PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Poor quality clinical data informing NICE decisions on treatments in over half of cases

20 year analysis shows no improvement in data quality submitted by manufacturers

2024-02-14
(Press-News.org) The quality of evidence submitted to the National Institute for Health and Care Excellence (NICE) for informing its decisions to recommend technologies for use in the NHS was poor in more than half of cases, reveals a 20-year analysis, published in the open access journal BMJ Open.

 

And the data quality submitted for health technology appraisals by manufacturers between 2000 and 2019 was consistently poor, with no improvement during that time, the analysis shows.

NICE advises the NHS on the clinical and cost-effectiveness of both new and existing technologies, through an independent body of specialists, which make up its appraisal committee.

This committee’s decisions are based on reports from its independent technology assessors, plus advice from consultees, clinical, NHS commissioning, and patient experts.

In recent years, NICE has expanded the evidence it considers, to include a broader range of factors that influence health: registry data; national statistics; surveys; clinical practice recommendations; expert opinions; and additional knowledge from manufacturers.

In light of this, the researchers wanted to systematically review all NICE’s active technology appraisals published between 2000 and 2019 to scrutinise the clinical evidence submitted by the manufacturers and assess its quality for decision-making.

They therefore extracted data from the independent assessment group and evidence review group reports and final appraisal determinations on the quality of submitted randomised controlled clinical trials and the overall quality of evidence submitted for decision-making.

For single technology appraisals (STAs), which evaluate a single product, device, or technology for a single indication, and usually involve new drugs or indications, they also extracted data on quality of life evidence and comparative clinical evidence.

Each category was scored for quality—2 for good; 1 for acceptable; 0 for poor; and −1 for unacceptable. The scores were peer reviewed by all the members of the research team to try and minimise bias.

In all, the evidence for 409 technology appraisals was analysed: 104 multiple technology appraisals (MTA), which evaluate technologies that share one or more criteria; and 305 STAs. 

The appraisals included 25 non-pharmaceutical products, 14 medical devices, 6 other therapies, 5 surgical procedures, and 384 drugs.

In two thirds of all appraisals, the overall quality of evidence was judged to be either poor (224; 55%) or unacceptable (41;10%). The quality of evidence was judged acceptable in a third (139, 34%) or good in only 1% (5). 

In nearly 4 out of 10 (39%; 119) STAs, the quality of comparative evidence was considered poor, and in 17% (51) unacceptable. In 44% (135) the quality of quality of life data was considered poor, and unacceptable in 15% (47). In only a third (102) of STA appraisals was the quality deemed acceptable, and good in only 7% (21).

Based on analysis of the comments from the review group reports, over half of the clinical trials presented in the manufacturers' submissions for all appraisals were deemed to be either poor (166; 41%) or unacceptable (40;10%) quality. Just under half were considered to be of acceptable (173; 42%) or good (30;7%) quality.

Weak or insufficient evidence from poorly conducted clinical trials was often used because it was the only evidence available. But even when the trials had been done well, and the evidence was comprehensive, the comparators were often unsuitable for decision-making in the NHS context, the analysis showed.

And over the entire 20 year period the overall quality of evidence submitted to NICE didn’t change, and was consistently poor, the analysis indicated.

In particular, the researchers noted a lack of clarity on the methodologies used by the manufacturers when carrying out systematic reviews and indirect comparisons.

They found that comparator data often didn’t reflect the UK population and routine treatment pathways. Indirect comparisons were used in over two thirds (68%;207) of STAs to establish the comparative clinical effectiveness of interventions.

And the quality of life data was often of poor or unacceptable quality, even if collected in pivotal trials; and clarity in reporting methodology and details by both manufacturers and assessment bodies varied significantly.

The researchers acknowledge various limitations to their findings, chief among which was the subjective scoring system used for grading the quality of evidence, and the focus on only certain elements of the evidence submitted by manufacturers.

But they nevertheless conclude: “We found that the primary components of clinical evidence (comparative clinical effectiveness, measures of [quality of life] outcomes and overall design of [randomised controlled trials]) that influence patients and are crucial for NICE’s decision making framework are of poor quality. 

“Since the evidence bar continues to be lowered, it is essential to have [health technology assessment] bodies and payers’ input to ensure that the generation of evidence submitted to NICE is strengthened. 

“However, it is essential that stakeholders are aware of this and that organisations put more effort into generating high-quality evidence premarket and postmarket entry.”

END


ELSE PRESS RELEASES FROM THIS DATE:

Age when periods first start and early menopause linked to heightened COPD risk

2024-02-14
A range of reproductive factors, including age when periods first start and an early menopause, are all linked to a heightened risk of COPD—the umbrella term for progressive lung conditions that cause breathing difficulties—finds research published online in the journal Thorax. Miscarriage, stillbirth, infertility, and having 3 or more children are also associated with a heightened risk of COPD, which includes emphysema and chronic bronchitis, the findings show. Recent evidence indicates substantial gender  differences in susceptibility ...

Hostile environment policies linked to prolonged distress in people with Black Caribbean ancestry

2024-02-14
Psychological distress increased among people with Black Caribbean heritage in the UK, relative to the White population, following the 2014 Immigration Act and the Windrush scandal, finds a new study led by UCL researchers. The researchers say their findings, published in The Lancet Psychiatry, suggest a causal link between government policies and a subsequent decline in mental health. They were investigating the impact of the Immigration Act 2014, requiring landlords, employers, the NHS, banks and the police to check right-to-stay documentation. This was a key part of a set of measures known as the Home Office hostile environment policy, seeking ...

Clinical trial shows rheumatoid arthritis drug could prevent disease

2024-02-14
A drug used to treat rheumatoid arthritis could also prevent the disease in individuals deemed to be at risk. Results from a Phase 2b clinical trial, published today in The Lancet by researchers led by King’s College London, provides hope for arthritis sufferers after it was shown that the biologic drug abatacept reduces progression to this agonising chronic inflammatory disease. Rheumatoid arthritis affects half a million people in the UK and develops when the body’s immune system attacks itself, causing joint pain, swelling and significant disability. The disease most commonly begins in middle age, but much younger age groups can be afflicted, and until ...

Do apes have humor?

Do apes have humor?
2024-02-14
Babies playfully tease others as young as eight months of age. Since language is not required for this behavior, similar kinds of playful teasing might be present in non-human animals. Now cognitive biologists and primatologists from the University of California Los Angeles (UCLA, US), the Max Planck Institute of Animal Behavior (MPI-AB, Germany), Indiana University (IU, US), and the University of California San Diego (UCSD, US) have documented playful teasing in four species of great apes. Like joking behavior in humans, ape teasing is provocative, persistent, and includes elements of surprise and play. Because all four great ape species used playful teasing, it is likely that the ...

New digital therapy reduces anxiety and depression in people living with long-term physical health conditions

2024-02-14
A therapist-guided digital cognitive behavioural therapy reduced distress in 89 per cent of participants living with long-term physical health conditions, a new King’s College London study finds. Researchers at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London found that people living with long-term conditions who received the therapist-guided digital programme called COMPASS showed a significant reduction in psychological distress (a combined score of anxiety and depression) 12-weeks after starting the study.  194 patients were recruited via long-term condition charities, including Crohn’s & ...

Researchers edge closer to delivering personalized medicine to cancer patients

Researchers edge closer to delivering personalized medicine to cancer patients
2024-02-14
For the first time, Purdue researchers prove that measuring mechanical motions in living cancer tissues is a viable and promising approach for predicting chemoresistance Chemotherapy can save lives, but often a cancer patient may be resistant to their prescribed chemotherapy, which costs the patient valuable time. Chemoresistance is a topic that researchers need to understand better so that they can match the right type of chemo to the right patient, which is called personalized medicine. An unusual pairing of veterinary scientists and physicists believe ...

Trail cameras track ‘critically low’ New York bobcat population

2024-02-13
CORNELL UNIVERSITY MEDIA RELATIONS OFFICE FOR RELEASE: Feb. 13, 2024 Kaitlyn Serrao 607-882-1140 kms465@cornell.edu Trail cameras track ‘critically low’ New York bobcat population ITHACA, N.Y. – With thousands of strategically placed cameras covering more than 27,000 square miles in central and western New York, biologists have evidence that bobcat populations remain critically low in central and western New York state. Despite reports of recent recoveries elsewhere, bobcat populations in New York State displayed low occupancy, ...

Virginia Tech researchers discover that blocking an essential nutrient inhibits malaria parasite growth

Virginia Tech researchers discover that blocking an essential nutrient inhibits malaria parasite growth
2024-02-13
Living organisms often create what is needed for life from scratch. For humans, this process means the creation of most essential compounds needed to survive. But not every living thing has this capability, such as the parasite that causes malaria, which affected an estimated 249 million people in 2022. Virginia Tech researchers in the College of Agriculture and Life Sciences found that by preventing the malaria parasite from scavenging fatty acids, a type of required nutrient, it could no longer grow. “The key to this breakthrough is that we were able to develop a screening method for the malaria ...

Children's Hospital Los Angeles researchers uncover social and economic factors that influence acute liver failure in children—and ways to overcome them

Childrens Hospital Los Angeles researchers uncover social and economic factors that influence acute liver failure in children—and ways to overcome them
2024-02-13
Imagine your healthy child gets sick—so sick that you take them to the emergency department. You are shocked to find out that their liver is failing, and they will need a transplant to survive. Studies show that their chances of survival are higher the faster they can get to a hospital that performs liver transplants. But what factors affect how quickly that happens? Pediatric acute liver failure, also called PALF, is a life-threatening condition that emerges with very little warning in previously healthy children. It is rare, affecting about 5,000 children in the United States a year, and can result from viral ...

Uncovering insights about prostate cancer risk and genetic ancestry

2024-02-13
This study included larger groups of people from African, Hispanic and Asian ancestries than many other previous studies. A recent study involving scientists from the U.S. Department of Energy’s (DOE) Argonne National Laboratory has uncovered insights into the prostate cancer risks of people from a variety of genetic ancestries. The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs (VA) and DOE as ...

LAST 30 PRESS RELEASES:

A new approach to predicting malaria drug resistance

Coral adaptation unlikely to keep pace with global warming

Bioinspired droplet-based systems herald a new era in biocompatible devices

A fossil first: Scientists find 1.5-million-year-old footprints of two different species of human ancestors at same spot

The key to “climate smart” agriculture might be through its value chain

These hibernating squirrels could use a drink—but don’t feel the thirst

New footprints offer evidence of co-existing hominid species 1.5 million years ago

Moral outrage helps misinformation spread through social media

U-M, multinational team of scientists reveal structural link for initiation of protein synthesis in bacteria

New paper calls for harnessing agrifood value chains to help farmers be climate-smart

Preschool education: A key to supporting allophone children

CNIC scientists discover a key mechanism in fat cells that protects the body against energetic excess

Chemical replacement of TNT explosive more harmful to plants, study shows

Scientists reveal possible role of iron sulfides in creating life in terrestrial hot springs

Hormone therapy affects the metabolic health of transgender individuals

Survey of 12 European countries reveals the best and worst for smoke-free homes

First new treatment for asthma attacks in 50 years

Certain HRT tablets linked to increased heart disease and blood clot risk

Talking therapy and rehabilitation probably improve long covid symptoms, but effects modest

Ban medical research with links to the fossil fuel industry, say experts

Different menopausal hormone treatments pose different risks

Novel CAR T cell therapy obe-cel demonstrates high response rates in adult patients with advanced B-cell ALL

Clinical trial at Emory University reveals twice-yearly injection to be 96% effective in HIV prevention

Discovering the traits of extinct birds

Are health care disparities tied to worse outcomes for kids with MS?

For those with CTE, family history of mental illness tied to aggression in middle age

The sound of traffic increases stress and anxiety

Global food yields have grown steadily during last six decades

Children who grow up with pets or on farms may develop allergies at lower rates because their gut microbiome develops with more anaerobic commensals, per fecal analysis in small cohort study

North American Early Paleoindians almost 13,000 years ago used the bones of canids, felids, and hares to create needles in modern-day Wyoming, potentially to make the tailored fur garments which enabl

[Press-News.org] Poor quality clinical data informing NICE decisions on treatments in over half of cases
20 year analysis shows no improvement in data quality submitted by manufacturers