scholarly journals Does pre-notification increase questionnaire response rates: a nested randomised control trial

2021 ◽  
Author(s):  
Benjamin Woolf ◽  
Phil Edwards
Keyword(s):  
Systematic Review ◽  
Response Rates ◽  
Risk Of Bias ◽  
Randomised Control Trial ◽  
Questionnaire Response ◽  
Potential Study ◽  
Study Results ◽  
Study Participants ◽  
Unclear Risk

AbstractBackgroundStudy results can be badly affected by non-response. One way to potentially reduce non-response is by sending potential study participants advance communication. During the update of a systematic review examining the effect of pre-notification on response rates, a number of study authors needed to be contacted for further information.ObjectivesTo conduct an RCT to investigate the effect of pre-notification, nested within the request for further information for a systematic review.MethodsStudy authors included in the systematic review, whose studies were at unclear risk of bias, and who were contactable, were randomly sent or not set a pre-notification email prior to being sent the request for further information email.ResultsAt the end of follow up, 14/33 (42.4%) authors in the pre-notification condition had returned responses to the questionnaire, and 18/42 (42.9%). There was not evidence of a difference between these groups.ConclusionsThis study’s results do not support the hypothesis that pre-notification does increase response from participants.

scholarly journals Impact of Mobile Health Devices for the Detection of Atrial Fibrillation: Systematic Review

10.2196/26161 ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. e26161
Author(s):  
Tom E Biersteker ◽  
Martin J Schalij ◽  
Roderick W Treskes
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Mobile Health ◽  
Standard Care ◽  
Detection Rate ◽  
Increased Risk ◽  
Study Results ◽  
Statistical Heterogeneity ◽  
Study Participants

Background Atrial fibrillation (AF) is the most common arrhythmia, and its prevalence is increasing. Early diagnosis is important to reduce the risk of stroke. Mobile health (mHealth) devices, such as single-lead electrocardiogram (ECG) devices, have been introduced to the worldwide consumer market over the past decade. Recent studies have assessed the usability of these devices for detection of AF, but it remains unclear if the use of mHealth devices leads to a higher AF detection rate. Objective The goal of the research was to conduct a systematic review of the diagnostic detection rate of AF by mHealth devices compared with traditional outpatient follow-up. Study participants were aged 16 years or older and had an increased risk for an arrhythmia and an indication for ECG follow-up—for instance, after catheter ablation or presentation to the emergency department with palpitations or (near) syncope. The intervention was the use of an mHealth device, defined as a novel device for the diagnosis of rhythm disturbances, either a handheld electronic device or a patch-like device worn on the patient’s chest. Control was standard (traditional) outpatient care, defined as follow-up via general practitioner or regular outpatient clinic visits with a standard 12-lead ECG or Holter monitoring. The main outcome measures were the odds ratio (OR) of AF detection rates. Methods Two reviewers screened the search results, extracted data, and performed a risk of bias assessment. A heterogeneity analysis was performed, forest plot made to summarize the results of the individual studies, and albatross plot made to allow the P values to be interpreted in the context of the study sample size. Results A total of 3384 articles were identified after a database search, and 14 studies with a 4617 study participants were selected. All studies but one showed a higher AF detection rate in the mHealth group compared with the control group (OR 1.00-35.71), with all RCTs showing statistically significant increases of AF detection (OR 1.54-19.16). Statistical heterogeneity between studies was considerable, with a Q of 34.1 and an I2 of 61.9, and therefore it was decided to not pool the results into a meta-analysis. Conclusions Although the results of 13 of 14 studies support the effectiveness of mHealth interventions compared with standard care, study results could not be pooled due to considerable clinical and statistical heterogeneity. However, smartphone-connectable ECG devices provide patients with the ability to document a rhythm disturbance more easily than with standard care, which may increase empowerment and engagement with regard to their illness. Clinicians must beware of overdiagnosis of AF, as it is not yet clear when an mHealth-detected episode of AF must be deemed significant.

scholarly journals Non-randomised evaluations of strategies to increase participant retention in randomised controlled trials: a systematic review

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Adel Elfeky ◽  
Katie Gillies ◽  
Heidi Gardner ◽  
Cynthia Fraser ◽  
Timothy Ishaku ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Response Rate ◽  
Postal Questionnaire ◽  
Risk Of Bias ◽  
Randomised Trials ◽  
Questionnaire Response ◽  
Retention Strategies ◽  
Participant Retention

Abstract Background Retention of participants is essential to ensure the statistical power and internal validity of clinical trials. Poor participant retention reduces power and can bias the estimates of intervention effect. There is sparse evidence from randomised comparisons of effective strategies to retain participants in randomised trials. Currently, non-randomised evaluations of trial retention interventions embedded in host clinical trials are rejected from the Cochrane review of strategies to improve retention because it only included randomised evaluations. However, the systematic assessment of non-randomised evaluations may inform trialists’ decision-making about retention methods that have been evaluated in a trial context.Therefore, we performed a systematic review to synthesise evidence from non-randomised evaluations of retention strategies in order to supplement existing randomised trial evidence. Methods We searched MEDLINE, EMBASE, and Cochrane CENTRAL from 2007 to October 2017. Two reviewers independently screened abstracts and full-text articles for non-randomised studies that compared two or more strategies to increase participant retention in randomised trials. The retention trials had to be nested in real ‘host’ trials ( including feasibility studies) but not hypothetical trials. Two investigators independently rated the risk of bias of included studies using the ROBINS-I tool and determined the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. Results Fourteen non-randomised studies of retention were included in this review. Most retention strategies (in 10 studies) aimed to increase questionnaire response rate. Favourable strategies for increasing questionnaire response rate were telephone follow-up compared to postal questionnaire completion, online questionnaire follow-up compared to postal questionnaire, shortened version of questionnaires versus longer questionnaires, electronically transferred monetary incentives compared to cash incentives, cash compared with no incentive and reminders to non-responders (telephone or text messaging). However, each retention strategy was evaluated in a single observational study. This, together with risk of bias concerns, meant that the overall GRADE certainty was low or very low for all included studies. Conclusions This systematic review provides low or very low certainty evidence on the effectiveness of retention strategies evaluated in non-randomised studies. Some strategies need further evaluation to provide confidence around the size and direction of the underlying effect.

scholarly journals Does advance contact with research participants increase response to questionnaires: an updated systematic review and meta-analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Benjamin Woolf ◽  
Phil Edwards
Keyword(s):  
Systematic Review ◽  
Social Research ◽  
Data Extraction ◽  
Meta Analysis ◽  
Synthesis Method ◽  
Response Rates ◽  
Outcome Evaluation ◽  
Risk Of Bias ◽  
Study Results ◽  
Randomised Controlled

Abstract Background Questionnaires remain one of the most common forms of data collection in epidemiology, psychology and other human-sciences. However, results can be badly affected by non-response. One way to potentially reduce non-response is by sending potential study participants advance communication. The last systematic review to examine the effect of questionnaire pre-notification on response is 10 years old, and lacked a risk of bias assessment. Objectives Update the section of the Cochrane systematic review, Edwards et al. (2009), on pre-notification to include 1) recently published studies, 2) an assessment of risk of bias, 3) Explore if heterogeneity is reduced by: delay between pre-contact and questionnaire delivery, the method of pre-contact, if pre-contact and questionnaire delivery differ, if the pre-contact includes a foot-in-the-door manipulation, and study’s the risk of bias. Methods Inclusion criteria: population: any population, intervention: comparison of some type of pre-notification, comparison group: no pre-notification, outcome: response rates. Study design: randomised controlled trails. Exclusion criteria: NA. Data sources: Studies which cited or were included in Edwards et al. (2009); We additionally searched: CINAHL, Web of Science, PsycInfo, MEDLINE, EconLit, EMBASE, Cochrane Central, Cochrane CMR, ERIC, and Sociological Abstracts. The searches were implemented in June 2018 and May 2021. Study screening: a single reviewer screened studies, with a random 10% sample independently screened to ascertain accuracy. Data extraction: data was extracted by a single reviewer twice, with a week between each extraction. Risk of Bias: within studies bias was assessed using the Cochrane Risk of Bias tool (ROB1) by a single unblinded reviewer, across studies bias was assessed using funnel plots. Synthesis Method: study results were meta-analysed with a random effects model using the final response rate as the outcome. Evaluation of Uncertainty: Uncertainty was evaluated using the GRADE approach. Results One hundred seven trials were included with 211,802 participants. Over-all pre-notification increased response, OR = 1.33 (95% CI: 1.20–1.47). However, there was a large amount of heterogeneity (I2 = 97.1%), which was not explained by the subgroup analyses. In addition, when studies at high or unclear risk of bias were excluded the effect was to reduced OR = 1.09 (95% CI: 0.99–1.20). Because of the large amount of heterogeneity, even after restricting to low risk of bias studies, there is still moderate uncertainty in these results. Conclusions Using the GRADE evaluation, this review finds moderate evidence that pre-notification may not have an effect on response rates. Funding Economic and Social Research Council. Preregistration None.

Exercise interventions in lateral elbow tendinopathy have better outcomes than passive interventions, but the effects are small: a systematic review and meta-analysis of 2123 subjects in 30 trials

2020 ◽  
pp. bjsports-2020-102525
Author(s):  
Stefanos Karanasios ◽  
Vasileios Korakakis ◽  
Rod Whiteley ◽  
Ioannis Vasilogeorgis ◽  
Sarah Woodbridge ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Short Term ◽  
Lateral Elbow ◽  
Long Term Follow Up ◽  
Wait And See ◽  
Lateral Elbow Tendinopathy

ObjectiveTo evaluate the effectiveness of exercise compared with other conservative interventions in the management of lateral elbow tendinopathy (LET) on pain and function.DesignSystematic review and meta-analysis.MethodsWe used the Cochrane risk-of-bias tool 2 for randomised controlled trials (RCTs) to assess risk of bias and the Grading of Recommendations Assessment, Development and Evaluation methodology to grade the certainty of evidence. Self-perceived improvement, pain intensity, pain-free grip strength (PFGS) and elbow disability were used as primary outcome measures.Eligibility criteriaRCTs assessing the effectiveness of exercise alone or as an additive intervention compared with passive interventions, wait-and-see or injections in patients with LET.Results30 RCTs (2123 participants, 5 comparator interventions) were identified. Exercise outperformed (low certainty) corticosteroid injections in all outcomes at all time points except short-term pain reduction. Clinically significant differences were found in PFGS at short-term (mean difference (MD): 12.15, (95% CI) 1.69 to 22.6), mid-term (MD: 22.45, 95% CI 3.63 to 41.3) and long-term follow-up (MD: 18, 95% CI 11.17 to 24.84). Statistically significant differences (very low certainty) for exercise compared with wait-and-see were found only in self-perceived improvement at short-term, pain reduction and elbow disability at short-term and long-term follow-up. Substantial heterogeneity in descriptions of equipment, load, duration and frequency of exercise programmes were evident.ConclusionsLow and very low certainty evidence suggests exercise is effective compared with passive interventions with or without invasive treatment in LET, but the effect is small.PROSPERO registration numberCRD42018082703.

scholarly journals P014: Incidental findings in trauma whole-body CT scans: a systematic review

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S69-S69
Author(s):  
V. Tsang ◽  
K. Bao ◽  
J. Taylor
Keyword(s):  
Systematic Review ◽  
Incidental Findings ◽  
Traffic Accidents ◽  
Road Traffic ◽  
Subsequent Treatment ◽  
Whole Body ◽  
Trauma Patients ◽  
Patient Demographics ◽  
Study Results

Introduction: Whole-body computed tomography scans (WBCT) are a mainstay in the work-up of polytrauma or multiple trauma patients in the emergency department. While incredibly useful for identifying traumatic injuries, WBCTs also reveal incidental findings in patients, some of which require further diagnostic testing and subsequent treatment. Although the presence of incidental findings in WBCTs have been well documented, there has been no systematic review conducted to organize and interpret findings, determine IF prevalence, and document strategies for best management. Methods: A systematic review was conducted using MEDLINE, PUBMED, and EMBASE. Specific journals and reference lists were hand-mined, and Google Scholar was used to find any additional papers. Data synthesis was performed to gather information on patient demographics, prevalence and type of incidental findings (IFs), and follow-up management was collected. All documents were independently assessed by the two reviewers for inclusion and any disagreements were resolved by consensus. Results: 1231 study results were identified, 59 abstracts, and 12 included in final review. A mean of 53.9% of patients had at least one IF identified, 31.5% had major findings, and 68.5% had minor findings. A mean of 2.7 IFs per patient was reported for articles that included number of total IFs. The mean age of patients included in the studies were 44 years old with IFs more common in older patients and men with more IFs than women. IFs were most commonly found in the abdominal/pelvic region followed by kidneys. Frequency of follow-up documentation was poor. The most common reported mechanisms of injury for patients included in the study were MVA and road traffic accidents (60.0%) followed by falls from >3m (23.2%). Conclusion: Although there is good documentation on the mechanism of injury, patient demographics, and type of IF, follow-up for IFs following acute trauma admission lacks documentation and follow-up and is an identified issue in patient management. There is great need for systematic protocols to address management of IFs in polytrauma patients.

Oral Myofunctional and Articulation Disorders in Children with Malocclusions: A Systematic Review

2021 ◽  
pp. 1-16
Author(s):  
Zoë Thijs ◽  
Laura Bruneel ◽  
Guy De Pauw ◽  
Kristiane M. Van Lierde
Keyword(s):  
Systematic Review ◽  
Risk Of Bias ◽  
Open Bite ◽  
Anterior Open Bite ◽  
Eligibility Criteria ◽  
High Prevalence ◽  
Tongue Position ◽  
Articulation Disorders ◽  
Level 2 ◽  
Unclear Risk

<b><i>Background:</i></b> Relationships between malocclusion and orofacial myofunctional disorders (OMD), as well as malocclusions and articulation disorders (AD) have been described, though the exact relationships remain unclear. Given the high prevalence of these disorders in children, more clarity is needed. <b><i>Summary:</i></b> The purpose of this study was to determine the association between OMD (specifically, bruxism, deviate swallowing, caudal resting tongue posture, and biting habits), AD, and malocclusions in children and adolescents aged between 3 and 18 years. To conduct a systematic review, 4 databases were searched (MEDLINE, Embase, Web of Science, and Scopus). The identified articles were screened for the eligibility criteria. Data were extracted from the selected articles and quality assessment was performed using the tool of Munn et al. [Int J Health Policy Manag. 2014;3:123–81] in consensus. Using the search strategy, the authors identified 2,652 articles after the removal of duplicates. After reviewing the eligibility criteria, 17 articles were included in this study. One of the included articles was deemed to have an unclear risk of bias, whereas all other articles were considered to have a low risk of bias. The articles showed a relationship between anterior open bite and apico-alveolar articulatory distortions, as well as between anterior open bite and deviate swallowing. For the biting habits, bruxism, and low tongue position no clear conclusions could be drawn. <b><i>Key Messages:</i></b> The current review suggests a link between specific types of malocclusion and OMD and AD. However, more high-quality evidence (level 1 and level 2, Oxford Levels of Evidence) is needed to clarify the cooccurrence of other OMD, AD, and malocclusions.

scholarly journals Management of hypertensive disorders in pregnancy in Black women: a systematic review

2021 ◽  
Author(s):  
Jeeva John ◽  
Gwenetta Curry
Keyword(s):  
Systematic Review ◽  
Black Women ◽  
Randomised Control Trial ◽  
Free Text ◽  
Hypertensive Disorders ◽  
Black Patients ◽  
Study Results ◽  
Hypertensive Disorders In Pregnancy ◽  
Randomised Control Trials ◽  
In Pregnancy

Abstract Background: Black women are four times more likely to die than White women due to complications during pregnancy or childbirth in the U.K. This cohort are also more prone to Hypertensive Disorders in Pregnancy (HDP). Outside of pregnancy, there are race based differences in the management of hypertension as Calcium-Channel Blockers (CCB) 9 are more effective in reducing blood pressure in Black patients. It is unclear whether these differences in anti-hypertensive management extend to the management of hypertension in pregnancy. The primary objective was to address this gap in evidence by undertaking a systematic review of all randomised control trials investigating pharmacological management of HDP to assess whether CCBs are the most effective anti-hypertensive agent in Black pregnant women. Methods: The following electronic databases were searched: PubMed, MEDLINE and Embase. We used MeSH and free text terms in conjunction to increase sensitivity to potentially relevant studies. Inclusion criteria included: (1) study involved treatment of HDP; (2) study was of a randomised control trial design; (3) one of the treatment arms involved CCBs and (4) English full-text. Information regarding baseline participant data, type of anti-hypertensive, and clinical outcomes was extracted from each study. Results: This review highlighted four randomised control trials, which published race or ethnicity demographics, with only one trial that stratified HDP outcomes by ethnicity. Conclusions: There is a lack of evidence to draw definite conclusions as to whether CCBs are the most effective anti-hypertensive agent for Black patients with HDP, highlighting the need for further research in this area. However, this review demonstrates some evidence to support the hypothesis that CCBs could be more effective in the management of HDP in Black patients and that Labetalol, which is the current first-line management of HDP, may not represent the gold standard of treatment in this cohort.

Systematic Review and Meta-analyses of Effects of Phosphate-lowering Agents in Non-dialysis Chronic Kidney Disease

2021 ◽  
pp. ASN.2021040554
Author(s):  
Nicole Lioufas ◽  
Elaine Pascoe ◽  
Carmel Hawley ◽  
Grahame Elder ◽  
Sunil Badve ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Clinical Outcomes ◽  
Serum Phosphate ◽  
Risk Of Bias ◽  
Lowering Therapy ◽  
Mean Differences ◽  
Meta Analyses

Background: Benefits of phosphate-lowering interventions on clinical outcomes in patients with chronic kidney disease (CKD) are unclear; systematic reviews have predominantly involved dialysis patients. This study aimed to summarize evidence from randomized controlled trials (RCTs) concerning benefits and risks of non-calcium-based phosphate-lowering treatment in non-dialysis CKD. Methods: We conducted a systematic review and meta-analyses of RCTs involving noncalcium-based phosphate-lowering therapy compared to placebo, calcium-based binders, or no study medication, in adults with CKD not on dialysis or post-transplant. RCTs had ≥3 months follow up and outcomes included biomarkers of mineral metabolism, cardiovascular parameters, and adverse events. Outcomes were meta-analyzed using the Sidik-Jonkman method for random effects. Unstandardized mean differences were used as effect sizes for continuous outcomes, with common measurement units and Hedge's g standardized mean differences (SMD) otherwise. Odds ratios were used for binary outcomes. Cochrane risk of bias and GRADE assessment determined the certainty of evidence. Results: Twenty trials involving 2,498 participants (median sample size 120, median follow up 9 months) were eligible for inclusion. Overall, risk of bias was low. Compared with placebo, non calcium-based phosphate binders reduced serum phosphate (12 trials, weighted mean difference -0.37, 95% CI -0.58,-0.15 mg/dL, low certainty evidence) and urinary phosphate excretion (8 trials, SMD -0.61, 95% CI -0.90,-0.31, low certainty evidence), but resulted in increased constipation (9 trials, log odds ratio [OR] 0.93, 95% CI 0.02, 1.83, low certainty evidence) and greater vascular calcification score (3 trials, SMD 0.47, 95% CI 0.17, 0.77, very low certainty evidence). Data for effects of phosphate-lowering therapy on cardiovascular events (log OR 0.51 [95% CI -0.51, 1.17]) and death were scant. Conclusions: Non-calcium-based phosphate-lowering therapy reduced serum phosphate and urinary phosphate excretion, but there was an unclear effect on clinical outcomes and intermediate cardiovascular end-points. Adequately powered RCTs are required to evaluate benefits and risks of phosphate-lowering therapy on patient-centered outcomes.

scholarly journals Placebo response in trials of drug treatments for cancer-related fatigue: a systematic review, meta-analysis and meta-regression

2020 ◽  
Vol 10 (4) ◽  
pp. 385-394 ◽  
Author(s):  
Rocio Roji ◽  
Patrick Stone ◽  
Federico Ricciardi ◽  
Bridget Candy
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Placebo Response ◽  
Risk Of Bias ◽  
Small Samples ◽  
Contributing Factors ◽  
Cancer Related Fatigue ◽  
Study Results ◽  
Meta Regression ◽  
Multiple Drugs

BackgroundCancer-related fatigue (CRF) is one of the most distressing symptoms experienced by patients. There is no gold standard treatment, although multiple drugs have been tested with little evidence of efficacy. Randomised controlled trials (RCTs) of these drugs have commented on the existence or size of the placebo response (PR). The objective of this systematic review was to establish the magnitude of the PR in RCTs of drugs to relieve CRF and to identify contributing factors.MethodRCTs were included in which the objective was to treat CRF. A meta-analysis was conducted using the standardised mean change (SMC) between baseline and final measurement in the placebo group. To explore factors that may be associated with the PR (eg, population or drug), a meta-regression was undertaken. Risk of bias was assessed using the revised Cochrane tool.ResultsFrom 3916 citations, 30 relevant RCTs were identified. All had limitations that increased their risk of bias. The pooled SMC in reduction in fatigue status in placebo groups was −0.23 (95% confidence intervals −0.42 to −0.04). None of the variables analysed in the meta-regression were statistically significant related to PR.ConclusionThere is some evidence, based on trials with small samples, that the PR in trials testing drugs for CRF is non-trivial in size and statistically significant. We recommend that researchers planning drug studies in CRF should consider implementing alternative trial designs to better account for PR and decrease impact on the study results.

scholarly journals Serum magnesium at 18-20 weeks of gestation: can it be a predictor of gestational hypertension and fetomaternal outcome?

2020 ◽  
Vol 9 (4) ◽  
pp. 1402
Author(s):  
Sasikala Kathiresan ◽  
Agalya Angelina Sanjevrajah ◽  
Jeyashree Kathiresan
Keyword(s):  
Pregnant Women ◽  
Gestational Hypertension ◽  
Serum Magnesium ◽  
Colorimetric Method ◽  
Fetal Outcome ◽  
Mean Value ◽  
Term Birth ◽  
Study Results ◽  
Study Participants

Background: Hypertensive disorders of pregnancy (HDP) is a major cause of maternal, fetal morbidity and mortality complicating 10% of all gestations. As effective treatments are very limited, prediction of HDP occurrence is most importance. Though many biomarkers have shown relationship with HDP, serum magnesium (Mg) has shown better predictor as involved in maintaining vascular contractility, tone. This study is intended to analyse incidence of GHT and fetomaternal outcome in pregnant women with normal and low serum magnesium level measured at mid trimester (18-20 weeks).Methods: A total of 105 consecutive singleton pregnant women in between 18-20 weeks of gestation attending OBG outpatient department were enrolled. After obtaining the informed consent, structured proforma was used to collect demographic, clinical details. Serum magnesium was measured by the colorimetric method and study participants were divided into two groups based on Mg cut off 1.5 mg/dl and followed up throughout pregnancy for fetomaternal outcome.Results: This study results revealed that 35.2% (37/105) pregnant women had serum Mg level < 1.5 mg/dl and mean value of Mg of all participant is 1.7 mg/dl, just above the lower limit. During follow-up of these two groups, statistically significant correlation between serum Mg levels (< 1.5 mg/dl) with GHT (8/12) occurrence and pre term birth was found. Other fetomaternal outcome not had significant correlation.Conclusions: As per the findings, serum Mg concentration measurement in between 18-20 weeks can be considered as a one of the predictors for subsequent occurrence of maternal outcome of GHT and fetal outcome of pre-term birth.

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