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Colorectal Disease : the Official... Sep 2017This manuscript forms the final of seven that address the surgical management of chronic constipation (CC) in adults. The content coalesces results from the five... (Review)
Review
AIM
This manuscript forms the final of seven that address the surgical management of chronic constipation (CC) in adults. The content coalesces results from the five systematic reviews that precede it and of the European Consensus process to derive graded practice recommendations (GPR).
METHODS
Summary of review data, development of GPR and future research recommendations as outlined in detail in the 'introduction and methods' paper.
RESULTS
The overall quality of data in the five reviews was poor with 113/156(72.4%) of included studies providing only level IV evidence and only four included level I RCTs. Coalescence of data from the five procedural classes revealed that few firm conclusions could be drawn regarding procedural choice or patient selection: no single procedure dominated in addressing dynamic structural abnormalities of the anorectum and pelvic floor with each having similar overall efficacy. Of one hundred 'prototype' GPRs developed by the clinical guideline group, 85/100 were deemed 'appropriate' based on the independent scoring of a panel of 18 European experts and use of RAND-UCLA consensus methodology. The remaining 15 were all deemed uncertain. Future research recommendations included some potential RCTs but also a strong emphasis on delivery of large multinational high-quality prospective cohort studies.
CONCLUSION
While the evidence base for surgery in CC is poor, the widespread European consensus for GPRs is encouraging. Professional bodies have the opportunity to build on this work by supporting the efforts of their membership to help convert the documented recommendations into clinical guidelines.
Topics: Biomedical Research; Chronic Disease; Consensus; Constipation; Digestive System Surgical Procedures; Evidence-Based Medicine; Humans; Patient Selection; Practice Guidelines as Topic
PubMed: 28960922
DOI: 10.1111/codi.13775 -
The Journal of Manual & Manipulative... Mar 2024Disorders of the cervical spine are some of the costliest musculoskeletal conditions to manage globally. Joint mobilization and manipulation have been shown to be an... (Review)
Review
BACKGROUND
Disorders of the cervical spine are some of the costliest musculoskeletal conditions to manage globally. Joint mobilization and manipulation have been shown to be an effective treatment for neck pain. However, the generalizability and clinical translation depends on the nature of the trial designs that inform its use. The extent to which randomized control trials (RCTs) assessing manual therapy treatments for cervical spine disorders fall on the efficacy (explanatory) -effectiveness (pragmatic) spectrum often informs how the findings are translated into clinical practice.
OBJECTIVE
The aim of this systematic review was to determine where RCTs of manual therapy for neck disorders fall on the efficacy-effectiveness spectrum.
METHODS
A search of three electronic databases including PubMed, CINAHL, and CENTRAL were completed for trials published from inception to May 2023. RCTs in which joint mobilization or manipulation were used to treat cervical spine disorders were assessed on the effectiveness-efficacy spectrum using the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool and risk of bias using the Revised Cochrane Risk of Bias tool.
RESULTS
A total of 174 trials met eligibility. RITES domain two trial setting (71.3% vs 16.1%), domain three flexibility of intervention(s) (62.1% vs 23%), and domain four clinical relevance of experimental and comparison intervention(s) (51.7% vs 29.3%) all favored efficacy over effectiveness. Domain one participant characteristic(s) had a slightly greater emphasis on effectiveness compared to efficacy (36.8% vs 44.8%). Most studies (96%) had at least some risk of bias.
CONCLUSION
Over half of the RCTs assessing the treatment effect of joint mobilization and manipulation for neck pain favor efficacy (explanatory) over effectiveness (pragmatic) designs. Future RCTs on this topic should consider a greater emphasis on pragmatic trial design components in order to better reflect real-world translation to clinical practice.
PubMed: 38525785
DOI: 10.1080/10669817.2024.2327127 -
The Cochrane Database of Systematic... Feb 2018Systemic therapies for metastatic cutaneous melanoma, the most aggressive of all skin cancers, remain disappointing. Few lasting remissions are achieved and the... (Review)
Review
BACKGROUND
Systemic therapies for metastatic cutaneous melanoma, the most aggressive of all skin cancers, remain disappointing. Few lasting remissions are achieved and the therapeutic aim remains one of palliation.Many agents are used alone or in combination with varying degrees of toxicity and cost. It is unclear whether evidence exists to support these complex regimens over best supportive care / placebo.
OBJECTIVES
To review the benefits from the use of systemic therapies in metastatic cutaneous melanoma compared to best supportive care/placebo, and to establish whether a 'standard' therapy exists which is superior to other treatments.
SEARCH METHODS
Randomised controlled trials were identified from the MEDLINE, EMBASE and CCTR/CENTRAL databases. References, conference proceedings, and Science Citation Index/Scisearch were also used to locate trials. Cancer registries and trialists were also contacted.
SELECTION CRITERIA
Randomised controlled trials of adults with histologically proven metastatic cutaneous melanoma in which systemic anti-cancer therapy was compared with placebo or supportive care.
DATA COLLECTION AND ANALYSIS
Study selection was performed by two independent reviewers. Data extraction forms were used for studies which appeared to meet the selection criteria and, where appropriate, full text articles were retrieved and reviewed independently.
MAIN RESULTS
No randomised controlled trials were found comparing a systemic therapy with placebo or best supportive care in metastatic cutaneous melanoma.
AUTHORS' CONCLUSIONS
There is no evidence from randomised controlled clinical trials to show superiority of systemic therapy over best supportive care / placebo in the treatment of malignant cutaneous melanoma.Given that patients with metastatic melanoma frequently receive systemic therapy, it is our pragmatic view that a future systematic review could compare any systemic treatment, or combination of treatments, to single agent dacarbazine.
Topics: Antineoplastic Agents; Humans; Melanoma; Skin Neoplasms
PubMed: 29411867
DOI: 10.1002/14651858.CD001215.pub2 -
Journal of Clinical Epidemiology Nov 2007Systematic reviews (SRs) are convenient summaries of evidence for health care practitioners. They form a basis for clinical practice guidelines and suggest directions... (Review)
Review
OBJECTIVE
Systematic reviews (SRs) are convenient summaries of evidence for health care practitioners. They form a basis for clinical practice guidelines and suggest directions for new research. SRs are most helpful if they are current; however, most of them are not being updated. This SR summarizes strategies and methods describing when and how to update SRs.
STUDY DESIGN AND SETTING
We searched MEDLINE (1966 to December 2005), PsycINFO, the Cochrane Methodology Register, and the 2005 Cochrane Colloquium proceedings to identify records describing when and how to update SRs in health care.
RESULTS
Four updating strategies, one technique, and two statistical methods were identified. Three strategies addressed steps for updating, and one strategy presented a model for assessing the need to update. One technique discussed the use of the "entry date" field in bibliographic searching. The statistical methods were cumulative meta-analysis and a test for detecting outdated meta-analyses with statistically nonsignificant results.
CONCLUSION
Little research has been conducted on when and how to update SRs in contrast to other methodological areas of conducting SRs (e.g., publication bias, variance imputation). The feasibility and efficiency of the identified approaches is uncertain. More research is needed to develop pragmatic and efficient methodologies for updating SRs.
Topics: Bibliometrics; Data Interpretation, Statistical; Databases, Bibliographic; Meta-Analysis as Topic; Peer Review, Research; Periodicals as Topic; Randomized Controlled Trials as Topic; Review Literature as Topic
PubMed: 17938050
DOI: 10.1016/j.jclinepi.2007.03.008 -
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, Pā=ā0.46). 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 -
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 -
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 -
Respiratory Medicine 2019Evidence to support the implementation of telehealth (TH) interventions in the management of chronic obstructive pulmonary disease (COPD) varies throughout Europe.... (Review)
Review
BACKGROUND
Evidence to support the implementation of telehealth (TH) interventions in the management of chronic obstructive pulmonary disease (COPD) varies throughout Europe. Despite more than ten years of TH research in COPD management, it is still not possible to define which TH interventions are beneficial to which patient group. Therefore, informing policymakers on TH implementation is complicated. We aimed to examine the provision and efficacy of TH for COPD management to guide future decision-making.
METHODS
A mapping study of twelve systematic reviews of TH interventions for COPD management was conducted. This was followed by an in-depth review of fourteen clinical trials performed in Europe extracted from the systematic reviews. Efficacy outcomes for COPD management were synthesized.
RESULTS
The mapping study revealed that systematic reviews with a meta-analysis often report positive clinical outcomes. Despite this, we identified a lack of pragmatic trial design affecting the synthesis of reported outcomes. The in-depth review visualized outcomes for three TH categories, which revealed a plethora of heterogeneous outcomes. Suggestions for reporting within these three outcomes are synthesized as targets for future empirical research reporting.
CONCLUSION
The present study indicates the need for more standardized and updated systematic reviews. Policymakers should advocate for improved TH trial designs, focusing on the entire intervention's adoption process evaluation. One of the policymakers' priorities should be the harmonization of the outcome sets, which would be considered suitable for deciding about subsequent reimbursement. We propose possible outcome sets in three TH categories which could be used for discussion with stakeholders.
Topics: Delivery of Health Care, Integrated; Europe; Humans; Pulmonary Disease, Chronic Obstructive; Telemedicine
PubMed: 31614305
DOI: 10.1016/j.rmed.2019.09.005 -
Journal of the Neurological Sciences Oct 2016The aim of the present systematic review is to critically evaluate the effectiveness of OMT as an adjuvant therapy in the management of patients with neurological... (Review)
Review
OBJECTIVE
The aim of the present systematic review is to critically evaluate the effectiveness of OMT as an adjuvant therapy in the management of patients with neurological diseases.
METHODS
A systematic review was conducted and the findings were reported following the PRISMA statement. Twelve databases were searched for articles reporting the use of osteopathic manipulative treatment in neurological disorders. Each article was assessed using the Cochrane risk of bias tool and the Jadad score.
RESULTS
10 articles were included. OMT was used to test its efficacy and/or effectiveness in treating tension-type headache, migraine, cerebral palsy and gait analysis in patients affected by Parkinson's Disease. The general quality of the included trials ranged from very low, to low and moderate according to Cochrane standards. High heterogeneity between studies was found for the type of intervention, control and outcome measures used.
CONCLUSION
Results showed that studies on the efficacy and/or effectiveness of OMT treatments are scarce, heterogeneous, and of low methodological quality. Further studies should be conducted including a more pragmatic methodology, an exhaustive description of all investigated and concurrent interventions, and a systematic report of adverse events, so as to obtain robust and generalizable results.
Topics: Animals; Databases, Bibliographic; Humans; Manipulation, Osteopathic; Nervous System Diseases
PubMed: 27653920
DOI: 10.1016/j.jns.2016.08.062 -
Journal of Medical Internet Research Apr 2022Digital health refers to the proper use of technology for improving the health and well-being of people and enhancing the care of patients through the intelligent... (Review)
Review
BACKGROUND
Digital health refers to the proper use of technology for improving the health and well-being of people and enhancing the care of patients through the intelligent processing of clinical and genetic data. Despite increasing interest in well-being in both health care and technology, there is no clear understanding of what constitutes well-being, which leads to uncertainty in how to create well-being through digital health. In an effort to clarify this uncertainty, Brey developed a framework to define problems in technology for well-being using the following four categories: epistemological problem, scope problem, specification problem, and aggregation problem.
OBJECTIVE
This systematic scoping review aims to gain insights into how to define and address well-being in digital health.
METHODS
We followed the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. Papers were identified from 6 databases and included if they addressed the design or evaluation of digital health and reported the enhancement of patient well-being as their purpose. These papers were divided into design and evaluation papers. We studied how the 4 problems in technology for well-being are considered per paper.
RESULTS
A total of 117 studies were eligible for analysis (n=46, 39.3% design papers and n=71, 60.7% evaluation papers). For the epistemological problem, the thematic analysis resulted in various definitions of well-being, which were grouped into the following seven values: healthy body, functional me, healthy mind, happy me, social me, self-managing me, and external conditions. Design papers mostly considered well-being as healthy body and self-managing me, whereas evaluation papers considered the values of healthy mind and happy me. Users were rarely involved in defining well-being. For the scope problem, patients with chronic care needs were commonly considered as the main users. Design papers also regularly involved other users, such as caregivers and relatives. These users were often not involved in evaluation papers. For the specification problem, most design and evaluation papers focused on the provision of care support through a digital platform. Design papers used numerous design methods, whereas evaluation papers mostly considered pre-post measurements and randomized controlled trials. For the aggregation problem, value conflicts were rarely described.
CONCLUSIONS
Current practice has found pragmatic ways of circumventing or dealing with the problems of digital health for well-being. Major differences exist between the design and evaluation of digital health, particularly regarding their conceptualization of well-being and the types of users studied. In addition, we found that current methodologies for designing and evaluating digital health can be improved. For optimal digital health for well-being, multidisciplinary collaborations that move beyond the common dichotomy of design and evaluation are needed.
Topics: Caregivers; Delivery of Health Care; Humans
PubMed: 35377328
DOI: 10.2196/33787