there are several limitations that should be considered:
Sampling Bias: The study relies on blood samples collected for unrelated tests, which may introduce a sampling bias. Patients who undergo routine testing may differ from those who do not, potentially affecting the generalizability of the findings to the broader population.
Cross-Sectional Design: The study design is cross-sectional, meaning it captures data at a single point in time. This limits the ability to establish causation or assess changes over time. Longitudinal studies would provide more robust evidence of the effectiveness of opportunistic screening.
Exclusion Criteria: The study excludes samples from patients with a previous diagnosis of diabetes or those who underwent diabetes screening in the past 12 months. However, the accuracy of this exclusion depends on the completeness and accuracy of medical records, which might not capture all instances of diabetes diagnoses.
Age Discrepancies: The study finds age-related differences in HbA1c levels but adjusts for these differences. However, age alone may not capture the complexity of diabetes risk factors. Other factors such as lifestyle, family history, and comorbidities could contribute to variations in HbA1c levels.
Limited Generalizability: The study is conducted in a specific Australian setting, and the findings may not be directly applicable to other regions with different demographics, healthcare systems, or diabetes p...
there are several limitations that should be considered:
Sampling Bias: The study relies on blood samples collected for unrelated tests, which may introduce a sampling bias. Patients who undergo routine testing may differ from those who do not, potentially affecting the generalizability of the findings to the broader population.
Cross-Sectional Design: The study design is cross-sectional, meaning it captures data at a single point in time. This limits the ability to establish causation or assess changes over time. Longitudinal studies would provide more robust evidence of the effectiveness of opportunistic screening.
Exclusion Criteria: The study excludes samples from patients with a previous diagnosis of diabetes or those who underwent diabetes screening in the past 12 months. However, the accuracy of this exclusion depends on the completeness and accuracy of medical records, which might not capture all instances of diabetes diagnoses.
Age Discrepancies: The study finds age-related differences in HbA1c levels but adjusts for these differences. However, age alone may not capture the complexity of diabetes risk factors. Other factors such as lifestyle, family history, and comorbidities could contribute to variations in HbA1c levels.
Limited Generalizability: The study is conducted in a specific Australian setting, and the findings may not be directly applicable to other regions with different demographics, healthcare systems, or diabetes prevalence rates.
Limited Clinical Outcomes: The study focuses on the prevalence of undiagnosed diabetes based on HbA1c levels but does not assess the clinical outcomes or the impact of early detection on patient outcomes. Understanding the long-term effects of opportunistic screening would provide a more comprehensive perspective.
Cost Considerations: While the study mentions the potential cost-effectiveness of opportunistic screening, it does not provide a detailed cost-benefit analysis. Further research is needed to assess the economic implications, including the costs associated with false-positive results and subsequent confirmatory testing.
Ethical Considerations: The study obtained ethical approval for testing without participant consent, citing impracticability. However, this raises ethical concerns regarding autonomy and informed consent, especially when testing is performed for a condition unrelated to the initial purpose of the blood sample.
We read with interest the proposal for the FORGE trial. We are concerned that the authors are repeating work that has already been undertaken, without learning from previous trials. The authors criticise the PREVENTT trial, but fail to elaborate their reasons and then proceed to essentially duplicate the very same protocol.
In summary, the PREVENTT RCT (1) was the largest multicentre RCT to assess the role of IV iron compared to placebo in patients before major abdominal surgery. Included were 138 patients undergoing gynaecological surgery and most common operation was a Wertheim’s hysterectomy, a debulking procedure in gynaecological oncology. Of note about two thirds had Tsats < 20% (table 10), essentially representing the same PICO (and size) as proposed in the FORGE trial. There are a couple of key aspects of relevance to FORGE aside from the key question of why they need to repeat the data powered for change in haemoglobin?
A. A key limitation in recruitment was the ‘2-week rule’ whereby patients listed for cancer surgery are mandated to have their operation within 2 weeks (Chapter 4 of the NIHR report (1)). How do the authors propose to overcome this hurdle in FORGE?
B. The benefit of modern IV iron is the ability to give a full treatment dose, normally 20mg/kg, why are the authors proposing a lower dose?
We applaud the authors undertaking a randomised controlled trial but urge them to learn from existing studies to avoid future mist...
We read with interest the proposal for the FORGE trial. We are concerned that the authors are repeating work that has already been undertaken, without learning from previous trials. The authors criticise the PREVENTT trial, but fail to elaborate their reasons and then proceed to essentially duplicate the very same protocol.
In summary, the PREVENTT RCT (1) was the largest multicentre RCT to assess the role of IV iron compared to placebo in patients before major abdominal surgery. Included were 138 patients undergoing gynaecological surgery and most common operation was a Wertheim’s hysterectomy, a debulking procedure in gynaecological oncology. Of note about two thirds had Tsats < 20% (table 10), essentially representing the same PICO (and size) as proposed in the FORGE trial. There are a couple of key aspects of relevance to FORGE aside from the key question of why they need to repeat the data powered for change in haemoglobin?
A. A key limitation in recruitment was the ‘2-week rule’ whereby patients listed for cancer surgery are mandated to have their operation within 2 weeks (Chapter 4 of the NIHR report (1)). How do the authors propose to overcome this hurdle in FORGE?
B. The benefit of modern IV iron is the ability to give a full treatment dose, normally 20mg/kg, why are the authors proposing a lower dose?
We applaud the authors undertaking a randomised controlled trial but urge them to learn from existing studies to avoid future mistakes.
(1). Richards T, Baikady RR, Clevenger B, Butcher A, Abeysiri S, Chau M, et al. Preoperative intravenous iron for anaemia in elective major open abdominal surgery: the PREVENTT RCT. Health Technol Assess 2021;25(11).
I am writing to you regarding an amendment to the sample size section of the following 2021 published protocol paper: Mylrea-Foley B et al. TRUFFLE 2 Collaborators List. Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol. BMJ Open. 2022 Apr 15;12(4):e055543. doi: 10.1136/bmjopen-2021-055543. PMID: 35428631; PMCID: PMC9014041.
In light of a higher-than-expected overall rate of the primary outcome and based on advice from both the TRUFFLE 2 Independent Data Monitoring and the Trial Steering Committees, we have had to amend our sample size for the TRUFFLE 2 randomised trial. It is important for transparency, that the new section is published, and can be found below.
Yours sincerely,
Dr Rebecca Cannings-John, on behalf of the TRUFFLE 2 Trial Management Group
Statistics and data analysis
Sample size
The trial is powered to detect if immediate delivery following cerebral redistribution is superior to expectant management following cerebral redistribution on this outcome. The original sample size was based on a difference in the proportion with the primary outcome from 15% in the delayed delivery to 9% in the immediate delivery (based on the TRUFFLE 2 feasibility study) and demonstrated an odds ratio (OR) of 0.56. At two-sided 5% significance with 95% power, 780 participants per arm were required, giving 1560 in total.
I am writing to you regarding an amendment to the sample size section of the following 2021 published protocol paper: Mylrea-Foley B et al. TRUFFLE 2 Collaborators List. Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol. BMJ Open. 2022 Apr 15;12(4):e055543. doi: 10.1136/bmjopen-2021-055543. PMID: 35428631; PMCID: PMC9014041.
In light of a higher-than-expected overall rate of the primary outcome and based on advice from both the TRUFFLE 2 Independent Data Monitoring and the Trial Steering Committees, we have had to amend our sample size for the TRUFFLE 2 randomised trial. It is important for transparency, that the new section is published, and can be found below.
Yours sincerely,
Dr Rebecca Cannings-John, on behalf of the TRUFFLE 2 Trial Management Group
Statistics and data analysis
Sample size
The trial is powered to detect if immediate delivery following cerebral redistribution is superior to expectant management following cerebral redistribution on this outcome. The original sample size was based on a difference in the proportion with the primary outcome from 15% in the delayed delivery to 9% in the immediate delivery (based on the TRUFFLE 2 feasibility study) and demonstrated an odds ratio (OR) of 0.56. At two-sided 5% significance with 95% power, 780 participants per arm were required, giving 1560 in total.
In light of a higher than expected overall adverse event rate outcome of 36% (95% confidence interval = 28 to 44%) from 132 TRUFFLE-2 participants, and based on advice from both the Independent Data Monitoring and the Trial Steering Committees, on 30th June 2022 it was agreed to amend the trial sample size. Considering the 95% lower event rate limit of 28% as the benchmark to assume the control and intervention proportions for the sample size re-estimation, and assuming an OR of 0.56 remains the same, an event rate of 33.75% in the delayed delivery and 22.25% events in the immediate delivery was assumed. At two-sided 5% significance with 90% power, 319 participants per arm are required, giving 638 in total. Given the immediacy of this outcome, no loss to follow-up is expected.
An important non-inferiority secondary safety outcome is infant neurodevelopment, which is measured by parent completed questionnaire at 2 years using the PARCA-R, as recommended in NICE Guidance, supplemented by infant health information over the intervening 2 years. Assuming a loss to follow-up at 2 years of 20%, 2-year outcomes for approximately 510 infants are expected (255 per group assuming no difference in the lost to follow-up between the groups). The PARCA-R questionnaire provides a composite score for neurodevelopment with a standardised mean of 100 and SD of 15. With a one-sided significance level of 2.5%, under a non-inferiority hypothesis, a sample size of 255 in each group achieves an 85% power to detect a non-inferiority margin of difference in the mean PARCA-R score of no less than four points (0.25 of a SD). A margin of no less than three points can be detected with 62% power.
Dear editor
The treatment of asthma is based on four fundamental pillars: patient education, dealergenization or environmental control measures aimed at avoiding the allergen, symptomatic pharmacological treatment and allergen-specific immunotherapy.
In each country there must be political will from the state, which does not exist in underdeveloped countries, to successfully control asthma and avoid the numerous crises of the disease that deteriorate the quality of life of patients.
Adequate health education is necessary, establishing simplified treatment plans and promoting shared decision-making with asthmatics themselves and their family, in addition to the necessary knowledge on the part of the professionals who attend consultations in primary care to improve the control of these patients.
It is very important to emphasize the use of inhaled corticosteroids, essential medications for controlling the disease, as well as explaining and showing their proper handling because when this fails it leads to non-control of asthma. It is also very important to take into account the ages of the patients and their characteristics, collected in their medical history to personalize each of the behaviors to be taken and improve the quality of life of each patient.
Regarding immunotherapy, it has been shown in numerous studies that it is the only way capable of modifying the course of the disease, controlling it. There are several allergenic extracts in Cu...
Dear editor
The treatment of asthma is based on four fundamental pillars: patient education, dealergenization or environmental control measures aimed at avoiding the allergen, symptomatic pharmacological treatment and allergen-specific immunotherapy.
In each country there must be political will from the state, which does not exist in underdeveloped countries, to successfully control asthma and avoid the numerous crises of the disease that deteriorate the quality of life of patients.
Adequate health education is necessary, establishing simplified treatment plans and promoting shared decision-making with asthmatics themselves and their family, in addition to the necessary knowledge on the part of the professionals who attend consultations in primary care to improve the control of these patients.
It is very important to emphasize the use of inhaled corticosteroids, essential medications for controlling the disease, as well as explaining and showing their proper handling because when this fails it leads to non-control of asthma. It is also very important to take into account the ages of the patients and their characteristics, collected in their medical history to personalize each of the behaviors to be taken and improve the quality of life of each patient.
Regarding immunotherapy, it has been shown in numerous studies that it is the only way capable of modifying the course of the disease, controlling it. There are several allergenic extracts in Cuba, manufactured by BIOCEN, patented and with numerous studies that support their safety and effectiveness for the control of asthma, especially at this time when our country is going through a significant economic siege and we have large shortages of medications due to that its raw material is exported from abroad and cannot be manufactured in Cuba, especially asthma controllers.
Dear Editor
The R21/Matrix-M vaccine is a new vaccine recommended by the World Health Organization (WHO) for the prevention of malaria in children below age 5 years , in pregnant women, in travellers and individuals with HIV and AIDS (1) . It is the second malaria vaccine recommended by WHO, following the first RTS,S/AS01 vaccine, which received a WHO recommendation in 2021 (1) . The R21 vaccine is shown to be safe and effective in preventing malaria in children and, when implemented broadly, is expected to have high public health impact (1) in the rainy season.
The R21/Matrix-M vaccine was developed by the University of Oxford and is a low-dose vaccine that can be manufactured at mass scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden (3) . The vaccine targets the first form of the malaria parasite (the plasmodium sporozoite) to enter the body after a person is bitten by an infected mosquito (2)
The updated WHO malaria vaccine recommendation is informed by evidence from an ongoing R21 vaccine clinical trial and other studies, which showed high efficacy when given just before the high transmission season. In areas with highly seasonal malaria transmission (where malaria transmission is largely limited to 4 or 5 months per year as it is in Ghana and Nigeria), the R21 vaccine was shown to reduce symptomatic cases of malaria by 75%-77% during the 12...
Dear Editor
The R21/Matrix-M vaccine is a new vaccine recommended by the World Health Organization (WHO) for the prevention of malaria in children below age 5 years , in pregnant women, in travellers and individuals with HIV and AIDS (1) . It is the second malaria vaccine recommended by WHO, following the first RTS,S/AS01 vaccine, which received a WHO recommendation in 2021 (1) . The R21 vaccine is shown to be safe and effective in preventing malaria in children and, when implemented broadly, is expected to have high public health impact (1) in the rainy season.
The R21/Matrix-M vaccine was developed by the University of Oxford and is a low-dose vaccine that can be manufactured at mass scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden (3) . The vaccine targets the first form of the malaria parasite (the plasmodium sporozoite) to enter the body after a person is bitten by an infected mosquito (2)
The updated WHO malaria vaccine recommendation is informed by evidence from an ongoing R21 vaccine clinical trial and other studies, which showed high efficacy when given just before the high transmission season. In areas with highly seasonal malaria transmission (where malaria transmission is largely limited to 4 or 5 months per year as it is in Ghana and Nigeria), the R21 vaccine was shown to reduce symptomatic cases of malaria by 75%-77% during the 12 months following a 3-dose series (1)
The addition of R21 to the list of WHO-recommended malaria vaccines is expected to result in sufficient vaccine supply to benefit all children living in areas where malaria is a public health risk (1) .
The R21/Matrix-M vaccine is a subunit CSP vaccine that targets the first form of the malaria parasite (the plasmodium sporozoite) to enter the body after a person is bitten by an infected mosquito( 4.)The vaccine contains parts of a protein secreted by the sporozoite that are bundled up with a part of the hepatitis B virus that is known to trigger a strong immune response( 4). The Matrix-M adjuvant, which is a saponin-based adjuvant, enhances the immune T cell system response, making it more potent and more durable. It stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes (2).
The R21/Matrix-M vaccine has shown good safety and high efficacy in four countries with both seasonal and perennial malaria transmission( 5) .It is shown to be effective in reducing symptomatic cases of malaria by 75% during the 12 months following a 3-dose series given 4 weeks apart ,when given just before the high transmission season in areas with highly seasonal malaria transmission (5) followed by one booster dose after one year prior to malaria session
This R21/Matrix-M vaccine had a favorable safety profile and was well-tolerated. The majority of adverse events were mild, with the most common event being fever, pain and tenderness at site of injection. It is important to note that these are early reports and more data is needed to fully understand the safety profile of this vaccine. As with any vaccine, it is recommended that you speak with your healthcare provider if you have any concerns or questions about the R21/Matrix-M vaccine.
The efficacy of the vaccine is 75% following three doses for 12 months duration for plasmodium falciparum and plasmodium vivax infection but not for other species of plasmodium infections. This author still argue that, in combination with vaccination efforts, it is also crucial to maintain and possibly increase the intensity of existing malaria control measures to achieve greater protection for more children and eventually the eradication of the disease in Africa and also same in India. Enforcing existing control measures is a key part of the solution to preventing more children from contracting the disease, whilst the rollout of the vaccine is taking place in nations that have approved the vaccine, and deliberations are going on in other countries to determine the approval of the vaccine. Some of the malaria control measures the author shall propose should be reinforced, including those recommended by the Center for Disease Control that have been put in place in the past few years through the ministries of public health in different countries. This includes case management (diagnosing and treating people with malaria), the distribution of insecticide-treated nets (ITNs), indoor residual spraying (IRS), and intermittent preventive treatment of malaria in pregnant women, and infancy, amongst others
It is imperative to strengthen existing malaria control programmes and other preventive measures, especially in countries where the vaccine has not yet been approved.(6)
The R21/Matrix-M (R21) Phase 2 trial was conducted at one center in one country only. The study reported vaccine efficacy of 77% (95% CI: 66–84) in Nanoro, Burkina Faso, over 12-months of follow-up. The study was performed in a highly seasonal transmission setting, with vaccination coordinated to ensure peak immunity at the time of peak risk (so-called seasonal vaccination); peak risk occurred during the first 6 months of follow-up, followed by the low transmission dry season, with only a single clinical case observed in the control arm between days 200 and 300 of follow-up. It is therefore most appropriate to express these data as efficacy over one season and/or 6 months to align with the period of risk. Additional data, in settings of perennial transmission or over multiple seasons in regions of highly seasonal transmission, are needed to determine appropriately the efficacy of this vaccine candidate over longer follow-up periods and to enable more meaningful comparison to the RTS,S Phase 3 trial data.Also it is needed that how long the IGg antibodies against NANP repeat regions remains after final vaccination and how much protection it gives in adult people
The RTS,S Phase 3 trial was conducted at 11 centers across seven countries, including regions of both seasonal and perennial transmission. Aligned with the EPI schedule for dosing based on child age, the RTS,S vaccine delivery was not optimized to achieve peak immunity during the high transmission setting, nor do 6-month data occur during highest force of infection.The vaccine efficacy against clinical malaria, over 6 months of follow-up, across all 11 sites, was 68% (95% CI: 64–72); at the same Nanoro site, the vaccine efficacy was 72% (95% CI: 60–80).Direct comparisons of relatively short-acting vaccines or monoclonal antibodies employing different delivery strategies should be avoided, and hence the data available to date do not support the superiority of one vaccine over another(6)
6)Ashley Birkett, R. Scott Millerand Lorraine A. Soisson The Importance of Exercising Caution When Comparing Results from Malaria Vaccines Administered on the EPI Schedule and on a Seasonal Schedule The American journal of Tropical Medicine and hygiene vol 107 issue 6 page 1536
DOI: https://doi.org/10.4269/ https://www.ajtmh.org/view/journals/tpmd/107/6/article-p1356.xml
Thank you for providing us with the opportunity to respond to Dr. Peverill’s comment concerning our article entitled “Cardiac involvement assessment in systemic sclerosis using speckle tracking echocardiography: a systematic review and meta-analysis”. We also acknowledge and appreciate Dr. Peverill’s time spent reading our article and providing his comments to help us strengthen the article.
As proposed by Dr. Peverill and also stated in the article, our systematic review was conducted because of results from related studies were controversial. Based on the meta-analysis results, we found left ventricular (LV) global longitudinal strain (GLS) was lower in SSc patients than in healthy control subjects. We are sorry we included multiple sclerosis in the study by mistake. We will correct it as soon as possible with the help of our editors. As for the reported large standard deviation (SD) of GLS of 8.9% in the control group 1, we have carefully reviewed the article again, and this value has been mentioned many times and is difficult to identify as an error. Moreover, as suggested by Dr. Peverill, we will present the result with the study excluded in the supplementary file.
As Dr. Peverill suggests, age and sex may affect GLS. The effects of age and sex on the results of SSc and control groups need to be considered, however most studies include age- and sex- matched control groups [2-7], which may reduce the effect. In our study, we also perfor...
Thank you for providing us with the opportunity to respond to Dr. Peverill’s comment concerning our article entitled “Cardiac involvement assessment in systemic sclerosis using speckle tracking echocardiography: a systematic review and meta-analysis”. We also acknowledge and appreciate Dr. Peverill’s time spent reading our article and providing his comments to help us strengthen the article.
As proposed by Dr. Peverill and also stated in the article, our systematic review was conducted because of results from related studies were controversial. Based on the meta-analysis results, we found left ventricular (LV) global longitudinal strain (GLS) was lower in SSc patients than in healthy control subjects. We are sorry we included multiple sclerosis in the study by mistake. We will correct it as soon as possible with the help of our editors. As for the reported large standard deviation (SD) of GLS of 8.9% in the control group 1, we have carefully reviewed the article again, and this value has been mentioned many times and is difficult to identify as an error. Moreover, as suggested by Dr. Peverill, we will present the result with the study excluded in the supplementary file.
As Dr. Peverill suggests, age and sex may affect GLS. The effects of age and sex on the results of SSc and control groups need to be considered, however most studies include age- and sex- matched control groups [2-7], which may reduce the effect. In our study, we also performed a meta-regression to explore the relationship between myocardial strain parameters and demographic variables such as age and sex, but the results were not significant.
As noted in Dr. Peverill's comments, there was a statistically significant difference in GLS between patients with SSc and controls, but probably only a small difference on average, which may be related to the severity of the disease. Because cutoff values were affected by many factors, more high-quality studies are needed to make the conclusions more reliable. More evidence is needed on the clinical application of GLS in SSc. We look forward to additional studies in the future to confirm the benefits of GLS measurements in assessing cardiac involvement in SSc.
1.Zairi I, Mzoughi K, Jnifene Z, Kamoun S, Jabeur M, Ben Moussa F, Kraiem S. Speckle tracking echocardiography in systemic sclerosis: A useful method for detection of myocardial involvement. Ann Cardiol Angeiol (Paris). 2019 Oct;68(4):226-231.
2.Agoston G, Gargani L, Miglioranza MH, Caputo M, Badano LP, Moreo A, Muraru D, Mondillo S, Moggi Pignone A, Matucci Cerinic M, Sicari R, Picano E, Varga A. Left atrial dysfunction detected by speckle tracking in patients with systemic sclerosis. Cardiovasc Ultrasound. 2014 Aug 5;12:30.
3.Durmus E, Sunbul M, Tigen K, Kivrak T, Ozen G, Sari I, Direskeneli H, Basaran Y. Right ventricular and atrial functions in systemic sclerosis patients without pulmonary hypertension. Speckle-tracking echocardiographic study. Herz. 2015 Jun;40(4):709-15.
4.Guerra F, Stronati G, Fischietti C, Ferrarini A, Zuliani L, Pomponio G, Capucci A, Danieli MG, Gabrielli A. Global longitudinal strain measured by speckle tracking identifies subclinical heart involvement in patients with systemic sclerosis. Eur J Prev Cardiol. 2018 Oct;25(15):1598-1606.
5.Saito M, Wright L, Negishi K, Dwyer N, Marwick TH. Mechanics and prognostic value of left and right ventricular dysfunction in patients with systemic sclerosis. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):660-667.
6. Hajsadeghi S, Mirshafiee S, Pazoki M, Moradians V, Mansouri P, Kianmehr N, Iranpour A. The relationship between global longitudinal strain and pulmonary function tests in patients with scleroderma and normal ejection fraction and pulmonary artery pressure: a case-control study. Int J Cardiovasc Imaging. 2020 May;36(5):883-888.
7.Spethmann S, Dreger H, Schattke S, Riemekasten G, Borges AC, Baumann G, Knebel F. Two-dimensional speckle tracking of the left ventricle in patients with systemic sclerosis for an early detection of myocardial involvement. Eur Heart J Cardiovasc Imaging. 2012 Oct;13(10):863-70.
To close complex MHs, different options have been described in different small series which pioneered various adjuvants : mainly fresh or lyophilized human amniotic membrane (AM) transplantation either transplanted into the subretinal space1-3 either put in epiretinal position4,5, autologous or allogenic lens capsular (ALC) flap transplantation inside6 or over7 the MH, autologous neurosensory retinal (ANR) free flap transplantation8.
We would like to discuss several points with the authors, referring to additional references:
1/ First, the cut off of 400 μm chosen to include high myopia macular hole retinal detachment (HMMHRD), is questionable as most of the time HMMHRD are associated with extra-large macular holes (MH) (>>400 μm) with a various amount of sub retinal fluid (SRF). The authors could have chosen another cut off to increase extrapolation of their future findings, according to the trends of new classifications. Based on the closure rate and the functional results, some authors proposed to update the International Vitreomacular Traction Study group9, as Steel et al.10 with MH>500 μm, or Ch’ng et al.11 with MH>650 μm, or Rezende et al.12 with MH>800 μm, and so use new surgical techniques such as ILM or ALC flap or ANR transplantation : why do not choose the cut off of 500 or 650 μm to include HMMHRD patients for the proposed trial? For the sample size calculation, the closure rate chosen in the control group (65%) is questionable rega...
To close complex MHs, different options have been described in different small series which pioneered various adjuvants : mainly fresh or lyophilized human amniotic membrane (AM) transplantation either transplanted into the subretinal space1-3 either put in epiretinal position4,5, autologous or allogenic lens capsular (ALC) flap transplantation inside6 or over7 the MH, autologous neurosensory retinal (ANR) free flap transplantation8.
We would like to discuss several points with the authors, referring to additional references:
1/ First, the cut off of 400 μm chosen to include high myopia macular hole retinal detachment (HMMHRD), is questionable as most of the time HMMHRD are associated with extra-large macular holes (MH) (>>400 μm) with a various amount of sub retinal fluid (SRF). The authors could have chosen another cut off to increase extrapolation of their future findings, according to the trends of new classifications. Based on the closure rate and the functional results, some authors proposed to update the International Vitreomacular Traction Study group9, as Steel et al.10 with MH>500 μm, or Ch’ng et al.11 with MH>650 μm, or Rezende et al.12 with MH>800 μm, and so use new surgical techniques such as ILM or ALC flap or ANR transplantation : why do not choose the cut off of 500 or 650 μm to include HMMHRD patients for the proposed trial? For the sample size calculation, the closure rate chosen in the control group (65%) is questionable regarding literature mentioned above, particularly when considering the cut off of 400 μm chosen for MH inclusion.
2/ Second, the question of “to fill or not fill the MH” is currently unsolved : the aim is the best functional result and not only focus on the anatomical result with a MH closure. Cover and not fill the MH is less popular in real life or in published series, as it is often harder to cover the MH with an adjuvant and ensure no displacement of this adjuvant. Recent papers showed epiretinal position of ILM flap13,14 , resulted in significantly better recovery of photoreceptor layers (fewer ELM and EZ defects), and thus visual recovery. Thus, we wanted to know why Gong Q et al. did not present their study protocol with 4 arms : covering HMMHRD with ILM or ALC, and filling HMMHRD with ILM or ALC. Besides it could be interesting for the readers, to explain why tamponade chosen is systematically high viscosity silicone oil.
3/ Third, regarding potential per-operative issues for this adjuvant, the authors could have re-use our published tips and tricks using round autologous anterior lens capsules7 : graft preparation outside the eye to reduce potential complications such as light toxicity with more handling if trimming is done in the vitreous cavity, or remnants of ALC after trimming in the vitreous cavity; advantages of circular transplant (punched or femtosecond laser cut) combining circular shape and adapted size with quite large overlapping could be the key to avoid primary ALC displacement (if overlay is performed) synonymous with surgical failure; “no touch” technique for insertion in the vitreous cavity.
We really appreciate if Gong Q et al. could adjust their interesting study protocol: it should be discussed with a clear rationale to put all issues related to the treatment of complex MHs into perspective, in order to achieve a very efficient clinical trial for retina specialists community.
1 Rizzo, S. et al. A Human Amniotic Membrane Plug to Promote Retinal Breaks Repair and Recurrent Macular Hole Closure. Retina 39 Suppl 1, S95-S103 (2019). https://doi.org:10.1097/IAE.0000000000002320
2 Abouhussein, M. A., Elbaha, S. M. & Aboushousha, M. Human Amniotic Membrane Plug for Macular Holes Coexisting with Rhegmatogenous Retinal Detachment. Clinical ophthalmology 14, 2411-2416 (2020). https://doi.org:10.2147/OPTH.S272060
3 Huang, Y. H., Tsai, D. C., Wang, L. C. & Chen, S. J. Comparison between Cryopreserved and Dehydrated Human Amniotic Membrane Graft in Treating Challenging Cases with Macular Hole and Macular Hole Retinal Detachment. Journal of ophthalmology 2020, 9157518 (2020). https://doi.org:10.1155/2020/9157518
4 Moharram, H. M., Moustafa, M. T., Mortada, H. A. & Abdelkader, M. F. Use of Epimacular Amniotic Membrane Graft in Cases of Recurrent Retinal Detachment Due to Failure of Myopic Macular Hole Closure. Ophthalmic Surg Lasers Imaging Retina 51, 101-108 (2020). https://doi.org:10.3928/23258160-20200129-06
5 Garcin, T., Gain, P. & Thuret, G. Epiretinal large disc of blue-stained lyophilized amniotic membrane to treat complex macular holes: a 1-year follow-up. Acta ophthalmologica 100, e598-e608 (2022). https://doi.org:10.1111/aos.14909
6 Chen, S. N. & Yang, C. M. Lens Capsular Flap Transplantation in the Management of Refractory Macular Hole from Multiple Etiologies. Retina 36, 163-170 (2016). https://doi.org:10.1097/IAE.0000000000000674
7 Garcin, T., Gain, P. & Thuret, G. Femtosecond laser-cut autologous anterior lens capsule transplantation to treat refractory macular holes. Eye (2022). https://doi.org:10.1038/s41433-022-02062-x
8 Grewal, D. S. & Mahmoud, T. H. Autologous Neurosensory Retinal Free Flap for Closure of Refractory Myopic Macular Holes. JAMA ophthalmology 134, 229-230 (2016). https://doi.org:10.1001/jamaophthalmol.2015.5237
9 Duker, J. S. et al. The International Vitreomacular Traction Study Group classification of vitreomacular adhesion, traction, and macular hole. Ophthalmology 120, 2611-2619 (2013). https://doi.org:10.1016/j.ophtha.2013.07.042
10 Steel, D. H. et al. Factors affecting anatomical and visual outcome after macular hole surgery: findings from a large prospective UK cohort. Eye (2020). https://doi.org:10.1038/s41433-020-0844-x
11 Ch'ng, S. W. et al. The Manchester Large Macular Hole Study: Is it Time to Reclassify Large Macular Holes? American journal of ophthalmology 195, 36-42 (2018). https://doi.org:10.1016/j.ajo.2018.07.027
12 Rezende, F. A. et al. Surgical classification for large macular hole: based on different surgical techniques results: the CLOSE study group. Int J Retina Vitreous 9, 4 (2023). https://doi.org:10.1186/s40942-022-00439-4
13 Park, J. H., Lee, S. M., Park, S. W., Lee, J. E. & Byon, I. S. Comparative analysis of large macular hole surgery using an internal limiting membrane insertion versus inverted flap technique. Br J Ophthalmol 103, 245-250 (2019). https://doi.org:10.1136/bjophthalmol-2017-311770
14 Rossi, T. et al. Macular hole closure patterns: an updated classification. Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie 258, 2629-2638 (2020). https://doi.org:10.1007/s00417-020-04920-4
Dear Editor,
We have read with great interest the scoping review by Lee et al.[1], investigating efforts to integrate eye care into healthcare systems in low-income and middle-income countries (LMIC). We also share a belief in the importance of further integrating service delivery in this area.
Most of the cited studies addressed the integration of eye care into wider healthcare settings. The review highlights improved outcomes in management of retinopathy of prematurity achieved through enhancements to paediatrician-led care [2]. Furthermore, the review displays how improved provision of resources, training and enhanced engagement with other stakeholders has resulted in improved knowledge and guideline usage in primary care [3].
The review highlighted various interventions delivered as short training sessions or educational modules [4-6]. Whilst undeniably important for capacity building, these measures cannot in and of themselves achieve a highly integrated system, which would require changes in infrastructure, guidelines and referral systems.
We would appreciate a further understanding of the authors’ rationale for including certain studies in the review, which appear to contain remote or indirect references to eye care service delivery [7-12]. Some included studies [11, 12] appear to link improved management of hypertension and diabetes with prevention of associated retinopathy, though the articles do not appear to mention diabetic retinopathy e...
Dear Editor,
We have read with great interest the scoping review by Lee et al.[1], investigating efforts to integrate eye care into healthcare systems in low-income and middle-income countries (LMIC). We also share a belief in the importance of further integrating service delivery in this area.
Most of the cited studies addressed the integration of eye care into wider healthcare settings. The review highlights improved outcomes in management of retinopathy of prematurity achieved through enhancements to paediatrician-led care [2]. Furthermore, the review displays how improved provision of resources, training and enhanced engagement with other stakeholders has resulted in improved knowledge and guideline usage in primary care [3].
The review highlighted various interventions delivered as short training sessions or educational modules [4-6]. Whilst undeniably important for capacity building, these measures cannot in and of themselves achieve a highly integrated system, which would require changes in infrastructure, guidelines and referral systems.
We would appreciate a further understanding of the authors’ rationale for including certain studies in the review, which appear to contain remote or indirect references to eye care service delivery [7-12]. Some included studies [11, 12] appear to link improved management of hypertension and diabetes with prevention of associated retinopathy, though the articles do not appear to mention diabetic retinopathy explicitly.
A previous scoping review [13] concerns integrating eye health into primary healthcare in Africa, and makes wide-ranging points regarding changes to guidelines, protocols, governance, equipment and leadership – this literature may have been useful to reference in the current article.
The review by Lee et al. [1] highlights a few examples of successful integration of vision care into primary healthcare. This is understandable, given the significant pressures faced by primary healthcare globally. An alternative may be to explore integrating primary healthcare services into existing vision care platforms.
India, for example, has arguably the highest cataract surgical rate (CSR) of any lower- middle-income country, rivalling many high-income countries at 6000/million population/year. This salient strength of the healthcare system could potentially be leveraged in order to build capacity for the delivery of primary health care. Excellent eye care networks are available in India through organisations such as L V Prasad Eye Institute (LVPEI) and Aravind Eye Care[14][15]. LVPEI consists of 282 centres that provide extensive coverage, including remote and rural communities. LVPEI has a self-sustaining financial model, and the majority of patients have their care provided free of cost [15]. This excess capacity could potentially be harnessed not only to help support the delivery of primary care, but potentially to incentivise acceptance of care for chronic conditions through delivery of free eye care.
One key service for vision centres to deliver may be screening of non-communicable diseases (NCDs). Low-cost and rapid screening of blood pressure, fingerstick blood glucose, hearing and dental health could all be undertaken in existing vision centres. Furthermore, there lies the potential for eye care providers to ask for demonstrable proof of adherence to NCD care regimens as advised by medical professionals, and for this to be treated as a prerequisite for provision of vision care that is free of charge.
Several challenges must be overcome for this integration to be successfully implemented. There is a strong need to prove that adoption of these additional services by vision centres will not overburden the system and pose a threat to the sustainability of these networks. There is a need to identify the key priorities of care needed in each community and focus integration efforts on tackling the aspects of care that are most required. Additionally, high-quality trials would be needed, assessing community involvement and uptake of services under a new model of integration.
1. Lee, L., et al., Integrating eye care in low-income and middle-income settings: a scoping review. BMJ Open, 2023. 13(5): p. e068348.
2. Jacoby, M.R. and L. Du Toit, Screening for retinopathy of prematurity in a provincial hospital in Port Elizabeth, South Africa. S Afr Med J, 2016. 106(6).
3. Lilian, R.R., et al., Strengthening primary eye care in South Africa: An assessment of services and prospective evaluation of a health systems support package. PLoS One, 2018. 13(5): p. e0197432.
4. Mafwiri, M.M., et al., Mixed methods evaluation of a primary eye care training programme for primary health workers in Morogoro Tanzania. BMC Nurs, 2016. 15: p. 41.
5. Mafwiri, M.M., R. Kisenge, and C.E. Gilbert, A pilot study to evaluate incorporating eye care for children into reproductive and child health services in Dar-es-Salaam, Tanzania: a historical comparison study. BMC Nurs, 2014. 13: p. 15.
6. Malik, A.N.J., et al., Integrating eye health training into the primary child healthcare programme in Tanzania: a pre-training and post-training study. BMJ Paediatr Open, 2020. 4(1): p. e000629.
7. Ajay, V.S., et al., Development of a Smartphone-Enabled Hypertension and Diabetes Mellitus Management Package to Facilitate Evidence-Based Care Delivery in Primary Healthcare Facilities in India: The mPower Heart Project. J Am Heart Assoc, 2016. 5(12).
8. Abebe, A.M., M.W. Kassaw, and F.A. Mengistu, Assessment of Factors Affecting the Implementation of Integrated Management of Neonatal and Childhood Illness for Treatment of under Five Children by Health Professional in Health Care Facilities in Yifat Cluster in North Shewa Zone, Amhara Region, Ethiopia. Int J Pediatr, 2019. 2019: p. 9474612.
9. Carnell, M.A., et al., Effectiveness of scaling up the 'three pillars' approach to accelerating MDG 4 progress in Ethiopia. J Health Popul Nutr, 2014. 32(4): p. 549-63.
10. Jimenez Carrillo, M., et al., Comprehensive primary health care and non-communicable diseases management: a case study of El Salvador. International Journal for Equity in Health, 2020. 19(1): p. 50.
11. Lall, D., et al., Improving primary care for diabetes and hypertension: findings from implementation research in rural South India. BMJ Open, 2020. 10(12): p. e040271.
12. Lebina, L., et al., Process evaluation of implementation fidelity of the integrated chronic disease management model in two districts, South Africa. BMC Health Serv Res, 2019. 19(1): p. 965.
13. du Toit, R., et al., Evidence for integrating eye health into primary health care in Africa: a health systems strengthening approach. BMC Health Services Research, 2013. 13(1): p. 102.
14. Mehta MC, Narayanan R, Thomas Aretz H, Khanna R, Rao GN. The L V Prasad Eye Institute: A comprehensive case study of excellent and equitable eye care. Healthc (Amst). 2020 Mar;8(1):100408. doi: 10.1016/j.hjdsi.2019.100408. Epub 2020 Jan 14. PMID: 31948870.
15. Namperumalsamy P. Maintaining quality in community eye care - The Aravind model. Indian J Ophthalmol. 2020 Feb;68(2):285-287.
We read with interest Pathmanathan and Snelling’s deep exploration of the reasons that doctors leave UK medicine.[1] Considering all the negative ‘push’ factors provoking doctors to leave careers that they have spent years building, is a somewhat depressing (though compelling) read. As we consider what clinicians, policy-makers and medical educators should do with this information, it is important to reflect on another side to this story: Why do doctors ever stay in the profession?
Despite the cited problems, every year the majority of doctors do decide to stay. Is this due to loyalty to the profession, or perhaps to our patients? Is it simply a lack of imagination to consider what else we might do? Is it too hard to walk away from careers that we have invested so much of ourselves into (the sunk-cost effect[2])? Or perhaps, as the authors of the article allude to, our sense of identity is so intertwined with ’being a doctor’[3] that it is impossible to walk away without leaving a piece of ourselves behind.
While the insights from this paper do give stakeholders food for thought, we propose that it is also imperative to seek the views of those who choose to remain in UK medicine. We may be able to use these insights to help strengthen the reasons to stay in a profession that many of us consider a ‘calling’.[4]
References
1 Pathmanathan A, Snelling I. Exploring reasons behind UK doctors leaving the medical profession: a series of qualitativ...
We read with interest Pathmanathan and Snelling’s deep exploration of the reasons that doctors leave UK medicine.[1] Considering all the negative ‘push’ factors provoking doctors to leave careers that they have spent years building, is a somewhat depressing (though compelling) read. As we consider what clinicians, policy-makers and medical educators should do with this information, it is important to reflect on another side to this story: Why do doctors ever stay in the profession?
Despite the cited problems, every year the majority of doctors do decide to stay. Is this due to loyalty to the profession, or perhaps to our patients? Is it simply a lack of imagination to consider what else we might do? Is it too hard to walk away from careers that we have invested so much of ourselves into (the sunk-cost effect[2])? Or perhaps, as the authors of the article allude to, our sense of identity is so intertwined with ’being a doctor’[3] that it is impossible to walk away without leaving a piece of ourselves behind.
While the insights from this paper do give stakeholders food for thought, we propose that it is also imperative to seek the views of those who choose to remain in UK medicine. We may be able to use these insights to help strengthen the reasons to stay in a profession that many of us consider a ‘calling’.[4]
References
1 Pathmanathan A, Snelling I. Exploring reasons behind UK doctors leaving the medical profession: a series of qualitative interviews with former UK doctors. BMJ Open. 2023;13:e068202.
2 Arkes HR, Blumer C. The psychology of sunk cost. Organ Behav Hum Decis Process. 1985;35:124–40.
3 Van Dormael M, Dugas S, Kone Y, et al. Appropriate training and retention of community doctors in rural areas: a case study from Mali. Hum Resour Health. 2008;6:25.
4 Kao AC, Jager AJ. Medical students’ views of medicine as a calling and selection of a primary care-related residency. The Annals of Family Medicine. 2018;16:59–61.
In this review paper on the accuracy of gut feeling in diagnosing cancer in primary care, the authors conclude that “the findings support the continued and expanded use of gut feeling items in UK cancer referral pathways”. Whilst most clinicians will have experienced the gut feeling that their patient has a serious illness and be thankful for having done so, there is debate over what a gut feeling is and what it represents within the diagnostic process. Is it a subjective intuitive experience, or an objective recognition and response to an abnormal finding? In our teaching programme on ways to prevent diagnostic errors, we discuss the role that gut feeling has in the prevention of these errors through subconsciously alerting the clinician to the presence of an abnormal finding that has not been recognised by the cognitive part of the diagnostic process, or responded to by the clinician. To help explain this, gut feeling is conceptualised as representing a “twitch” of the clinician’s “medical antennae”.
The basis for this concept is as follows: All clinicians possess a set of medical antennae that twitch in response to an abnormal finding. Medical antennae function within the dual-process diagnostic reasoning model, where they monitor information as it is being gathered and processed. Their role within the diagnostic process is to act as a back-up warning system to alert the clinician to an abnormal finding that has not been recognised or responded to. It is postula...
In this review paper on the accuracy of gut feeling in diagnosing cancer in primary care, the authors conclude that “the findings support the continued and expanded use of gut feeling items in UK cancer referral pathways”. Whilst most clinicians will have experienced the gut feeling that their patient has a serious illness and be thankful for having done so, there is debate over what a gut feeling is and what it represents within the diagnostic process. Is it a subjective intuitive experience, or an objective recognition and response to an abnormal finding? In our teaching programme on ways to prevent diagnostic errors, we discuss the role that gut feeling has in the prevention of these errors through subconsciously alerting the clinician to the presence of an abnormal finding that has not been recognised by the cognitive part of the diagnostic process, or responded to by the clinician. To help explain this, gut feeling is conceptualised as representing a “twitch” of the clinician’s “medical antennae”.
The basis for this concept is as follows: All clinicians possess a set of medical antennae that twitch in response to an abnormal finding. Medical antennae function within the dual-process diagnostic reasoning model, where they monitor information as it is being gathered and processed. Their role within the diagnostic process is to act as a back-up warning system to alert the clinician to an abnormal finding that has not been recognised or responded to. It is postulated that antennae twitch is a subconscious response to a finding that is not present within the normal pattern of illness for a minor illness, or one that is present within the typical, atypical, or early pattern of a serious illness. Antennae twitch is experienced by the clinician as a feeling of unease, prompting a review the patient’s findings to establish the cause of this feeling. Therefore, antennae twitch is a subjective response to an objective finding. This establishes the important principle that the performance of the medical antennae is determined by the clinician’s knowledge of those findings, the sensitivity of the clinician’s antennae and the responsivity of the clinician.
Antennae performance, sensitivity and responsivity are important because they introduce the concept that there are factors that may positively and negatively affect whether a clinician experiences a gut feeling. For example, since antennae twitch is a response to a specific finding, learning what those specific findings are increases the likelihood that a twitch will occur. Conversely, if the clinician has not learned about or encountered one of those findings previously, they cannot experience a twitch. Antennae sensitivity and clinician responsivity can be compromised by both internal and external factors, such as tiredness, illness, mood disorders, workload, distractions and burn-out, resulting in “antennae droop”. Learning how to recognise and manage these periods of increased diagnostic risk safely has the potential to reduce the risk of diagnostic errors during consultations.
There are 4 ways in which the concept of medical antennae can contribute to the debate about gut feeling. Firstly, it postulates a mechanism by which gut feeling works in alerting the clinician to an abnormal finding. Secondly, it highlights the important role that gut feeling plays in identifying patients with serious illness and in preventing diagnostic errors. Thirdly, it treats gut feeling as a diagnostic tool, inferring that its performance can be enhanced through focused learning and the use of strategies to manage antennae droop safely. Finally, it is hoped that it will serve to stimulate further debate and research into whether gut feeling can be regarded as a diagnostic tool and taught as a diagnostic skill.
there are several limitations that should be considered:
Sampling Bias: The study relies on blood samples collected for unrelated tests, which may introduce a sampling bias. Patients who undergo routine testing may differ from those who do not, potentially affecting the generalizability of the findings to the broader population.
Cross-Sectional Design: The study design is cross-sectional, meaning it captures data at a single point in time. This limits the ability to establish causation or assess changes over time. Longitudinal studies would provide more robust evidence of the effectiveness of opportunistic screening.
Exclusion Criteria: The study excludes samples from patients with a previous diagnosis of diabetes or those who underwent diabetes screening in the past 12 months. However, the accuracy of this exclusion depends on the completeness and accuracy of medical records, which might not capture all instances of diabetes diagnoses.
Age Discrepancies: The study finds age-related differences in HbA1c levels but adjusts for these differences. However, age alone may not capture the complexity of diabetes risk factors. Other factors such as lifestyle, family history, and comorbidities could contribute to variations in HbA1c levels.
Limited Generalizability: The study is conducted in a specific Australian setting, and the findings may not be directly applicable to other regions with different demographics, healthcare systems, or diabetes p...
Show MoreWe read with interest the proposal for the FORGE trial. We are concerned that the authors are repeating work that has already been undertaken, without learning from previous trials. The authors criticise the PREVENTT trial, but fail to elaborate their reasons and then proceed to essentially duplicate the very same protocol.
In summary, the PREVENTT RCT (1) was the largest multicentre RCT to assess the role of IV iron compared to placebo in patients before major abdominal surgery. Included were 138 patients undergoing gynaecological surgery and most common operation was a Wertheim’s hysterectomy, a debulking procedure in gynaecological oncology. Of note about two thirds had Tsats < 20% (table 10), essentially representing the same PICO (and size) as proposed in the FORGE trial. There are a couple of key aspects of relevance to FORGE aside from the key question of why they need to repeat the data powered for change in haemoglobin?
A. A key limitation in recruitment was the ‘2-week rule’ whereby patients listed for cancer surgery are mandated to have their operation within 2 weeks (Chapter 4 of the NIHR report (1)). How do the authors propose to overcome this hurdle in FORGE?
B. The benefit of modern IV iron is the ability to give a full treatment dose, normally 20mg/kg, why are the authors proposing a lower dose?
We applaud the authors undertaking a randomised controlled trial but urge them to learn from existing studies to avoid future mist...
Show MoreI am writing to you regarding an amendment to the sample size section of the following 2021 published protocol paper: Mylrea-Foley B et al. TRUFFLE 2 Collaborators List. Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol. BMJ Open. 2022 Apr 15;12(4):e055543. doi: 10.1136/bmjopen-2021-055543. PMID: 35428631; PMCID: PMC9014041.
In light of a higher-than-expected overall rate of the primary outcome and based on advice from both the TRUFFLE 2 Independent Data Monitoring and the Trial Steering Committees, we have had to amend our sample size for the TRUFFLE 2 randomised trial. It is important for transparency, that the new section is published, and can be found below.
Yours sincerely,
Dr Rebecca Cannings-John, on behalf of the TRUFFLE 2 Trial Management Group
Statistics and data analysis
Sample size
The trial is powered to detect if immediate delivery following cerebral redistribution is superior to expectant management following cerebral redistribution on this outcome. The original sample size was based on a difference in the proportion with the primary outcome from 15% in the delayed delivery to 9% in the immediate delivery (based on the TRUFFLE 2 feasibility study) and demonstrated an odds ratio (OR) of 0.56. At two-sided 5% significance with 95% power, 780 participants per arm were required, giving 1560 in total.
In light of a higher than expected overa...
Show MoreDear editor
Show MoreThe treatment of asthma is based on four fundamental pillars: patient education, dealergenization or environmental control measures aimed at avoiding the allergen, symptomatic pharmacological treatment and allergen-specific immunotherapy.
In each country there must be political will from the state, which does not exist in underdeveloped countries, to successfully control asthma and avoid the numerous crises of the disease that deteriorate the quality of life of patients.
Adequate health education is necessary, establishing simplified treatment plans and promoting shared decision-making with asthmatics themselves and their family, in addition to the necessary knowledge on the part of the professionals who attend consultations in primary care to improve the control of these patients.
It is very important to emphasize the use of inhaled corticosteroids, essential medications for controlling the disease, as well as explaining and showing their proper handling because when this fails it leads to non-control of asthma. It is also very important to take into account the ages of the patients and their characteristics, collected in their medical history to personalize each of the behaviors to be taken and improve the quality of life of each patient.
Regarding immunotherapy, it has been shown in numerous studies that it is the only way capable of modifying the course of the disease, controlling it. There are several allergenic extracts in Cu...
Dear Editor
Show MoreThe R21/Matrix-M vaccine is a new vaccine recommended by the World Health Organization (WHO) for the prevention of malaria in children below age 5 years , in pregnant women, in travellers and individuals with HIV and AIDS (1) . It is the second malaria vaccine recommended by WHO, following the first RTS,S/AS01 vaccine, which received a WHO recommendation in 2021 (1) . The R21 vaccine is shown to be safe and effective in preventing malaria in children and, when implemented broadly, is expected to have high public health impact (1) in the rainy season.
The R21/Matrix-M vaccine was developed by the University of Oxford and is a low-dose vaccine that can be manufactured at mass scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden (3) . The vaccine targets the first form of the malaria parasite (the plasmodium sporozoite) to enter the body after a person is bitten by an infected mosquito (2)
The updated WHO malaria vaccine recommendation is informed by evidence from an ongoing R21 vaccine clinical trial and other studies, which showed high efficacy when given just before the high transmission season. In areas with highly seasonal malaria transmission (where malaria transmission is largely limited to 4 or 5 months per year as it is in Ghana and Nigeria), the R21 vaccine was shown to reduce symptomatic cases of malaria by 75%-77% during the 12...
Dear Editor,
Thank you for providing us with the opportunity to respond to Dr. Peverill’s comment concerning our article entitled “Cardiac involvement assessment in systemic sclerosis using speckle tracking echocardiography: a systematic review and meta-analysis”. We also acknowledge and appreciate Dr. Peverill’s time spent reading our article and providing his comments to help us strengthen the article.
As proposed by Dr. Peverill and also stated in the article, our systematic review was conducted because of results from related studies were controversial. Based on the meta-analysis results, we found left ventricular (LV) global longitudinal strain (GLS) was lower in SSc patients than in healthy control subjects. We are sorry we included multiple sclerosis in the study by mistake. We will correct it as soon as possible with the help of our editors. As for the reported large standard deviation (SD) of GLS of 8.9% in the control group 1, we have carefully reviewed the article again, and this value has been mentioned many times and is difficult to identify as an error. Moreover, as suggested by Dr. Peverill, we will present the result with the study excluded in the supplementary file.
As Dr. Peverill suggests, age and sex may affect GLS. The effects of age and sex on the results of SSc and control groups need to be considered, however most studies include age- and sex- matched control groups [2-7], which may reduce the effect. In our study, we also perfor...
Show MoreTo close complex MHs, different options have been described in different small series which pioneered various adjuvants : mainly fresh or lyophilized human amniotic membrane (AM) transplantation either transplanted into the subretinal space1-3 either put in epiretinal position4,5, autologous or allogenic lens capsular (ALC) flap transplantation inside6 or over7 the MH, autologous neurosensory retinal (ANR) free flap transplantation8.
We would like to discuss several points with the authors, referring to additional references:
Show More1/ First, the cut off of 400 μm chosen to include high myopia macular hole retinal detachment (HMMHRD), is questionable as most of the time HMMHRD are associated with extra-large macular holes (MH) (>>400 μm) with a various amount of sub retinal fluid (SRF). The authors could have chosen another cut off to increase extrapolation of their future findings, according to the trends of new classifications. Based on the closure rate and the functional results, some authors proposed to update the International Vitreomacular Traction Study group9, as Steel et al.10 with MH>500 μm, or Ch’ng et al.11 with MH>650 μm, or Rezende et al.12 with MH>800 μm, and so use new surgical techniques such as ILM or ALC flap or ANR transplantation : why do not choose the cut off of 500 or 650 μm to include HMMHRD patients for the proposed trial? For the sample size calculation, the closure rate chosen in the control group (65%) is questionable rega...
Dear Editor,
Show MoreWe have read with great interest the scoping review by Lee et al.[1], investigating efforts to integrate eye care into healthcare systems in low-income and middle-income countries (LMIC). We also share a belief in the importance of further integrating service delivery in this area.
Most of the cited studies addressed the integration of eye care into wider healthcare settings. The review highlights improved outcomes in management of retinopathy of prematurity achieved through enhancements to paediatrician-led care [2]. Furthermore, the review displays how improved provision of resources, training and enhanced engagement with other stakeholders has resulted in improved knowledge and guideline usage in primary care [3].
The review highlighted various interventions delivered as short training sessions or educational modules [4-6]. Whilst undeniably important for capacity building, these measures cannot in and of themselves achieve a highly integrated system, which would require changes in infrastructure, guidelines and referral systems.
We would appreciate a further understanding of the authors’ rationale for including certain studies in the review, which appear to contain remote or indirect references to eye care service delivery [7-12]. Some included studies [11, 12] appear to link improved management of hypertension and diabetes with prevention of associated retinopathy, though the articles do not appear to mention diabetic retinopathy e...
We read with interest Pathmanathan and Snelling’s deep exploration of the reasons that doctors leave UK medicine.[1] Considering all the negative ‘push’ factors provoking doctors to leave careers that they have spent years building, is a somewhat depressing (though compelling) read. As we consider what clinicians, policy-makers and medical educators should do with this information, it is important to reflect on another side to this story: Why do doctors ever stay in the profession?
Despite the cited problems, every year the majority of doctors do decide to stay. Is this due to loyalty to the profession, or perhaps to our patients? Is it simply a lack of imagination to consider what else we might do? Is it too hard to walk away from careers that we have invested so much of ourselves into (the sunk-cost effect[2])? Or perhaps, as the authors of the article allude to, our sense of identity is so intertwined with ’being a doctor’[3] that it is impossible to walk away without leaving a piece of ourselves behind.
While the insights from this paper do give stakeholders food for thought, we propose that it is also imperative to seek the views of those who choose to remain in UK medicine. We may be able to use these insights to help strengthen the reasons to stay in a profession that many of us consider a ‘calling’.[4]
References
Show More1 Pathmanathan A, Snelling I. Exploring reasons behind UK doctors leaving the medical profession: a series of qualitativ...
In this review paper on the accuracy of gut feeling in diagnosing cancer in primary care, the authors conclude that “the findings support the continued and expanded use of gut feeling items in UK cancer referral pathways”. Whilst most clinicians will have experienced the gut feeling that their patient has a serious illness and be thankful for having done so, there is debate over what a gut feeling is and what it represents within the diagnostic process. Is it a subjective intuitive experience, or an objective recognition and response to an abnormal finding? In our teaching programme on ways to prevent diagnostic errors, we discuss the role that gut feeling has in the prevention of these errors through subconsciously alerting the clinician to the presence of an abnormal finding that has not been recognised by the cognitive part of the diagnostic process, or responded to by the clinician. To help explain this, gut feeling is conceptualised as representing a “twitch” of the clinician’s “medical antennae”.
The basis for this concept is as follows: All clinicians possess a set of medical antennae that twitch in response to an abnormal finding. Medical antennae function within the dual-process diagnostic reasoning model, where they monitor information as it is being gathered and processed. Their role within the diagnostic process is to act as a back-up warning system to alert the clinician to an abnormal finding that has not been recognised or responded to. It is postula...
Show MorePages