Systematic Reviews May Not Address Adverse Side Effects

MedicalResearch.com Interview with:

Dr Su Golder, PhD Department of Health Sciences University of York

Dr. Golder

Dr. Su Golder, PhD
Department of Health Sciences
University of York

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  Patients and providers need to know about the relative benefits and harms of an intervention. It is not just those adverse events deemed to be serious that are important but also those categorized as minor.

Systematic reviews are summaries of the evidence, often used in to inform guidelines and decision-making. It is common for systematic reviews to focus on the potential benefits of an intervention without addressing the adverse effects. This leads to bias and an incomplete picture of the evidence.

To aid transparency in systematic reviews, authors should published a protocol, describing what they intend to do. We look at protocols with a completed systematic review published in 2017 or 2018. We found that only 38% said that they would record adverse effects.

Equally worrying of those authors that stated in their protocol that they intended to look at adverse effects – only 65% fully reported the adverse outcome exactly as they set out to do.  Continue reading

‘Deprescribing’ Can Reduce Harm of Medications in Elderly

MedicalResearch.com Interview with:
“Pills” by Victor is licensed under CC BY 2.0Khalid Ali, MBBS, FRCP, MD

Senior lecturer in Geriatrics
Brighton and Sussex Medical School, UK 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Older people are more like to have more than one chronic condition (multi-morbidity), and as such as are more likely to be prescribed several medications (poly pharmacy) to treat those conditions. At the point of hospital discharge, older people are given different / new medications in addition to their old ones, and this puts them at higher risk of harm related to medicines. Our study led by  Brighton and Sussex Medical School (BSMS) and King’s College London involved five hospitals and 1,280 patients (average age 82 years) in South England. Senior pharmacists interviewed patients and carers, reviewed GP records and analysed hospital readmission to determine medication-related harm.

The study found that more than one in three patients (37%) experienced harm from their medicines within two months of hospital discharge, and that this was potentially preventable in half of the cases. Medication-related harm was most commonly found to occur from the toxicity of the medicine itself and in a quarter of cases from poor adherence.  The medicines found to pose the highest risk were opiates, antibiotics and benzodiazepines. Patients suffered a range of side effects including serious kidney injury, psychological disturbance, irregular heart rhythms, confusion, dizziness, falls, diarrhoea, constipation and bleeding.

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20% of Hospitalized Patients Receiving Antibiotics Experience Side Effects

MedicalResearch.com Interview with:

Pranita Tamma, MD Assistant Professor Director, Pediatric Antimicrobial Stewardship Program Assistant Professor of Pediatrics Johns Hopkins Bloomberg School of Public Health

Dr. Pranita D. Tamma
Assistant Professor of Pediatrics
Director, Pediatric Antimicrobial Stewardship Program
The Johns Hopkins University School of Medicine 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A study examining the impact of antibiotics prescribed for nearly 1500 adult patients admitted to The Johns Hopkins Hospital found that adverse side effects occurred in a fifth of them, and that nearly a fifth of those side effects occurred in patients who didn’t need antibiotics in the first place.

In the study, the researchers evaluated the electronic medical records of 1488 adults admitted to the general medicine services at The Johns Hopkins Hospital between September 2013 and June 2014. The patients were admitted for reasons ranging from trauma to chronic disease, but all received at least 24 hours of antibiotic treatment.

The researchers followed patients for 30 days after hospital discharge to evaluate for the development of antibiotic-associated adverse events. To determine the likelihood that an adverse reaction was most likely due to antibiotics and to identify how many adverse reactions could be avoided by eliminating unnecessary antibiotic use, two infectious disease clinicians reviewed all of the data.

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Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions May Differ

MedicalResearch.com Interview with:

Dr Su Golder PhD Research Fellow Department of Health Sciences University of York

Dr. Su Golder

Dr Su Golder PhD
Research Fellow
Department of Health Sciences
University of York

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Serious concerns have emerged regarding publication bias or selective omission of outcomes data, whereby negative results are less likely to be published than positive results. There remains considerable uncertainty about the extent of unpublished data on adverse events beyond that reported in the published literature. We aimed to estimate the potential impact of additional data sources and the extent of unpublished information when conducting syntheses of adverse events.

We found that less published papers contain adverse events information. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies.

We also found even when adverse events are reported in the published and unpublished versions of the same study that the numbers of adverse events do not always match The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%.
Lastly we found that inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals) in three-quarters of pooled analyses, but did not markedly change the direction or statistical significance of the risk in most cases.

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