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PloS One 2015Chronic inflammatory diseases (CID) are globally highly prevalent and characterized by severe pathological medical conditions. Several trials were conducted aiming at... (Review)
Review
BACKGROUND
Chronic inflammatory diseases (CID) are globally highly prevalent and characterized by severe pathological medical conditions. Several trials were conducted aiming at measuring the effects of manipulative therapies on patients affected by CID. The purpose of this review was to explore the extent to which osteopathic manipulative treatment (OMT) can be benefi-cial in medical conditions also classified as CID.
METHODS
This review included any type of experimental study which enrolled sub-jects with CID comparing OMT with any type of control procedure. The search was conducted on eight databases in January 2014 using a pragmatic literature search approach. Two independent re-viewers conducted study selection and data extraction for each study. The risk of bias was evaluated according to the Cochrane methods. Heterogeneity was assessed and meta-analysis performed where possible.
RESULTS
10 studies met the inclusion criteria for this review enrolling 386 subjects. The search identified six RCTs, one laboratory study, one cross-over pilot studies, one observation-al study and one case control pilot study. Results suggest a potential effect of osteopathic medicine on patients with medical pathologies associated with CID (in particular Chronic Obstructive Pul-monary Disease (COPD), Irritable Bowel Syndrome, Asthma and Peripheral Arterial Disease) com-pared to no treatment or sham therapy although data remain elusive. Moreover one study showed possible effects on arthritis rat model. Meta-analysis was performed for COPD studies only show-ing no effect of any type of OMT applied versus control. No major side effects were reported by those receiving OMT.
CONCLUSION
The present systematic review showed inconsistent data on the effect of OMT in the treatment of medical conditions potentially associated with CID, however the OMT appears to be a safe approach. Further more robust trials are needed to determine the direction and magnitude of the effect of OMT and to generalize favorable results.
Topics: Animals; Asthma; Bone Diseases; Chronic Disease; Humans; Inflammation; Irritable Bowel Syndrome; Peripheral Arterial Disease; Pulmonary Disease, Chronic Obstructive; Rats
PubMed: 25781621
DOI: 10.1371/journal.pone.0121327 -
Medicine Apr 2016This systematic review was performed to investigate the ethical justification, methodological quality, validity and safety of placebo controls in randomized... (Meta-Analysis)
Meta-Analysis Review
This systematic review was performed to investigate the ethical justification, methodological quality, validity and safety of placebo controls in randomized placebo-controlled surgical trials.Central, MEDLINE, and EMBASE were systematically searched to identify randomized controlled trials comparing a surgical procedure to a placebo. "Surgical procedure" was defined as a medical procedure involving an incision with instruments. Placebo was defined as a blinded sham operation involving no change to the structural anatomy and without an expectable physiological response in the target body compartment.Ten randomized placebo-controlled controlled surgical trials were included, all of them published in high-ranking medical journals (mean impact factor: 20.1). Eight of 10 failed to show statistical superiority of the experimental intervention. Serious adverse events did not differ between the groups (rate ratio [RR] 1.38, 95% confidence interval [CI]: 0.92-2.06, P = 0.46). None of the trials had a high risk of bias in any domain. The ethical justification for the use of a placebo control remained unclear in 2 trials.Placebo-controlled surgical trials are feasible and provide high-quality data on efficacy of surgical treatments. The surgical placebo entails a considerable risk for study participants. Consequently, a placebo should be used only if justified by the clinical question and by methodological necessity. Based on the current evidence, a pragmatic proposal for the use of placebo controls in future randomized controlled surgical trials is made.
Topics: Patient Safety; Placebo Effect; Randomized Controlled Trials as Topic; Surgical Procedures, Operative
PubMed: 27124060
DOI: 10.1097/MD.0000000000003516 -
JMIR MHealth and UHealth Nov 2020Coronary heart disease (CHD) is a leading cause of disability and deaths worldwide. Secondary prevention, including cardiac rehabilitation (CR), is crucial to improve... (Review)
Review
BACKGROUND
Coronary heart disease (CHD) is a leading cause of disability and deaths worldwide. Secondary prevention, including cardiac rehabilitation (CR), is crucial to improve risk factors and to reduce disease burden and disability. Accessibility barriers contribute to underutilization of traditional center-based CR programs; therefore, alternative delivery models, including cardiac telerehabilitation (ie, delivery via mobile, smartphone, and/or web-based apps), have been tested. Experimental studies have shown cardiac telerehabilitation to be effective and cost-effective, but there is inadequate evidence about how to translate this research into routine clinical practice.
OBJECTIVE
This systematic review aimed to synthesize research evaluating the effectiveness of implementing cardiac telerehabilitation interventions at scale in routine clinical practice, including factors underlying successful implementation processes, and experimental research evaluating implementation-related outcomes.
METHODS
MEDLINE, Embase, PsycINFO, and Global Health databases were searched from 1990 through November 9, 2018, for studies evaluating the implementation of telerehabilitation for the self-management of CHD. Reference lists of included studies and relevant systematic reviews were hand searched to identify additional studies. Implementation outcomes of interest included acceptability, appropriateness, adoption, feasibility, fidelity, implementation cost, penetration, and sustainability. A narrative synthesis of results was carried out.
RESULTS
No included studies evaluated the implementation of cardiac telerehabilitation in routine clinical practice. A total of 10 studies of 2250 participants evaluated implementation outcomes, including acceptability (8/10, 80%), appropriateness (9/10, 90%), adoption (6/10, 60%), feasibility (6/10, 60%), fidelity (7/10, 70%), and implementation cost (4/10, 40%), predominantly from the participant perspective. Cardiac telerehabilitation interventions had high acceptance among the majority of participants, but technical challenges such as reliable broadband internet connectivity can impact acceptability and feasibility. Many participants considered telerehabilitation to be an appropriate alternative CR delivery model, as it was convenient, flexible, and easy to access. Participants valued interactive intervention components, such as real-time exercise monitoring and feedback as well as individualized support. The penetration and sustainability of cardiac telerehabilitation, as well as the perspectives of CR practitioners and health care organizations, have received little attention in existing cardiac telerehabilitation research.
CONCLUSIONS
Experimental trials suggest that participants perceive cardiac telerehabilitation to be an acceptable and appropriate approach to improve the reach and utilization of CR, but pragmatic implementation studies are needed to understand how interventions can be sustainably translated from research into clinical practice. Addressing this gap could help realize the potential impact of telerehabilitation on CR accessibility and participation as well as person-centered, health, and economic outcomes.
TRIAL REGISTRATION
International Prospective Register of Systematic Reviews (PROSPERO) CRD42019124254; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=124254.
Topics: Cardiovascular Diseases; Exercise; Humans; Secondary Prevention; Self-Management; Telerehabilitation
PubMed: 33245286
DOI: 10.2196/17957 -
Hand Therapy Mar 2016Trapeziometacarpal osteoarthritis is associated with more pain and restrictions than other hand osteoarthritis due to the functional importance of the thumb. While the... (Review)
Review
Effectiveness of physical and occupational therapy on pain, function and quality of life in patients with trapeziometacarpal osteoarthritis - A systematic review and meta-analysis.
INTRODUCTION
Trapeziometacarpal osteoarthritis is associated with more pain and restrictions than other hand osteoarthritis due to the functional importance of the thumb. While the effectiveness of surgical and pharmacological interventions has been widely examined, there is a lack of specific evidence about conservative non-pharmacological trapeziometacarpal osteoarthritis therapies. The objective of this systematic review was to provide evidence-based knowledge on the effectiveness of physiotherapy and occupational therapy on pain, function and quality of life.
METHODS
A literature search of Medline, CINAHL, PEDro, OTseeker, EMB Dare Cochrane Database of Systematic Reviews and Cochrane CENTRAL was performed. Randomized and quasi-randomized controlled trials and corresponding systematic reviews, observational studies, pragmatic studies and case-control studies were included. The risk of bias was assessed.
RESULTS
Out of 218 studies, 27 were retained. A narrative summary and a series of meta-analyses were performed. Concerning pain reduction, the meta-analysis showed parity of pre-fabricated neoprene and custom-made thermoplastic splints: standardized mean difference (SMD) -0.01 (95%CI -0.43, 0.40) (p=0.95). Multimodal interventions are more effective on pain compared to single interventions: standardized mean difference -3.16 (95%CI -5.56, -0.75) ( = 0.01).
DISCUSSION
Physical and occupational therapy-related interventions, especially multimodal interventions, seem to be effective to treat pain in patients with trapeziometacarpal osteoarthritis. Pre-fabricated neoprene splints and custom-made thermoplastic splints may reduce pain equally. Single interventions seem not to be effective. Significant evidence for effectiveness on function and quality of life could not be found.
PubMed: 27110291
DOI: 10.1177/1758998315614037 -
The Patient Nov 2022Patient support programs aim to provide solutions beyond the medication itself, by enhancing treatment adherence, improving clinical outcomes, elevating patient...
BACKGROUND AND OBJECTIVE
Patient support programs aim to provide solutions beyond the medication itself, by enhancing treatment adherence, improving clinical outcomes, elevating patient experience, and/or increasing quality of life. As patient support programs increasingly play an important role in assisting patients, numerous observational studies and pragmatic trials designed to evaluate their impact on healthcare have been conducted in recent years. This review aims to characterize these studies.
METHODS
A systematic literature review, supplemented by a broad search of gray literature, was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane recommendations. Observational studies and pragmatic trials conducted in Europe to evaluate the impact of patient support programs, published in English or Spanish between 17/03/2010 and 17/03/2020, were reviewed. Two patient support program definitions were applied starting with Ganguli et al.'s broad approach, followed by the European Medicines Agency definition, narrowed to Marketing Authorization Holders organized systems and their medicines. The quality of publications was assessed using the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement 22-item checklist.
RESULTS
Of the 49 identified studies following the Ganguli et al. definition, 20 studies met the European Medicines Agency definition and were reviewed. Patient support program impact was evaluated based on a wide range of methodologies: 70% assessed patient support program-related patient-reported outcomes, 55% reported clinical outcomes, and 25% reported economic impacts on health resources. Only 45% conducted a comparative analysis. Overall, 75% of the studies achieved their proposed objectives.
CONCLUSIONS
The heterogeneity of the observational studies reviewed reflects the complexity of patient support programs that are built ad hoc for specific diseases, treatments, and patients. Results suggest that patient support programs play a key role in promoting treatment effectiveness, clinical outcomes, and satisfaction. However, there is a need for standardizing the definition of patient support programs and the methods to evaluate their impact.
Topics: Humans; Quality of Life; Checklist; Treatment Outcome; Europe
PubMed: 35725866
DOI: 10.1007/s40271-022-00582-y -
Nutrients Sep 2022The education sector is recognised as an ideal platform to promote good nutrition and decision making around food and eating. Examining adolescents in this setting is... (Meta-Analysis)
Meta-Analysis Review
The Impact of Modifying Food Service Practices in Secondary Schools Providing a Routine Meal Service on Student's Food Behaviours, Health and Dining Experience: A Systematic Review and Meta-Analysis.
The education sector is recognised as an ideal platform to promote good nutrition and decision making around food and eating. Examining adolescents in this setting is important because of the unique features of adolescence compared to younger childhood. This systematic review and meta-analysis examine interventions in secondary schools that provide a routine meal service and the impact on adolescents’ food behaviours, health and dining experience in this setting. The review was guided by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Checklist and Cochrane Handbook recommendations. Studies published in English searched in four databases and a hand search yielded 42 interventions in 35 studies. Risk of bias was assessed independently by two reviewers. Interventions were classified using the NOURISHING framework, and their impact analysed using meta-analysis, vote-counting synthesis or narrative summary. The meta-analysis showed an improvement in students selecting vegetables (odds ratio (OR): 1.39; 1.12 to 1.23; p = 0.002), fruit serves selected (mean difference (MD): 0.09; 0.09 to 0.09; p < 0.001) and consumed (MD: 0.10; 0.04 to 0.15; p < 0.001), and vegetable serves consumed (MD: 0.06; 0.01 to 0.10; p = 0.024). Vote-counting showed a positive impact for most interventions that measured selection (15 of 25; 41% to 77%; p = 0.002) and consumption (14 of 24; 39% to 76%; p = 0.013) of a meal component. Interventions that integrate improving menu quality, assess palatability, accessibility of healthier options, and student engagement can enhance success. These results should be interpreted with caution as most studies were not methodologically strong and at higher risk of bias. There is a need for higher quality pragmatic trials, strategies to build and measure sustained change, and evaluation of end-user attitudes and perceptions towards intervention components and implementation for greater insight into intervention success and future directions (PROSPERO registration: CRD42020167133).
Topics: Adolescent; Child; Food Services; Health Behavior; Humans; Schools; Students; Vegetables
PubMed: 36079897
DOI: 10.3390/nu14173640 -
The Cochrane Database of Systematic... Oct 2017Lengthy duration of use may be a risk factor for umbilical venous catheter-associated bloodstream infection in newborn infants. Early planned removal of umbilical venous... (Review)
Review
BACKGROUND
Lengthy duration of use may be a risk factor for umbilical venous catheter-associated bloodstream infection in newborn infants. Early planned removal of umbilical venous catheters (UVCs) is recommended to reduce the incidence of infection and associated morbidity and mortality.
OBJECTIVES
To compare the effectiveness of early planned removal of UVCs (up to two weeks after insertion) versus an expectant approach or a longer fixed duration in preventing bloodstream infection and other complications in newborn infants.To perform subgroup analyses by gestational age at birth and prespecified planned duration of UVC placement (see "Subgroup analysis and investigation of heterogeneity").
SEARCH METHODS
We used the standard Cochrane Neonatal search strategy including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4), Ovid MEDLINE, Embase, and the Maternity & Infant Care Database (until May 2017), as well as conference proceedings and previous reviews.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that compared effects of early planned removal of UVCs (up to two weeks after insertion) versus an expectant approach or a longer fixed duration in preventing bloodstream infection and other complications in newborn infants.
DATA COLLECTION AND ANALYSIS
Two review authors assessed trial eligibility and risk of bias and independently undertook data extraction. We analysed treatment effects and reported risk ratio (RR) and risk difference (RD) for dichotomous data, and mean difference (MD) for continuous data, with respective 95% confidence intervals (CIs). We planned to use a fixed-effect model in meta-analyses and to explore potential causes of heterogeneity in sensitivity analyses. We assessed the quality of evidence for the main comparison at the outcome level using GRADE methods.
MAIN RESULTS
We found one eligible trial. Participants were 210 newborn infants with birth weight less than 1251 grams. The trial was unblinded but otherwise of good methodological quality. This trial compared removal of an umbilical venous catheter within 10 days after insertion (and replacement with a peripheral cannula or a percutaneously inserted central catheter as required) versus expectant management (UVC in place up to 28 days). More infants in the early planned removal group than in the expectant management group (83 vs 33) required percutaneous insertion of a central catheter (PICC). Trial results showed no difference in the incidence of catheter-related bloodstream infection (RR 0.65, 95% CI 0.35 to 1.22), in hospital mortality (RR 1.12, 95% CI 0.42 to 2.98), in catheter-associated thrombus necessitating removal (RR 0.33, 95% confidence interval 0.01 to 7.94), or in other morbidity. GRADE assessment indicated that the quality of evidence was "low" at outcome level principally as the result of imprecision and risk of surveillance bias due to lack of blinding in the included trial.
AUTHORS' CONCLUSIONS
Currently available trial data are insufficient to show whether early planned removal of umbilical venous catheters reduces risk of infection, mortality, or other morbidity in newborn infants. A large, simple, and pragmatic randomised controlled trial is needed to resolve this ongoing uncertainty.
Topics: Catheter-Related Infections; Catheterization, Peripheral; Catheters; Cause of Death; Central Venous Catheters; Device Removal; Humans; Infant, Newborn; Infant, Very Low Birth Weight; Thrombosis; Time Factors; Umbilical Veins
PubMed: 29017005
DOI: 10.1002/14651858.CD012142.pub2 -
The Cochrane Database of Systematic... Jul 2016Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published Cochrane review.
OBJECTIVES
To determine the effect of timing of dornase alfa inhalation on measures of clinical efficacy in people with cystic fibrosis (in relation to airway clearance techniques or time of day).
SEARCH METHODS
Relevant randomised and quasi-randomised controlled trials were identified from the Cochrane Cystic Fibrosis Trials Register, Physiotherapy Evidence Database (PEDro), and international cystic fibrosis conference proceedings.Date of the most recent search: 25 April 2016.
SELECTION CRITERIA
Any trial of dornase alfa in people with cystic fibrosis where timing of inhalation was the randomised element in the study with either: inhalation before compared to after airway clearance techniques; or morning compared to evening inhalation.
DATA COLLECTION AND ANALYSIS
Both authors independently selected trials, assessed risk of bias and extracted data with disagreements resolved by discussion. Relevant data were extracted and, where possible, meta-analysed.
MAIN RESULTS
We identified 115 trial reports representing 55 studies, of which five studies (providing data on 122 participants) met our inclusion criteria. All five studies used a cross-over design. Intervention periods ranged from two to eight weeks. Four trials compared dornase alfa inhalation before versus after airway clearance techniques. Inhalation after instead of before airway clearance did not significantly change forced expiratory volume at one second. Similarly, forced vital capacity and quality of life were not significantly affected; forced expiratory flow at 25% was significantly worse with dornase alfa inhalation after airway clearance, mean difference -0.17 litres (95% confidence interval -0.28 to -0.05), based on the pooled data from two small studies in children (seven to 19 years) with well-preserved lung function. All other secondary outcomes were statistically non-significant.In one trial, morning versus evening inhalation had no impact on lung function or symptoms.
AUTHORS' CONCLUSIONS
The current evidence derived from a small number of participants does not indicate that inhalation of dornase alfa after airway clearance techniques is more or less effective than the traditional recommendation to inhale nebulised dornase alfa 30 minutes prior to airway clearance techniques, for most outcomes. For children with well-preserved lung function, inhalation before airway clearance may be more beneficial for small airway function than inhalation after. However, this result relied on a measure with high variability and studies with variable follow up. In the absence of strong evidence to indicate that one timing regimen is better than another, the timing of dornase alpha inhalation can be largely based on pragmatic reasons or individual preference with respect to the time of airway clearance and time of day. Further research is warranted.
Topics: Administration, Inhalation; Adolescent; Child; Combined Modality Therapy; Cystic Fibrosis; Deoxyribonuclease I; Drug Administration Schedule; Humans; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins; Respiratory Therapy; Time Factors; Young Adult
PubMed: 27457496
DOI: 10.1002/14651858.CD007923.pub4 -
BMC Medical Research Methodology Oct 2013The benefits of stroke unit care in terms of reducing death, dependency and institutional care were demonstrated in a 2009 Cochrane review carried out by the Stroke Unit... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The benefits of stroke unit care in terms of reducing death, dependency and institutional care were demonstrated in a 2009 Cochrane review carried out by the Stroke Unit Trialists' Collaboration.
METHODS
As requested by the Belgian health authorities, a systematic review and meta-analysis of the effect of acute stroke units was performed. Clinical trials mentioned in the original Cochrane review were included. In addition, an electronic database search on Medline, Embase, the Cochrane Central Register of Controlled Trials, and Physiotherapy Evidence Database (PEDro) was conducted to identify trials published since 2006. Trials investigating acute stroke units compared to alternative care were eligible for inclusion. Study quality was appraised according to the criteria recommended by Scottish Intercollegiate Guidelines Network (SIGN) and the GRADE system. In the meta-analysis, dichotomous outcomes were estimated by calculating odds ratios (OR) and continuous outcomes were estimated by calculating standardized mean differences. The weight of a study was calculated based on inverse variance.
RESULTS
Evidence from eight trials comparing acute stroke unit and conventional care (general medical ward) were retained for the main synthesis and analysis. The findings from this study were broadly in line with the original Cochrane review: acute stroke units can improve survival and independency, as well as reduce the chance of hospitalization and the length of inpatient stay. The improvement with stroke unit care on mortality was less conclusive and only reached borderline level of significance (OR 0.84, 95% CI 0.70 to 1.00, P = 0.05). This improvement became statistically non-significant (OR 0.87, 95% CI 0.74 to 1.03, P = 0.12) when data from two unpublished trials (Goteborg-Ostra and Svendborg) were added to the analysis. After further also adding two additional trials (Beijing, Stockholm) with very short observation periods (until discharge), the difference between acute stroke units and general medical wards on death remained statistically non-significant (OR 0.86, 95% CI 0.74 to 1.01, P = 0.06). Furthermore, based on figures reported by the clinical trials included in this study, a slightly higher proportion of patients became dependent after receiving care in stroke units than those treated in general medical wards - although the difference was not statistically significant. This result could have an impact on the future demand for healthcare services for individuals that survive a stroke but became dependent on their care-givers.
CONCLUSIONS
These findings demonstrate that a well-conducted meta-analysis can produce results that can be of value to policymakers but the choice of inclusion/exclusion criteria and outcomes in this context needs careful consideration. The financing of interventions such as stroke units that increase independency and reduce inpatient stays are worthwhile in a context of an ageing population with increasing care needs. One limitation of this study was the selection of trials published in only four languages: English, French, Dutch and German. This choice was pragmatic in the context of this study, where the objective was to support health authorities in their decision processes.
Topics: Hospital Units; Humans; Length of Stay; Needs Assessment; Stroke; Treatment Outcome
PubMed: 24164771
DOI: 10.1186/1471-2288-13-132 -
BMC Nursing Apr 2022The Covid-19 pandemic has produced unprecedented challenges across all aspects of health and social care sectors globally. Nurses and healthcare workers in care homes...
BACKGROUND
The Covid-19 pandemic has produced unprecedented challenges across all aspects of health and social care sectors globally. Nurses and healthcare workers in care homes have been particularly impacted due to rapid and dramatic changes to their job roles, workloads, and working environments, and residents' multimorbidity. Developed by the World Health Organisation, Psychological First Aid (PFA) is a brief training course delivering social, emotional, supportive, and pragmatic support that can reduce the initial distress after disaster and foster future adaptive functioning.
OBJECTIVES
This review aimed to synthesise findings from studies exploring the usefulness of PFA for the well-being of nursing and residential care home staff.
METHODS
A systematic search was conducted across 15 databases (Social Care Online, Kings Fund Library, Prospero, Dynamed, BMJ Best Practice, SIGN, NICE, Ovid, Proquest, Campbell Library, Clinical Trials, Web of Knowledge, Scopus, Ebsco CINAHL, and Cochrane Library), identifying peer-reviewed articles published in English language from database inception to 20th June 2021.
RESULTS
Of the 1,159 articles screened, 1,146 were excluded at title and abstract; the remaining 13 articles were screened at full text, all of which were then excluded.
CONCLUSION
This review highlights that empirical evidence of the impact of PFA on the well-being of nursing and residential care home staff is absent. PFA has likely been recommended to healthcare staff during the Covid-19 pandemic. The lack of evidence found here reinforces the urgent need to conduct studies which evaluates the outcomes of PFA particularly in the care home staff population.
PubMed: 35468786
DOI: 10.1186/s12912-022-00866-6