-
The Cochrane Database of Systematic... Jan 2015Terminally ill people experience a variety of symptoms in the last hours and days of life, including delirium, agitation, anxiety, terminal restlessness, dyspnoea, pain,... (Review)
Review
BACKGROUND
Terminally ill people experience a variety of symptoms in the last hours and days of life, including delirium, agitation, anxiety, terminal restlessness, dyspnoea, pain, vomiting, and psychological and physical distress. In the terminal phase of life, these symptoms may become refractory, and unable to be controlled by supportive and palliative therapies specifically targeted to these symptoms. Palliative sedation therapy is one potential solution to providing relief from these refractory symptoms. Sedation in terminally ill people is intended to provide relief from refractory symptoms that are not controlled by other methods. Sedative drugs such as benzodiazepines are titrated to achieve the desired level of sedation; the level of sedation can be easily maintained and the effect is reversible.
OBJECTIVES
To assess the evidence for the benefit of palliative pharmacological sedation on quality of life, survival, and specific refractory symptoms in terminally ill adults during their last few days of life.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 11), MEDLINE (1946 to November 2014), and EMBASE (1974 to December 2014), using search terms representing the sedative drug names and classes, disease stage, and study designs.
SELECTION CRITERIA
We included randomised controlled trials (RCTs), quasi-RCTs, non-RCTs, and observational studies (e.g. before-and-after, interrupted-time-series) with quantitative outcomes. We excluded studies with only qualitative outcomes or that had no comparison (i.e. no control group or no within-group comparison) (e.g. single arm case series).
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles and abstracts of citations, and full text of potentially eligible studies. Two review authors independently carried out data extraction using standard data extraction forms. A third review author acted as arbiter for both stages. We carried out no meta-analyses due to insufficient data for pooling on any outcome; therefore, we reported outcomes narratively.
MAIN RESULTS
The searches resulted in 14 included studies, involving 4167 adults, of whom 1137 received palliative sedation. More than 95% of people had cancer. No studies were randomised or quasi-randomised. All were consecutive case series, with only three having prospective data collection. Risk of bias was high, due to lack of randomisation. No studies measured quality of life or participant well-being, which was the primary outcome of the review. Five studies measured symptom control, using four different methods, so pooling was not possible. The results demonstrated that despite sedation, delirium and dyspnoea were still troublesome symptoms in these people in the last few days of life. Control of other symptoms appeared to be similar in sedated and non-sedated people. Only one study measured unintended adverse effects of sedative drugs and found no major events; however, four of 70 participants appeared to have drug-induced delirium. The study noticed no respiratory suppression. Thirteen of the 14 studies measured survival time from admission or referral to death, and all demonstrated no statistically significant difference between sedated and non-sedated groups.
AUTHORS' CONCLUSIONS
There was insufficient evidence about the efficacy of palliative sedation in terms of a person's quality of life or symptom control. There was evidence that palliative sedation did not hasten death, which has been a concern of physicians and families in prescribing this treatment. However, this evidence comes from low quality studies, so should be interpreted with caution. Further studies that specifically measure the efficacy and quality of life in sedated people, compared with non-sedated people, and quantify adverse effects are required.
Topics: Adult; Conscious Sedation; Deep Sedation; Humans; Hypnotics and Sedatives; Palliative Care; Selection Bias; Terminal Care; Terminally Ill
PubMed: 25879099
DOI: 10.1002/14651858.CD010206.pub2 -
The Cochrane Database of Systematic... Jun 2015Dental caries is a major public health problem in most industrialised countries, affecting 60% to 90% of school children. Community water fluoridation was initiated in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Dental caries is a major public health problem in most industrialised countries, affecting 60% to 90% of school children. Community water fluoridation was initiated in the USA in 1945 and is currently practised in about 25 countries around the world; health authorities consider it to be a key strategy for preventing dental caries. Given the continued interest in this topic from health professionals, policy makers and the public, it is important to update and maintain a systematic review that reflects contemporary evidence.
OBJECTIVES
To evaluate the effects of water fluoridation (artificial or natural) on the prevention of dental caries.To evaluate the effects of water fluoridation (artificial or natural) on dental fluorosis.
SEARCH METHODS
We searched the following electronic databases: The Cochrane Oral Health Group's Trials Register (to 19 February 2015); The Cochrane Central Register of Controlled Trials (CENTRAL; Issue 1, 2015); MEDLINE via OVID (1946 to 19 February 2015); EMBASE via OVID (1980 to 19 February 2015); Proquest (to 19 February 2015); Web of Science Conference Proceedings (1990 to 19 February 2015); ZETOC Conference Proceedings (1993 to 19 February 2015). We searched the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization's WHO International Clinical Trials Registry Platform for ongoing trials. There were no restrictions on language of publication or publication status in the searches of the electronic databases.
SELECTION CRITERIA
For caries data, we included only prospective studies with a concurrent control that compared at least two populations - one receiving fluoridated water and the other non-fluoridated water - with outcome(s) evaluated at at least two points in time. For the assessment of fluorosis, we included any type of study design, with concurrent control, that compared populations exposed to different water fluoride concentrations. We included populations of all ages that received fluoridated water (naturally or artificially fluoridated) or non-fluoridated water.
DATA COLLECTION AND ANALYSIS
We used an adaptation of the Cochrane 'Risk of bias' tool to assess risk of bias in the included studies.We included the following caries indices in the analyses: decayed, missing and filled teeth (dmft (deciduous dentition) and DMFT (permanent dentition)), and proportion caries free in both dentitions. For dmft and DMFT analyses we calculated the difference in mean change scores between the fluoridated and control groups. For the proportion caries free we calculated the difference in the proportion caries free between the fluoridated and control groups.For fluorosis data we calculated the log odds and presented them as probabilities for interpretation.
MAIN RESULTS
A total of 155 studies met the inclusion criteria; 107 studies provided sufficient data for quantitative synthesis.The results from the caries severity data indicate that the initiation of water fluoridation results in reductions in dmft of 1.81 (95% CI 1.31 to 2.31; 9 studies at high risk of bias, 44,268 participants) and in DMFT of 1.16 (95% CI 0.72 to 1.61; 10 studies at high risk of bias, 78,764 participants). This translates to a 35% reduction in dmft and a 26% reduction in DMFT compared to the median control group mean values. There were also increases in the percentage of caries free children of 15% (95% CI 11% to 19%; 10 studies, 39,966 participants) in deciduous dentition and 14% (95% CI 5% to 23%; 8 studies, 53,538 participants) in permanent dentition. The majority of studies (71%) were conducted prior to 1975 and the widespread introduction of the use of fluoride toothpaste.There is insufficient information to determine whether initiation of a water fluoridation programme results in a change in disparities in caries across socioeconomic status (SES) levels.There is insufficient information to determine the effect of stopping water fluoridation programmes on caries levels.No studies that aimed to determine the effectiveness of water fluoridation for preventing caries in adults met the review's inclusion criteria.With regard to dental fluorosis, we estimated that for a fluoride level of 0.7 ppm the percentage of participants with fluorosis of aesthetic concern was approximately 12% (95% CI 8% to 17%; 40 studies, 59,630 participants). This increases to 40% (95% CI 35% to 44%) when considering fluorosis of any level (detected under highly controlled, clinical conditions; 90 studies, 180,530 participants). Over 97% of the studies were at high risk of bias and there was substantial between-study variation.
AUTHORS' CONCLUSIONS
There is very little contemporary evidence, meeting the review's inclusion criteria, that has evaluated the effectiveness of water fluoridation for the prevention of caries.The available data come predominantly from studies conducted prior to 1975, and indicate that water fluoridation is effective at reducing caries levels in both deciduous and permanent dentition in children. Our confidence in the size of the effect estimates is limited by the observational nature of the study designs, the high risk of bias within the studies and, importantly, the applicability of the evidence to current lifestyles. The decision to implement a water fluoridation programme relies upon an understanding of the population's oral health behaviour (e.g. use of fluoride toothpaste), the availability and uptake of other caries prevention strategies, their diet and consumption of tap water and the movement/migration of the population. There is insufficient evidence to determine whether water fluoridation results in a change in disparities in caries levels across SES. We did not identify any evidence, meeting the review's inclusion criteria, to determine the effectiveness of water fluoridation for preventing caries in adults.There is insufficient information to determine the effect on caries levels of stopping water fluoridation programmes.There is a significant association between dental fluorosis (of aesthetic concern or all levels of dental fluorosis) and fluoride level. The evidence is limited due to high risk of bias within the studies and substantial between-study variation.
Topics: Adolescent; Child; Child, Preschool; DMF Index; Dental Caries; Fluoridation; Fluorosis, Dental; Humans; Observational Studies as Topic; Prospective Studies; Selection Bias
PubMed: 26092033
DOI: 10.1002/14651858.CD010856.pub2 -
The Cochrane Database of Systematic... Oct 2020Respiratory distress, particularly respiratory distress syndrome (RDS), is the single most important cause of morbidity and mortality in preterm infants. In infants with... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Respiratory distress, particularly respiratory distress syndrome (RDS), is the single most important cause of morbidity and mortality in preterm infants. In infants with progressive respiratory insufficiency, intermittent positive pressure ventilation (IPPV) with surfactant has been the usual treatment, but it is invasive, potentially resulting in airway and lung injury. Continuous positive airway pressure (CPAP) has been used for the prevention and treatment of respiratory distress, as well as for the prevention of apnoea, and in weaning from IPPV. Its use in the treatment of RDS might reduce the need for IPPV and its sequelae.
OBJECTIVES
To determine the effect of continuous distending pressure in the form of CPAP on the need for IPPV and associated morbidity in spontaneously breathing preterm infants with respiratory distress.
SEARCH METHODS
We used the standard strategy of Cochrane Neonatal to search CENTRAL (2020, Issue 6); Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions; and CINAHL on 30 June 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.
SELECTION CRITERIA
All randomised or quasi-randomised trials of preterm infants with respiratory distress were eligible. Interventions were CPAP by mask, nasal prong, nasopharyngeal tube or endotracheal tube, compared with spontaneous breathing with supplemental oxygen as necessary.
DATA COLLECTION AND ANALYSIS
We used standard methods of Cochrane and its Neonatal Review Group, including independent assessment of risk of bias and extraction of data by two review authors. We used the GRADE approach to assess the certainty of evidence. Subgroup analyses were planned on the basis of birth weight (greater than or less than 1000 g or 1500 g), gestational age (groups divided at about 28 weeks and 32 weeks), timing of application (early versus late in the course of respiratory distress), pressure applied (high versus low) and trial setting (tertiary compared with non-tertiary hospitals; high income compared with low income) MAIN RESULTS: We included five studies involving 322 infants; two studies used face mask CPAP, two studies used nasal CPAP and one study used endotracheal CPAP and continuing negative pressure for a small number of less ill babies. For this update, we included one new trial. CPAP was associated with lower risk of treatment failure (death or use of assisted ventilation) (typical risk ratio (RR) 0.64, 95% confidence interval (CI) 0.50 to 0.82; typical risk difference (RD) -0.19, 95% CI -0.28 to -0.09; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% CI 4 to 11; I = 50%; 5 studies, 322 infants; very low-certainty evidence), lower use of ventilatory assistance (typical RR 0.72, 95% CI 0.54 to 0.96; typical RD -0.13, 95% CI -0.25 to -0.02; NNTB 8, 95% CI 4 to 50; I = 55%; very low-certainty evidence) and lower overall mortality (typical RR 0.53, 95% CI 0.34 to 0.83; typical RD -0.11, 95% CI -0.18 to -0.04; NNTB 9, 95% CI 2 to 13; I = 0%; 5 studies, 322 infants; moderate-certainty evidence). CPAP was associated with increased risk of pneumothorax (typical RR 2.48, 95% CI 1.16 to 5.30; typical RD 0.09, 95% CI 0.02 to 0.16; number needed to treat for an additional harmful outcome (NNTH) 11, 95% CI 7 to 50; I = 0%; 4 studies, 274 infants; low-certainty evidence). There was no evidence of a difference in bronchopulmonary dysplasia, defined as oxygen dependency at 28 days (RR 1.04, 95% CI 0.35 to 3.13; I = 0%; 2 studies, 209 infants; very low-certainty evidence). The trials did not report use of surfactant, intraventricular haemorrhage, retinopathy of prematurity, necrotising enterocolitis and neurodevelopment outcomes in childhood.
AUTHORS' CONCLUSIONS
In preterm infants with respiratory distress, the application of CPAP is associated with reduced respiratory failure, use of mechanical ventilation and mortality and an increased rate of pneumothorax compared to spontaneous breathing with supplemental oxygen as necessary. Three out of five of these trials were conducted in the 1970s. Therefore, the applicability of these results to current practice is unclear. Further studies in resource-poor settings should be considered and research to determine the most appropriate pressure level needs to be considered.
Topics: Bronchopulmonary Dysplasia; Continuous Positive Airway Pressure; Humans; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Intermittent Positive-Pressure Ventilation; Outcome Assessment, Health Care; Pneumothorax; Pulmonary Surfactants; Randomized Controlled Trials as Topic; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Selection Bias; Treatment Failure
PubMed: 33058208
DOI: 10.1002/14651858.CD002271.pub3 -
BMJ (Clinical Research Ed.) Mar 2009To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies. (Review)
Review
OBJECTIVES
To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies.
DESIGN
Systematic review.
DATA SOURCES
Embase, Medline, and the Cochrane Library up to March 2008, reference lists from pertinent articles, and searches of electronic citations.
STUDY SELECTION
Prospective observational studies reporting characteristics of participants and non-participants approached for informed consent to use their medical records. Studies were selected independently in duplicate; a third reviewer resolved disagreements.
DATA EXTRACTION
Age, sex, race, education, income, or health status of participants and non-participants, the participation rate in each study, and susceptibility of these calculations to threats of selection and reporting bias.
RESULTS
Of 1650 citations 17 unique studies met inclusion criteria and had analysable data. Across all outcomes there were differences between participants and non-participants; however, there was a lack of consistency in the direction and the magnitude of effect. Of 161 604 eligible patients, 66.9% consented to use of data from their medical records.
CONCLUSIONS
Significant differences between participants and non-participants may threaten the validity of results from observational studies that require consent for use of data from medical records. To ensure that legislation on privacy does not unduly bias observational studies using medical records, thoughtful decision making by research ethics boards on the need for mandatory consent is necessary.
Topics: Humans; Informed Consent; Medical Records; Research Design; Selection Bias
PubMed: 19282440
DOI: 10.1136/bmj.b866 -
Annals of Internal Medicine Apr 2023Yoga, a multicomponent mind-body practice, improves several domains of physical and psychological health and may affect frailty in older adults. (Review)
Review
BACKGROUND
Yoga, a multicomponent mind-body practice, improves several domains of physical and psychological health and may affect frailty in older adults.
PURPOSE
To evaluate the available trial evidence on the effect of yoga-based interventions on frailty in older adults.
DATA SOURCES
MEDLINE, EMBASE, and Cochrane Central from their inception to 12 December 2022.
STUDY SELECTION
Randomized controlled trials evaluating the effect of yoga-based interventions, including at least 1 session of physical postures, on a validated frailty scale or single-item markers of frailty in adults aged 65 years or older.
DATA EXTRACTION
Two authors independently screened articles and extracted data; 1 author assessed risk of bias with review from a second author. Disagreements were resolved through consensus and as-needed input from a third author.
DATA SYNTHESIS
Thirty-three studies ( = 2384 participants) were identified in varied populations, including community dwellers, nursing home residents, and those with chronic disease. Yoga styles were primarily based on Hatha yoga and most often included Iyengar or chair-based methods. Single-item frailty markers included measures of gait speed, handgrip strength, balance, lower-extremity strength and endurance, and multicomponent physical performance measures; no studies included a validated definition of frailty. When compared with education or inactive control, there was moderate-certainty evidence that yoga improved gait speed and lower-extremity strength and endurance, low-certainty evidence for balance and multicomponent physical function measures, and very low-certainty evidence for handgrip strength.
LIMITATION
Heterogeneity in study design and yoga style, small sample sizes, and reporting deficiencies leading to concerns for selection bias.
CONCLUSION
Yoga may affect frailty markers that are associated with clinically meaningful outcomes in older adult populations but may not offer benefit over active interventions (for example, exercise).
PRIMARY FUNDING SOURCE
None. (PROSPERO: CRD42020130303).
Topics: Humans; Aged; Yoga; Frailty; Hand Strength; Exercise; Physical Examination
PubMed: 36913687
DOI: 10.7326/M22-2553 -
The Cochrane Database of Systematic... Mar 2015Children with developmental speech sound disorders have difficulties in producing the speech sounds of their native language. These speech difficulties could be due to... (Review)
Review
BACKGROUND
Children with developmental speech sound disorders have difficulties in producing the speech sounds of their native language. These speech difficulties could be due to structural, sensory or neurophysiological causes (e.g. hearing impairment), but more often the cause of the problem is unknown. One treatment approach used by speech-language therapists/pathologists is non-speech oral motor treatment (NSOMT). NSOMTs are non-speech activities that aim to stimulate or improve speech production and treat specific speech errors. For example, using exercises such as smiling, pursing, blowing into horns, blowing bubbles, and lip massage to target lip mobility for the production of speech sounds involving the lips, such as /p/, /b/, and /m/. The efficacy of this treatment approach is controversial, and evidence regarding the efficacy of NSOMTs needs to be examined.
OBJECTIVES
To assess the efficacy of non-speech oral motor treatment (NSOMT) in treating children with developmental speech sound disorders who have speech errors.
SEARCH METHODS
In April 2014 we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (R) and Ovid MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Education Resources Information Center (ERIC), PsycINFO and 11 other databases. We also searched five trial and research registers, checked the reference lists of relevant titles identified by the search and contacted researchers to identify other possible published and unpublished studies.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that compared (1) NSOMT versus placebo or control; and (2) NSOMT as adjunctive treatment or speech intervention versus speech intervention alone, for children aged three to 16 years with developmental speech sound disorders, as judged by a speech and language therapist. Individuals with an intellectual disability (e.g. Down syndrome) or a physical disability were not excluded.
DATA COLLECTION AND ANALYSIS
The Trials Search Co-ordinator of the Cochrane Developmental, Psychosocial and Learning Problems Group and one review author ran the searches. Two review authors independently screened titles and abstracts to eliminate irrelevant studies, extracted data from the included studies and assessed risk of bias in each of these studies. In cases of ambiguity or information missing from the paper, we contacted trial authors.
MAIN RESULTS
This review identified three studies (from four reports) involving a total of 22 children that investigated the efficacy of NSOMT as adjunctive treatment to conventional speech intervention versus conventional speech intervention for children with speech sound disorders. One study, a randomised controlled trial (RCT), included four boys aged seven years one month to nine years six months - all had speech sound disorders, and two had additional conditions (one was diagnosed as "communication impaired" and the other as "multiply disabled"). Of the two quasi-randomised controlled trials, one included 10 children (six boys and four girls), aged five years eight months to six years nine months, with speech sound disorders as a result of tongue thrust, and the other study included eight children (four boys and four girls), aged three to six years, with moderate to severe articulation disorder only. Two studies did not find NSOMT as adjunctive treatment to be more effective than conventional speech intervention alone, as both intervention and control groups made similar improvements in articulation after receiving treatments. One study reported a change in postintervention articulation test results but used an inappropriate statistical test and did not report the results clearly. None of the included studies examined the effects of NSOMTs on any other primary outcomes, such as speech intelligibility, speech physiology and adverse effects, or on any of the secondary outcomes such as listener acceptability.The RCT was judged at low risk for selection bias. The two quasi-randomised trials used randomisation but did not report the method for generating the random sequence and were judged as having unclear risk of selection bias. The three included studies were deemed to have high risk of performance bias as, given the nature of the intervention, blinding of participants was not possible. Only one study implemented blinding of outcome assessment and was at low risk for detection bias. One study showed high risk of other bias as the baseline characteristics of participants seemed to be unequal. The sample size of each of the included studies was very small, which means it is highly likely that participants in these studies were not representative of its target population. In the light of these serious limitations in methodology, the overall quality of the evidence provided by the included trials is judged to be low. Therefore, further research is very likely to have an important impact on our confidence in the estimate of treatment effect and is likely to change the estimate.
AUTHORS' CONCLUSIONS
The three included studies were small in scale and had a number of serious methodological limitations. In addition, they covered limited types of NSOMTs for treating children with speech sound disorders of unknown origin with the sounds /s/ and /z/. Hence, we judged the overall applicability of the evidence as limited and incomplete. Results of this review are consistent with those of previous reviews: Currently no strong evidence suggests that NSOMTs are an effective treatment or an effective adjunctive treatment for children with developmental speech sound disorders. Lack of strong evidence regarding the treatment efficacy of NSOMTs has implications for clinicians when they make decisions in relation to treatment plans. Well-designed research is needed to carefully investigate NSOMT as a type of treatment for children with speech sound disorders.
Topics: Articulation Disorders; Child; Child, Preschool; Dysphonia; Exercise Therapy; Female; Humans; Language Disorders; Male; Randomized Controlled Trials as Topic; Speech Sound Disorder; Speech Therapy
PubMed: 25805060
DOI: 10.1002/14651858.CD009383.pub2 -
The Cochrane Database of Systematic... Apr 2019Urinary tract infection (UTI) is common in children. Symptoms include fever, lethargy, anorexia, and vomiting. UTI is caused by Escherichia coli in over 80% of cases and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Urinary tract infection (UTI) is common in children. Symptoms include fever, lethargy, anorexia, and vomiting. UTI is caused by Escherichia coli in over 80% of cases and treatment is a course of antibiotics. Due to acute illness caused by UTI and the risk of pyelonephritis-induced permanent kidney damage, many children are given long-term (several months to 2 years) antibiotics aimed at preventing recurrence. This is the third update of a review first published in 2001 and updated in 2006, and 2011.
OBJECTIVES
To assess whether long-term antibiotic prophylaxis was more effective than placebo/no treatment in preventing recurrence of UTI in children, and if so which antibiotic in clinical use was the most effective. We also assessed the harms of long-term antibiotic treatment.
SEARCH METHODS
We searched the Cochrane Kidney and Transplant Register of Studies up to 30 July 2018 through contact with the Cochrane Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.
SELECTION CRITERIA
Randomised comparisons of antibiotics with other antibiotics, placebo or no treatment to prevent recurrent UTI in children.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed and extracted information for the initial and previous updates. A random-effects model was used to estimate risk ratio (RR) and risk difference (RD) for recurrent UTI with 95% confidence intervals (CI).
MAIN RESULTS
In this update sixteen studies (2036 children randomised, 1977 analysed) were included. Seven studies (612 children) compared two or more types of antibiotics, six (1088 children) compared antibiotics with placebo or no treatment, one four-armed study compared circumcision with and without antibiotic treatment, one study compared dose of antibiotic, and one three-armed study compared two different antibiotics as well as no treatment. Of the sixteen included studies only one study was judged to be at low risk of bias for all domains, with the majority judged to be at unclear risk of bias due to very poorly reported methodology. The number of studies judged to be a low risk of bias was: selection bias (7); performance bias (4); detection bias (1); attrition bias (6); reporting bias (7); and other bias (2). The number of studies judged to be at high risk of bias was: selection bias (0); performance bias (5); detection bias (1); attrition bias (4); reporting bias (6); and other bias (1).Compared to placebo/no treatment, antibiotics lead to a modest decrease in the number of repeat symptomatic UTI in children; however the estimate from combining all studies was not certain and the confidence interval indicates low precision indicating that antibiotics may make little or no difference to risk of repeat infection (RR 0.75, 95% CI 0.28 to 1.98). When we combined only the data from studies with concealed treatment allocation, there was a similar reduction in risk of repeat symptomatic UTI in children taking antibiotics (RR 0.68) and we have greater certainty in this estimate because of the more robust study designs, the confidence interval is smaller and it does not include the point of no effect (95% CI 0.48 to 0.95). The estimated reduction in risk of repeat symptomatic UTI for children taking antibiotics was similar in children with vesicoureteric reflux (VUR) (RR 0.65, 95% CI 0.39 to 1.07) compared to those without VUR (RR 0.56, 95% CI 0.15 to 2.12) however there was considerable uncertainty due to imprecision from fewer events in the smaller group of children with VUR. There was no consistency in occurrence of adverse events, with one study having more events in the placebo group and a second study having more events in the antibiotics group. Three studies reported data for antibiotic resistance with the analysis estimating the risk of a UTI caused by a bacteria resistant to the prophylactic antibiotic being almost 2.5 times greater in children on antibiotics than for children on placebo or no treatment (RR 2.40, 95% CI 0.62 to 9.26). However the confidence interval is wide, showing imprecision and there may be little or no difference between the two groups.Eight studies involving 659 children compared one antibiotic with another but few studies compared the same combination for the same outcome so little data could be pooled. Two studies reported microbial resistance data and analysis showed that treatment with nitrofurantoin may lead to a lower risk of a UTI caused by a bacteria resistant to the treatment drug compared to children given trimethoprim-sulphamethoxazole as their prophylactic treatment (RR 0.54, 95% CI 0.31 to 0.92).
AUTHORS' CONCLUSIONS
Long-term antibiotics may reduce the risk of repeat symptomatic UTI in children who have had one or more previous UTIs but the benefit may be small and must be considered together with the increased risk of microbial resistance.
Topics: Anti-Infective Agents, Urinary; Antibiotic Prophylaxis; Child; Drug Therapy, Combination; Female; Humans; Male; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Urinary Tract Infections; Vesico-Ureteral Reflux
PubMed: 30932167
DOI: 10.1002/14651858.CD001534.pub4 -
The Journal of Hand Surgery Jun 2022Inappropriately reported or conducted studies may decrease the quality of care due to under- or overestimation of the benefits or harms of interventions. Our aim was to...
PURPOSE
Inappropriately reported or conducted studies may decrease the quality of care due to under- or overestimation of the benefits or harms of interventions. Our aim was to evaluate how often hand surgical randomized controlled trials (RCTs) use and report adequate methods to ensure internal validity, and whether inadequate reporting or methods are associated with the magnitude of treatment effect estimates.
METHODS
Data Sources were the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase databases until November 2020. We included published RCTs investigating the effects of any surgical intervention in the hand and wrist region. We assessed internal validity using the Cochrane Risk of Bias (RoB) tool for 6 domains: selection, performance, detection, attrition, selective reporting, and "other" bias. We extracted the primary outcome and calculated the effect size for each study. We used mixed-effect meta-regression to assess whether the RoB modified the magnitude of the effects.
RESULTS
For 207 assessed trials, the RoB was unclear or high for 72% in selection, 93% in performance, 88% in detection, 25% in attrition, 22% in selective reporting, and 34% in the "other" bias domain. Trials with a high or unclear risk of selection bias yielded 0.28 standardized mean difference (95% confidence interval, 0.02-0.55) larger effect sizes compared to studies with a low risk. Risks of bias for other domains did not modify the intervention effects. The risk for selection bias declined over time: the odds ratio for a high or unclear RoB was 0.90 (95% confidence interval, 0.85-0.95) per additional year of publication CONCLUSIONS: The internal validity and credibility of hand surgical RCTs can be improved by using established methods to achieve true randomization, blinding of the participants and study personnel, publishing the trial protocol and avoiding selective reporting of the outcomes, and reporting the trial as recommended in the Consolidated Standards of Reporting Trials statement.
CLINICAL RELEVANCE
Clinicians should be aware that RCTs that do not use or report proper randomization and allocation concealment may overestimate the treatment effects.
Topics: Bias; Epidemiologic Studies; Humans; Odds Ratio; Randomized Controlled Trials as Topic
PubMed: 35341627
DOI: 10.1016/j.jhsa.2022.01.027 -
Pharmacoepidemiology and Drug Safety Dec 2016We systematically reviewed pharmacoepidemiologic and comparative effectiveness studies that use probabilistic bias analysis to quantify the effects of systematic error... (Review)
Review
PURPOSE
We systematically reviewed pharmacoepidemiologic and comparative effectiveness studies that use probabilistic bias analysis to quantify the effects of systematic error including confounding, misclassification, and selection bias on study results.
METHODS
We found articles published between 2010 and October 2015 through a citation search using Web of Science and Google Scholar and a keyword search using PubMed and Scopus. Eligibility of studies was assessed by one reviewer. Three reviewers independently abstracted data from eligible studies.
RESULTS
Fifteen studies used probabilistic bias analysis and were eligible for data abstraction-nine simulated an unmeasured confounder and six simulated misclassification. The majority of studies simulating an unmeasured confounder did not specify the range of plausible estimates for the bias parameters. Studies simulating misclassification were in general clearer when reporting the plausible distribution of bias parameters. Regardless of the bias simulated, the probability distributions assigned to bias parameters, number of simulated iterations, sensitivity analyses, and diagnostics were not discussed in the majority of studies.
CONCLUSION
Despite the prevalence and concern of bias in pharmacoepidemiologic and comparative effectiveness studies, probabilistic bias analysis to quantitatively model the effect of bias was not widely used. The quality of reporting and use of this technique varied and was often unclear. Further discussion and dissemination of the technique are warranted. Copyright © 2016 John Wiley & Sons, Ltd.
Topics: Bias; Comparative Effectiveness Research; Confounding Factors, Epidemiologic; Humans; Pharmacoepidemiology; Research Design; Selection Bias
PubMed: 27593968
DOI: 10.1002/pds.4076 -
JBJS Reviews Sep 2021There is controversy regarding the optimal treatment for infection following shoulder arthroplasty. The purpose of this systematic review is to analyze the bias in...
BACKGROUND
There is controversy regarding the optimal treatment for infection following shoulder arthroplasty. The purpose of this systematic review is to analyze the bias in treatment selection, infection clearance rates, and functional outcomes after 1 versus 2-stage revision surgery for periprosthetic shoulder infections.
METHODS
A systematic search strategy following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted in 4 phases. Articles were identified using MEDLINE (PubMed), Embase (Elsevier), and Cochrane Library databases with Boolean search terms related to infection after shoulder arthroplasty. Included articles were analyzed for quality, and data were extracted for use. Preoperative treatment selection bias was analyzed and postoperative infection clearance rates and functional outcome scores were compared between 1 and 2-stage revision surgery for periprosthetic shoulder infection.
RESULTS
Overall, 163 1-stage shoulder procedures and 289 2-stage shoulder procedures were included in the analysis. Cutibacterium acnes was the organism most frequently grown on culture (37%) followed by coagulase-negative Staphylococcus (19%). The overall infection clearance rate was 95.6% for 1-stage and 85.2% for 2-stage procedures. In a comparison of the change in outcome scores from preoperatively to postoperatively between 1-stage and 2-stage revision, the Constant-Murley Score (CMS) improved 21.0 points (1-stage) versus 22.8 points (2-stage), the American Shoulder and Elbow Surgeons (ASES) score improved 26.2 points versus 33.6 points, and the Simple Shoulder Test (SST) score improved 3.5 points versus 6.4 points, respectively. Overall, 23 of 26 studies cited a reason for selection of a 1 versus 2-stage procedure, which was due to standard treatment protocol in 10 studies, based on the timing of the infection (acute versus subacute versus chronic) in 5, due to a combination of factors (age, comorbidities, intraoperative appearance, adequacy of debridement, bone loss) in 6, and due to preoperative identification of a specific organism in 2.
CONCLUSIONS
One-stage revisions resulted in higher infection clearance rates; however, 2-stage revisions resulted in greater functional improvement as measured with ASES and SST scores from the preoperative assessment to the final postoperative follow-up. The decision between 1 and 2-stage revisions is due to a combination of factors including pathogen type, timing of infection, findings on the preoperative clinical examination, the patient's own decision, the surgeon's preference, and the intraoperative soft-tissue/osseous appearance, which may have biased the overall results. There is no consensus in the literature on the decision between 1 and 2-stage treatment for periprosthetic shoulder infection, which is based on a combination of factors. However, both treatment strategies are effective in treating periprosthetic shoulder infection.
LEVEL OF EVIDENCE
Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Topics: Arthroplasty, Replacement, Shoulder; Humans; Prosthesis-Related Infections; Selection Bias; Shoulder Joint; Treatment Outcome
PubMed: 35417431
DOI: 10.2106/JBJS.RVW.20.00219