Tag: Prevention

Semaglutide and Cardiovascular Disease: Looking Critically at Absolute Risk Reduction, Cost-Effectiveness and Safety

The recent media coverage on semaglutide’s potential in reducing the risk of cardiovascular disease (CVD) has raised hopes and questions alike. While the drug has shown promise in reducing cardiovascular risk, it’s crucial to look beyond the relative risk reduction figures often highlighted in the news.

To truly understand the impact of semaglutide, we must delve into the absolute risk reduction, cost-effectiveness, and long-term safety data. While the reported relative risk reduction is significant, it’s crucial to consider the absolute risk reduction to accurately assess the semaglutide’s effectiveness and calculate the number needed to treat (NNT) to prevent one adverse CVD event.

These principles can be used to look at how any drug should be used in healthcare system’s such as the UK’s NHS. What are the key considerations?

Relative Risk Reduction (RRR): Indicates the percentage reduction in risk between the treatment group and the control group.

Absolute Risk Reduction (ARR): Measures the actual difference in event rates between the treatment and control groups, offering a clearer view of the treatment’s real-world impact.

Number Needed to Treat (NNT): NNT is derived from the ARR and indicates how many patients need to be treated to prevent one adverse event. It is calculated as NNT = 1/ARR.

Relative risk reduction (RRR), a commonly reported statistic in research articles and press releases, can sometimes exaggerate a drug’s benefits. Absolute risk reduction (ARR), on the other hand, provides a clearer picture of the actual difference in risk between those taking the medication and those who are not. This is crucial because a seemingly impressive RRR might translate to a small ARR, especially in low-risk populations.

The number needed to treat (NNT), derived from the ARR, tells us how many patients need to be treated to prevent one adverse event. A lower NNT indicates a more effective treatment. Understanding the NNT in different risk groups is essential for making informed decisions about treatment and resource allocation.

Importance in Different Risk Populations:

High-risk patients often show more substantial absolute benefits from treatments. In lower-risk patients, the ARR might be smaller, leading to a larger NNT, which influences cost-effectiveness and decisions about resource allocation.

Cost-Effectiveness: Assessing the economic viability of semaglutide involves comparing the cost of the drug against the healthcare savings from prevented CVD events. While semaglutide shows potential in CVD prevention, its cost-effectiveness is a significant factor, particularly for healthcare systems with limited budgets. Thorough health economics studies are needed to weigh the drug’s cost against the potential savings from prevented CVD events. This will help determine if the benefits justify the expense, especially for widespread use.

Hence, health economics studies are essential to determine if the benefits justify the expense, particularly in public health systems with budget constraints.

Side Effects and Safety Profile: Understanding the adverse effects of semaglutide is critical. Long-term safety data, as well as information on the severity and frequency of side effects, must be evaluated. Balancing the benefits of CVD risk reduction against potential harms from side effects is necessary for informed decision-making.

Semaglutide’s long-term safety profile is still under investigation. While initial studies are promising, continued monitoring is crucial to identify any potential side effects or risks associated with prolonged use. Balancing the benefits of CVD risk reduction against potential harms is essential for responsible decision-making.

The Road Ahead: Research and Evidence

To fully harness the potential of semaglutide in CVD management, we need more comprehensive data. This includes detailed reporting of ARR in diverse patient populations, robust cost-effectiveness analyses in various healthcare settings, and long-term studies to monitor safety and efficacy. While semaglutide shows promise in the treatment of CVD, more comprehensive data is required to fully understand its impact, particularly in areas such as the ARR in different patient populations (such as those at low risk of CVD)to calculate precise NNT values.

Conclusion: Semaglutide shows promise as a valuable tool in the fight against cardiovascular disease. However, it is essential to maintain a critical eye. By focusing on metrics such as absolute risk reduction, cost-effectiveness, and long-term safety data, we can make informed decisions that prioritise patient well-being and responsible resource allocation. As research continues, we will gain a clearer understanding of semaglutide’s role in CVD prevention and treatment, paving the way for its appropriate use by healthcare systems across the world.

Staying healthy this winter and making the most of the NHS

With England’s NHS under immense pressure even before the full onset of winter, here are some tips on how you can make the most of the NHS, use health services more appropriately, and obtain the care you and your family need to protect your health and wellbeing.

  1. Attend for appointments for medication reviews and for the management of long-term conditions when invited. This is important because it helps to ensure that your medication is up-to-date and that your condition is being managed effectively.
  2. Take-up the offer of Covid-19 and flu vaccinations if you are eligible. Vaccinations are the best way to protect yourself from these serious illnesses. Also take up any other NHS vaccinations you and your family are eligible for.
  3. Use the NHS app to book appointments, view your GP medical record and order repeat prescriptions. This is a convenient and efficient way to manage your healthcare.
  4. Be aware of the range of options for NHS care – including opticians, pharmacists, self-referral services (e.g., podiatry, Talking Therapies, smoking cessation), and NHS 111. This can help you to access the care you need quickly and easily.
  5. Use the NHS electronic prescription service so that your prescription is sent directly to a pharmacy. This can save you time and hassle.
  6. For queries about hospital care, contact the hospital Patient Advice and Liaison Service (PALS) team rather than your GP. The PALS team is there to help patients and their families with any concerns or questions they have about their hospital care. The contact details are usually present on the hospital’s website.
  7. Apply for online access to your hospital records if this is available. This can give you access to your medical information at any time, which can be helpful if you need to manage your own care or if you need to see a new doctor.
  8. Don’t Smoke. Smoking is a major risk factor for many diseases, including cancer, heart disease, and stroke.
  9. Exercise regularly including outdoors so that you get some sunlight exposure. Exercise is important for overall health and well-being, and sunlight exposure helps to produce vitamin D, which is essential for bone health.
  10. Eat 5 portions of fruit and vegetables every day and eat plenty of high-fibre foods. Eating a healthy diet is important for maintaining a healthy weight and reducing the risk of chronic diseases.
  11. Limit your sugar and salt intake. Consuming too much sugar and salt can increase the risk of obesity, heart disease, and other health problems.
  12. Limit your alcohol intake to a safe level. Consuming too much alcohol can damage the liver and increase the risk of other health problems.
  13. Take time to improve your mental health; including by meeting regularly with friends and family. Mental health is just as important as physical health, and it is important to take steps to protect and improve your mental well-being.
  14. Check your own blood pressure. High blood pressure is a major risk factor for stroke and heart disease, so it is important to monitor your blood pressure regularly.
  15. Take your medication as prescribed. It is important to take the correct dose of your medication at the correct time in order to get the best results.
  16. Stay Hydrated: Drinking enough water is crucial, especially when using heating systems that can dehydrate.
  17. Manage Stress: Stress can have a negative impact on your immune system. Consider incorporating mindfulness or relaxation techniques into your daily routine.
  18. Telemedicine: Use telehealth options when appropriate, to save time and minimise exposure to potential infections.
  19. First Aid Kit: Keep a well-stocked first aid kit and know how to use the basic items. This can be particularly useful for minor injuries and illnesses.
  20. Home Safety: Falls and accidents are common during the winter due to icy conditions. Making your home slip-proof can prevent unnecessary hospital visits.
  21. Keep Emergency Numbers Handy: Important contact numbers should be easily accessible, whether it’s on your fridge or saved in your phone.
  22. Regular Hand Washing: Promote good hand hygiene, especially if interacting with vulnerable populations like the elderly or very young.
  23. Know the Signs of More Serious Conditions: Understanding the early symptoms of conditions like strokes, heart attacks, and other acute illnesses can save precious time in an emergency.
  24. Air Quality: Try to keep up the air quality in your home and at work; for example, through ventilation.
  25. Supplement Vitamin D: Sunlight exposure may be limited, so consider vitamin D supplementation if you are in a group that this is recommended for.
  26. Community Support: If possible, check on neighbours and family members who might be vulnerable during the winter months, whether due to age, health conditions, or social isolation.
  27. Use of Over-the-Counter (OTC) Medication: Understand when to use OTC medications for minor illnesses and when to seek professional advice.
  28. Get a good night’s sleep. Sleep is essential for good health, so it is important to get at least 7-8 hours of sleep each night.
  29. Listen to experts on health issues and not random people on social media. There is a lot of misinformation about health issues circulating on social media, so it is important to get your health information from reliable sources, such as the NHS website or healthcare professionals.

Let patients self-refer to lifestyle management services

Recent draft guidance from NICE gives a much bigger role to exercise and weight loss in people with osteoarthritis, and painkillers such as paracetamol and strong opioids not advised.

I agree that the aims of the new draft NICE guidance on the management of osteoarthritis in primary care are good but the problem will be in providing patients with access to suitable lifestyle and exercise programmes. In many parts of England, these services are either not currently in place or have very limited capacity. As well as putting in place services with sufficient capacity, we also need to ensure there is equitable access to them, based on clinical need. We know from prior experience that it is more affluent and better educated patients who are more likely to take up these kind of lifestyle and exercise interventions.

We also need to simplify clinical pathways and allow patients to refer themselves directly to services without requiring a referral from a GP. This will improve the speed of access to these services for patients and reduce the demands on already over-stretched GP services.

A version of this blog was first published in the British Medical Journal.

A Clinician-Assisted Digital Cognitive Behavioural Therapy Intervention for Smoking Cessation

In a study published in the journal Nicotine and Tobacco Research, we evaluated the secondary effectiveness outcomes for Quit Genius, a digital clinician-assisted cognitive behavioural therapy (CBT) intervention for smoking cessation.

Adult smokers (N=556) were randomly assigned to Quit Genius (n=277), a digital, clinician-assisted CBT intervention or Very Brief Advice (VBA) to stop smoking, an evidence-based, 30-second intervention designed to facilitate quit attempts, coupled with referral to a cessation service (n=279). Participants were offered combination nicotine replacement therapy (patches and gum) tailored to individual nicotine dependence. Analyses (N=530), by intention-to-treat, compared Quit Genius and VBA at 4, 26, and 52 weeks post-quit date.

The primary outcome was self-reported seven-day point prevalence abstinence at 4 weeks post-quit date. Consecutive seven-day point-prevalence abstinence, defined as abstinent at two or more consecutive timepoints, was examined at weeks 26 and 52 to indicate long-term effectiveness. Abstinence was verified using a random sample of participants with carbon monoxide breath testing of <5 parts per million (n=280).

Self-reported consecutive seven-day point prevalence abstinence at weeks 26 and 52 for Quit Genius was 27.2% and 22.6% respectively, compared to VBA which was 16.6% and 13.2% (RR=1.70,95% CI,1.22-2.37;p=0.003, 26 weeks; RR=1.71,95% CI,1.17-2.50; p=0.005, 52 weeks). Biochemically verified abstinence was significantly different at 26- (p=0.03) but not 52 weeks (p=0.16). Quit Genius participants were more likely to remain abstinent than those who received VBA (RR=1.71,95% CI 1.17-2.50;p=0.005).

This study provides secondary evidence for the long-term effectiveness of Quit Genius in comparison with VBA. Future trials of digital interventions without clinician support and comparisons with active treatment are needed.

The long-term effectiveness of clinician-assisted digital smoking cessation interventions has not been well-studied. This study established the long-term effectiveness of an extended CBT-based intervention; results may inform implementation of scalable approaches to smoking cessation in the health system.

DOI: https://doi.org/10.1093/ntr/ntac113

Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial

Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation. Our research was published in the journal JMIR Mental Health.

We used a 2-arm, single-blinded, parallel-group randomized controlled trial design. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date.

556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed.

We concluded that the Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.

DOI: https://doi.org/10.2196/22833

Development of a questionnaire to evaluate patients’ awareness of CVD risk in England’s NHS Health Check Programme

Cardiovascular disease (CVD) is a major cause of disability and premature mortality worldwide. In England, it accounts for a third of deaths and costs the National Health Service (NHS) and the UK economy £30 billion annually.

The National Health Service (NHS) Health Check is a CVD risk assessment and management programme in England aiming to increase CVD risk awareness among people at increased risk of CVD. There was previously no tool to assess the effectiveness of the programme in communicating CVD risk to patients. In research published in the journal BMJ Open, we describe how we developed a questionnaire examining patients’ CVD risk awareness for use in health service research evaluations of the NHS Health Check programme.

We developed an 85-item questionnaire to determine patients’ views of their risk of CVD. The questionnaire was based on a review of the relevant literature. After review by an expert panel and focus group discussion, 22 items were dropped and 2 new items were added. The resulting 65-item questionnaire with satisfactory content validity (content validity indices≥0.80) and face validity was tested on 110 NHS Health Check attendees.

Following analyses of data, we reduced the questionnaire from 65 to 26 items. The 26-item questionnaire constitutes four scales: Knowledge of CVD Risk and Prevention, Perceived Risk of Heart Attack/Stroke, Perceived Benefits and Intention to Change Behaviour and Healthy Eating Intentions. Perceived Risk (Cronbach’s α=0.85) and Perceived Benefits and Intention to Change Behaviour (Cronbach’s α=0.82) have satisfactory reliability (Cronbach’s α≥0.70). Healthy Eating Intentions (Cronbach’s α=0.56) is below minimum threshold for reliability but acceptable for a three-item scale.

This is the first study that describes the development of a short, validated questionnaire with satisfactory content and face validity and reliability examining CVD risk awareness among the NHS Health Check attendees. The ABCD Risk Questionnaire may be used for evaluating the accuracy of perceived CVD risk, general knowledge of CVD and intention to change behaviour regarding diet and exercise among NHS Health Check attendees.

Agreement between perceived and predicted CVD risk suggests that the tool performs well in assessing perceived CVD risk. As the questionnaire was developed using both an expert panel and a patient focus group, it ought to be relatively easy to understand for both patients and clinicians. If NHS Health Check recommendations change over time, it may need to be updated. The resulting questionnaire, with its satisfactory reliability and validity, may be used in assessing patients’ awareness of CVD risk among NHS Health Check attendees.

DOI: http://dx.doi.org/10.1136/bmjopen-2016-014413

Clinical impact of lifestyle interventions for the prevention of type 2 diabetes

In a study published in the journal BMJ Open, we reviewed the clinical outcomes of combined diet and physical activity interventions for people at high risk of type 2 diabetes. We looked at combined diet and physical activity interventions including ≥2 interactions with a healthcare professional, and ≥12 months follow-up. Our primary outcome measures included glycaemia, diabetes incidence. Secondary outcomes included behaviour change, measures of adiposity, vascular disease and mortality.

We identified 19 recent reviews for inclusion in our study. Most reviews reported that interventions were associated with net reductions in diabetes incidence, measures of glycaemia and adiposity. Small effect sizes and potentially transient effect were reported in some studies, and some reviewers noted that durability of intervention impact was potentially sensitive to duration of intervention and adherence to behaviour change. Behaviour change, vascular disease and mortality outcome data were infrequently reported, and evidence of the impact of intervention on these outcomes was minimal. Evidence for age effect was mixed, and sex and ethnicity effect were little considered.

We concluded that relatively long-duration lifestyle interventions can limit or delay progression to diabetes under trial conditions. However, outcomes from more time-limited interventions, and those applied in routine clinical settings, are more variable, in keeping with the findings of recent pragmatic trials. There is little evidence of intervention impact on vascular outcomes or mortality end points in any context. Hence, ‘real-world’ implementation of lifestyle interventions for diabetes prevention may be expected to lead to modest outcomes.