Background
Industry funders can simply provide money or collaborate in trial design, analysis, or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomized controlled trials (RCT).
Methods
We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary endpoint; blinding of the patient, clinician, and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding.
Results
We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88–6·83], p<·0001), intention-to-treat analysis (RR 1·32, 95% CI [1·04–1·67], p=·02), and blinding of patients (RR 3·05, 95% CI [1·71–5·44], p<·0001), clinicians (RR 3·36, 95% CI [1·83–6·16], p=<·001), and outcomes assessors (RR 3·03, 95% CI [1·57–5·83], p=·0002). They did not differ in use of overall survival as a primary endpoint (RR 1·27 95% CI [0·72–2·24]) and were similarly likely to report positive results (RR 1·11 95% CI [0·85–1·46], p=0·45). Studies with funding only did not differ from those without funding.
Conclusions
Oncology RCTs with industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias.
As the Coronavirus disease 2019 (COVID-19) pandemic spread to the US, so too did descriptions of an associated coagulopathy and thrombotic complications. Hospitals created institutional protocols for inpatient management of COVID-19 coagulopathy and thrombosis in response to this developing data. We collected and analyzed protocols from 21 US academic medical centers developed between January and May 2020. We found greatest consensus on recommendations for heparin-based pharmacologic venous thromboembolism (VTE) prophylaxis in COVID-19 patients without contraindications. Protocols differed regarding incorporation of D-dimer tests, dosing of VTE prophylaxis, indications for post-discharge pharmacologic VTE prophylaxis, how to evaluate for VTE, and the use of empiric therapeutic anticoagulation. These findings support ongoing efforts to establish international, evidence-based guidelines.
This paper demonstrates that POC has limited short-term and long-term systemic toxicity and most of the ocular complications were acute, not delayed. Only two select cases showed long-term complete responses to POC alone and the data do not support the use as monotherapy, although where it was used in combination with other modalities, 39% of the eyes were saved.
BackgroundOver-ordering of daily laboratory tests adversely affects patient care through hospital-acquired anaemia, patient discomfort, burden on front-line staff and unnecessary downstream testing. This remains a prevalent issue despite the 2013 Choosing Wisely recommendation to minimise unnecessary daily labs. We conducted a systematic review of the literature to identify interventions targeting unnecessary laboratory testing.MethodsWe systematically searched MEDLINE, EMBASE, Cochrane Central and SCOPUS databases to identify interventions focused on reducing daily complete blood count, complete metabolic panel and basic metabolic panel labs. We defined interventions as ‘effective’ if a statistically significant reduction was attained and ‘highly effective’ if a reduction of ≥25% was attained.ResultsThe search yielded 5646 studies with 41 articles that met inclusion criteria. We grouped interventions into one or more categories: audit and feedback, cost display, education, electronic medical record (EMR) change, and policy change. Most interventions lasted less than a year and used a multipronged approach. All five strategies were effective in most studies with EMR change being the most commonly used independent strategy. EMR change and policy change were the strategies most frequently reported as effective. EMR change was the strategy most frequently reported as highly effective.ConclusionOur analysis identified five categories of interventions targeting daily laboratory testing. All categories were effective in most studies, with EMR change being most frequently highly effective.PROSPERO registration numberCRD42021254076.
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