths between the exercise and no-exercise groups (relative risk (RR) 1.00, 95% confidence interval (CI) 0.06 to 15.78; participants = 421; I² = 0%; deaths = 2). Very low-quality evidence from five trials suggested no clear difference between groups for serious adverse events (RR 1.01, 95% CI 0.98 to 1.05; participants = 381; I² = 0%; events = 8). Low-quality evidence from two trials suggested no clear difference in health-related quality of life for the Short Form-36 (SF-36) physical component summary measure (mean difference (MD) 1.96, 95% CI -2.50 to 6.42; participants = 224; I² = 69%), or the SF-36 mental component summary measure (MD 1.99, 95% CI -0.48 to 4.46; participants = 224; I² = 0%). Exercise capacity was assessed by cumulated work, or maximal power (Watt), obtained by cycle ergometer, or by six minute walking test, or ergospirometry testing measuring VO2 peak. We found moderate-quality evidence from two studies that exercise-based rehabilitation increased exercise capacity, measured by VO2 peak, more than no exercise (MD 3.76, 95% CI 1.37 to 6.15; participants = 208; I² = 0%); and very low-quality evidence from four studies that exercise-based rehabilitation increased exercise capacity more than no exercise, measured by the six-minute walking test (MD 75.76, 95% CI 14.00 to 137.53; participants = 272; I² = 85%). When we combined the different assessment tools for exercise capacity, we found very low-quality evidence from six trials that exercise-based rehabilitation increased exercise capacity more than no exercise (standardised mean difference (SMD) 0.86, 95% CI 0.46 to 1.26; participants = 359; I² = 65%). Overall, the quality of the evidence for the outcomes ranged from moderate to very-low.
AUTHORS' CONCLUSIONS
Due to few randomised patients and outcomes, we could not evaluate the real impact of exercise-based cardiac rehabilitation on mortality or serious adverse events. The evidence showed no clinically relevant effect on health-related quality of life. Pooled data showed a positive effect on the surrogate outcome of physical exercise capacity, but due to the low number of patients and the moderate to very low-quality of the underpinning evidence, we could not be certain of the magnitude of the effect. Future high-quality randomised trials are needed to assess the benefits and harms of exercise-based cardiac rehabilitation for adults with atrial fibrillation on patient-relevant outcomes.
Topics: Adult; Atrial Fibrillation; Cardiac Rehabilitation; Exercise Therapy; Exercise Tolerance; Humans; Qigong; Quality of Life; Randomized Controlled Trials as Topic; Resistance Training
PubMed: 28181684
DOI: 10.1002/14651858.CD011197.pub2 -
PloS One 2016To determine whether there is an association between healthcare professionals' wellbeing and burnout, with patient safety. (Review)
Review
OBJECTIVE
To determine whether there is an association between healthcare professionals' wellbeing and burnout, with patient safety.
DESIGN
Systematic research review.
DATA SOURCES
PsychInfo (1806 to July 2015), Medline (1946 to July 2015), Embase (1947 to July 2015) and Scopus (1823 to July 2015) were searched, along with reference lists of eligible articles.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Quantitative, empirical studies that included i) either a measure of wellbeing or burnout, and ii) patient safety, in healthcare staff populations.
RESULTS
Forty-six studies were identified. Sixteen out of the 27 studies that measured wellbeing found a significant correlation between poor wellbeing and worse patient safety, with six additional studies finding an association with some but not all scales used, and one study finding a significant association but in the opposite direction to the majority of studies. Twenty-one out of the 30 studies that measured burnout found a significant association between burnout and patient safety, whilst a further four studies found an association between one or more (but not all) subscales of the burnout measures employed, and patient safety.
CONCLUSIONS
Poor wellbeing and moderate to high levels of burnout are associated, in the majority of studies reviewed, with poor patient safety outcomes such as medical errors, however the lack of prospective studies reduces the ability to determine causality. Further prospective studies, research in primary care, conducted within the UK, and a clearer definition of healthcare staff wellbeing are needed.
IMPLICATIONS
This review illustrates the need for healthcare organisations to consider improving employees' mental health as well as creating safer work environments when planning interventions to improve patient safety.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO registration number: CRD42015023340.
Topics: Burnout, Professional; Female; Health Personnel; Humans; Male; Mental Health; Patient Safety; United Kingdom
PubMed: 27391946
DOI: 10.1371/journal.pone.0159015