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The Cochrane Database of Systematic... Jul 2021Botulinum toxin type A (BontA) is the most frequent treatment for facial wrinkles, but its effectiveness and safety have not previously been assessed in a Cochrane... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Botulinum toxin type A (BontA) is the most frequent treatment for facial wrinkles, but its effectiveness and safety have not previously been assessed in a Cochrane Review.
OBJECTIVES
To assess the effects of all commercially available botulinum toxin type A products for the treatment of any type of facial wrinkles.
SEARCH METHODS
We searched the following databases up to May 2020: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers, and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).
SELECTION CRITERIA
We included RCTs with over 50 participants, comparing BontA versus placebo, other types of BontA, or fillers (hyaluronic acid), for treating facial wrinkles in adults.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Primary outcomes were participant assessment of success and major adverse events (AEs) (eyelid ptosis, eyelid sensory disorder, strabismus). Secondary outcomes included physician assessment of success; proportion of participants with at least one AE and duration of treatment effect. We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS
We included 65 RCTs, involving 14,919 randomised participants. Most participants were female, aged 18 to 65 years. All participants were outpatients (private office or day clinic). Study duration was between one week and one year. No studies were assessed as low risk of bias in all domains; the overall risk of bias was unclear for most studies. The most common comparator was placebo (36 studies). An active control was used in 19 studies. There were eight dose-ranging studies of onabotulinumtoxinA, and a small number of studies compared against fillers. Treatment was given in one cycle (54 studies), two cycles (three studies), or three or more cycles (eight studies). The treated regions were glabella (43 studies), crow's feet (seven studies), forehead (two studies), perioral (two studies), full face (one study), or more than two regions (nine studies). Most studies analysed moderate to severe wrinkles; mean duration of treatment was 20 weeks. The following results summarise the main comparisons, based on studies of one treatment cycle for the glabella. AEs were collected over the duration of these studies (over four to 24 weeks). Compared to placebo, onabotulinumtoxinA-20 U probably has a higher success rate when assessed by participants (risk ratio (RR) 19.45, 95% confidence interval (CI) 8.60 to 43.99; 575 participants; 4 studies; moderate-certainty evidence) or physicians (RR 17.10, 95% CI 10.07 to 29.05; 1339 participants; 7 studies; moderate-certainty evidence) at week four. Major AEs are probably higher with onabotulinumtoxinA-20 U (Peto OR 3.62, 95% CI 1.50 to 8.74; 1390 participants; 8 studies; moderate-certainty evidence), but there may be no difference in any AEs (RR 1.14, 95% CI 0.89 to 1.45; 1388 participants; 8 studies; low-certainty evidence). Compared to placebo, abobotulinumtoxinA-50 U has a higher participant-assessed success rate at week four (RR 21.22, 95% CI 7.40 to 60.56; 915 participants; 6 studies; high-certainty evidence); and probably has a higher physician-assessed success rate (RR 14.93, 95% CI 8.09 to 27.55; 1059 participants; 7 studies; moderate-certainty evidence). There are probably more major AEs with abobotulinumtoxinA-50 U (Peto OR 3.36, 95% CI 0.88 to 12.87; 1294 participants; 7 studies; moderate-certainty evidence). Any AE may be more common with abobotulinumtoxinA-50 U (RR 1.25, 95% CI 1.05 to 1.49; 1471 participants; 8 studies; low-certainty evidence). Compared to placebo, incobotulinumtoxinA-20 U probably has a higher participant-assessed success rate at week four (RR 66.57, 95% CI 13.50 to 328.28; 547 participants; 2 studies; moderate-certainty evidence), and physician-assessed success rate (RR 134.62, 95% CI 19.05 to 951.45; 547 participants; 2 studies; moderate-certainty evidence). Major AEs were not observed (547 participants; 2 studies; moderate-certainty evidence). There may be no difference between groups in any AEs (RR 1.17, 95% CI 0.90 to 1.53; 547 participants; 2 studies; low-certainty evidence). AbobotulinumtoxinA-50 U is no different to onabotulinumtoxinA-20 U in participant-assessed success rate (RR 1.00, 95% CI 0.92 to 1.08, 388 participants, 1 study, high-certainty evidence) and physician-assessed success rate (RR 1.01, 95% CI 0.95 to 1.06; 388 participants; 1 study; high-certainty evidence) at week four. Major AEs are probably more likely in the abobotulinumtoxinA-50 U group than the onabotulinumtoxinA-20 U group (Peto OR 2.65, 95% CI 0.77 to 9.09; 433 participants; 1 study; moderate-certainty evidence). There is probably no difference in any AE (RR 1.02, 95% CI 0.67 to 1.54; 492 participants; 2 studies; moderate-certainty evidence). IncobotulinumtoxinA-24 U may be no different to onabotulinumtoxinA-24 U in physician-assessed success rate at week four (RR 1.01, 95% CI 0.96 to 1.05; 381 participants; 1 study; low-certainty evidence) (participant assessment was not measured). One participant reported ptosis with onabotulinumtoxinA, but we are uncertain of the risk of AEs (Peto OR 0.02, 95% CI 0.00 to 1.77; 381 participants; 1 study; very low-certainty evidence). Compared to placebo, daxibotulinumtoxinA-40 U probably has a higher participant-assessed success rate (RR 21.10, 95% CI 11.31 to 39.34; 683 participants; 2 studies; moderate-certainty evidence) and physician-assessed success rate (RR 23.40, 95% CI 12.56 to 43.61; 683 participants; 2 studies; moderate-certainty evidence) at week four. Major AEs were not observed (716 participants; 2 studies; moderate-certainty evidence). There may be an increase in any AE with daxibotulinumtoxinA compared to placebo (RR 2.23, 95% CI 1.46 to 3.40; 716 participants; 2 studies; moderate-certainty evidence). Major AEs reported were mainly ptosis; BontA is also known to carry a risk of strabismus or eyelid sensory disorders.
AUTHORS' CONCLUSIONS
BontA treatment reduces wrinkles within four weeks of treatment, but probably increases risk of ptosis. We found several heterogeneous studies (different types or doses of BontA, number of cycles, and different facial regions) hindering meta-analyses. The certainty of the evidence for effectiveness outcomes was high, low or moderate; for AEs, very low to moderate. Future RCTs should compare the most common BontA (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, daxibotulinumtoxinA, prabotulinumtoxinA) and evaluate long-term outcomes. There is a lack of evidence about the effects of multiple cycles of BontA, frequency of major AEs, duration of effect, efficacy of recently-approved BontA and comparisons with other treatments.
Topics: Adult; Aged; Bias; Botulinum Toxins, Type A; Dermal Fillers; Face; Female; Humans; Male; Middle Aged; Placebos; Randomized Controlled Trials as Topic; Skin Aging
PubMed: 34224576
DOI: 10.1002/14651858.CD011301.pub2 -
Implementation Science : IS Jan 2019Shared decision-making (SDM) is rarely implemented in pediatric practice. Pediatric health decision-making differs from that of adult practice. Yet, little is known...
BACKGROUND
Shared decision-making (SDM) is rarely implemented in pediatric practice. Pediatric health decision-making differs from that of adult practice. Yet, little is known about the factors that influence the implementation of pediatric shared decision-making (SDM). We synthesized pediatric SDM barriers and facilitators from the perspectives of healthcare providers (HCP), parents, children, and observers (i.e., persons who evaluated the SDM process, but were not directly involved).
METHODS
We conducted a systematic review guided by the Ottawa Model of Research Use (OMRU). We searched MEDLINE, EMBASE, Cochrane Library, CINAHL, PubMed, and PsycINFO (inception to March 2017) and included studies that reported clinical pediatric SDM barriers and/or facilitators from the perspective of HCPs, parents, children, and/or observers. We considered all or no comparison groups and included all study designs reporting original data. Content analysis was used to synthesize barriers and facilitators and categorized them according to the OMRU levels (i.e., decision, innovation, adopters, relational, and environment) and participant types (i.e., HCP, parents, children, and observers). We used the Mixed Methods Appraisal Tool to appraise study quality.
RESULTS
Of 20,008 identified citations, 79 were included. At each OMRU level, the most frequent barriers were features of the options (decision), poor quality information (innovation), parent/child emotional state (adopter), power relations (relational), and insufficient time (environment). The most frequent facilitators were low stake decisions (decision), good quality information (innovation), agreement with SDM (adopter), trust and respect (relational), and SDM tools/resources (environment). Across participant types, the most frequent barriers were insufficient time (HCPs), features of the options (parents), power imbalances (children), and HCP skill for SDM (observers). The most frequent facilitators were good quality information (HCP) and agreement with SDM (parents and children). There was no consistent facilitator category for observers. Overall, study quality was moderate with quantitative studies having the highest ratings and mixed-method studies having the lowest ratings.
CONCLUSIONS
Numerous diverse and interrelated factors influence SDM use in pediatric clinical practice. Our findings can be used to identify potential pediatric SDM barriers and facilitators, guide context-specific barrier and facilitator assessments, and inform interventions for implementing SDM in pediatric practice.
TRIAL REGISTRATION
PROSPERO CRD42015020527.
Topics: Adolescent; Attitude of Health Personnel; Child; Child Health Services; Child, Preschool; Clinical Decision-Making; Decision Making; Emotions; Health Services Accessibility; Humans; Implementation Science; Infant; Infant, Newborn; Information Dissemination; Parents; Patient Acceptance of Health Care; Patient Participation; Power, Psychological; Professional-Patient Relations; Workload
PubMed: 30658670
DOI: 10.1186/s13012-018-0851-5 -
JBI Database of Systematic Reviews and... Apr 2016Teamwork is seen as an important element of patient care in acute hospital settings. The complexity of the journey of care for patients highlights the need for health... (Review)
Review
BACKGROUND
Teamwork is seen as an important element of patient care in acute hospital settings. The complexity of the journey of care for patients highlights the need for health professionals to collaborate and communicate clearly with each other. Health organizations in western countries are committed to improving patient safety through education of staff and teamwork education programs have been integral to this focus. There are no current systematic reviews of the experience of health professionals who participate in teamwork education in acute hospital settings.
OBJECTIVES
The objective of this systematic review was to search for the best available evidence on the experiences of health professionals who participate in teamwork education in acute hospital settings.
INCLUSION CRITERIA TYPES OF PARTICIPANTS
This review considered studies reporting on experiences of registered health professionals who work in acute hospitals. This included medical, nursing and midwifery and allied health professionals.
PHENOMENA OF INTEREST
The focus of the meta-synthesis was the experiences and reflections of health professionals who were involved in teamwork education in acute hospital settings.
CONTEXT
The geographical context for this review was acute hospitals in rural or metropolitan settings in Australia and overseas countries. The review focused on the experiences of health professionals who work in acute hospitals and participated in teamwork education programs.
TYPES OF STUDIES
This review considered studies that focused on qualitative data including, but not limited to, designs such as phenomenology, grounded theory, ethnography, action research and feminist research.In the absence of research studies, other text such as opinion papers, discussion papers and reports were considered. Studies published in English and from 1990 to 2013 were included in this review.
SEARCH STRATEGY
The literature search for relevant papers occurred between 13 September and 26 October 2013. A three-step search strategy was utilized in this review. The databases searched were PubMed, CINAHL, Embase and Scopus.
METHODOLOGICAL QUALITY
The standardized critical appraisal tool the Joanna Briggs Institute Qualitative Assessment and Review Instrument (JBI-QARI) was used to assess the methodological quality of included papers.
DATA EXTRACTION
Data that included statements and text of interest was extracted from papers included in the study using the standardized data extraction tool from JBI-QARI.
DATA SYNTHESIS
Qualitative research findings were pooled using JBI-QARI. This involved the aggregation and synthesis of findings to generate a set of statements that represented that aggregation.
RESULTS
In total, 116 papers were selected for analysis of full text, 11 papers were selected for critical appraisal and seven papers were selected for data synthesis. This resulted in 44 findings. The findings were assigned to 16 categories based on identified similarities across the papers. The categories were integrated into six meta-syntheses. These were: Meta-synthesis One: It is important to recognize that organizational culture and expectations have an impact on health professionals' participation and experience of teamwork education. Meta-synthesis Two: Understanding how successful teams function is central to the development of teamwork education programs and the experience of participants. Meta-synthesis Three: A health professional's experience of teamwork education will be influenced by his/her starting point of learning. Meta-synthesis Four: Participants highly value teamwork education programs that are implemented by facilitators who create practical authentic learning opportunities and foster reflection and debriefing for participants. Meta-synthesis Five: High fidelity simulation used with specific communication strategies provides a powerful learning opportunity for health professions to practice teamwork skills. Meta-synthesis Six: Participants have increased confidence and are motivated to apply their newly learnt teamwork skills into their daily practice.
CONCLUSIONS
The review identified qualitative evidence that can guide organizations and education facilitators in the development and implementation of teamwork education in acute hospital settings. Although the quality of the specific teamwork education programs was an important factor, there were a number of issues that also impacted on the experiences of health professionals who participated in teamwork education programs. These included the context that the program was delivered in, the diversity of health care teams, starting points of individual learners, the type of tools utilized in education programs, the levels of confidence and motivation of learners post training and the opportunity to transfer into practice new learning.
IMPLICATIONS FOR PRACTICE
Drawing from the synthesized findings of the review, recommendations for practice have been devised in order to guide the development and implementation of teamwork education in acute hospital settings and to improve the experience of participating health professionals. The Joanna Briggs Institute utilizes Grades of Recommendation to rate a health management strategy in terms of its desirable effects, evidence of adequate quality supporting its use, benefits of use, and the inclusion of patient experience, values and preferences. A strong recommendation has a Grade A and a weak recommendation has a Grade B. The FAME (Feasibility, Appropriateness, Meaningfulness and Effectiveness) scale was used to inform the strength of the following six recommendations for practice from the review: RECOMMENDATION ONE: All members of a team should be encouraged by their organization/managers to participate in teamwork education programs in order to foster a positive culture of learning and teamwork within the team.JBI Recommendation: Grade A. This recommendation is appropriate and applicable to all health professionals in acute hospital settings, is associated with positive experiences for participants of teamwork education programs and has a beneficial effect on participants.
RECOMMENDATION TWO
Facilitators of teamwork education programs should understand how successful teams function and consider these factors when planning or delivering training.JBI Recommendation: Grade A. This recommendation is associated with positive experiences for participants and creates a beneficial effect to the quality of a teamwork education program.
RECOMMENDATION THREE
Facilitators of teamwork education programs need to explore participant learning needs and their prior experiences of working in teams before implementing teamwork education programs.JBI Recommendation: Grade A. This recommendation creates a beneficial effect to the participants of teamwork education programs and to the quality of education provided by facilitators.
RECOMMENDATION FOUR
Facilitators of teamwork education programs should provide learning opportunities that are practical, authentic to participants and foster constructive debriefing and reflection.JBI Recommendation: Grade A. This recommendation is applicable to all health professionals and circumstances in which teamwork education occurs, is associated with positive experiences and has a beneficial effect on participants.
RECOMMENDATION FIVE
High fidelity simulation should be considered in acute hospitals for the training of teamwork skills in addition to clinical skills. Scenarios provide realistic opportunities for participants to practice communication strategies that enhance teamwork.JBI Recommendation: Grade A. This recommendation is applicable to all health professionals and circumstances in which teamwork education occurs and has a beneficial effect on participants of education programs.
RECOMMENDATION SIX
Team managers should harness the new confidence and motivation of staff around teamwork skills following participation in teamwork education programs and ensure that there are opportunities in the workplace to apply new skills and knowledge into daily practice.JBI Recommendation: Grade A. This recommendation is applicable to all health professionals and circumstances in which teamwork education occurs, is adaptable to a variety of circumstances and has a beneficial effect on health professional's daily practice of teamwork skills.
IMPLICATIONS FOR RESEARCH
In order to strengthen the evidence base about teamwork education in acute hospital settings there needs to be quantitative and qualitative research into:How organizations that have successfully embedded a culture of collaboration and safety in health teams have planned, implemented and evaluated teamwork education programs in acute hospital settings?What are the characteristics of teams that have led to successful participation in teamwork education and positive outcomes for team performance?What are the experiences, training and support provided to education facilitators who successfully implement teamwork education programs in acute hospitals?
Topics: Australia; Clinical Competence; Female; Health Personnel; Humans; Patient Care Team; Pregnancy; Qualitative Research
PubMed: 27532314
DOI: 10.11124/JBISRIR-2016-1843 -
Lancet (London, England) Sep 2023Intravenous thrombolysis is recommended before endovascular treatment, but its value has been questioned in patients who are admitted directly to centres capable of... (Meta-Analysis)
Meta-Analysis
Value of intravenous thrombolysis in endovascular treatment for large-vessel anterior circulation stroke: individual participant data meta-analysis of six randomised trials.
BACKGROUND
Intravenous thrombolysis is recommended before endovascular treatment, but its value has been questioned in patients who are admitted directly to centres capable of endovascular treatment. Existing randomised controlled trials have indicated non-inferiority of endovascular treatment alone or have been statistically inconclusive. We formed the Improving Reperfusion Strategies in Acute Ischaemic Stroke collaboration to assess non-inferiority of endovascular treatment alone versus intravenous thrombolysis plus endovascular treatment.
METHODS
We conducted a systematic review and individual participant data meta-analysis to establish non-inferiority of endovascular treatment alone versus intravenous thrombolysis plus endovascular treatment. We searched PubMed and MEDLINE with the terms "stroke", "endovascular treatment", "intravenous thrombolysis", and synonyms for articles published from database inception to March 9, 2023. We included randomised controlled trials on the topic of interest, without language restrictions. Authors of the identified trials agreed to take part, and individual participant data were provided by the principal investigators of the respective trials and collated centrally by the collaborators. Our primary outcome was the 90-day modified Rankin Scale (mRS) score. Non-inferiority of endovascular treatment alone was assessed using a lower boundary of 0·82 for the 95% CI around the adjusted common odds ratio (acOR) for shift towards improved outcome (analogous to 5% absolute difference in functional independence) with ordinal regression. We used mixed-effects models for all analyses. This study is registered with PROSPERO, CRD42023411986.
FINDINGS
We identified 1081 studies, and six studies (n=2313; 1153 participants randomly assigned to receive endovascular treatment alone and 1160 randomly assigned to receive intravenous thrombolysis and endovascular treatment) were eligible for analysis. The risk of bias of the included studies was low to moderate. Variability between studies was small, and mainly related to the choice and dose of the thrombolytic drug and country of execution. The median mRS score at 90 days was 3 (IQR 1-5) for participants who received endovascular treatment alone and 2 (1-4) for participants who received intravenous thrombolysis plus endovascular treatment (acOR 0·89, 95% CI 0·76-1·04). Any intracranial haemorrhage (0·82, 0·68-0·99) occurred less frequently with endovascular treatment alone than with intravenous thrombolysis plus endovascular treatment. Symptomatic intracranial haemorrhage and mortality rates did not differ significantly.
INTERPRETATION
We did not establish non-inferiority of endovascular treatment alone compared with intravenous thrombolysis plus endovascular treatment in patients presenting directly at endovascular treatment centres. Further research could focus on cost-effectiveness analysis and on individualised decisions when patient characteristics, medication shortages, or delays are expected to offset a potential benefit of administering intravenous thrombolysis before endovascular treatment.
FUNDING
Stryker and Amsterdam University Medical Centers, University of Amsterdam.
Topics: Humans; Stroke; Brain Ischemia; Intracranial Hemorrhages; Ischemic Stroke; Thrombolytic Therapy; Randomized Controlled Trials as Topic
PubMed: 37640037
DOI: 10.1016/S0140-6736(23)01142-X -
The Cochrane Database of Systematic... Oct 2021Intermittent catheterisation (IC) is a commonly recommended procedure for people with incomplete bladder emptying. Frequent complications are urinary tract infection... (Review)
Review
BACKGROUND
Intermittent catheterisation (IC) is a commonly recommended procedure for people with incomplete bladder emptying. Frequent complications are urinary tract infection (UTI), urethral trauma and discomfort during catheter use. Despite the many designs of intermittent catheter, including different lengths, materials and coatings, it is unclear which catheter techniques, strategies or designs affect the incidence of UTI and other complications, measures of satisfaction/quality of life and cost-effectiveness. This is an update of a Cochrane Review first published in 2007. OBJECTIVES: To assess the clinical and cost-effectiveness of different catheterisation techniques, strategies and catheter designs, and their impact, on UTI and other complications, and measures of satisfaction/quality of life among adults and children whose long-term bladder condition is managed by intermittent catheterisation.
SEARCH METHODS
We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 12 April 2021), the reference lists of relevant articles and conference proceedings, and we attempted to contact other investigators for unpublished data or for clarification.
SELECTION CRITERIA
Randomised controlled trials (RCTs) or randomised cross-over trials comparing at least two different catheterisation techniques, strategies or catheter designs.
DATA COLLECTION AND ANALYSIS
As per standard Cochrane methodological procedures, two review authors independently extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE. Outcomes included the number of people with symptomatic urinary tract infections, complications such as urethral trauma/bleeding, comfort and ease of use of catheters, participant satisfaction and preference, quality of life measures and economic outcomes.
MAIN RESULTS
We included 23 trials (1339 randomised participants), including twelve RCTs and eleven cross-over trials. Most were small (fewer than 60 participants completed), although three trials had more than 100 participants. Length of follow-up ranged from one month to 12 months and there was considerable variation in definitions of UTI. Most of the data from cross-over trials were not presented in a useable form for this review. Risk of bias was unclear in many domains due to insufficient information in the trial reports and several trials were judged to have a high risk of performance bias due to lack of blinding and a high risk of attrition bias. The certainty of evidence was downgraded for risk of bias, and imprecision due to low numbers of participants. Aseptic versus clean technique We are uncertain if there is any difference between aseptic and clean techniques in the risk of symptomatic UTI because the evidence is low-certainty and the 95% confidence interval (CI) is consistent with possible benefit and possible harm (RR 1.20 95% CI 0.54 to 2.66; one study; 36 participants). We identified no data relating to the risk of adverse events comparing aseptic and clean techniques or participant satisfaction or preference. Single-use (sterile) catheter versus multiple-use (clean) We are uncertain if there is any difference between single-use and multiple-use catheters in terms of the risk of symptomatic UTI because the certainty of evidence is low and the 95% CI is consistent with possible benefit and possible harm (RR 0.98, 95% CI 0.55, 1.74; two studies; 97 participants). One study comparing single-use catheters to multiple-use catheters reported zero adverse events in either group; no other adverse event data were reported for this comparison. We identified no data for participant satisfaction or preference. Hydrophilic-coated catheters versus uncoated catheters We are uncertain if there is any difference between hydrophilic and uncoated catheters in terms of the number of people with symptomatic UTI because the certainty of evidence is low and the 95% CI is consistent with possible benefit and possible harm (RR 0.89, 95% CI 0.69 to 1.14; two studies; 98 participants). Uncoated catheters probably slightly reduce the risk of urethral trauma and bleeding compared to hydrophilic-coated catheters (RR 1.37, 95% CI 1.01 to 1.87; moderate-certainty evidence). The evidence is uncertain if hydrophilic-coated catheters compared with uncoated catheters has any effect on participant satisfaction measured on a 0-10 scale (MD 0.7 higher, 95% CI 0.19 to 1.21; very low-certainty evidence; one study; 114 participants). Due to the paucity of data, we could not assess the certainty of evidence relating to participant preference (one cross-over trial of 29 participants reported greater preference for a hydrophilic-coated catheter (19/29) compared to an uncoated catheter (10/29)). AUTHORS' CONCLUSIONS: Despite a total of 23 trials, the paucity of useable data and uncertainty of the evidence means that it remains unclear whether the incidence of UTI or other complications is affected by use of aseptic or clean technique, single (sterile) or multiple-use (clean) catheters, coated or uncoated catheters or different catheter lengths. The current research evidence is uncertain and design and reporting issues are significant. More well-designed trials are needed. Such trials should include analysis of cost-effectiveness because there are likely to be substantial differences associated with the use of different catheterisation techniques and strategies, and catheter designs.
Topics: Adult; Catheters, Indwelling; Child; Humans; Male; Urinary Bladder; Urinary Catheterization; Urinary Incontinence; Urinary Tract Infections
PubMed: 34699062
DOI: 10.1002/14651858.CD006008.pub5 -
Journal of Science and Medicine in Sport Feb 2020Systematic review of randomized controlled trials.
STUDY DESIGN
Systematic review of randomized controlled trials.
OBJECTIVES
To determine the most effective non-surgical treatment interventions for reducing pain and improving function for patients with patellar tendinopathy.
METHODS
Studies considered for this systematic review were from peer-reviewed journals published between January 2012 and September 2017. All included studies used a visual analogue scale (VAS) to evaluate the participant's pain. The majority of the included studies also used the Victorian Institute of Sport Assessment Patellar Tendinopathy (VISA-P questionnaire) to assess participant's symptoms and function.
RESULTS
Nine randomized controlled trials fit the inclusion criteria and were analyzed. The results of three studies supported the use of isometric exercise to reduce pain immediately. One study found patellar strapping and sports taping to be effective for reduction in pain during sport and immediately after. Eccentric exercise, Dry Needling (DN) (2 studies), injections with Platelet Rich Plasma (PRP), Autologous Blood Injection (ABI), and saline were found to have a more sustained effect on reducing pain and improving knee function.
CONCLUSION
Isometric exercise, patellar strapping, sports taping, eccentric exercise, injections with PRP, ABI, and saline and DN demonstrated a short-term pain relieving and functional improvement effect in subjects with patellar tendinopathy. Longer term follow up on interventions involving eccentric exercise, DN, and injections with PRP, ABI and saline showed sustained pain reduction and improvement in knee function.
LEVEL OF EVIDENCE
Level 1.
Topics: Athletic Tape; Dry Needling; Exercise Therapy; Humans; Pain Measurement; Patellar Ligament; Platelet-Rich Plasma; Randomized Controlled Trials as Topic; Surveys and Questionnaires; Tendinopathy
PubMed: 31606317
DOI: 10.1016/j.jsams.2019.09.008 -
International Journal of Sports Medicine Jun 2023Urinary incontinence (UI) in female athletes can impair their quality-of-life (QoL) and reduce their participation in sports. This review aims to evaluate the effect of...
Urinary incontinence (UI) in female athletes can impair their quality-of-life (QoL) and reduce their participation in sports. This review aims to evaluate the effect of pelvic floor muscle training (PFMT) in treating UI in women participating in high-impact sports. Furthermore, to assess the influence of PFMT on pelvic floor muscles (PFM) function and the UI impact on their QoL. For this purpose, a systematic review of randomized controlled trials (RCTs) and non-RCTs was performed. An electronic search was conducted on PubMed, EMBASE, SciELO, and Scopus. The quality of evidence was assessed using the PEDro and ROBINS-I scales. The Consensus on Exercise Reporting Template (CERT) was used to assess the quality of PFMT protocols. All studies were available in full-text including incontinent female participants who are practitioners of high-impact sports, investigating PFMT vs control groups(inactive) or undergoing other treatments. Three RCTs and two non-RCTs (104 participants) were analyzed. PFMT provided a significant improvement in UI symptoms with a reduction in the frequency (n=3) and the amount of UI (n=5). PFM function was assessed in three studies, and two found improvement in maximal contraction and one in vaginal resting pressure in favor of PFMT. None of the two studies that assessed QoL found a difference after PFMT intervention.
Topics: Female; Humans; Pelvic Floor; Exercise Therapy; Urinary Incontinence; Sports; Exercise; Treatment Outcome; Urinary Incontinence, Stress
PubMed: 36075371
DOI: 10.1055/a-1939-4798 -
The Cochrane Database of Systematic... Mar 2020Shock wave therapy has seen widespread use since the 1990s to treat various musculoskeletal disorders including rotator cuff disease, but evidence of its efficacy... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Shock wave therapy has seen widespread use since the 1990s to treat various musculoskeletal disorders including rotator cuff disease, but evidence of its efficacy remains equivocal.
OBJECTIVES
To determine the benefits and harms of shock wave therapy for rotator cuff disease, with or without calcification, and to establish its usefulness in the context of other available treatment options.
SEARCH METHODS
We searched Ovid MEDLINE, Ovid Embase, CENTRAL, ClinicalTrials.gov and the WHO ICTRP up to November 2019, with no restrictions on language. We reviewed the reference lists of retrieved trials to identify potentially relevant trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) that used quasi-randomised methods to allocate participants, investigating participants with rotator cuff disease with or without calcific deposits. We included trials of comparisons of extracorporeal or radial shock wave therapy versus any other intervention. Major outcomes were pain relief greater than 30%, mean pain score, function, patient-reported global assessment of treatment success, quality of life, number of participants experiencing adverse events and number of withdrawals due to adverse events.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies for inclusion, extracted data and assessed the certainty of evidence using GRADE. The primary comparison was shock wave therapy compared to placebo.
MAIN RESULTS
Thirty-two trials (2281 participants) met our inclusion criteria. Most trials (25) included participants with rotator cuff disease and calcific deposits, five trials included participants with rotator cuff disease and no calcific deposits, and two trials included a mixed population of participants with and without calcific deposits. Twelve trials compared shock wave therapy to placebo, 11 trials compared high-dose shock wave therapy (0.2 mJ/mm² to 0.4 mJ/mm² and above) to low-dose shock wave therapy. Single trials compared shock wave therapy to ultrasound-guided glucocorticoid needling, ultrasound-guided hyaluronic acid injection, transcutaneous electric nerve stimulation (TENS), no treatment or exercise; dual session shock wave therapy to single session therapy; and different delivery methods of shock wave therapy. Our main comparison was shock wave therapy versus placebo and results are reported for the 3 month follow up. All trials were susceptible to bias; including selection (74%), performance (62%), detection (62%), and selective reporting (45%) biases. No trial measured participant-reported pain relief of 30%. However, in one trial (74 participants), at 3 months follow up, 14/34 participants reported pain relief of 50% or greater with shock wave therapy compared with 15/40 with placebo (risk ratio (RR) 1.10, 95% confidence interval (CI) 0.62 to 1.94); low-quality evidence (downgraded for bias and imprecision). Mean pain (0 to 10 scale, higher scores indicate more pain) was 3.02 points in the placebo group and 0.78 points better (0.17 better to 1.4 better; clinically important change was 1.5 points) with shock wave therapy (9 trials, 608 participants), moderate-quality evidence (downgraded for bias). Mean function (scale 0 to 100, higher scores indicate better function) was 66 points with placebo and 7.9 points better (1.6 better to 14 better, clinically important difference 10 points) with shock wave therapy (9 trials, 612 participants), moderate-quality evidence (downgraded for bias). Participant-reported success was reported by 58/150 people in shock wave therapy group compared with 35/137 people in placebo group (RR 1.59, 95% CI 0.87 to 2.91; 6 trials, 287 participants), low-quality evidence (downgraded for bias and imprecision). None of the trials measured quality of life. Withdrawal rate or adverse event rates may not differ between extracorporeal shock wave therapy and placebo, but we are uncertain due to the small number of events. There were 11/34 withdrawals in the extracorporeal shock wave therapy group compared with 13/40 withdrawals in the placebo group (RR 0.75, 95% CI 0.43 to 1.31; 7 trials, 581 participants) low-quality evidence (downgraded for bias and imprecision); and 41/156 adverse events with extracorporeal shock wave therapy compared with 10/139 adverse events in the placebo group (RR 3.61, 95% CI 2.00 to 6.52; 5 trials, 295 participants) low-quality evidence (downgraded for bias and imprecision). Subgroup analyses indicated that there were no between-group differences in pain and function outcomes in participants who did or did not have calcific deposits in the rotator cuff.
AUTHORS' CONCLUSIONS
Based upon the currently available low- to moderate-certainty evidence, there were very few clinically important benefits of shock wave therapy, and uncertainty regarding its safety. Wide clinical diversity and varying treatment protocols means that we do not know whether or not some trials tested subtherapeutic doses, possibly underestimating any potential benefits. Further trials of extracorporeal shock wave therapy for rotator cuff disease should be based upon a strong rationale and consideration of whether or not they would alter the conclusions of this review. A standard dose and treatment protocol should be decided upon before further research is conducted. Development of a core set of outcomes for trials of rotator cuff disease and other shoulder disorders would also facilitate our ability to synthesise the evidence.
Topics: Calcinosis; Exercise Therapy; Extracorporeal Shockwave Therapy; Glucocorticoids; Humans; Hyaluronic Acid; Middle Aged; Muscular Diseases; Patient Dropouts; Randomized Controlled Trials as Topic; Rotator Cuff; Shoulder Pain; Transcutaneous Electric Nerve Stimulation; Viscosupplements
PubMed: 32128761
DOI: 10.1002/14651858.CD008962.pub2 -
The Cochrane Database of Systematic... Apr 2018Chronic peripheral joint pain due to osteoarthritis (OA) is extremely prevalent and a major cause of physical dysfunction and psychosocial distress. Exercise is... (Review)
Review
BACKGROUND
Chronic peripheral joint pain due to osteoarthritis (OA) is extremely prevalent and a major cause of physical dysfunction and psychosocial distress. Exercise is recommended to reduce joint pain and improve physical function, but the effect of exercise on psychosocial function (health beliefs, depression, anxiety and quality of life) in this population is unknown.
OBJECTIVES
To improve our understanding of the complex inter-relationship between pain, psychosocial effects, physical function and exercise.
SEARCH METHODS
Review authors searched 23 clinical, public health, psychology and social care databases and 25 other relevant resources including trials registers up to March 2016. We checked reference lists of included studies for relevant studies. We contacted key experts about unpublished studies.
SELECTION CRITERIA
To be included in the quantitative synthesis, studies had to be randomised controlled trials of land- or water-based exercise programmes compared with a control group consisting of no treatment or non-exercise intervention (such as medication, patient education) that measured either pain or function and at least one psychosocial outcome (self-efficacy, depression, anxiety, quality of life). Participants had to be aged 45 years or older, with a clinical diagnosis of OA (as defined by the study) or self-reported chronic hip or knee (or both) pain (defined as more than six months' duration).To be included in the qualitative synthesis, studies had to have reported people's opinions and experiences of exercise-based programmes (e.g. their views, understanding, experiences and beliefs about the utility of exercise in the management of chronic pain/OA).
DATA COLLECTION AND ANALYSIS
We used standard methodology recommended by Cochrane for the quantitative analysis. For the qualitative analysis, we extracted verbatim quotes from study participants and synthesised studies of patients' views using framework synthesis. We then conducted an integrative review, synthesising the quantitative and qualitative data together.
MAIN RESULTS
Twenty-one trials (2372 participants) met the inclusion criteria for quantitative synthesis. There were large variations in the exercise programme's content, mode of delivery, frequency and duration, participant's symptoms, duration of symptoms, outcomes measured, methodological quality and reporting. Comparator groups were varied and included normal care; education; and attention controls such as home visits, sham gel and wait list controls. Risk of bias was high in one and unclear risk in five studies regarding the randomisation process, high for 11 studies regarding allocation concealment, high for all 21 studies regarding blinding, and high for three studies and unclear for five studies regarding attrition. Studies did not provide information on adverse effects.There was moderate quality evidence that exercise reduced pain by an absolute percent reduction of 6% (95% confidence interval (CI) -9% to -4%, (9 studies, 1058 participants), equivalent to reducing (improving) pain by 1.25 points from 6.5 to 5.3 on a 0 to 20 scale and moderate quality evidence that exercise improved physical function by an absolute percent of 5.6% (95% CI -7.6% to 2.0%; standardised mean difference (SMD) -0.27, 95% CI -0.37 to -0.17, equivalent to reducing (improving) WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) function on a 0 to 100 scale from 49.9 to 44.3) (13 studies, 1599 participants)). Self-efficacy was increased by an absolute percent of 1.66% (95% CI 1.08% to 2.20%), although evidence was low quality (SMD 0.46, 95% CI 0.34 to 0.58, equivalent to improving the ExBeliefs score on a 17 to 85 scale from 64.3 to 65.4), with small benefits for depression from moderate quality evidence indicating an absolute percent reduction of 2.4% (95% CI -0.47% to 0.5%) (SMD -0.16, 95% CI -0.29 to -0.02, equivalent to improving depression measured using HADS (Hospital Anxiety and Depression Scale) on a 0 to 21 scale from 3.5 to 3.0) but no clinically or statistically significant effect on anxiety (SMD -0.11, 95% CI -0.26 to 0.05, 2% absolute improvement, 95% CI -5% to 1% equivalent to improving HADS anxiety on a 0 to 21 scale from 5.8 to 5.4; moderate quality evidence). Five studies measured the effect of exercise on health-related quality of life using the 36-item Short Form (SF-36) with statistically significant benefits for social function, increasing it by an absolute percent of 7.9% (95% CI 4.1% to 11.6%), equivalent to increasing SF-36 social function on a 0 to 100 scale from 73.6 to 81.5, although the evidence was low quality. Evidence was downgraded due to heterogeneity of measures, limitations with blinding and lack of detail regarding interventions. For 20/21 studies, there was a high risk of bias with blinding as participants self-reported and were not blinded to their participation in an exercise intervention.Twelve studies (with 6 to 29 participants) met inclusion criteria for qualitative synthesis. Their methodological rigour and quality was generally good. From the patients' perspectives, ways to improve the delivery of exercise interventions included: provide better information and advice about the safety and value of exercise; provide exercise tailored to individual's preferences, abilities and needs; challenge inappropriate health beliefs and provide better support.An integrative review, which compared the findings from quantitative trials with low risk of bias and the implications derived from the high-quality studies in the qualitative synthesis, confirmed the importance of these implications.
AUTHORS' CONCLUSIONS
Chronic hip and knee pain affects all domains of people's lives. People's beliefs about chronic pain shape their attitudes and behaviours about how to manage their pain. People are confused about the cause of their pain, and bewildered by its variability and randomness. Without adequate information and advice from healthcare professionals, people do not know what they should and should not do, and, as a consequence, avoid activity for fear of causing harm. Participation in exercise programmes may slightly improve physical function, depression and pain. It may slightly improve self-efficacy and social function, although there is probably little or no difference in anxiety. Providing reassurance and clear advice about the value of exercise in controlling symptoms, and opportunities to participate in exercise programmes that people regard as enjoyable and relevant, may encourage greater exercise participation, which brings a range of health benefits to a large population of people.
Topics: Anxiety; Arthralgia; Chronic Pain; Depression; Exercise Therapy; Health Knowledge, Attitudes, Practice; Humans; Middle Aged; Osteoarthritis, Hip; Osteoarthritis, Knee; Qualitative Research; Quality of Life; Randomized Controlled Trials as Topic; Self Efficacy; Social Participation; Symptom Assessment
PubMed: 29664187
DOI: 10.1002/14651858.CD010842.pub2 -
Journal of Medical Internet Research Sep 2023Providing informed consent means agreeing to participate in a clinical trial and having understood what is involved. Flawed informed consent processes, including missing... (Review)
Review
BACKGROUND
Providing informed consent means agreeing to participate in a clinical trial and having understood what is involved. Flawed informed consent processes, including missing dates and signatures, are common regulatory audit findings. Electronic consent (eConsent) uses digital technologies to enable the consenting process. It aims to improve participant comprehension and engagement with study information and to address data quality concerns.
OBJECTIVE
This systematic literature review aimed to assess the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, and study enrollment and retention rates, as well as the effects of eConsent on the time patients took to perform the consenting process ("cycle time") and on-site workload in comparison with traditional paper-based consenting.
METHODS
The systematic review was conducted and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Ovid Embase and Ovid MEDLINE were systematically searched for publications reporting original, comparative data on the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, enrollment and retention rates, cycle time, and site workload. The methodological validity of the studies that compared outcomes for comprehension, acceptability, and usability across paper consent and eConsent was assessed. Study methodologies were categorized as having "high" validity if comprehensive assessments were performed using established instruments.
RESULTS
Overall, 37 publications describing 35 studies (13,281 participants) were included. All studies comparing eConsenting and paper-based consenting for comprehension (20/35, 57% of the studies; 10 with "high" validity), acceptability (8/35, 23% of the studies; 1 with "high" validity), and usability (5/35, 14% of the studies; 1 with "high" validity) reported significantly better results with eConsent, better results but without significance testing, or no significant differences in overall results. None of the studies reported better results with paper than with eConsent. Among the "high" validity studies, 6 studies on comprehension reported significantly better understanding of at least some concepts, the study on acceptability reported statistically significant higher satisfaction scores, and the study on usability reported statistically significant higher usability scores with eConsent than with paper (P<.05 for all). Cycle times were increased with eConsent, potentially reflecting greater patient engagement with the content. Data on enrollment and retention were limited. Comparative data from site staff and other study researchers indicated the potential for reduced workload and lower administrative burden with eConsent.
CONCLUSIONS
This systematic review showed that compared with patients using paper-based consenting, patients using eConsent had a better understanding of the clinical trial information, showed greater engagement with content, and rated the consenting process as more acceptable and usable. eConsent solutions thus have the potential to enhance understanding, acceptability, and usability of the consenting process while inherently being able to address data quality concerns, including those related to flawed consenting processes.
Topics: Humans; Data Accuracy; Digital Technology; Electronics; Informed Consent; Patient Participation
PubMed: 37656499
DOI: 10.2196/43883