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Psychiatry Research Jan 2020Implementation science is focused on maximizing the adoption, appropriate use, and sustainability of effective clinical practices in real world clinical settings. Many... (Review)
Review
Implementation science is focused on maximizing the adoption, appropriate use, and sustainability of effective clinical practices in real world clinical settings. Many implementation science questions can be feasibly answered by fully experimental designs, typically in the form of randomized controlled trials (RCTs). Implementation-focused RCTs, however, usually differ from traditional efficacy- or effectiveness-oriented RCTs on key parameters. Other implementation science questions are more suited to quasi-experimental designs, which are intended to estimate the effect of an intervention in the absence of randomization. These designs include pre-post designs with a non-equivalent control group, interrupted time series (ITS), and stepped wedges, the last of which require all participants to receive the intervention, but in a staggered fashion. In this article we review the use of experimental designs in implementation science, including recent methodological advances for implementation studies. We also review the use of quasi-experimental designs in implementation science, and discuss the strengths and weaknesses of these approaches. This article is therefore meant to be a practical guide for researchers who are interested in selecting the most appropriate study design to answer relevant implementation science questions, and thereby increase the rate at which effective clinical practices are adopted, spread, and sustained.
Topics: Biomedical Research; Control Groups; Humans; Implementation Science; Randomized Controlled Trials as Topic; Research Design
PubMed: 31255320
DOI: 10.1016/j.psychres.2019.06.027 -
Vaccine Jun 2017Case-control studies are commonly used to evaluate effectiveness of licensed vaccines after deployment in public health programs. Such studies can provide... (Review)
Review
Case-control studies are commonly used to evaluate effectiveness of licensed vaccines after deployment in public health programs. Such studies can provide policy-relevant data on vaccine performance under 'real world' conditions, contributing to the evidence base to support and sustain introduction of new vaccines. However, case-control studies do not measure the impact of vaccine introduction on disease at a population level, and are subject to bias and confounding, which may lead to inaccurate results that can misinform policy decisions. In 2012, a group of experts met to review recent experience with case-control studies evaluating the effectiveness of several vaccines; here we summarize the recommendations of that group regarding best practices for planning, design and enrollment of cases and controls. Rigorous planning and preparation should focus on understanding the study context including healthcare-seeking and vaccination practices. Case-control vaccine effectiveness studies are best carried out soon after vaccine introduction because high coverage creates strong potential for confounding. Endpoints specific to the vaccine target are preferable to non-specific clinical syndromes since the proportion of non-specific outcomes preventable through vaccination may vary over time and place, leading to potentially confusing results. Controls should be representative of the source population from which cases arise, and are generally recruited from the community or health facilities where cases are enrolled. Matching of controls to cases for potential confounding factors is commonly used, although should be reserved for a limited number of key variables believed to be linked to both vaccination and disease. Case-control vaccine effectiveness studies can provide information useful to guide policy decisions and vaccine development, however rigorous preparation and design is essential.
Topics: Case-Control Studies; Control Groups; Female; Humans; Immunization Programs; Immunogenicity, Vaccine; Male; Treatment Outcome; Vaccination; Vaccines
PubMed: 28442231
DOI: 10.1016/j.vaccine.2017.04.037 -
BMJ (Clinical Research Ed.) Feb 2016There are two common misconceptions about case-control studies: that matching in itself eliminates (controls) confounding by the matching factors, and that if matching...
There are two common misconceptions about case-control studies: that matching in itself eliminates (controls) confounding by the matching factors, and that if matching has been performed, then a “matched analysis” is required. However, matching in a case-control study does not control for confounding by the matching factors; in fact it can introduce confounding by the matching factors even when it did not exist in the source population. Thus, a matched design may require controlling for the matching factors in the analysis. However, it is not the case that a matched design requires a matched analysis. Provided that there are no problems of sparse data, control for the matching factors can be obtained, with no loss of validity and a possible increase in precision, using a “standard” (unconditional) analysis, and a “matched” (conditional) analysis may not be required or appropriate.
Topics: Case-Control Studies; Confounding Factors, Epidemiologic; Control Groups; Data Interpretation, Statistical
PubMed: 26916049
DOI: 10.1136/bmj.i969 -
BMC Health Services Research Jul 2018Anxiety disorders are common, yet treatment options in general practice are often limited to medication or CBT. There is a lack of evidence for the effectiveness of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Anxiety disorders are common, yet treatment options in general practice are often limited to medication or CBT. There is a lack of evidence for the effectiveness of exercise in the treatment of anxiety in patients who present to general practice and also about the intensity of exercise required to lead to improvement. The aim of this systematic review was to assess the use of exercise versus waiting list control groups in the treatment of anxiety and also to assess the benefit of high intensity exercise vs low intensity exercise. Long term follow up scores were also analysed. We included patients who met diagnostic criteria for anxiety disorders or had clinically raised anxiety levels on a validated rating scale and performed a subgroup analysis of the outcomes between the two groups. The intervention was any aerobic exercise programme carried out for at least two weeks, or exercise carried out at high intensity for at least two weeks. The comparison groups were either a waiting list control group or low intensity exercise.
METHOD
Systematic review of randomised controlled trials. Three databases were searched; CENTRAL, Medline and Embase. Outcome assessment was based on validated anxiety rating scales. The quality of the studies was appraised according to the Cochrane Risk of Bias tool. Effect sizes were calculated using the standardised mean difference.
RESULTS
Fifteen studies were identified with a total of 675 patients. Nine trials had participants with diagnosed anxiety disorders and six trials had participants with raised anxiety on a validated rating scale. Aerobic exercise was effective in the treatment of raised anxiety compared to waiting list control groups (effect size - 0.41, 95% CI = - 0.70 to - 0.12). High intensity exercise programmes showed greater effects than low intensity programmes. There was no significant difference in outcomes between groups of patients with diagnosed anxiety disorders and patients who had raised anxiety on a rating scale. Conclusions were limited by the small number of studies and wide variation in the delivery of exercise interventions.
CONCLUSION
Exercise programmes are a viable treatment option for the treatment of anxiety. High intensity exercise regimens were found to be more effective than low intensity regimens. The results have implications for the use of exercise schemes in General Practice.
Topics: Anxiety Disorders; Control Groups; Exercise; Exercise Therapy; General Practice; Humans; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Waiting Lists
PubMed: 30012142
DOI: 10.1186/s12913-018-3313-5 -
International Journal of Environmental... Jun 2021This randomized, double-blind and controlled clinical trial investigates how a diode laser lingual frenectomy can improve obstructive sleep apnea syndrome (OSAS) in... (Randomized Controlled Trial)
Randomized Controlled Trial
UNLABELLED
This randomized, double-blind and controlled clinical trial investigates how a diode laser lingual frenectomy can improve obstructive sleep apnea syndrome (OSAS) in pediatric patients.
BACKGROUND
Several authors have shown that a short lingual frenulum causes a reduction in incoming air flow and the relationship between OSAS and a short lingual frenulum.
METHODS
Thirty-two pediatric patients were equally randomly divided into a Study Group (SG) and a Control Group (CG). On each SG patient a polysomnography 1 (PSG1) and a lingual frenectomy were performed using a diode laser via Doctor Smile Wiser technology, power 7 W. After three months, a new polysomnography (PSG2) was performed to evaluate the lingual frenectomy efficacy in pediatric patients. The pain was assessed by a numerical rating scale (NRS) before and after surgery. The CG followed the same protocol without a lingual frenectomy but myofunctional and speech therapy were conducted to qualitatively and quantitatively improve the lingual functionality. In the SG, eight subjects (50%) had severe OSAS and eight had moderate (50%) while in the CG, three subjects had severe OSAS (18.8%) and thirteen had moderate (81.2%).
RESULTS
In the SG, 93.8% were classified as mild OSAS and 6.2% as moderate. In contrast, in the CG, 18.75% were classified as mild OSAS, 62.5% as moderate and 18.75% as severe.
CONCLUSION
The study demonstrates how a lingual laser frenectomy can improve OSAS in pediatric patients.
Topics: Child; Control Groups; Double-Blind Method; Humans; Lasers, Semiconductor; Lingual Frenum; Sleep Apnea, Obstructive
PubMed: 34204017
DOI: 10.3390/ijerph18116112 -
JAMA Network Open Sep 2023The onset age of nonalcoholic fatty liver disease (NAFLD) is decreasing, and whether earlier ages of NAFLD onset are associated with increased cancer risk is currently...
IMPORTANCE
The onset age of nonalcoholic fatty liver disease (NAFLD) is decreasing, and whether earlier ages of NAFLD onset are associated with increased cancer risk is currently unclear.
OBJECTIVE
To explore the association between NAFLD new-onset age and cancer risk.
DESIGN, SETTING, AND PARTICIPANTS
This cohort study was conducted among 179 328 participants included in the Kailuan Cohort Study between 2006 and 2021. In total, 46 100 incident NAFLD cases were identified. For each case, a participant matched by age (older or younger by 1 year) and sex was randomly selected to create a new matched study cohort. Data were analyzed from December 2022 through April 2023.
EXPOSURE
Onset of NAFLD.
MAIN OUTCOMES AND MEASURES
The association between the onset age of NAFLD and the risk of different cancer types was evaluated using weighted Cox regression models. Population-attributable fractions (PAFs) were used to quantify the association of NAFLD with cancer risk at different ages.
RESULTS
Among 63 696 participants (mean [SD] age, 51.37 [12.43] years; 10 932 females [17.2%] and 52 764 males [82.8%]), 31 848 individuals had NAFLD and 31 848 individuals were in the control group. During a median (IQR) follow-up of 10.16 (7.89-11.67) years, 2415 patients were diagnosed with cancer. Compared with the matched group, patients aged less than 45 years at NAFLD onset exhibited a higher risk of cancer (average hazard ratio [AHR], 1.52; 95% CI, 1.09-2.12), and as the onset age of NAFLD increased, the cancer risk decreased (ages 45-54 years: AHR, 1.50; 95% CI, 1.15-1.97; ages 55-64 years: AHR, 1.13; 95% CI, 0.97-1.33; ages >65 years: AHR, 0.75; 95% CI, 0.45-1.27; P for interaction < .001). Among patients aged less than 45 years at NAFLD onset, cancers were mainly digestive system and lung cancers, with AHR values of 2.00 (95% CI, 1.08-3.47) and 2.14 (95% CI, 1.05-4.36), respectively. PAFs also showed that in patients aged less than 45 years at NAFLD onset, 17.83% (95% CI, 4.92%-29.86%) of cancer risk was attributable to NAFLD..
CONCLUSIONS AND RELEVANCE
This study found that NAFLD was associated with increased cancer risk and there was an interaction with onset age, such that the younger the onset age of NAFLD, the greater the cancer risk.
Topics: Female; Humans; Male; Middle Aged; Age of Onset; Cohort Studies; Control Groups; Lung Neoplasms; Non-alcoholic Fatty Liver Disease; Adult
PubMed: 37747732
DOI: 10.1001/jamanetworkopen.2023.35511 -
Perspectives on Psychological Science :... Mar 2017Claims about alterations in perception based on manipulations of the energetics hypothesis (and other influences) are often framed as interesting specifically because...
Claims about alterations in perception based on manipulations of the energetics hypothesis (and other influences) are often framed as interesting specifically because they affect our perceptual experience. Many control experiments conducted on such perceptual effects suggest, however, that they are the result of attribution effects and other kinds of judgmental biases influencing the reporting process rather than perception itself. Schnall (2017, this issue), appealing to Heider's work on attribution, argues that it is fruitless to try to distinguish between perception and attribution. This makes the energetics hypothesis less interesting.
Topics: Control Groups; Humans; Judgment; Reading Frames; Social Perception
PubMed: 28346119
DOI: 10.1177/1745691616677829 -
Minerva Anestesiologica Mar 2018Postoperative analgesic interventions are often tested adjunct to basic non-opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control... (Review)
Review
INTRODUCTION
Postoperative analgesic interventions are often tested adjunct to basic non-opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control groups, and possible assay sensitivity, differs between trials. We hypothesized that postoperative opioid requirements and pain intensities vary between different control groups in analgesic trials.
EVIDENCE ACQUISITION
Control groups from RCTs investigating analgesic interventions after total hip and knee arthroplasty were categorized based on standardized basic analgesic treatment. Morphine consumption 0 to 24 hours postoperatively, and resting pain scores at 6 and 24 hours for subgroups of basic treatments, were compared with ANOVA. In an additional analysis, we compared pain and opioid requirements in trials where a non-steroidal anti-inflammatory drug (NSAID) was administered as an intervention with trial where NSAID was administered in a control group.
EVIDENCE SYNTHESIS
We included 171 RCTs employing 28 different control groups with large variability in pain scores and opioid requirements. Four types of control groups (comprising 78 trials) were eligible for subgroup comparisons. These subgroups received "opioid" alone, "NSAID + opioid", "acetaminophen + opioid", or "NSAID + acetaminophen + opioid", respectively. Morphine consumption and pain scores varied substantially between these groups, with no consistent superior efficacy in any subgroup. Additionally, trials administering NSAID as an intervention demonstrated lower pain scores and opioid requirements than trials where NSAID was administered in a control group.
CONCLUSIONS
Analgesic treatment in RCT control groups varies considerably. Control groups receiving various combinations of opioid, NSAID and acetaminophen did not differ consistently in pain and opioid requirements. Pain and opioid requirements were lower in trials administering NSAID as an intervention compared with trials administering NSAID in a control group.
Topics: Analgesia; Analgesics, Opioid; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Control Groups; Humans; Pain Measurement; Pain, Postoperative; Randomized Controlled Trials as Topic
PubMed: 29152935
DOI: 10.23736/S0375-9393.17.12271-6 -
Journal of Studies on Alcohol and Drugs Nov 2022Brief alcohol interventions (BAIs) are evidence-based practices that can help reduce hazardous drinking among patients in medical settings. However, descriptions of the... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Brief alcohol interventions (BAIs) are evidence-based practices that can help reduce hazardous drinking among patients in medical settings. However, descriptions of the treatment-as-usual (TAU) control groups that BAIs are compared to in clinical trials often lack clarity and detail. This systematic review and meta-analysis quantified and compared descriptions of intervention and TAU control arms within reports of randomized controlled trials and examined whether treatment effects were affected by level of detail in narrative descriptions.
METHOD
A systematic literature search to identify eligible articles was performed. Studies were rated on methodological quality, and the Template for Intervention Description and Replication (TIDieR) checklist was used to rate the level of clarity and detail included in descriptions of the intervention and TAU conditions in eligible articles. Data were extracted from articles for use in meta-analysis and meta-regression.
RESULTS
Twenty-one studies met inclusion criteria. Across the studies, TIDieR ratings for intervention arms were higher than ratings for control arms. BAIs were linked to reductions in drinks per week, heavy drinking episodes, and alcohol consequences over time when compared with TAU. TIDieR ratings for control groups were significantly associated with larger treatment effects on drinks per week and alcohol consequences but were not significant for heavy drinking episodes.
CONCLUSIONS
This meta-analysis reiterated the effectiveness of BAIs in medical settings. Yet the lack of clarity in TAU descriptions raises concerns regarding the validity of BAI trials, suggesting need for more detailed reporting and use of the TIDieR guidelines for support.
Topics: Humans; Control Groups; Ethanol; Research Design
PubMed: 36484591
DOI: 10.15288/jsad.21-00260 -
Intensive Care Medicine Dec 2016The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the... (Review)
Review
PURPOSE
The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials.
METHODS
We searched for original articles presenting randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting.
RESULTS
A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58 % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2-17) were reported. Only 2 (8 %) trials provided adequate data to confirm that their control group treatment represented usual care.
CONCLUSIONS
Recent trials in septic shock provide inadequate data on the control group treatment and hemodynamic values. We propose a standardized trial dataset to be created and validated, comprising characteristics of patient population, interventions administered, hemodynamic values achieved, surrogate organ dysfunction, and mortality outcomes, to allow better analysis and interpretation of future trial results.
Topics: Biomedical Research; Control Groups; Humans; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Shock, Septic
PubMed: 27448676
DOI: 10.1007/s00134-016-4444-y