Differences in methodological quality between positive and negative published clinical trials

Chiavetta, Noelle M.; Martins, Ana; Henriques, Inês C.R.; Fregni, Felipe

doi:10.1111/jan.12380

Cited by 13 publications

(9 citation statements)

References 90 publications

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“…This is in contrast to a recent paper that reviewed studies published in nursing journals in which investigators found significantly higher level of methodological quality for negative studies. 26 Nevertheless, the authors also reported that positive studies were published more frequently than negative studies (73.6% vs 26.4%), in line with our results. The uneven distribution of positive and negative studies was similar among observational and RCT cohort in our study.…”

Section: Discussionsupporting

confidence: 91%

Comparison of methodological quality of positive versus negative comparative studies published in Indian medical journals: a systematic review

Charan¹,

Chaudhari

Jackson

et al. 2015

BMJ Open

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ObjectivesPublished negative studies should have the same rigour of methodological quality as studies with positive findings. However, the methodological quality of negative versus positive studies is not known. The objective was to assess the reported methodological quality of positive versus negative studies published in Indian medical journals.DesignA systematic review (SR) was performed of all comparative studies published in Indian medical journals with a clinical science focus and impact factor >1 between 2011 and 2013. The methodological quality of randomised controlled trials (RCTs) was assessed using the Cochrane risk of bias tool, and the Newcastle-Ottawa scale for observational studies. The results were considered positive if the primary outcome was statistically significant and negative otherwise. When the primary outcome was not specified, we used data on the first outcome reported in the history followed by the results section. Differences in various methodological quality domains between positive versus negative studies were assessed by Fisher's exact test.ResultsSeven journals with 259 comparative studies were included in this SR. 24% (63/259) were RCTs, 24% (63/259) cohort studies, and 49% (128/259) case–control studies. 53% (137/259) of studies explicitly reported the primary outcome. Five studies did not report sufficient data to enable us to determine if results were positive or negative. Statistical significance was determined by p value in 78.3% (199/254), CI in 2.8% (7/254), both p value and CI in 11.8% (30/254), and only descriptive in 6.3% (16/254) of studies. The overall methodological quality was poor and no statistically significant differences between reporting of methodological quality were detected between studies with positive versus negative findings.ConclusionsThere was no difference in the reported methodological quality of positive versus negative studies. However, the uneven reporting of positive versus negative studies (72% vs 28%) indicates a publication bias in Indian medical journals with an impact factor of >1.

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Section: Discussionsupporting

confidence: 91%

Comparison of methodological quality of positive versus negative comparative studies published in Indian medical journals: a systematic review

Charan¹,

Chaudhari

Jackson

et al. 2015

BMJ Open

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“…Two well-trained independent reviewers evaluated the quality of RCTs using the Jadad Quality Score (Chiavetta, Martins, Henriques, & Fregni, 2014;Jadad et al, 1996) and Cochrane RoB 2.0 (Eldridge et al, 2016). The reviewers examined the quality of trails using the Jadad Quality Score based on three aspects: randomization, double blinding, and reasons for patient dropout/loss to follow-up.…”

Section: Quality Appraisalmentioning

confidence: 99%

Meta-analysis: Effectiveness of Comprehensive Geriatric Care for Elderly Following Hip Fracture Surgery

Lin

Yeh

2019

West J Nurs Res

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Hip fractures may increase mortality and decrease mobility in elderly patients. Effectiveness of comprehensive geriatric care (CGC) has not been verified. A systematic review and a meta-analysis were conducted by searching full-text databases (1988–2018) of Cochrane Library, Clinical Key, Embase, MEDLINE, CINAHL, and ProQuest for randomized controlled trials (RCTs) of CGC following hip fractures. Outcome measures were mortality, activities of daily living, hospital stay, and discharge to institutional setting. Cochrane RoB 2.0, Jadad Quality Score, and Group Reading Assessment were used for analysis. Of the 11 studies included, 8 examined mortality (effect size Z = 2.51, p = 0.01), 5 examined daily activities (effect size Z = 3.31, p = 0.0009), 7 examined length of hospital stay (effect size Z = 0.18, p = 0.85), and 5 examined discharged to an institutional setting (effect size Z = 0.81, p = 0.42). Results showed that CGC decreased mortality and improved daily living activities.

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“…The publications reporting in favour of IHC were more likely to have uncertain/high risk of bias ratings across most domains than publications reporting no differences between groups, or effects in favour of usual care. While low methodological quality may be associated with larger estimates of treatment effect in some disciplines and disease areas, this phenomenon is not universal . As such, the degree to which this phenomenon applies to IHC research requires further exploration.…”

Section: Discussionmentioning

confidence: 99%

The effectiveness of integrative healthcare for chronic disease: A systematic review

et al. 2019

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Background The past few decades have witnessed a surge in consumer, clinician and academic interest in the field of integrative healthcare (IHC). Yet, there is still uncertainty regarding the effectiveness of IHC for complex, long‐term health conditions. Objective To assess the effectiveness of IHC for the management of any chronic health condition. Methods Seven databases and four clinical trial registries were searched from inception through to May 2018 for comparative/controlled clinical trials investigating the effectiveness of IHC for any chronic disease, and assessing any outcome. Risk of bias was assessed using the Cochrane Collaboration Risk of Bias tool. Results The search yielded 6,926 results. Eight studies met the inclusion criteria. All studies had at least three design features that carried an uncertain/high risk of bias. Differences in physiological, psychological and functional outcomes, and quality of life between patients receiving IHC and patients receiving conventional/usual care were varied and inconsistent. Changes in patient satisfaction with care were inconclusive. No studies reported the effectiveness of IHC on workforce‐ or administration‐related parameters. Evidence from one trial suggested IHC may be more cost‐effective than conventional care. Conclusions The findings indicate some promising effects for the use of IHC to manage chronic disease. However, the uncertain/high risk of bias across multiple domains, diverse and inconsistent findings, and heterogeneity of outcome measures and study populations prevents firm conclusions from being reached. Along with conducting further well‐designed, long‐term studies in this field, there is a need to ensure interventions closely align with the definition/principles of IHC.

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Differences in methodological quality between positive and negative published clinical trials

Cited by 13 publications

References 90 publications

Comparison of methodological quality of positive versus negative comparative studies published in Indian medical journals: a systematic review

Comparison of methodological quality of positive versus negative comparative studies published in Indian medical journals: a systematic review

Meta-analysis: Effectiveness of Comprehensive Geriatric Care for Elderly Following Hip Fracture Surgery

The effectiveness of integrative healthcare for chronic disease: A systematic review

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