Doing no harm: Addressing the quality of evidence in translating research to practice in preliminary research fields

2017 ◽  
Vol 5 (4) ◽  
pp. 490
Author(s):  
Mei'En Lim ◽  
Corrine Reid

Background: Current evidence appraisal rating systems, such as the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, are oriented toward and anchored by randomized controlled trials (RCTs) as the gold standard methodology. In many fields, this standard of evidence is rarely, if ever, met. Often, research at the clinical application end of the translational process is embedded in real world practice that does not lend itself to RCTs and is characterised by more pragmatic research using mixed methodologies. Arguably, accountability through research evaluation is even more important in such cases where research design is preliminary and clinical impact is, often, already a reality. Further, practice translation must be privileged as the central goal of the research synthesis under such circumstances in that the destination of all clinical science is the person of the patient.. Methods: In response to these demand characteristics, a practitioner-informed research framework was used to drive and pilot development of an evidence quality grading system that could accommodate a disparate and oblique evidence base. Reid’s person-centered framework was used to establish whether clinician-derived criteria for quality research practice had been met. Results: This brief report presents the Quality of Evidence Rating System (QERS) in the hope of facilitating discussion about accountability pathways for translational scientist-practitioners.Conclusion: The QERS provides a scaffold to help when looking for evidence that researchers have consciously addressed the issues of evidence quality when reporting their research in the published literature.

2022 ◽  
Author(s):  
Dedi Ardinata

Evidence-based medicine (EBM), which emphasizes that medical decisions must be based on the most recent best evidence, is gaining popularity. Individual clinical expertise is combined with the best available external clinical evidence derived from systematic research in the practice of EBM. The key and core of EBM is the hierarchical system for categorizing evidence. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system divides evidence quality into four categories: high, moderate, low, and very low. GRADE is based on the lowest quality of evidence for any of the outcomes that are critical to making a decision, reducing the risk of mislabeling the overall evidence quality, when evidence for a critical outcome is lacking. This principle is also used in acupuncture as a complementary and integrative treatment modality, but incorporating scientific evidence is more difficult due to a number of factors. The goal of this chapter is to discuss how to establish a clinical evidence system for acupuncture, with a focus on the current quality of evidence for a variety of conditions or diseases.


PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259048
Author(s):  
Claudia R. Schneider ◽  
Alexandra L. J. Freeman ◽  
David Spiegelhalter ◽  
Sander van der Linden

Background The quality of evidence about the effectiveness of non-pharmaceutical health interventions is often low, but little is known about the effects of communicating indications of evidence quality to the public. Methods In two blinded, randomised, controlled, online experiments, US participants (total n = 2140) were shown one of several versions of an infographic illustrating the effectiveness of eye protection in reducing COVID-19 transmission. Their trust in the information, understanding, feelings of effectiveness of eye protection, and the likelihood of them adopting it were measured. Findings Compared to those given no quality cues, participants who were told the quality of the evidence on eye protection was ‘low’, rated the evidence less trustworthy (p = .001, d = 0.25), and rated it as subjectively less effective (p = .018, d = 0.19). The same effects emerged compared to those who were told the quality of the evidence was ‘high’, and in one of the two studies, those shown ‘low’ quality of evidence said they were less likely to use eye protection (p = .005, d = 0.18). Participants who were told the quality of the evidence was ‘high’ showed no statistically significant differences on these measures compared to those given no information about evidence quality. Conclusions Without quality of evidence cues, participants responded to the evidence about the public health intervention as if it was high quality and this affected their subjective perceptions of its efficacy and trust in the provided information. This raises the ethical dilemma of weighing the importance of transparently stating when the evidence base is actually low quality against evidence that providing such information can decrease trust, perception of intervention efficacy, and likelihood of adopting it.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhujiazi Zhang ◽  
Luodan Suo ◽  
Jingbin Pan ◽  
Dan Zhao ◽  
Li Lu

Abstract Background The objectives of this review were to evaluate the vaccine effectiveness (VE) of the two-dose varicella vaccine for healthy children in China and explore the application of the approach of Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) in observational studies on VE. Methods We searched for observational studies on two-dose varicella VE for children in China aged 1–12 years that were published from 1997 to 2019, and assessed the quality of each study using the Newcastle Ottawa Scale (NOS). We used meta-analysis models to obtain the pooled two-dose VE, and the studies were divided into subgroups and analysed according to whether or not it was an outbreak investigation and its NOS score. The quality of evidence of VEs were rated by approach of the GRADE system. Results A total of 12 studies and 87,196 individuals were included. The pooled two-dose VE was 90% (95% confidence interval [CI]: 69–97%). The VE of outbreak studies (87% [95% CI: 76–93%]) was lower than non-outbreak studies (99% [95% CI: 98–99%]). There was no significant difference in VEs by different NOS quality. The quality of the evidence assessment of pooled two-dose VE was “low”, which was rated down by one category in limitations and publication bias respectively and rated up by two category in large effect. The quality of evidence assessment in subgroup of NOS score ≥ 7 was “moderate”. Conclusions The VE of two-dose varicella vaccine is relatively high in preventing varicella, and is recommended for countries which need further control for varicella. However, higher quality evidence is needed as a supplement for stronger recommendations. The approach of GRADE could be applied for rating the quality of evidence in observational study.


2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Jinke Huang ◽  
Mengxiong Lu ◽  
Yijun Zheng ◽  
Jinxin Ma ◽  
Xiangxue Ma ◽  
...  

Objectives. To systematically collate, appraise, and synthesize the current evidence on acupuncture for irritable bowel syndrome (IBS). Methods. Systematic reviews (SRs)/meta-analyses (MAs) of acupuncture for IBS were searched in eight databases. For quality evaluation of the enrolled studies, Assessment of Multiple Systematic Reviews 2 (AMSTAR-2) was used for methodological quality, Preferred Reporting Item for Systematic Reviews and Meta-Analyses (PRISMA) for reporting quality, and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) for evidence quality. Results. Ten studies were included in our review. According to AMSTAR-2, only one study met all the criteria and was rated as high methodological quality, and the rest were rated as low or very low methodological quality. According to the PRISMA checklist, most of the items were fully reported, with the exception of Q5 (protocol and registration), Q8 (search), and Q27 (funding). With the GRADE system, no outcome measure was rated as high quality. Conclusions. Acupuncture may be a promising therapy for IBS. However, this conclusion must be treated with caution since the quality of SRs/MAs providing evidence is generally low.


2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Boram Lee ◽  
Chan-Young Kwon

Introduction. For situations in which effective and safe natural-derived products to treat hypertension are needed, recent studies suggest that an herbal medicine, Sihogayonggolmoryeo-tang (SYM), can improve both hypertension and concurrent mood symptoms. We aimed to evaluate the effectiveness and safety of SYM in treating hypertension. Methods. Thirteen English, Korean, and Chinese databases were comprehensively searched from their inception to May 2020. Randomized controlled trials (RCTs) using SYM as a monotherapy or adjunctive therapy for hypertension were evaluated. The primary outcome was the systolic and diastolic blood pressure (BP). Descriptive analyses of the relevant data were conducted, and where appropriate data were available, a meta-analysis was performed, and the results were presented as a risk ratio or mean difference with 95% confidence intervals. The risk of bias was assessed using the Cochrane risk of bias tool, and the quality of evidence was evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Results. Seven RCTs with 711 participants were included. Compared with placebo, SYM significantly lowered systolic and diastolic BP and concurrent depression. SYM significantly lowered systolic and diastolic BP compared with active controls; however, subgroup analysis revealed no differences between SYM and antihypertensives. In addition, SYM significantly decreased the level of concurrent depression compared with antidepressants. There was no consistent difference in BP reduction between SYM combined with antihypertensives and antihypertensives alone. No serious adverse events were reported following SYM administration. Most of the included studies had an unclear risk of bias, and the quality of evidence was generally rated “low.” Conclusion. Current evidence suggests that SYM may have the potential to lower hypertension and concurrent depressive symptoms without serious adverse events. Additional high-quality, placebo-controlled RCTs should be conducted to confirm the efficacy of SYM.


2020 ◽  
Vol 163 (5) ◽  
pp. 860-869
Author(s):  
Guo Liu ◽  
Ciyun Xiao ◽  
Xu Zhou ◽  
Feng Liu

Objective To evaluate whether plasma ablation tonsillectomy is superior to other hot techniques in reducing postoperative morbidity. Data Sources The databases of PubMed, EMBASE, and Web of Science were used to search the literature, from inception to January 2, 2020. Randomized controlled trials (RCTs) that compared plasma ablation tonsillectomy with any other hot techniques were eligible. Review Methods A modified Cochrane tool was used to assess the risk of bias. The standardized mean difference (SMD) and 95% confidence interval (CI) were used to estimate pooled effects of postoperative pain, and the risk ratio (RR) was used for postoperative bleeding. Subgroup analysis was prespecified to explore the source of heterogeneity. The evidence quality of each outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results A total of 15 RCTs were included (n = 1293). Comparing with other hot techniques, plasma ablation tonsillectomy may cause less pain on postoperative day 7 (SMD, −0.53; 95% CI, −0.84 to −0.23). However, the magnitude of the difference may be clinically meaningless. There were no significant differences not only in terms of postoperative pain on day 1 and day 3 but also in the incidence of postoperative bleeding, reoperation hemostasis, and return to normal diet and activities between the 2 groups. Conclusion There is still substantial uncertainty on postoperative pain, bleeding, and recovery. The current evidence is insufficient to demonstrate that plasma ablation is superior to other hot techniques for tonsillectomy.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
M Oberndorfer ◽  
I Grabovac ◽  
S Haider ◽  
T E Dorner

Abstract Background Reports of the effectiveness of e-cigarettes (ECs) for smoking cessation vary across different studies making implementation recommendations hard to attain. We performed a systematic review and meta-analysis to synthesise the current evidence regarding the effectiveness of ECs for smoking cessation. Methods PubMed, PsycInfo and Embase databases were searched for randomized controlled trials comparing nicotine ECs with non-nicotine ECs or with established smoking cessation interventions (nicotine replacement therapy (NRT) and or counselling) published between 01/01/2014 and 01/05/2019. Data from eligible studies were extracted and used for random-effects meta-analyses. Results Our literature review yielded 13190 publications with 10 studies being identified as eligible for systematic review, covering 8362 participants, and 8 for meta-analyses (n = 30 - 6006). Using the last follow-up of eligible studies, the proportion of smokers achieving abstinence was 1.67 [95CI:0.99 - 2.81] times higher in nicotine EC users compared to non-nicotine EC users. The proportion of abstinent smokers was 1.69 [95CI:1.25 - 2.27] times higher in EC users compared to participants receiving NRT. EC users showed a 2.70 [95CI:1.15 - 6.30] times higher proportion of abstinent smokers in comparison to participants solely receiving counselling. Conclusions Our analysis showed modest effects of nicotine-ECs compared to non-nicotine ECs. When compared to NRT or counselling, results suggest that nicotine EC may be more effective for smoking cessation. As ECs also help maintaining routinized behaviour and social aspects of smoking, we hypothesise that this may explain their advantage as a tool for smoking cessation. However, given the small number of included studies, different populations, heterogeneous designs, and the overall moderate to low quality of evidence, it is not possible to offer clear recommendations. More comparable data is needed to strengthen confidence in the quality of evidence. Key messages The number of previous studies assessing the effectiveness of ECs for smoking cessation is limited. Further, comparability of these studies is restricted, weakening the quality of evidence. Although current evidence on the effectiveness of ECs for smoking cessation is inconclusive, our meta-analyses suggest that ECs could be a promising alternative tool in attempts to achieve abstinence.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ran Liu ◽  
Kun Zhang ◽  
Qiu-yu Tong ◽  
Guang-wei Cui ◽  
Wen Ma ◽  
...  

Abstract Background Acupuncture for post-stroke depression (PSD) has been evolving, but uncertainty remains. To assess the existing evidence from randomized clinical trials (RCTs) of acupuncture for PSD, we sought to draw conclusions by synthesizing RCTs. Methods An exhaustive literature search was conducted in seven electronic databases from their inception dates to April 19, 2020, to identify systematic reviews (SRs) and meta-analyses (MAs) on this topic. The primary RCTs included in the SRs/MAs were identified. We also conducted a supplementary search for RCTs published from January 1, 2015, to May 12, 2020. Two reviewers extracted data separately and pooled data using RevMan 5.3 software. The quality of evidence was critically appraised with the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system. Results A total of 17 RCTs involving 1402 patients were included. Meta-analysis showed that participants who received a combination of acupuncture and conventional treatments exhibited significantly lower scores on the HAM-D17, HAM-D24 and HAM-D (MD, − 5.08 [95% CI, − 6.48 to − 3.67], I2 = 0%), (MD, − 9.72 [95% CI, − 14.54 to − 4.91], I2 = 65%) and (MD, − 2.72 [95% CI, − 3.61 to − 1.82], respectively) than those who received conventional treatment. However, there was no significant difference in acupuncture versus antidepressants in terms of the 17-item, 24-item and HAM-D scales (MD, − 0.43 [95% CI, − 1.61 to 0.75], I2 = 51%), (MD, − 3.09 [95% CI, − 10.81 to 4.63], I2 = 90%) and (MD, − 1.55 [95% CI, − 4.36 to 1.26], I2 = 95%, respectively). For adverse events, acupuncture was associated with fewer adverse events than antidepressants (RR, 0.16 [95% CI, 0.07 to 0.39], I2 = 35%), but there was no significant difference in the occurrence of adverse events between the combination of acupuncture and conventional treatments versus conventional treatments (RR, 0.63 [95% CI, 0.21 to 1.83], I2 = 38%). The quality of evidence was low to very low due to the substantial heterogeneity among the included studies. Conclusions The current review indicates that acupuncture has greater effect on PSD and better safety profile than antidepressants, but high-quality evidence evaluating acupuncture for PSD is still needed.


2017 ◽  
Vol 76 (11) ◽  
pp. 1870-1882 ◽  
Author(s):  
Sabrina M Nielsen ◽  
Else M Bartels ◽  
Marius Henriksen ◽  
Eva E Wæhrens ◽  
Henrik Gudbergsen ◽  
...  

ObjectivesWeight loss is commonly recommended for gout, but the magnitude of the effect has not been evaluated in a systematic review. The aim of this systematic review was to determine benefits and harms associated with weight loss in overweight and obese patients with gout.MethodsWe searched six databases for longitudinal studies, reporting the effect of weight loss in overweight/obese gout patients. Risk of bias was assessed using the tool Risk of Bias in Non-Randomised Studies of Interventions. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation.ResultsFrom 3991 potentially eligible studies, 10 were included (including one randomised trial). Interventions included diet with/without physical activity, bariatric surgery, diuretics, metformin or no intervention. Mean weight losses ranged from 3 kg to 34 kg. Clinical heterogeneity in study characteristics precluded meta-analysis. The effect on serum uric acid (sUA) ranged from −168 to 30 μmol/L, and 0%–60% patients achieving sUA target (<360 μmol/L). Six out of eight studies (75%) showed beneficial effects on gout attacks. Two studies indicated dose–response relationship for sUA, achieving sUA target and gout attacks. At short term, temporary increased sUA and gout attacks tended to occur after bariatric surgery.ConclusionsThe available evidence is in favour of weight loss for overweight/obese gout patients, with low, moderate and low quality of evidence for effects on sUA, achieving sUA target and gout attacks, respectively. At short term, unfavourable effects may occur. Since the current evidence consists of a few studies (mostly observational) of low methodological quality, there is an urgent need to initiate rigorous prospective studies (preferably randomised controlled trials).Systematic review registrationPROSPERO, CRD42016037937.


2019 ◽  
Vol 9 (3) ◽  
pp. 116-123 ◽  
Author(s):  
Robert J. Willborn ◽  
Colleen P. Hall ◽  
Matthew A. Fuller

AbstractIntroductionAll symptoms in schizophrenia may impact functioning. Although Food and Drug Administration-approved medications typically benefit positive symptoms, negative symptoms are generally refractory to medication interventions. N-acetylcysteine's (NAC) influence on glutamatergic neurotransmission has been established. An emerging body of research has attempted to correlate this action with reduction in symptom severity, evaluating response in positive, negative, and cognitive symptom domains.MethodsA literature review was performed to analyze available data on NAC intervention and improvement in the positive, negative, and cognitive symptom domains in patients with schizophrenia. Quality of evidence was systematically assessed to determine level of certainty in results.ResultsThree randomized controlled trials were identified. Across studies, negative symptoms decreased more with NAC compared to placebo; ranging between 11.9% and 24.1%. The assessment determined a low level of certainty regarding benefit of NAC on negative and cognitive symptoms and moderate certainty for NAC regarding findings of side effects and lack of benefit on positive symptoms.DiscussionConsistent reporting of benefit in negative symptoms is found across studies of NAC intervention. These improvements are notable for symptoms that have generally remained refractory to medication intervention. Inconsistent benefit was reported in positive and cognitive symptoms. GRADE (grading of recommendations assessment, development and evaluation) assessment of current evidence indicates a low certainty of benefit for negative symptoms with standard use of NAC in patients with schizophrenia. However, a trial of this low-risk intervention may be warranted in patients with resistant negative symptoms and subsequent impaired functioning despite appropriate antipsychotic therapy as they may experience additional benefit in this symptom domain.


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