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The Cochrane Database of Systematic... Feb 2018Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. (Review)
Review
BACKGROUND
Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research.
OBJECTIVES
To quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment.
SEARCH METHODS
We searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index & Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015).
SELECTION CRITERIA
Randomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants.
DATA COLLECTION AND ANALYSIS
We extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison.
MAIN RESULTS
We identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in health care.We found 72 comparisons, but just three are supported by high-certainty evidence according to GRADE.1. Open trials rather than blinded, placebo trials. The absolute improvement was 10% (95% CI 7% to 13%).2. Telephone reminders to people who do not respond to a postal invitation. The absolute improvement was 6% (95% CI 3% to 9%). This result applies to trials that have low underlying recruitment. We are less certain for trials that start out with moderately good recruitment (i.e. over 10%).3. Using a particular, bespoke, user-testing approach to develop participant information leaflets. This method involved spending a lot of time working with the target population for recruitment to decide on the content, format and appearance of the participant information leaflet. This made little or no difference to recruitment: absolute improvement was 1% (95% CI -1% to 3%).We had moderate-certainty evidence for eight other comparisons; our confidence was reduced for most of these because the results came from a single study. Three of the methods were changes to trial management, three were changes to how potential participants received information, one was aimed at recruiters, and the last was a test of financial incentives. All of these comparisons would benefit from other researchers replicating the evaluation. There were no evaluations in paediatric trials.We had much less confidence in the other 61 comparisons because the studies had design flaws, were single studies, had very uncertain results or were hypothetical (mock) trials rather than real ones.
AUTHORS' CONCLUSIONS
The literature on interventions to improve recruitment to trials has plenty of variety but little depth. Only 3 of 72 comparisons are supported by high-certainty evidence according to GRADE: having an open trial and using telephone reminders to non-responders to postal interventions both increase recruitment; a specialised way of developing participant information leaflets had little or no effect. The methodology research community should improve the evidence base by replicating evaluations of existing strategies, rather than developing and testing new ones.
Topics: Humans; Patient Education as Topic; Patient Selection; Randomized Controlled Trials as Topic; Reminder Systems; Sample Size; Telephone
PubMed: 29468635
DOI: 10.1002/14651858.MR000013.pub6 -
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... Jul 2018This is the third update of a review that was originally published in the Cochrane Library in 2002, Issue 2. People with cancer, their families and carers have a high... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is the third update of a review that was originally published in the Cochrane Library in 2002, Issue 2. People with cancer, their families and carers have a high prevalence of psychological stress, which may be minimised by effective communication and support from their attending healthcare professionals (HCPs). Research suggests communication skills do not reliably improve with experience, therefore, considerable effort is dedicated to courses that may improve communication skills for HCPs involved in cancer care. A variety of communication skills training (CST) courses are in practice. We conducted this review to determine whether CST works and which types of CST, if any, are the most effective.
OBJECTIVES
To assess whether communication skills training is effective in changing behaviour of HCPs working in cancer care and in improving HCP well-being, patient health status and satisfaction.
SEARCH METHODS
For this update, we searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 4), MEDLINE via Ovid, Embase via Ovid, PsycInfo and CINAHL up to May 2018. In addition, we searched the US National Library of Medicine Clinical Trial Registry and handsearched the reference lists of relevant articles and conference proceedings for additional studies.
SELECTION CRITERIA
The original review was a narrative review that included randomised controlled trials (RCTs) and controlled before-and-after studies. In updated versions, we limited our criteria to RCTs evaluating CST compared with no CST or other CST in HCPs working in cancer care. Primary outcomes were changes in HCP communication skills measured in interactions with real or simulated people with cancer or both, using objective scales. We excluded studies whose focus was communication skills in encounters related to informed consent for research.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials and extracted data to a pre-designed data collection form. We pooled data using the random-effects method. For continuous data, we used standardised mean differences (SMDs).
MAIN RESULTS
We included 17 RCTs conducted mainly in outpatient settings. Eleven trials compared CST with no CST intervention; three trials compared the effect of a follow-up CST intervention after initial CST training; two trials compared the effect of CST and patient coaching; and one trial compared two types of CST. The types of CST courses evaluated in these trials were diverse. Study participants included oncologists, residents, other doctors, nurses and a mixed team of HCPs. Overall, 1240 HCPs participated (612 doctors including 151 residents, 532 nurses, and 96 mixed HCPs).Ten trials contributed data to the meta-analyses. HCPs in the intervention groups were more likely to use open questions in the post-intervention interviews than the control group (SMD 0.25, 95% CI 0.02 to 0.48; P = 0.03, I² = 62%; 5 studies, 796 participant interviews; very low-certainty evidence); more likely to show empathy towards their patients (SMD 0.18, 95% CI 0.05 to 0.32; P = 0.008, I² = 0%; 6 studies, 844 participant interviews; moderate-certainty evidence), and less likely to give facts only (SMD -0.26, 95% CI -0.51 to -0.01; P = 0.05, I² = 68%; 5 studies, 780 participant interviews; low-certainty evidence). Evidence suggesting no difference between CST and no CST on eliciting patient concerns and providing appropriate information was of a moderate-certainty. There was no evidence of differences in the other HCP communication skills, including clarifying and/or summarising information, and negotiation. Doctors and nurses did not perform differently for any HCP outcomes.There were no differences between the groups with regard to HCP 'burnout' (low-certainty evidence) nor with regard to patient satisfaction or patient perception of the HCPs communication skills (very low-certainty evidence). Out of the 17 included RCTs 15 were considered to be at a low risk of overall bias.
AUTHORS' CONCLUSIONS
Various CST courses appear to be effective in improving HCP communication skills related to supportive skills and to help HCPs to be less likely to give facts only without individualising their responses to the patient's emotions or offering support. We were unable to determine whether the effects of CST are sustained over time, whether consolidation sessions are necessary, and which types of CST programs are most likely to work. We found no evidence to support a beneficial effect of CST on HCP 'burnout', the mental or physical health and satisfaction of people with cancer.
Topics: Anxiety; Caregivers; Communication; Empathy; Health Personnel; Humans; Medical Oncology; Neoplasms; Oncology Nursing; Professional-Patient Relations; Randomized Controlled Trials as Topic; Stress, Psychological
PubMed: 30039853
DOI: 10.1002/14651858.CD003751.pub4 -
Sports (Basel, Switzerland) Dec 2023Sports participation and the risk of osteoarthritis (OA) have been a concern for decades. Few research efforts have been dedicated to clarify this issue for females,... (Review)
Review
Sports participation and the risk of osteoarthritis (OA) have been a concern for decades. Few research efforts have been dedicated to clarify this issue for females, although they are considered at greater risk of developing OA than males. In contrast, several reviews have established an association between sports participation and OA for males. The aim of the systematic review was to assess the association between OA and participation in popular sports for females. PubMed, Embase, and Google Scholar were searched and yielded 578 articles. Nine eligible studies were included and covered ballet (age range: 19-54 years), running or tennis (age range: 40-65 years), Olympic sports (age range: not specified), volleyball (age range: 16.0 ± 0.8 to 46.8 ± 5.1 years), and cross-country skiing (age range: 15 to ≥60 years). For females, participating in sports at an elite level was associated with a higher risk of OA and an increased need for surgical treatment. At non-elite level, it was associated with a higher risk of OA, but it did not materialize to an increased risk for surgical treatment. Few studies compared females and males, and these studies suggested that sex did not affect the risk of developing OA from participating in sports. Nevertheless, to isolate the precise effect of sports participation on the development of OA remains difficult as injuries are common among athletes and are independently associated with an increased risk of OA.
PubMed: 38251289
DOI: 10.3390/sports12010015 -
The Cochrane Database of Systematic... Mar 2022Arthroscopic knee surgery remains a common treatment for symptomatic knee osteoarthritis, including for degenerative meniscal tears, despite guidelines strongly... (Review)
Review
BACKGROUND
Arthroscopic knee surgery remains a common treatment for symptomatic knee osteoarthritis, including for degenerative meniscal tears, despite guidelines strongly recommending against its use. This Cochrane Review is an update of a non-Cochrane systematic review published in 2017.
OBJECTIVES
To assess the benefits and harms of arthroscopic surgery, including debridement, partial menisectomy or both, compared with placebo surgery or non-surgical treatment in people with degenerative knee disease (osteoarthritis, degenerative meniscal tears, or both).
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and two trials registers up to 16 April 2021, unrestricted by language.
SELECTION CRITERIA
We included randomised controlled trials (RCTs), or trials using quasi-randomised methods of participant allocation, comparing arthroscopic surgery with placebo surgery or non-surgical interventions (e.g. exercise, injections, non-arthroscopic lavage/irrigation, drug therapy, and supplements and complementary therapies) in people with symptomatic degenerative knee disease (osteoarthritis or degenerative meniscal tears or both). Major outcomes were pain, function, participant-reported treatment success, knee-specific quality of life, serious adverse events, total adverse events and knee surgery (replacement or osteotomy).
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and the certainty of evidence using GRADE. The primary comparison was arthroscopic surgery compared to placebo surgery for outcomes that measured benefits of surgery, but we combined data from all control groups to assess harms and knee surgery (replacement or osteotomy).
MAIN RESULTS
Sixteen trials (2105 participants) met our inclusion criteria. The average age of participants ranged from 46 to 65 years, and 56% of participants were women. Four trials (380 participants) compared arthroscopic surgery to placebo surgery. For the remaining trials, arthroscopic surgery was compared to exercise (eight trials, 1371 participants), a single intra-articular glucocorticoid injection (one trial, 120 participants), non-arthroscopic lavage (one trial, 34 participants), non-steroidal anti-inflammatory drugs (one trial, 80 participants) and weekly hyaluronic acid injections for five weeks (one trial, 120 participants). The majority of trials without a placebo control were susceptible to bias: in particular, selection (56%), performance (75%), detection (75%), attrition (44%) and selective reporting (75%) biases. The placebo-controlled trials were less susceptible to bias and none were at risk of performance or detection bias. Here we limit reporting to the main comparison, arthroscopic surgery versus placebo surgery. High-certainty evidence indicates arthroscopic surgery leads to little or no difference in pain or function at three months after surgery, moderate-certainty evidence indicates there is probably little or no improvement in knee-specific quality of life three months after surgery, and low-certainty evidence indicates arthroscopic surgery may lead to little or no difference in participant-reported success at up to five years, compared with placebo surgery. Mean post-operative pain in the placebo group was 40.1 points on a 0 to 100 scale (where lower score indicates less pain) compared to 35.5 points in the arthroscopic surgery group, a difference of 4.6 points better (95% confidence interval (CI) 0.02 better to 9 better; I = 0%; 4 trials, 309 participants). Mean post-operative function in the placebo group was 75.9 points on a 0 to 100 rating scale (where higher score indicates better function) compared to 76 points in the arthroscopic surgery group, a difference of 0.1 points better (95% CI 3.2 worse to 3.4 better; I = 0%; 3 trials, 302 participants). Mean post-operative knee-specific health-related quality of life in the placebo group was 69.7 points on a 0 to 100 rating scale (where higher score indicates better quality of life) compared with 75.3 points in the arthroscopic surgery group, a difference of 5.6 points better (95% CI 0.36 better to 10.68 better; I = 0%; 2 trials, 188 participants). We downgraded this evidence to moderate certainty as the 95% confidence interval does not rule in or rule out a clinically important change. After surgery, 74 out of 100 people reported treatment success with placebo and 82 out of 100 people reported treatment success with arthroscopic surgery at up to five years (risk ratio (RR) 1.11, 95% CI 0.66 to 1.86; I = 53%; 3 trials, 189 participants). We downgraded this evidence to low certainty due to serious indirectness (diversity in definition and timing of outcome measurement) and serious imprecision (small number of events). We are less certain if the risk of serious or total adverse events increased with arthroscopic surgery compared to placebo or non-surgical interventions. Serious adverse events were reported in 6 out of 100 people in the control groups and 8 out of 100 people in the arthroscopy groups from eight trials (RR 1.35, 95% CI 0.64 to 2.83; I = 47%; 8 trials, 1206 participants). Fifteen out of 100 people reported adverse events with control interventions, and 17 out of 100 people with surgery at up to five years (RR 1.15, 95% CI 0.78 to 1.70; I = 48%; 9 trials, 1326 participants). The certainty of the evidence was low, downgraded twice due to serious imprecision (small number of events) and possible reporting bias (incomplete reporting of outcome across studies). Serious adverse events included death, pulmonary embolism, acute myocardial infarction, deep vein thrombosis and deep infection. Subsequent knee surgery (replacement or high tibial osteotomy) was reported in 2 out of 100 people in the control groups and 4 out of 100 people in the arthroscopy surgery groups at up to five years in four trials (RR 2.63, 95% CI 0.94 to 7.34; I = 11%; 4 trials, 864 participants). The certainty of the evidence was low, downgraded twice due to the small number of events.
AUTHORS' CONCLUSIONS
Arthroscopic surgery provides little or no clinically important benefit in pain or function, probably does not provide clinically important benefits in knee-specific quality of life, and may not improve treatment success compared with a placebo procedure. It may lead to little or no difference, or a slight increase, in serious and total adverse events compared to control, but the evidence is of low certainty. Whether or not arthroscopic surgery results in slightly more subsequent knee surgery (replacement or osteotomy) compared to control remains unresolved.
Topics: Aged; Arthroscopy; Female; Humans; Middle Aged; Osteoarthritis, Knee; Pain Measurement; Pain, Postoperative; Quality of Life
PubMed: 35238404
DOI: 10.1002/14651858.CD014328 -
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 -
The Cochrane Database of Systematic... May 2018Early childhood vaccination is an essential global public health practice that saves two to three million lives each year, but many children do not receive all the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Early childhood vaccination is an essential global public health practice that saves two to three million lives each year, but many children do not receive all the recommended vaccines. To achieve and maintain appropriate coverage rates, vaccination programmes rely on people having sufficient awareness and acceptance of vaccines.Face-to-face information or educational interventions are widely used to help parents understand why vaccines are important; explain where, how and when to access services; and address hesitancy and concerns about vaccine safety or efficacy. Such interventions are interactive, and can be adapted to target particular populations or identified barriers.This is an update of a review originally published in 2013.
OBJECTIVES
To assess the effects of face-to-face interventions for informing or educating parents about early childhood vaccination on vaccination status and parental knowledge, attitudes and intention to vaccinate.
SEARCH METHODS
We searched the CENTRAL, MEDLINE, Embase, five other databases, and two trial registries (July and August 2017). We screened reference lists of relevant articles, and contacted authors of included studies and experts in the field. We had no language or date restrictions.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and cluster-RCTs evaluating the effects of face-to-face interventions delivered to parents or expectant parents to inform or educate them about early childhood vaccination, compared with control or with another face-to-face intervention. The World Health Organization recommends that children receive all early childhood vaccines, with the exception of human papillomavirus vaccine (HPV), which is delivered to adolescents.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Two authors independently reviewed all search results, extracted data and assessed the risk of bias of included studies.
MAIN RESULTS
In this update, we found four new studies, for a total of ten studies. We included seven RCTs and three cluster-RCTs involving a total of 4527 participants, although we were unable to pool the data from one cluster-RCT. Three of the ten studies were conducted in low- or middle- income countries.All included studies compared face-to-face interventions with control. Most studies evaluated the effectiveness of a single intervention session delivered to individual parents. The interventions were an even mix of short (ten minutes or less) and longer sessions (15 minutes to several hours).Overall, elements of the study designs put them at moderate to high risk of bias. All studies but one were at low risk of bias for sequence generation (i.e. used a random number sequence). For allocation concealment (i.e. the person randomising participants was unaware of the study group to which participant would be allocated), three were at high risk and one was judged at unclear risk of bias. Due to the educational nature of the intervention, blinding of participants and personnel was not possible in any studies. The risk of bias due to blinding of outcome assessors was judged as low for four studies. Most studies were at unclear risk of bias for incomplete outcome data and selective reporting. Other potential sources of bias included failure to account for clustering in a cluster-RCT and significant unexplained baseline differences between groups. One cluster-RCT was at high risk for selective recruitment of participants.We judged the certainty of the evidence to be low for the outcomes of children's vaccination status, parents' attitudes or beliefs, intention to vaccinate, adverse effects (e.g. anxiety), and immunisation cost, and moderate for parents' knowledge or understanding. All studies had limitations in design. We downgraded the certainty of the evidence where we judged that studies had problems with randomisation or allocation concealment, or when outcomes were self-reported by participants who knew whether they'd received the intervention or not. We also downgraded the certainty for inconsistency (vaccination status), imprecision (intention to vaccinate and adverse effects), and indirectness (attitudes or beliefs, and cost).Low-certainty evidence from seven studies (3004 participants) suggested that face-to-face interventions to inform or educate parents may improve vaccination status (risk ratio (RR) 1.20, 95% confidence interval (CI) 1.04 to 1.37). Moderate-certainty evidence from four studies (657 participants) found that face-to-face interventions probably slightly improved parent knowledge (standardised mean difference (SMD) 0.19, 95% CI 0.00 to 0.38), and low-certainty evidence from two studies (179 participants) suggested they may slightly improve intention to vaccinate (SMD 0.55, 95% CI 0.24 to 0.85). Low-certainty evidence found the interventions may lead to little or no change in parent attitudes or beliefs about vaccination (SMD 0.03, 95% CI -0.20 to 0.27; three studies, 292 participants), or in parents' anxiety (mean difference (MD) -1.93, 95% CI -7.27 to 3.41; one study, 90 participants). Only one study (365 participants) measured the intervention cost of a case management strategy, reporting that the estimated additional cost per fully immunised child for the intervention was approximately eight times higher than usual care (low-certainty evidence). No included studies reported outcomes associated with parents' experience of the intervention (e.g. satisfaction).
AUTHORS' CONCLUSIONS
There is low- to moderate-certainty evidence suggesting that face-to-face information or education may improve or slightly improve children's vaccination status, parents' knowledge, and parents' intention to vaccinate.Face-to-face interventions may be more effective in populations where lack of awareness or understanding of vaccination is identified as a barrier (e.g. where people are unaware of new or optional vaccines). The effect of the intervention in a population where concerns about vaccines or vaccine hesitancy is the primary barrier is less clear. Reliable and validated scales for measuring more complex outcomes, such as attitudes or beliefs, are necessary in order to improve comparisons of the effects across studies.
Topics: Child; Child, Preschool; Health Education; Humans; Infant; Mothers; Parents; Randomized Controlled Trials as Topic; Vaccination
PubMed: 29736980
DOI: 10.1002/14651858.CD010038.pub3 -
The Cochrane Database of Systematic... May 2022Motor neuron disease (MND), also known as amyotrophic lateral sclerosis (ALS), is a progressive neurodegenerative condition that may cause dysphagia, as well as limb... (Review)
Review
BACKGROUND
Motor neuron disease (MND), also known as amyotrophic lateral sclerosis (ALS), is a progressive neurodegenerative condition that may cause dysphagia, as well as limb weakness, dysarthria, emotional lability, and respiratory failure. Since normal salivary production is 0.5 L to 1.5 L daily, loss of salivary clearance due to dysphagia leads to salivary pooling and sialorrhea, often resulting in distress and inconvenience to people with MND. This is an update of a review first published in 2011.
OBJECTIVES
To assess the effects of treatments for sialorrhea in MND, including medications, radiotherapy and surgery.
SEARCH METHODS
On 27 August 2021, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL, ClinicalTrials.gov and the WHO ICTRP. We checked the bibliographies of the identified randomized trials and contacted trial authors as needed. We contacted known experts in the field to identify further published and unpublished papers.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-RCTs, including cross-over trials, on any intervention for sialorrhea and related symptoms, compared with each other, placebo or no intervention, in people with ALS/MND.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We identified four RCTs involving 110 participants with MND who were described as having intractable sialorrhea or bulbar dysfunction. A well-designed study of botulinum toxin B compared to placebo injected into the parotid and submandibular glands of 20 participants showed that botulinum toxin B may produce participant-reported improvement in sialorrhea, but the confidence interval (CI) was also consistent with no effect. Six of nine participants in the botulinum group and two of nine participants in the placebo group reported improvement (risk ratio (RR) 3.00, 95% CI 0.81 to 11.08; 1 RCT; 18 participants; low-certainty evidence). An objective measure indicated that botulinum toxin B probably reduced saliva production (in mL/5 min) at eight weeks compared to placebo (MD -0.50, 95% CI -1.07 to 0.07; 18 participants, moderate-certainty evidence). Botulinum toxin B may have little to no effect on quality of life, measured on the Schedule for Evaluation of Individual Quality of Life direct weighting scale (SEIQoL-DW; 0-100, higher values indicate better quality of life) (MD -2.50, 95% CI -17.34 to 12.34; 1 RCT; 17 participants; low-certainty evidence). The rate of adverse events may be similar with botulinum toxin B and placebo (20 participants; low-certainty evidence). Trialists did not consider any serious events to be related to treatment. A randomized pilot study of botulinum toxin A or radiotherapy in 20 participants, which was at high risk of bias, provided very low-certainty evidence on the primary outcome of the Drool Rating Scale (DRS; range 8 to 39 points, higher scores indicate worse drooling) at 12 weeks (effect size -4.8, 95% CI -10.59 to 0.92; P = 0.09; 1 RCT; 16 participants). Quality of life was not measured. Evidence for adverse events, measured immediately after treatment (RR 7.00, 95% CI 1.04 to 46.95; 20 participants), and after four weeks (when two people in each group had viscous saliva) was also very uncertain. A phase 2, randomized, placebo-controlled cross-over study of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate (DMQ) found that DMQ may produce a participant-reported improvement in sialorrhea, indicated by a slight improvement (decrease) in mean scores for the primary outcome, the Center for Neurologic Study Bulbar Function Scale (CNS-BFS). Mean total CNS-BFS (range 21 (no symptoms) to 112 (maximum symptoms)) was 53.45 (standard error (SE) 1.07) for the DMQ treatment period and 59.31 (SE 1.10) for the placebo period (mean difference) MD -5.85, 95% CI -8.77 to -2.93) with a slight decrease in the CNS-BFS sialorrhea subscale score (range 7 (no symptoms) to 35 (maximum symptoms)) compared to placebo (MD -1.52, 95% CI -2.52 to -0.52) (1 RCT; 60 participants; moderate-certainty evidence). The trial did not report an objective measure of saliva production or measure quality of life. The study was at an unclear risk of bias. Adverse events were similar to other trials of DMQ, and may occur at a similar rate as placebo (moderate-certainty evidence, 60 participants), with the most common side effects being constipation, diarrhea, nausea, and dizziness. Nausea and diarrhea on DMQ treatment resulted in one withdrawal. A randomized, double-blind, placebo-controlled cross-over study of scopolamine (hyoscine), administered using a skin patch, involved 10 randomized participants, of whom eight provided efficacy data. The participants were unrepresentative of clinic cohorts under routine clinical care as they had feeding tubes and tracheostomy ventilation, and the study was at high risk of bias. The trial provided very low-certainty evidence on sialorrhea in the short term (7 days' treatment, measured on the Amyotrophic Lateral Scelerosis Functional Rating Scale-Revised (ALSFRS-R) saliva item (P = 0.572)), and the amount of saliva production in the short term, as indicated by the weight of a cotton roll (P = 0.674), or daily oral suction volume (P = 0.69). Quality of life was not measured. Adverse events evidence was also very uncertain. One person treated with scopolamine had a dry mouth and one died of aspiration pneumonia considered unrelated to treatment.
AUTHORS' CONCLUSIONS
There is some low-certainty or moderate-certainty evidence for the use of botulinum toxin B injections to salivary glands and moderate-certainty evidence for the use of oral dextromethorphan with quinidine (DMQ) for the treatment of sialorrhea in MND. Evidence on radiotherapy versus botulinum toxin A injections, and scopolamine patches is too uncertain for any conclusions to be drawn. Further research is required on treatments for sialorrhea. Data are needed on the problem of sialorrhea in MND and its measurement, both by participant self-report measures and objective tests. These will allow the development of better RCTs.
Topics: Amyotrophic Lateral Sclerosis; Botulinum Toxins, Type A; Clinical Trials, Phase II as Topic; Deglutition Disorders; Diarrhea; Humans; Motor Neuron Disease; Nausea; Randomized Controlled Trials as Topic; Saliva; Scopolamine Derivatives; Sialorrhea
PubMed: 35593746
DOI: 10.1002/14651858.CD006981.pub3 -
The Cochrane Database of Systematic... Dec 2020The introduction and advancement of enteral feeds for preterm or low birth weight infants is often delayed because of concerns that early full enteral feeding will not... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The introduction and advancement of enteral feeds for preterm or low birth weight infants is often delayed because of concerns that early full enteral feeding will not be well tolerated or may increase the risk of necrotising enterocolitis. Early full enteral feeding, however, might increase nutrient intake and growth rates; accelerate intestinal physiological, metabolic, and microbiomic postnatal transition; and reduce the risk of complications associated with intravascular devices for fluid administration. OBJECTIVES: To determine how early full enteral feeding, compared with delayed or progressive introduction of enteral feeds, affects growth and adverse events such as necrotising enterocolitis, in preterm or low birth weight infants.
SEARCH METHODS
We used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials; MEDLINE Ovid, Embase Ovid, Maternity & Infant Care Database Ovid, the Cumulative Index to Nursing and Allied Health Literature, and clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials to October 2020.
SELECTION CRITERIA
Randomised controlled trials that compared early full enteral feeding with delayed or progressive introduction of enteral feeds in preterm or low birth weight infants.
DATA COLLECTION AND ANALYSIS
We used the standard methods of Cochrane Neonatal. Two review authors separately assessed trial eligibility, evaluated trial quality, extracted data, and synthesised effect estimates using risk ratios (RR), risk differences, and mean differences (MD) with 95% confidence intervals (CI). We used the GRADE approach to assess the certainty of evidence.
MAIN RESULTS
We included six trials. All were undertaken in the 2010s in neonatal care facilities in India. In total, 526 infants participated. Most were very preterm infants of birth weight between 1000 g and 1500 g. Trials were of good methodological quality, but a potential source of bias was that parents, clinicians, and investigators were not masked. The trials compared early full feeding (60 mL/kg to 80 mL/kg on day one after birth) with minimal enteral feeding (typically 20 mL/kg on day one) supplemented with intravenous fluids. Feed volumes were advanced daily as tolerated by 20 mL/kg to 30 mL/kg body weight to a target steady-state volume of 150 mL/kg to 180 mL/kg/day. All participating infants were fed preferentially with maternal expressed breast milk, with two trials supplementing insufficient volumes with donor breast milk and four supplementing with preterm formula. Few data were available to assess growth parameters. One trial (64 participants) reported a slower rate of weight gain (median difference -3.0 g/kg/day), and another (180 participants) reported a faster rate of weight gain in the early full enteral feeding group (MD 1.2 g/kg/day). We did not meta-analyse these data (very low-certainty evidence). None of the trials reported rate of head circumference growth. One trial reported that the mean z-score for weight at hospital discharge was higher in the early full enteral feeding group (MD 0.24, 95% CI 0.06 to 0.42; low-certainty evidence). Meta-analyses showed no evidence of an effect on necrotising enterocolitis (RR 0.98, 95% CI 0.38 to 2.54; 6 trials, 522 participants; I² = 51%; very low-certainty evidence).
AUTHORS' CONCLUSIONS
Trials provided insufficient data to determine with any certainty how early full enteral feeding, compared with delayed or progressive introduction of enteral feeds, affects growth in preterm or low birth weight infants. We are uncertain whether early full enteral feeding affects the risk of necrotising enterocolitis because of the risk of bias in the trials (due to lack of masking), inconsistency, and imprecision.
Topics: Body Weight; Enteral Nutrition; Enterocolitis, Necrotizing; Fluid Therapy; Humans; Infant Formula; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Milk, Human; Randomized Controlled Trials as Topic; Weight Gain
PubMed: 33368149
DOI: 10.1002/14651858.CD013542.pub2 -
Trials Jan 2023For children and young people with eye and vision conditions, research is essential to advancing evidence-based recommendations in diagnosis, prevention, treatments and... (Review)
Review
BACKGROUND
For children and young people with eye and vision conditions, research is essential to advancing evidence-based recommendations in diagnosis, prevention, treatments and cures. Patient 'experience' reflects a key measure of quality in health care (Department of Health. High Quality Care for All: NHS Next Stage Review Final Report: The Stationery Office (2008)); research participant 'experiences' are equally important. Therefore, in order to achieve child-centred, high-quality paediatric ophthalmic research, we need to understand participation experiences. We conducted a systematic review of existing literature; our primary outcome was to understand what children and young people, parents and research staff perceive to support or hinder positive paediatric eye and vision research experiences. Our secondary outcomes explored whether any adverse or positive effects were perceived to be related to participation experiences, and if any interventions to improve paediatric ophthalmic research experiences had previously been developed or used.
METHODS
We searched (from inception to November 2018, updated July 2020) in MEDLINE, Embase, CINAHL, Web of Science, NICE evidence and The Cochrane Library (CDSR and CENTRAL), key journals (by hand), grey literature databases and Google Scholar; looking for evidence from the perspectives of children, young people, parents and staff with experience of paediatric ophthalmic research. The National Institute for Health Research (NIHR) Participant in Research Experience Survey (PRES) (National Institute for Health Research. Research Participant Experience Survey Report 2018-19 (2019); National Institute for Health Research. Optimising the Participant in Research Experience Checklist (2019)) identified 'five domains' pivotal to shaping positive research experiences; we used these domains as an 'a priori' framework to conduct a 'best fit' synthesis (Carroll et al., BMC Med Res Methodol. 11:29, 2011; Carroll et al., BMC Med Res Methodol. 13:37, 2013).
RESULTS
Our search yielded 13,020 papers; two studies were eligible. These evaluated research experiences from the perspectives of parents and staff; the perspectives of children and young people themselves were not collected. No studies were identified addressing our secondary objectives. Synthesis confirmed the experiences of parents were shaped by staff characteristics, information provision, trial organisation and personal motivations, concurring with the 'PRES domains' (National Institute for Health Research. Optimising the Participant in Research Experience Checklist (2019)) and generating additional dimensions to participation motivations and the physical and emotional costs of study organisation.
CONCLUSIONS
The evidence base is limited and importantly omits the voices of children and young people. Further research, involving children and young people, is necessary to better understand the research experiences of this population, and so inform quality improvements for paediatric ophthalmic research care and outcomes.
TRIAL REGISTRATION
Review registered with PROSPERO, International prospective register of systematic reviews: CRD42018117984. Registered on 11 December 2018.
Topics: Adolescent; Child; Humans; Delivery of Health Care; Health Facilities; Motivation
PubMed: 36709306
DOI: 10.1186/s13063-022-07021-1