Industry-funded versus non-profit-funded critical care research: a meta-epidemiological overview.
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ABSTRACT:
SUBMITTER: Janiaud P
PROVIDER: S-EPMC6182357 | biostudies-literature | 2018 Oct
REPOSITORIES: biostudies-literature
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Project description:INTRODUCTION: Small-study effects refer to the fact that trials with limited sample sizes are more likely to report larger beneficial effects than large trials. However, this has never been investigated in critical care medicine. Thus, the present study aimed to examine the presence and extent of small-study effects in critical care medicine. METHODS: Critical care meta-analyses involving randomized controlled trials and reported mortality as an outcome measure were considered eligible for the study. Component trials were classified as large (?100 patients per arm) and small (<100 patients per arm) according to their sample sizes. Ratio of odds ratio (ROR) was calculated for each meta-analysis and then RORs were combined using a meta-analytic approach. ROR<1 indicated larger beneficial effect in small trials. Small and large trials were compared in methodological qualities including sequence generating, blinding, allocation concealment, intention to treat and sample size calculation. RESULTS: A total of 27 critical care meta-analyses involving 317 trials were included. Of them, five meta-analyses showed statistically significant RORs <1, and other meta-analyses did not reach a statistical significance. Overall, the pooled ROR was 0.60 (95% CI: 0.53 to 0.68); the heterogeneity was moderate with an I2 of 50.3% (chi-squared = 52.30; P = 0.002). Large trials showed significantly better reporting quality than small trials in terms of sequence generating, allocation concealment, blinding, intention to treat, sample size calculation and incomplete follow-up data. CONCLUSIONS: Small trials are more likely to report larger beneficial effects than large trials in critical care medicine, which could be partly explained by the lower methodological quality in small trials. Caution should be practiced in the interpretation of meta-analyses involving small trials.
| S-EPMC4056100 | biostudies-literature
Project description:BackgroundStudies have shown that industry-sponsored meta-analyses of drugs lack scientific rigour and have biased conclusions. However, these studies have been restricted to certain medical specialities. We compared all industry-supported meta-analyses of drug-drug comparisons with those without industry support.MethodsWe searched PubMed for all meta-analyses that compared different drugs or classes of drugs published in 2004. Two authors assessed the meta-analyses and independently extracted data. We used a validated scale for judging the methodological quality and a binary scale for judging conclusions. We divided the meta-analyses according to the type of support in 3 categories: industry-supported, non-profit support or no support, and undeclared support.ResultsWe included 39 meta-analyses. Ten had industry support, 18 non-profit or no support, and 11 undeclared support. On a 0-7 scale, the median quality score was 6 for meta-analyses with non-profit or no support and 2.5 for the industry-supported meta-analyses (P < 0.01). Compared with industry-supported meta-analyses, more meta-analyses with non-profit or no support avoided bias in the selection of studies (P = 0.01), more often stated the search methods used to find studies (P = 0.02), searched comprehensively (P < 0.01), reported criteria for assessing the validity of the studies (P = 0.02), used appropriate criteria (P = 0.04), described methods of allocation concealment (P = 0.05), described methods of blinding (P = 0.05), and described excluded patients (P = 0.08) and studies (P = 0.15). Forty percent of the industry-supported meta-analyses recommended the experimental drug without reservations, compared with 22% of the meta-analyses with non-profit or no support (P = 0.57).In a sensitivity analysis, we contacted the authors of the meta-analyses with undeclared support. Eight who replied that they had not received industry funding were added to those with non-profit or no support, and 3 who did not reply were added to those with industry support. This analysis did not change the results much.ConclusionTransparency is essential for readers to make their own judgment about medical interventions guided by the results of meta-analyses. We found that industry-supported meta-analyses are less transparent than meta-analyses with non-profit support or no support.
| S-EPMC2553412 | biostudies-literature
Project description:BackgroundThe Cochrane risk of bias tool is a prominent instrument used to evaluate potential biases in clinical trials. In three updates of our Cochrane review on neuraminidase inhibitors, we assessed risk of bias on the same trials using different levels of detail: the trials in journal publications, in core reports, and in full clinical study reports. Here we analyse whether progressively greater amounts of information and detail in full clinical study reports (including trial protocols, statistical analysis plans, certificates of analyses, individual participant data listings and randomisation lists) affected our risk of bias assessments.Methods and findingsWe used the Cochrane risk of bias tool to assess and compare risk of bias in 14 oseltamivir trials (reported in 10 clinical study reports) obtained from the European Medicines Agency (EMA) and the manufacturer, Roche. With more detailed information, reported in clinical study reports, no previous assessment of 'high' risk of bias was reclassified as 'low' or 'unclear' in the main analysis, and over half (55%, 34/62) of the previous assessments of 'low' risk of bias were reclassified as 'high'. Most assessments of 'unclear' risk of bias (67%, or 28/42) were reclassified as 'high' risk of bias when our judgements were based on full clinical study reports. The limits of our study were our relative inexperience in dealing with large information sets, sometimes subjective bias judgements and focus on industry trials. Comparison with journal publications was not possible because of the low number of trials published.ConclusionsWe found that as information increased in the document, this increased our assessment of bias. This may mean that risk of bias has been insufficiently assessed in Cochrane reviews based on journal publications.
| S-EPMC4179405 | biostudies-literature
Project description:BACKGROUND:It has been shown that patients cared for at private for-profit hospitals have higher risk-adjusted mortality rates than those cared for at private not-for-profit hospitals. Uncertainty remains, however, about the economic implications of these forms of health care delivery. Since some policy-makers might still consider for-profit health care if expenditure savings were sufficiently large, we undertook a systematic review and meta-analysis to compare payments for care at private for-profit and private not-for-profit hospitals. METHODS:We used 6 search strategies to identify published and unpublished observational studies that directly compared the payments for care at private for-profit and private not-for-profit hospitals. We masked the study results before teams of 2 reviewers independently evaluated the eligibility of all studies. We confirmed data or obtained additional data from all but 1 author. For each study, we calculated the payments for care at private for-profit hospitals relative to private not-for-profit hospitals and pooled the results using a random effects model. RESULTS:Eight observational studies, involving more than 350 000 patients altogether and a median of 324 hospitals each, fulfilled our eligibility criteria. In 5 of 6 studies showing higher payments for care at private for-profit hospitals, the difference was statistically significant; in 1 of 2 studies showing higher payments for care at private not-for-profit hospitals, the difference was statistically significant. The pooled estimate demonstrated that private for-profit hospitals were associated with higher payments for care (relative payments for care 1.19, 95% confidence interval 1.07-1.33, p = 0.001). INTERPRETATION:Private for-profit hospitals result in higher payments for care than private not-for-profit hospitals. Evidence strongly supports a policy of not-for-profit health care delivery at the hospital level.
| S-EPMC419772 | biostudies-literature
Project description:INTRODUCTION:Our objective was to re-analyse the data used in an industry-funded working paper to study the effect of plain packaging on youth smoking prevalence in Australia, allowing for other tobacco control measures introduced over the period 2001-2013, and using a more appropriate method of analysis. METHODS:Monthly smoking prevalence and sample sizes from repeat cross-sectional surveys were reconstructed from the working paper by reverse engineering of the industry-presented data, and analysed as a time series using logistic regression. Power analysis presented in the industry-funded working paper was re-calculated. RESULTS:Smoking prevalence among minors in Australia declined from 11.6% to 5.6% over the 13-year period examined; an overall 52% relative reduction or an average annual reduction of 5.5% (95% confidence interval 4.6% to 6.4%). There was a 12.1% (-4.8% to 26.2%) relative reduction in smoking prevalence when plain packaging was introduced, though the reduction was not statistically significant. Re-calculated power values were much lower than those reported in the industry-funded paper, confirming the inconclusiveness of its findings, as pointed out in previous critiques. CONCLUSIONS:Our findings suggest a decline of smoking prevalence in minors following the introduction of plain packaging in Australia. They differ substantially from those presented in an industry-funded study on the effects of plain packaging on smoking prevalence in minors in Australia, which used the same data.
| S-EPMC7232792 | biostudies-literature
Project description:PurposeSince the introduction of the first prosthetic mesh for abdominal hernia repair, there has been a search for the "ideal mesh." The use of preclinical or animal models for assessment of necessary characteristics of new and existing meshes is an indispensable part of hernia research. Unfortunately, in our experience there is a lack of consensus among different research groups on which model to use. Therefore, we hypothesized that there is a lack of comparability within published animal research on hernia surgery due to wide range in experimental setup among different research groups.MethodsA systematic search of the literature was performed to provide a complete overview of all animal models published between 2000 and 2014. Relevant parameters on model characteristics and outcome measurement were scored on a standardized scoring sheet.ResultsDue to the wide range in different animals used, ranging from large animal models like pigs to rodents, we decided to limit the study to 168 articles concerning rat models. Within these rat models, we found wide range of baseline animal characteristics, operation techniques, and outcome measurements. Making reliable comparison of results among these studies is impossible.ConclusionThere is a lack of comparability among experimental hernia research, limiting the impact of this experimental research. We therefore propose the establishment of guidelines for experimental hernia research by the EHS.
| S-EPMC5608772 | biostudies-literature
Project description:BackgroundEnrollment challenges for critical care research are common. Contributing factors include short enrollment windows, the crisis nature of critical illness, lack of research staff, unavailable legal proxy, family dynamics, and language barriers.ObjectiveTo describe enrollment statistics for an ongoing critical care nursing trial, barriers to recruitment, and strategies to enhance enrollment.MethodsTwo years' worth of recruitment and enrollment data from an oral care intervention trial in critically ill adults receiving mechanical ventilation at 1 hospital were analyzed. Recruitment logs include number of patients screened, eligible, enrolled, and declined and patients' sex, race, and ethnicity.ResultsTarget enrollment (15.5 patients per month) was based on experience and historical data. Strategies implemented to promote enrollment included providing study personnel at least 18 hours per day for 7 days per week, regular rounds, communication with direct care staff, and Spanish consent processes. In 2 years, 6963 patients were screened; 1551 (22%) were eligible. Consent was sought from 366 (24% of eligible patients). Enrollment averaged 13.3 patients per month (86% of projected target). The main factor impeding enrollment was unavailability of a legal proxy to provide consent (88%). The refusal rates of white (11%), black (13%), and Hispanic (16%) patients did not differ significantly. However, those classified as Asian or as more than 1 race declined significantly more often (35%) than did white or black patients (P = .02).ConclusionsUnavailability of a legal proxy within a short enrollment window was the major challenge to enrollment. Various factors influenced consent decisions. Clinical study design requires more conservative estimates.
| S-EPMC6015765 | biostudies-literature
Project description:BackgroundThe objective of this systematic review and meta-analysis was to assess the relationship between the chloride content of intravenous resuscitation fluids and patient outcomes in the perioperative or intensive care setting.MethodsSystematic searches were performed of PubMed/MEDLINE, Embase and Cochrane Library (CENTRAL) databases in accordance with PRISMA guidelines. Randomized clinical trials, controlled clinical trials and observational studies were included if they compared outcomes in acutely ill or surgical patients receiving either high-chloride (ion concentration greater than 111?mmol/l up to and including 154?mmol/l) or lower-chloride (concentration 111?mmol/l or less) crystalloids for resuscitation. Endpoints examined were mortality, measures of kidney function, serum chloride, hyperchloraemia/metabolic acidosis, blood transfusion volume, mechanical ventilation time, and length of hospital and intensive care unit stay. Risk ratios (RRs), mean differences (MDs) or standardized mean differences (SMDs) and confidence intervals were calculated using fixed-effect modelling.ResultsThe search identified 21 studies involving 6253 patients. High-chloride fluids did not affect mortality but were associated with a significantly higher risk of acute kidney injury (RR 1.64, 95 per cent c.i. 1.27 to 2.13; P?<?0.001) and hyperchloraemia/metabolic acidosis (RR 2.87, 1.95 to 4.21; P?<?0.001). High-chloride fluids were also associated with greater serum chloride (MD 3.70 (95 per cent c.i. 3.36 to 4.04) mmol/l; P?<?0.001), blood transfusion volume (SMD 0.35, 0.07 to 0.63; P?=?0.014) and mechanical ventilation time (SMD 0.15, 0.08 to 0.23; P?<?0.001). Sensitivity analyses excluding heavily weighted studies resulted in non-statistically significant effects for acute kidney injury and mechanical ventilation time.ConclusionA weak but significant association between higher chloride content fluids and unfavourable outcomes was found, but mortality was unaffected by chloride content.
| S-EPMC4282059 | biostudies-literature
Project description:Dirofilaria immitis, also known as heartworm, is a major parasitic threat for dogs and cats around the world. Because of its impact on the health and welfare of companion animals, heartworm disease is of huge veterinary and economic importance especially in North America, Europe, Asia and Australia. Within the animal health market many different heartworm preventive products are available, all of which contain active components of the same drug class, the macrocyclic lactones. In addition to compliance issues, such as under-dosing or irregular treatment intervals, the occurrence of drug-resistant heartworms within the populations in the Mississippi River areas adds to the failure of preventive treatments. The objective of this review is to provide an overview of the disease, summarize the current disease control measures and highlight potential new avenues and best practices for treatment and prevention.
| S-EPMC8163879 | biostudies-literature
Project description:ObjectiveTo characterise the research profile of UK critical care physiotherapists including experience, training needs, and barriers and enablers to engagement in critical care research. 'Research' was defined broadly to encompass activities related to quantitative and qualitative studies, service evaluations, clinical audit and quality improvements.DesignClosed-question online survey, with optional free-text responses.SettingUK critical care community.ParticipantsUK critical care physiotherapists, regardless of clinical grade or existing research experience.Results268 eligible survey responses were received during the 12-week study period (21 incomplete, 7.8%). Respondents were based in university-affiliated (n=133, 49.6%) and district general (n=111, 41.4%) hospitals, and generally of senior clinical grade. Nearly two-thirds had postgraduate qualifications at master's level or above (n=163, 60.8%). Seven had a doctoral-level qualification. Respondents reported a range of research experience, predominantly data acquisition (n=144, 53.7%) and protocol development (n=119, 44.4%). Perceived research training needs were prevalent, including topics of research methods, critical literature appraisal, protocol development and statistical analysis (each reported by ≥50% respondents). Multiple formats for delivery of future research training were identified. Major barriers to research engagement included lack of protected time (n=220, 82.1%), funding (n=177, 66.0%) and perceived experience (n=151, 56.3%). Barriers were conceptually categorised into capability, opportunity and motivation themes. Key enabling strategies centred on greater information provision about clinical research opportunities, access to research training, secondment roles and professional networks.ConclusionsUK critical care physiotherapists are skilled, experienced and motivated to participate in research, including pursuing defined academic research pathways. Nonetheless wide-ranging training needs and notable barriers preclude further involvement. Strategies to harness the unique skills of this profession to enhance the quality, quantity and scope of critical care research, benefiting from a multiprofessional National Clinical Research Network, are required.
| S-EPMC5988191 | biostudies-literature