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Therapeutic Advances in Musculoskeletal... 2021There are currently many treatment options for patients with subacromial shoulder conditions (SSCs). Clinical decision-making regarding the best treatment option is...
BACKGROUND
There are currently many treatment options for patients with subacromial shoulder conditions (SSCs). Clinical decision-making regarding the best treatment option is often difficult. This study aims to evaluate the comparative effectiveness of treatment options for relieving pain and improving function in patients with SSCs.
METHODS
Eight databases [including MEDLINE, Embase, CINAHL, AMED, PEDro, Cochrane Database of Systematic Reviews and World Health Organization (WHO) International Clinical Trials Registry] were searched from inception until April 2020. Randomised clinical/controlled trials of adult patients investigating the effects of nonsurgical (e.g. corticosteroid injections, therapeutic exercise, shockwave therapy) and surgical treatment for SSCs, compared with each other, placebo, usual care or no treatment, were retrieved. Pairs of reviewers screened studies independently, quality appraised eligible studies using the Cochrane risk of bias tool, extracted and checked data for accuracy. Primary outcomes were pain and disability in the short term (⩽3 months) and long term (⩾6 months). Direct and indirect evidence of treatment effectiveness was synthesised using random-effects network meta-analysis.
RESULTS
The review identified 177 eligible trials. Summary estimates (based on 99 trials providing suitable data, 6764 patients, 20 treatment options) showed small to moderate effects for several treatments, but no significant differences on pain or function between many active treatment comparisons. The primary analysis indicated that exercise and laser therapy may provide comparative benefit in terms of both pain and function at different follow-up time-points, with larger effects found for laser in the short term at 2-6 weeks, although direct evidence was provided by one trial only, and for exercise in the longer term [standardised mean difference (SMD) 0.39, 95% confidence interval (CI) 0.18, 0.59 at 3-6 months] compared with control. Sensitivity analyses excluding studies at increased risk of bias confirmed only the comparative effects of exercise as being robust for both pain and function up until 3-month follow-up.
CONCLUSION
Current evidence shows small to moderate effect sizes for most treatment options for SSCs. Six treatments had a high probability of being most effective, in the short term, for pain and function [acupuncture, manual therapy, exercise, exercise plus manual therapy, laser therapy and Microcurrent (MENS) (TENS)], but with low certainty for most treatment options. After accounting for risk of bias, there is evidence of moderate certainty for the comparative effects of exercise on function in patients with SSCs. Future large, high-quality pragmatic randomised trials or meta-analyses are needed to better understand whether specific subgroups of patients respond better to some treatments than others.
PubMed: 34527083
DOI: 10.1177/1759720X211037530 -
Archives of Physiotherapy 2024Manual therapy is an often-utilized intervention for the management of knee osteoarthritis (OA). The interpretation of results presented by these trials can be affected... (Review)
Review
INTRODUCTION
Manual therapy is an often-utilized intervention for the management of knee osteoarthritis (OA). The interpretation of results presented by these trials can be affected by how well the study designs align applicability to real-world clinical settings.
AIM
To examine the existing body of clinical trials investigating manual therapy for knee OA to determine where they fall on the efficacy-effectiveness spectrum.
METHODS
This systematic review has been guided and informed by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Randomized controlled trials that investigated manual therapy treatments for adults with knee OA were retrieved via searches of multiple databases to identify trials published prior to April 2023. The Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool was used to objectively rate the efficacy-effectiveness nature of each trial design. The Cochrane Risk of Bias 2.0 assessment tool (RoB-2) was used to assess the risk of bias across five domains.
RESULTS
Of the 36 trials, a higher percentage of trials had a greater emphasis on efficacy within all four domains: participant characteristics (75.0%), trial setting (77.8%), flexibility of intervention (58.3%), and clinical relevance of experimental and comparison intervention (47.2%). In addition, 13.9% of the trials had low risk of bias, 41.7% had high risk of bias, and 44.4% had some concerns regarding bias.
CONCLUSIONS
While many trials support manual therapy as effective for the management of knee OA, a greater focus on study designs with an emphasis on effectiveness would improve the applicability and generalizability of future trials.
PubMed: 38444787
DOI: 10.33393/aop.2024.2916 -
The Cochrane Database of Systematic... Dec 2019Clinical practice guidelines suggest that magnetic resonance imaging (MRI) of the brain should be performed at certain time points or intervals distant from diagnosis... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Clinical practice guidelines suggest that magnetic resonance imaging (MRI) of the brain should be performed at certain time points or intervals distant from diagnosis (interval or surveillance imaging) of cerebral glioma, to monitor or follow up the disease; it is not known, however, whether these imaging strategies lead to better outcomes among patients than triggered imaging in response to new or worsening symptoms.
OBJECTIVES
To determine the effect of different imaging strategies (in particular, pre-specified interval or surveillance imaging, and symptomatic or triggered imaging) on health and economic outcomes for adults with glioma (grades 2 to 4) in the brain.
SEARCH METHODS
The Cochrane Gynaecological, Neuro-oncology and Orphan Cancers (CGNOC) Group Information Specialist searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase up to 18 June 2019 and the NHS Economic Evaluation Database (EED) up to December 2014 (database closure).
SELECTION CRITERIA
We included randomised controlled trials, non-randomised controlled trials, and controlled before-after studies with concurrent comparison groups comparing the effect of different imaging strategies on survival and other health outcomes in adults with cerebral glioma; and full economic evaluations (cost-effectiveness analyses, cost-utility analyses and cost-benefit analyses) conducted alongside any study design, and any model-based economic evaluations on pre- and post-treatment imaging in adults with cerebral glioma.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane review methodology with two authors independently performing study selection and data collection, and resolving disagreements through discussion. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included one retrospective, single-institution study that compared post-operative imaging within 48 hours (early post-operative imaging) with no early post-operative imaging among 125 people who had surgery for glioblastoma (GBM: World Health Organization (WHO) grade 4 glioma). Most patients in the study underwent maximal surgical resection followed by combined radiotherapy and temozolomide treatment. Although patient characteristics in the study arms were comparable, the study was at high risk of bias overall. Evidence from this study suggested little or no difference between early and no early post-operative imaging with respect to overall survival (deaths) at one year after diagnosis of GBM (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.61 to 1.21; 48% vs 55% died, respectively; very low certainty evidence) and little or no difference in overall survival (deaths) at two years after diagnosis of GBM (RR 1.06, 95% CI 0.91 to 1.25; 86% vs 81% died, respectively; very low certainty evidence). No other review outcomes were reported. We found no evidence on the effectiveness of other imaging schedules. In addition, we identified no relevant economic evaluations assessing the efficiency of the different imaging strategies.
AUTHORS' CONCLUSIONS
The effect of different imaging strategies on survival and other health outcomes remains largely unknown. Existing imaging schedules in glioma seem to be pragmatic rather than evidence-based. The limited evidence suggesting that early post-operative brain imaging among GBM patients who will receive combined chemoradiation treatment may make little or no difference to survival needs to be further researched, particularly as early post-operative imaging also serves as a quality control measure that may lead to early re-operation if residual tumour is identified. Mathematical modelling of a large glioma patient database could help to distinguish the optimal timing of surveillance imaging for different types of glioma, with stratification of patients facilitated by assessment of individual tumour growth rates, molecular biomarkers and other prognostic factors. In addition, paediatric glioma study designs could be used to inform future research of imaging strategies among adults with glioma.
Topics: Brain Neoplasms; Controlled Before-After Studies; Glioma; Humans; Magnetic Resonance Imaging; Randomized Controlled Trials as Topic; Reoperation
PubMed: 31873964
DOI: 10.1002/14651858.CD013137.pub2 -
Indian Journal of Dental Research :... 2022Clinical use of antibiotics prophylaxis (AP) for preventing infective endocarditis (IE) after invasive dental procedures is controversial. Expert consensus guidelines... (Review)
Review
BACKGROUND
Clinical use of antibiotics prophylaxis (AP) for preventing infective endocarditis (IE) after invasive dental procedures is controversial. Expert consensus guidelines are inconsistent, either restricting its use to high-risk individuals or advising its use again.
OBJECTIVES
To determine whether there is a genuine need for AP to prevent IE in high-risk patients undergoing invasive dental procedures.
METHODS
Online search was performed on PubMed, Science Direct, British Dental Journal and Cochrane Register of Controlled Trials. The methodological quality of each study was assessed using the Cochrane Handbook for Systematic Reviews of Interventions.
RESULTS
Seventeen (17) clinical trials were included in the final analysis recruiting 2,410 patients (AP = 1,366; placebo = 1,044). Bacteraemia was detected in 302 AP patients (22.1%) and 362 placebo patients (34.7%). AP reduced the risk of bacteraemia by 49% (risk ratio: 0.51; 95% CI; 0.45 to 0.58; P = 0.0001).
CONCLUSION
Although using AP for IE may be pragmatic and justified for high-risk patients undergoing invasive dental procedures, the evidence is inconclusive because post-procedural bacteraemia may not be a good surrogate marker for IE. Moreover, trials investigating the direct association between AP and IE are lacking due to low disease prevalence and high-cost challenges.
Topics: Humans; Antibiotic Prophylaxis; Bacteremia; Dentistry; Endocarditis; Endocarditis, Bacterial
PubMed: 37006014
DOI: 10.4103/ijdr.ijdr_810_21 -
Journal of Tissue Viability Aug 2020To be in accord with the Consolidated Standards of Reporting Trials (CONSORT) Statement, all important adverse events in randomised controlled trials (RCTs) should be...
AIM
To be in accord with the Consolidated Standards of Reporting Trials (CONSORT) Statement, all important adverse events in randomised controlled trials (RCTs) should be reported, as well as trial registration. Neither concern has been investigated in venous leg ulcer trials. We therefore aimed to quantify and explore compliance with adverse event reporting and trials registration in RCTs that reported interventions for treating venous leg ulceration.
MATERIALS AND METHODS
We searched the Cochrane Controlled Trials Register, Medline, Embase, and CINAHL for studies reported between 2001 and 2017. Included studies must have been described as randomised controlled trials evaluating any intervention in a VLU population. Data was then extracted by one author into a standard form and checked by a second author.
RESULTS
We screened 3100 titles and identified 204 trials involving pharmaceuticals (82), medicated and non-medicated devices (102), organisational (5) or other interventions (15) published in 76 journals. Eighty-four trials reported adverse events (41.2%), while 18 reported no events occurred (8.8%) and 78 did not report adverse events (38.2%). Types of adverse events reported included all-cause (20.1%), ulcer-related only (38.2%), treatment-related only (11.3%) and serious adverse events only (1.0%). Only 38 trials were registered (18.6%). Trial registration was associated with reporting of any adverse events (Odds Ratio 3.0, 95%CI 1.1-7.9), as was the trial being a pharmaceutical trial (Odds Ratio 2.9, 95%CI 1.5-5.7) or a multicentre trial (Odds Ratio 4.2, 95%CI 2.2-8.1).
CONCLUSION
Adverse event reporting in VLU trials is variable with about one third of trials not reporting on adverse events at all. Trials registration is a the modifiable factor associated with better reporting of adverse events. Journal editors could explore how they can promote trials registration to enhance better reporting of harms in VLU trials.
Topics: Humans; Pragmatic Clinical Trials as Topic; Pressure Ulcer; Risk Management
PubMed: 31587922
DOI: 10.1016/j.jtv.2019.09.005 -
Pilot and Feasibility Studies 2019Researchers publish the processes they use to develop interventions to improve health. Reflecting on this endeavour may help future developers to improve their practice. (Review)
Review
BACKGROUND
Researchers publish the processes they use to develop interventions to improve health. Reflecting on this endeavour may help future developers to improve their practice.
METHODS
Our aim was to collate, describe, and analyse the actions developers take when developing complex interventions to improve health. We carried out a systematic mapping review of empirical research studies that report the development of complex interventions to improve health. A search was undertaken of five databases over 2015-2016 using the term 'intervention dev*'. Eighty-seven journal articles reporting the process of intervention development were identified. A purposive subset of 30 articles, using a range of published approaches to developing interventions, was selected for in-depth analysis using principles of realist synthesis to identify the actions of intervention development and rationales underpinning those actions.
RESULTS
The 87 articles were from the USA (39/87), the UK (32/87), continental Europe (6/87), and the rest of the world (10/87). These mainly took a pragmatic self-selected approach ( = 43); a theory- and evidence-based approach, e.g. Intervention Mapping, Behaviour Change Wheel ( = 22); or a partnership approach, e.g. community-based participatory research, co-design ( = 10). Ten actions of intervention development were identified from the subset of 30 articles, including identifying a need for an intervention, selecting the intervention development approach to follow, considering the needs of the target population, reviewing published evidence, involving stakeholders, drawing or generating theory, and designing and refining the intervention. Rationales for these actions were that they would produce more engaging, acceptable, feasible, and effective interventions.
CONCLUSIONS
Developers take a variety of approaches to the international endeavour of complex intervention development. We have identified and described a set of actions taken within this endeavour regardless of whether developers follow a published approach or not. Future developers can use these actions and the rationales that underpin them to help them make decisions about the process of intervention development.
TRIAL REGISTRATION
PROSPERO, CRD42017080545.
PubMed: 31720005
DOI: 10.1186/s40814-019-0512-8 -
BMC Medical Research Methodology Jul 2021The Iberoamerican Cochrane Network is currently developing an extensive project to identify Spanish-language journals that publish original clinical research in Spain...
BACKGROUND
The Iberoamerican Cochrane Network is currently developing an extensive project to identify Spanish-language journals that publish original clinical research in Spain and Latin America. The project is called BADERI (Database of Iberoamerican Essays and Journal) and feeds the research articles, mainly randomised clinical trials (RCTs), into CENTRAL (Cochrane Collaboration Central Register of Controlled Trials). This study aims to assess the quality of reporting of RCTs published in Spanish and Latin American journals for three clinical fields and assess changes over time.
METHODS
We did a systematic survey with time trend analysis of RCTs for dentistry, geriatrics, and neurology. These fields were chosen for pragmatic reasons as they had not yet been completed in BADERI. After screening RCTs from 1990 to 2018 for randomised or quasi-randomised clinical trials, we extracted data for 23 CONSORT items. The primary outcome was the total score of the 23 predefined CONSORT 2010 items for each RCT (score range from 0 to 34). The secondary outcome measure was the score for each one of these 23 items.
RESULTS
A total of 392 articles from 1990 to 2018 were included as follows: dentistry (282), neurology (80), and geriatrics (30). We found that the overall compliance score for the CONSORT items included in this study for all 392 RCTs analysed was 12.6 on a scale with a maximum score of 34. With time, the quality of reporting improved slightly for all RCTs. None of the articles achieved the complete individual CONSORT item compliance score. The lowest overall compliance percentage was for item 10 (Randomisation implementation) and item 24 (Protocol registration), with a dismal 1% compliance across all included RCTs, regardless of country.
CONCLUSIONS
CONSORT compliance is very poor in the 392 analysed RCTs. The impact of the CONSORT statement on improving the completeness of RCT reporting in Latin America and Spain is not clear. Iberoamerican journals should become more involved in endorsing and enforcing adherence to the CONSORT guidelines.
Topics: Dentistry; Geriatrics; Humans; Latin America; Neurology; Periodicals as Topic; Spain
PubMed: 34311704
DOI: 10.1186/s12874-021-01337-3 -
The Journal of Hospital Infection Sep 2021Hospital-onset COVID-19 infections (HOCIs) are associated with excess morbidity and mortality in patients and healthcare workers. The aim of this review was to explore...
Hospital-onset COVID-19 infections (HOCIs) are associated with excess morbidity and mortality in patients and healthcare workers. The aim of this review was to explore and describe the current literature in HOCI surveillance. Medline, EMBASE, the Cochrane Database of Systematic Reviews, the Cochrane Register of Controlled Trials, and MedRxiv were searched up to 30 November 2020 using broad search criteria. Articles of HOCI surveillance systems were included. Data describing HOCI definitions, HOCI incidence, types of HOCI identification surveillance systems, and level of system implementation were extracted. A total of 292 citations were identified. Nine studies on HOCI surveillance were included. Six studies reported on the proportion of HOCI among hospitalized COVID-19 patients, which ranged from 0 to 15.2%. Six studies provided HOCI case definitions. Standardized national definitions provided by the UK and US governments were identified. Four studies included healthcare workers in the surveillance. One study articulated a multimodal strategy of infection prevention and control practices including HOCI surveillance. All identified HOCI surveillance systems were implemented at institutional level, with eight studies focusing on all hospital inpatients and one study focusing on patients in the emergency department. Multiple types of surveillance were identified. Four studies reported automated surveillance, of which one included real-time analysis, and one included genomic data. Overall, the study quality was limited by the observational nature with short follow-up periods. In conclusion, HOCI case definitions and surveillance methods were developed pragmatically. Whilst standardized case definitions and surveillance systems are ideal for integration with existing routine surveillance activities and adoption in different settings, we acknowledged the difficulties in establishing such standards in the short-term.
Topics: Humans; COVID-19; Cross Infection; Hospitals; SARS-CoV-2
PubMed: 34098049
DOI: 10.1016/j.jhin.2021.05.016 -
Health Technology Assessment... Jan 2024Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional...
BACKGROUND
Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear.
OBJECTIVE
To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented.
METHODS
Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0-18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains.
RESULTS
Stakeholders prioritised outcomes, developed a model which informed evidence synthesis and identified evidence gaps.
SCOPING REVIEW
651 studies, including 190 randomised controlled trials and 236 primary studies, conservatively reported 48 interventions/intervention combinations.
EFFECTIVENESS SYSTEMATIC REVIEWS
studies explored service delivery models ( = 15); interventions delivered by families/carers ( = 32), wider children's workforce ( = 21), continence teams ( = 31) and specialist consultant-led teams ( = 42); complementary therapies ( = 15); and psychosocial interventions ( = 4). One intervention (probiotics) had moderate-quality evidence; all others had low to very-low-quality evidence. Thirty-one studies reported evidence relating to cost or resource use; data were insufficient to support generalisable conclusions. One hundred and six studies described implementation barriers and facilitators.
CONCLUSIONS
Management of childhood chronic functional constipation is complex. The available evidence remains limited, with small, poorly conducted and reported studies. Many evidence gaps were identified. Treatment recommendations within current clinical guidelines remain largely unchanged, but there is a need for research to move away from considering effectiveness of single interventions. Clinical care and future studies must consider the individual characteristics of children.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42019159008.
FUNDING
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 128470) and is published in full in ; Vol. 28, No. 5. See the NIHR Funding and Awards website for further award information.
Topics: Child; Adult; Humans; Systematic Reviews as Topic; Health Personnel; Constipation
PubMed: 38343084
DOI: 10.3310/PLTR9622 -
BMC Family Practice Jun 2021Learning health systems have been gaining traction over the past decade. The purpose of this study was to understand the spread of learning health systems in primary...
BACKGROUND
Learning health systems have been gaining traction over the past decade. The purpose of this study was to understand the spread of learning health systems in primary care, including where they have been implemented, how they are operating, and potential challenges and solutions.
METHODS
We completed a scoping review by systematically searching OVID Medline®, Embase®, IEEE Xplore®, and reviewing specific journals from 2007 to 2020. We also completed a Google search to identify gray literature.
RESULTS
We reviewed 1924 articles through our database search and 51 articles from other sources, from which we identified 21 unique learning health systems based on 62 data sources. Only one of these learning health systems was implemented exclusively in a primary care setting, where all others were integrated health systems or networks that also included other care settings. Eighteen of the 21 were in the United States. Examples of how these learning health systems were being used included real-time clinical surveillance, quality improvement initiatives, pragmatic trials at the point of care, and decision support. Many challenges and potential solutions were identified regarding data, sustainability, promoting a learning culture, prioritization processes, involvement of community, and balancing quality improvement versus research.
CONCLUSIONS
We identified 21 learning health systems, which all appear at an early stage of development, and only one was primary care only. We summarized and provided examples of integrated health systems and data networks that can be considered early models in the growing global movement to advance learning health systems in primary care.
Topics: Humans; Learning; Learning Health System; Primary Health Care; Quality Improvement
PubMed: 34162336
DOI: 10.1186/s12875-021-01483-z