Breaking News
December 16, 2018 - Young Breast Cancer Patients Face Higher Risk for Osteoporosis
December 16, 2018 - 3-D printing offers helping hand to people with arthritis
December 16, 2018 - Community Health Choice helps manage complex and chronic care conditions
December 16, 2018 - Regular trips out could dramatically reduce depression in older age
December 16, 2018 - CWRU to use VivaLNK’s Vital Scout device for stress study in student athletes
December 16, 2018 - ‘Easy Way Out’? Stigma May Keep Many From Weight Loss Surgery
December 16, 2018 - Gout drug may protect against chronic kidney disease
December 16, 2018 - Talking about memories enhances the wellbeing of older and younger people
December 16, 2018 - Occupational exposure to pesticides increases risk for cardiovascular disease among Latinos
December 16, 2018 - A biomarker in the brain’s circulation system may be Alzheimer’s earliest warning
December 16, 2018 - Magnesium may play important role in optimizing vitamin D levels, study shows
December 16, 2018 - The effect of probiotics on intestinal flora of premature babies
December 16, 2018 - Parents spend more time talking with kids about mechanics of using mobile devices
December 16, 2018 - Biohaven Announces Positive Results from Ongoing Rimegepant Long-Term Safety Study
December 16, 2018 - Arterial stiffness may predict dementia risk
December 16, 2018 - Study explores link between work stress and increased cancer risk
December 16, 2018 - Sex work criminalization linked to incidences of violence finds study
December 16, 2018 - Johns Hopkins researchers discover swarming behavior in fish-dwelling parasite
December 16, 2018 - Schistosomiasis prevention and treatment could help control HIV
December 16, 2018 - Early postpartum opioids linked with persistent usage
December 16, 2018 - Johns Hopkins researchers identify molecular causes of necrotizing enterocolitis in preemies
December 16, 2018 - Advanced illumination expands capabilities of light-sheet microscopy
December 16, 2018 - Alzheimer’s could possibly be spread via contaminated neurosurgery
December 16, 2018 - Unraveling the complexity of cancer biology can prompt new avenues for drug development
December 16, 2018 - Inflammatory Bowel Disease, Prostate Cancer Linked
December 16, 2018 - Cannabis youth prevention strategy should target mental wellbeing
December 15, 2018 - Recent developments and challenges in hMAT inhibitors
December 15, 2018 - Sewage bacteria found lurking in Hudson River sediments
December 15, 2018 - CDC selects UMass Amherst biostatistician model that helps predict influenza outbreaks
December 15, 2018 - Researchers reveal brain mechanism that drives itch-evoked scratching behavior
December 15, 2018 - New computer model helps predict course of the disease in prostate cancer patients
December 15, 2018 - Obesity to Blame for Almost 1 in 25 Cancers Worldwide
December 15, 2018 - How the brain tells you to scratch that itch
December 15, 2018 - New findings could help develop new immunotherapies against cancer
December 15, 2018 - World’s largest AI-powered medical research network launched by OWKIN
December 15, 2018 - Young people suffering chronic pain battle isolation and stigma as they struggle to forge their identities
December 15, 2018 - Lifespan extension at low temperatures depends on individual’s genes, study shows
December 15, 2018 - New ingestible capsule can be controlled using Bluetooth wireless technology
December 15, 2018 - Researchers uncover microRNAs involved in the control of social behavior
December 15, 2018 - Research offers hope for patients with serious bone marrow cancer
December 15, 2018 - Link between poverty and obesity is only about 30 years old, study shows
December 15, 2018 - Mass spectrometry throws light on old case of intentional heavy metal poisoning
December 15, 2018 - BeyondSpring Announces Phase 3 Study 105 of its Lead Asset Plinabulin for Chemotherapy-Induced Neutropenia Meets Primary Endpoint at Interim Analysis
December 15, 2018 - Study finds that in treating obesity, one size does not fit all
December 15, 2018 - Tenacity and flexibility help maintain psychological well-being, mobility in older people
December 15, 2018 - Study reveals role of brain mechanism in memory recall
December 15, 2018 - High levels of oxygen encourage the brain to remain in deep, restorative sleep
December 15, 2018 - Experimental HIV vaccine strategy works in non-human primates, research shows
December 15, 2018 - Genetically modified pigs could limit replication of classical swine fever virus, study shows
December 15, 2018 - FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin
December 15, 2018 - Cost and weight-loss potential matter most to bariatric surgery patients
December 15, 2018 - Cancer Research UK and AstraZeneca open new Functional Genomics Centre
December 15, 2018 - New research lays out potential path for treatment of Huntington’s disease
December 15, 2018 - Prestigious R&D 100 Award presented to Leica Microsystems
December 15, 2018 - Study shows septin proteins detect and kill gut pathogen, Shigella
December 15, 2018 - Study sheds new light on disease-spreading mosquitoes
December 15, 2018 - 2017 Saw Slowing in National Health Care Spending
December 15, 2018 - Monitoring movement reflects efficacy of mandibular splint
December 15, 2018 - Study supports BMI as useful tool for assessing obesity and health
December 15, 2018 - Self-guided, internet-based therapy platforms effectively reduce depression
December 15, 2018 - Organically farmed food has bigger climate impact than conventional food production
December 15, 2018 - Faster, cheaper test has potential to enhance prostate cancer evaluation
December 15, 2018 - Researchers study abnormal blood glucose levels of patients after hospital discharge
December 15, 2018 - Swedish scientists explore direct association of dementia and ischemic stroke deaths
December 15, 2018 - Study finds 117% increase in number of dementia sufferers in 26 years
December 15, 2018 - Eczema Can Drive People to Thoughts of Suicide: Study
December 15, 2018 - Link between neonatal vitamin D deficiency and schizophrenia confirmed
December 15, 2018 - Nurse denied life insurance because she carries naloxone
December 15, 2018 - Ritalin drug affects organization of pathways that build brain networks used in attention, learning
December 15, 2018 - Research pinpoints two proteins involved in creation of stem cells
December 15, 2018 - Gut bacteria may modify effectiveness of anti-diabetes drugs
December 15, 2018 - A new type of ‘painless’ adhesive for biomedical applications
December 15, 2018 - Early physical therapy associated with reduction in opioid use
December 15, 2018 - Breast cancer protection from pregnancy begins many decades later, study finds
December 15, 2018 - How often pregnant women follow food avoidance strategy to prevent allergy in offspring?
December 15, 2018 - Using machine learning to predict risk of developing life-threatening infections
December 15, 2018 - How imaginary friends could boost children’s development
December 15, 2018 - Folate deficiency creates more damaging chromosomal abnormalities than previously known
December 15, 2018 - Study provides new insights into molecular mechanisms underlying role of amyloid in Alzheimer’s disease
December 15, 2018 - For the asking, a check is in the mail to help pay for costly drugs
Researchers reassess negative pressure wound therapy as its benefit and harm remain unclear

Researchers reassess negative pressure wound therapy as its benefit and harm remain unclear

image_pdfDownload PDFimage_print

About one decade after its first benefit assessment of negative pressure wound therapy (NPWT), the German Institute for Quality and Efficiency in Health Care (IQWiG) is reassessing this treatment method. However, then as now, its benefit and harm are unclear. Whereas only few studies with very limited informative value were available in 2006, over 100 clinical comparisons with several thousands of patients have been conducted since. But results have been published for only some of these studies, as not only the manufacturers of the medical devices used, but also researchers, are concealing data, thus violating ethical and scientific standards. Assessing the benefit and harm of the treatment solely on the basis of the published data could have entailed a seriously biased result. Hence, there is still no valid basis for the assessment of the benefit and harm of this treatment.

The current report deals with NPWT for wounds healing by secondary intention; wounds healing by primary intention are the subject of a second benefit assessment. In NPWT, negative pressure in the wound is used to promote wound healing, and to accelerate the healing of large wounds in particular.

Over 100 studies with several thousands of participants

The Institute has now found that a large number of further randomized controlled trials (RCTs) comparing NPWT with standard treatment have been completed since its last report. There are currently over 100 studies involving several thousands of patients, which is an unusually large number for a non-drug intervention. One would think that this would be a good starting point for a benefit assessment.

Publication bias: positive effect often overestimated

The inclusion of the results of all studies in the assessment is indispensable to be able to draw reliable conclusions. The use of only published data could lead to an overestimation of the positive effects of a medical intervention, because it is known from research that studies with “unfavorable” results are usually the ones that remain in the file drawer or are published only years later. This is referred to as “publication bias”.

For this reason, IQWiG not only conducts searches in databases or registries, but also sends requests to manufacturers and authors who have reported studies in journals, trial registries or presentations, for example. “Detective work” is sometimes required to identify studies.

Agreement with sponsors to facilitate cooperation

To be able to also use the results from studies sponsored by manufacturers as completely as possible and to facilitate cooperation, the Institutes regularly offers a contract to such sponsors, which has advantages for both sides: Confidential information such as confidential business and commercial information remains protected in any case. In return, the manufacturer agrees to submit the complete data on all published and unpublished studies. IQWiG may use and publish the results and the underlying methods.

The Institute has concluded such a contract with several manufacturers of NPWT systems. This is a comprehensive agreement, i.e. irrespective of a division of the commission by type of wound (primary, secondary).

Data missing for a large proportion of relevant studies

Many of the newly searched RCTs recorded and reported usable data on so-called patient-relevant outcomes such as mortality, wound closure, pain, complications (of treatment), length of hospital stay, or need of long-term care, and were therefore relevant for the assessment. However, there were also a large number of studies for which the results were not available, although the Institute had repeatedly requested information from the respective study investigators.

KCI does not comply with the contract

Despite several requests, the US-based manufacturer KCI Medical Devices (Acelity) provided neither a complete overview nor complete clinical study reports on all the studies for which the company is responsible. As a result, data were incomplete for half of all participants (842 of 1681). The IQWiG researchers therefore could not consider these studies for their benefit assessment of NPWT.

Standards violated also by researchers

However, there are also gaps in the remaining studies, most of them so-called investigator-initiated trials (IITs), which were, for example, initiated by university-based researchers: Regarding secondary wound healing, usable study results were missing for at least 1703 of 4251 participants in total, corresponding to 40%. Since this magnitude impedes a meaningful interpretation of the results, here too, the Institute dispensed with an assessment of benefit and harm.

Nothing is known about the researchers’ motives. Their own research interests or dependencies might play a role. It is obvious at least for some of the IITs that even though the manufacturers did not act as sponsors, they were involved indirectly, e.g. by granting scholarships or by supporting the analysis of the data and the production of manuscripts (medical writing).

Concealing data harms patients and physicians

Stefan Sauerland, Head of the Department of Non-Drug Interventions, notes with frustration: “The evidence base was meager when we conducted our first assessments. Now there are studies with several thousands of patients, but we still cannot say whether NPWT is better, equivalent, or possibly even worse than conventional wound treatment.”

The reason is that both companies and researchers are concealing data. “This violates ethical and scientific standards”, says Stefan Sauerland. “And they harm patients and physicians as well as the community of insured citizens, which to me, as a physician and researcher, is very disconcerting.”

Registration and publication of the results must be mandatory

NPWT is an example showing that further legal regulations are required, also for studies on non-drug interventions and medical devices. Unlike in other countries such as the United States, medical devices in Europe are not subject to a central approval process. A certification by “designated bodies”, which are private sector organizations, is sufficient to launch a medical device. In many cases, clinical studies have not been necessary for this, even though Europe’s Medical Device Directive is a considerable improvement for the requirements of a clinical assessment. In addition, in Germany, almost all new non-drug interventions can be used in hospitals and be reimbursed by statutory health insurance funds without prior assessment of their benefit or harm. A positive benefit assessment is only required for the outpatient sector.

New legislation would have to stipulate the registration of studies on non-drug interventions or medical devices before their start and the timely publication of their results. “More progress has been made in drug studies”, says Stefan Sauerland. An EU directive and the German Act on the Reform of the Market for Medicinal Products (AMNOG) have notably increased transparency regarding drugs. Stefan Sauerland is convinced: “Without similar regulations, reliable data on interventions such as NPWT will still not be available in 10 years’ time.”

Source:

https://www.iqwig.de/en/press/press-releases/negative-pressure-wound-therapy-violation-of-ethical-and-scientific-standards.10021.html

Tagged with:

About author

Related Articles