Thank you for your response to my concerns and comments on the article. I wish to correct an apparent misunderstanding about concomitant use of SSRIs and stimulants. I did not state that SSRIs have any indication for treating ADHD, I am aware of research to the contrary and have never used SSRIs to treat ADHD. My statement that "SSRIs have FDA-indications for treating both conditions" was intended to refer to the conditions of anxiety and depression; upon re-reading the statement when looking to see how a conclusion was made that I was treating ADHD with SSRIs I can see how it could be mis-construed. Regarding studies of the safety of the combination of stimulants and SSRIs (or other anti-depressants), I also am not aware of any. A prospective study would be challenging to do, to say the least. A retrospective analysis with inclusion of diagnosis-specific information and directly correlating diagnosis, treatment including dosages and duration, and outcomes would probably be challenging as well but I think that degree of detail and specificity is necessary before drawing conclusions about the safety of combinations of medications (drugs) used to treat any condition.
Thank you again for your careful consideration of my initial comments.
Respectfully,
David P. Pomeroy MD
Regarding my statement that "stimulants and SSRIs are basically safe" I was not contesting the fact that each has Black Box warnings and serious side effects and...
Thank you for your response to my concerns and comments on the article. I wish to correct an apparent misunderstanding about concomitant use of SSRIs and stimulants. I did not state that SSRIs have any indication for treating ADHD, I am aware of research to the contrary and have never used SSRIs to treat ADHD. My statement that "SSRIs have FDA-indications for treating both conditions" was intended to refer to the conditions of anxiety and depression; upon re-reading the statement when looking to see how a conclusion was made that I was treating ADHD with SSRIs I can see how it could be mis-construed. Regarding studies of the safety of the combination of stimulants and SSRIs (or other anti-depressants), I also am not aware of any. A prospective study would be challenging to do, to say the least. A retrospective analysis with inclusion of diagnosis-specific information and directly correlating diagnosis, treatment including dosages and duration, and outcomes would probably be challenging as well but I think that degree of detail and specificity is necessary before drawing conclusions about the safety of combinations of medications (drugs) used to treat any condition.
Thank you again for your careful consideration of my initial comments.
Respectfully,
David P. Pomeroy MD
Regarding my statement that "stimulants and SSRIs are basically safe" I was not contesting the fact that each has Black Box warnings and serious side effects and misuse can occur. I do not believe any of either class of medications would have been approved by the FDA if they were not reasonably safe. The warnings are certainly appropriate, addiction, abuse and suicide are serious conditions and situations. Suicidal ideation related to use of SSRIs is possible but of low incidence; one analysis determined that the Number Needed to Treat (with benefit) for SSRIs was 3 , the Number Needed to Harm (any significant side effect) was 254. The number of completed suicides actually increased when prescribing of SSRIs decreased immediately after the Black Box warning was issued.
I recognize the abuse potential and misuse of all stimulants, particularly in the college-attending population. I do believe, however, that a person with accurately diagnosed and appropriately treated ADHD is unlikely to become addicted to CII stimulants because of one fact : when patients take a higher dosage of stimulant than necessary for optimal benefit to their ADHD-related impairments, they feel worse. They have adverse reactions, symptoms which are intolerable, so there is no incentive for them to take higher and higher amounts. They do not experience the euphoria which those who do not have ADHD apparently experience and to which they quickly develop tolerance and take higher amounts, chasing the "high".
I did not mean to question any of the co-authors with respect to their clinical acumen or status and I apologize for any insult taken. I should have considered the wording of my concerns more carefully before publishing them, thank you for bringing my attention to that. I admit I do not know the clinical experience of many physicians in treating ADHD, those that I do have had experiences similar to mine detailed above.
We are grateful to Axel Skafte-Holm et al. for their careful reading of our systematic review and for highlighting challenges in the classification of Ureaplasma species. We aimed to include studies that identified U. urealyticum or U. parvum using appropriate microbiological methods to examine associations with adverse pregnancy outcomes. For the 14 articles highlighted by Skafte-Holm et al. [1-14], we acknowledge that we used data that the authors of the included studies reported, but which were not consistent with the actual microbiological methods used.
There is inconsistent reporting of Ureaplasma species owing to changes made to their taxonomy; the resulting misclassification of these species compounds the shortcomings of epidemiological methods of studies in this systematic review. As such, it reinforces our conclusion, that “The currently available literature does not allow conclusions about the role of mycoplasmas in adverse pregnancy and birth outcomes”.
We updated our analysis of associations between the two Ureaplasma spp. and adverse pregnancy outcomes, following Skafte-Holm and colleagues’ investigations. We removed data from meta-analyses if identification of U. urealyticum was ambiguous and we amended data from studies that identified biovars of Ureaplasma spp. but reported them incorrectly.
The original systematic review included 57 articles. Of the 14 articles highlighted by Skafte-Holm et al., 10 would remain; 2...
We are grateful to Axel Skafte-Holm et al. for their careful reading of our systematic review and for highlighting challenges in the classification of Ureaplasma species. We aimed to include studies that identified U. urealyticum or U. parvum using appropriate microbiological methods to examine associations with adverse pregnancy outcomes. For the 14 articles highlighted by Skafte-Holm et al. [1-14], we acknowledge that we used data that the authors of the included studies reported, but which were not consistent with the actual microbiological methods used.
There is inconsistent reporting of Ureaplasma species owing to changes made to their taxonomy; the resulting misclassification of these species compounds the shortcomings of epidemiological methods of studies in this systematic review. As such, it reinforces our conclusion, that “The currently available literature does not allow conclusions about the role of mycoplasmas in adverse pregnancy and birth outcomes”.
We updated our analysis of associations between the two Ureaplasma spp. and adverse pregnancy outcomes, following Skafte-Holm and colleagues’ investigations. We removed data from meta-analyses if identification of U. urealyticum was ambiguous and we amended data from studies that identified biovars of Ureaplasma spp. but reported them incorrectly.
The original systematic review included 57 articles. Of the 14 articles highlighted by Skafte-Holm et al., 10 would remain; 2 with revised data [1,13]; and 8 with data removed from some meta-analyses, but which also reported on Mycoplasma hominis [5-11,14]. Four articles would not be eligible for the review because the methods reported did not distinguish between Ureaplasma spp. [2-4,12].
We repeated the random effects meta-analysis on revised datasets to estimate the summary odds ratio (OR) and 95% confidence intervals (CI) for 4 of 10 organism-outcome pairs involving Ureaplasma species. In 2 other pairs, only 1 study remained. We also removed data for one study, with no positive samples, from the meta-analysis of U. urealyticum and preterm birth.
The direction of results did not change for new analyses of either U. urealyticum or U. parvum; the OR increased for 4 organism-outcome pairs and decreased for 2, with overlapping CIs for original and revised analyses in each pair. For U. urealyticum, the new analyses included fewer studies, which reduces the precision of summary ORs.
Here we report the new findings, expressed as OR, 95% CI, and number of included studies (corresponding findings from the original version in brackets). The primary outcome was preterm birth. For U. urealyticum, the new summary was OR 1.96, 95% CI 1.14-3.39, 16 studies (original, 1.84, 1.34-2.55, 27 studies). For U. parvum, the new summary OR was 1.79, 95% CI 1.28-2.52, 13 studies (original, 1.60, 1.12-2.30, 11 studies).
For secondary outcomes, we found the following associations between U. urealyticum and: premature rupture of membranes, summary OR 9.87, 95% CI 1.81-53.72, 4 studies (original, 4.27, 1.83-9.98, 11 studies); low birth weight, OR 1.08, 95% CI 0.08-14.41, 1 study (original, 2.24, 95% CI 1.16-4.33, 2 studies); spontaneous abortion, summary OR 2.43, 95% CI 1.21-4.86, 3 studies (original 1.74, 1.02-2.95, 4 studies); perinatal death, OR 3.52, 95% CI 0. 14-87.08, 1 study (original 9.50, 2.99-30.13, 2 studies). Secondary outcomes for associations with U. parvum were unaffected by the revised data.
The revised results in this rapid response address Skafte-Holm et al.’s concern about how misclassification of Ureaplasma spp. Might have affected our systematic review findings. We will replace the full manuscript with a corrected version, in which we will replace text, tables, figures and supplemental material with the revised results. The authors of primary studies should also be alerted to errors in their articles. The causal role of genital mycoplasmas in adverse pregnancy outcomes still needs to be understood. The increasing number of commercially available PCR tests that detect multiple genital organisms, some of uncertain clinical relevance, will result in antimicrobial treatment that may be unnecessary. If, however, these organisms are important causes of adverse pregnancy outcomes, further research is needed to determine whether antenatal screening interventions are warranted. We propose multidisciplinary research to design definitive studies with state-of-the-art microbiological, clinical, epidemiological and statistical methods.
References
1. Mitsunari M, Yoshida S, Deura I, Horie S, Tsukihara S, Harada T, et al. Cervical Ureaplasma Urealyticum Colonization Might Be Associated with Increased Incidence of Preterm Delivery in Pregnant Women without Prophlogistic Microorganisms on Routine Examination. J Obstet Gynaecol Res. 2005;31(1):16-21. Epub 2005/01/27. doi: 10.1111/j.1447-0756.2005.00246.x. PubMed PMID: 15669986.
2. Kafetzis DA, Skevaki CL, Skouteri V, Gavrili S, Peppa K, Kostalos C, et al. Maternal Genital Colonization with Ureaplasma Urealyticum Promotes Preterm Delivery: Association of the Respiratory Colonization of Premature Infants with Chronic Lung Disease and Increased Mortality. Clin Infect Dis. 2004;39(8):1113-22. Epub 2004/10/16. doi: 10.1086/424505. PubMed PMID: 15486833.
3. Aaltone R, Jalava J, Laurikainen E, Karkkainen U, Alanen A. Cervical Ureaplasma Urealyticum Colonization: Comparison of Pcr and Culture for Its Detection and Association with Preterm Birth. Scand J Infect Dis. 2002;34(1):35-40. Epub 2002/03/05. doi: 10.1080/00365540110077074. PubMed PMID: 11874162.
4. Povlsen K, Thorsen P, Lind I. Relationship of Ureaplasma Urealyticum Biovars to the Presence or Absence of Bacterial Vaginosis in Pregnant Women and to the Time of Delivery. Eur J Clin Microbiol Infect Dis. 2001;20(1):65-7. Epub 2001/03/14. doi: 10.1007/pl00011237. PubMed PMID: 11245329.
5. Usui R, Ohkuchi A, Matsubara S, Izumi A, Watanabe T, Suzuki M, et al. Vaginal Lactobacilli and Preterm Birth. J Perinat Med. 2002;30(6):458-66. Epub 2003/01/18. doi: 10.1515/JPM.2002.072. PubMed PMID: 12530101.
6. Kwak DW, Hwang HS, Kwon JY, Park YW, Kim YH. Co-Infection with Vaginal Ureaplasma Urealyticum and Mycoplasma Hominis Increases Adverse Pregnancy Outcomes in Patients with Preterm Labor or Preterm Premature Rupture of Membranes. J Matern Fetal Neonatal Med. 2014;27(4):333-7. Epub 2013/06/26. doi: 10.3109/14767058.2013.818124. PubMed PMID: 23796000.
7. Kacerovsky M, Pavlovsky M, Tosner J. Preterm Premature Rupture of the Membranes and Genital Mycoplasmas. Acta Medica (Hradec Kralove). 2009;52(3):117-20. Epub 2010/01/16. doi: 10.14712/18059694.2016.115. PubMed PMID: 20073423.
8. Montenegro DA, Borda LF, Neuta Y, Gomez LA, Castillo DM, Loyo D, et al. Oral and Uro-Vaginal Intra-Amniotic Infection in Women with Preterm Delivery: A Case-Control Study. J Investig Clin Dent. 2019;10(2):e12396. Epub 2019/01/22. doi: 10.1111/jicd.12396. PubMed PMID: 30663264.
9. Lee MY, Kim MH, Lee WI, Kang SY, Jeon YL. Prevalence and Antibiotic Susceptibility of Mycoplasma Hominis and Ureaplasma Urealyticum in Pregnant Women. Yonsei Med J. 2016;57(5):1271-5. Epub 2016/07/13. doi: 10.3349/ymj.2016.57.5.1271. PubMed PMID: 27401661; PubMed Central PMCID: PMC4960396.
10. Nasution TA, Cheong SF, Lim CT, Leong EW, Ngeow YF. Multiplex Pcr for the Detection of Urogenital Pathogens in Mothers and Newborns. Malays J Pathol. 2007;29(1):19-24. Epub 2007/06/01. PubMed PMID: 19105324.
11. Daskalakis G, Thomakos N, Papapanagiotou A, Papantoniou N, Mesogitis S, Antsaklis A. Amniotic Fluid Interleukin-18 at Mid-Trimester Genetic Amniocentesis: Relationship to Intraamniotic Microbial Invasion and Preterm Delivery. BJOG. 2009;116(13):1743-8. Epub 2009/11/13. doi: 10.1111/j.1471-0528.2009.02364.x. PubMed PMID: 19906019.
12. Abele-Horn M, Scholz M, Wolff C, Kolben M. High-Density Vaginal Ureaplasma Urealyticum Colonization as a Risk Factor for Chorioamnionitis and Preterm Delivery. Acta Obstet Gynecol Scand. 2000;79(11):973-8. Epub 2000/11/18. PubMed PMID: 11081683.
13. Harada K, Tanaka H, Komori S, Tsuji Y, Nagata K, Tsutsui H, et al. Vaginal Infection with Ureaplasma Urealyticum Accounts for Preterm Delivery Via Induction of Inflammatory Responses. Microbiol Immunol. 2008;52(6):297-304. Epub 2008/06/26. doi: 10.1111/j.1348-0421.2008.00039.x. PubMed PMID: 18577163.
14. Schwab FD, Zettler EK, Moh A, Schotzau A, Gross U, Gunthert AR. Predictive Factors for Preterm Delivery under Rural Conditions in Post-Tsunami Banda Aceh. J Perinat Med. 2016;44(5):511-5. Epub 2015/05/20. doi: 10.1515/jpm-2015-0004. PubMed PMID: 25980381.
Authors
Nicola Low, Professor of Epidemiology and Public Health, University of Bern (corresponding author)
Marinjho Jonduo, PhD student, Papua New Guinea Institute of Medical Research
Emma L Sweeney, Postdoctoral Research Fellow, University of Queensland
Lisa M Vallely, Senior Research Fellow, University of New South Wales
Handan Wand, Associate Professor (Biostatistics and Databases), University of New South Wales
Dianne Egli-Gany, Project Manager, University of Bern
John M Kaldor, Scientia Professor, University of New South Wales
Andrew J Vallely, Professor of Clinical Epidemiology, University of New South Wales
The persistent effort towards making India defecation free have met with mixed success that is defining characteristics linked with this adversity and regions with greater failures in this regard. An exercise that uses the most recently obtained data to investigate the correlates of open defecation places the obvious i.e. socio-economic adversity being responsible for this failure. While this phenomenon has a dual bearing of deprivation on one hand and behavioral dimension on the other, a mere provisioning may not translate into changed behavior. But then OD as a practice needs to be read in association with the cultural belief system on ideal hygiene practice and circumstantial convenience. Most enquiries on this subject may well be finding a contesting force between beliefs and practice and convenience together that sustains and justifies OD despite provisioning and promotion of modern sanitary practice. In all these attempts, a variable that perhaps facilitates convenience is the density ( i.e availability of open space) remains overlooked. Owing to inconvenience, it has gained greater success in urban space compared with the rural hinterland. In addition, realization of its success/failure and its geography will also have a systematic connect with population density. Finally, a unidimensional focus on provisioning of sanitation infrastructure may not achieve the dream goal of OD free India rather than it being a part of improving living environment in its entirety that...
The persistent effort towards making India defecation free have met with mixed success that is defining characteristics linked with this adversity and regions with greater failures in this regard. An exercise that uses the most recently obtained data to investigate the correlates of open defecation places the obvious i.e. socio-economic adversity being responsible for this failure. While this phenomenon has a dual bearing of deprivation on one hand and behavioral dimension on the other, a mere provisioning may not translate into changed behavior. But then OD as a practice needs to be read in association with the cultural belief system on ideal hygiene practice and circumstantial convenience. Most enquiries on this subject may well be finding a contesting force between beliefs and practice and convenience together that sustains and justifies OD despite provisioning and promotion of modern sanitary practice. In all these attempts, a variable that perhaps facilitates convenience is the density ( i.e availability of open space) remains overlooked. Owing to inconvenience, it has gained greater success in urban space compared with the rural hinterland. In addition, realization of its success/failure and its geography will also have a systematic connect with population density. Finally, a unidimensional focus on provisioning of sanitation infrastructure may not achieve the dream goal of OD free India rather than it being a part of improving living environment in its entirety that includes decent housing, electricity, water and sustainable waste disposal. Freedom from open defecation will be reality with a focus on decent living.
The striking findings by Alami et al., published in The BMJ, that their “meta-analysis indicates that within 30-day follow-up period, vaccinated individuals were twice as likely to develop myo/pericarditis in the absence of SARS-CoV-2 infection compared to unvaccinated individuals, with a rate ratio of 2.05 (95% CI 1.49–2.82)” adds to the recent spate of evidence on the not-so-insignificant risk of COVID-19 vaccine-induced myocarditis.1 For example, Cho et al., publishing in the European Heart Journal, found a COVID vaccine-induced myocarditis incidence rate of around 1 in 100,000, and around 1 in 19,000 for males between the ages of 12 and 17 years; also finding that a significant number of vaccine-induced myocarditis sufferers (around 5%) end up dying soon afterwards.2
Contrast this with the UK government’s determination of numbers needed to vaccinate to prevent a severe COVID hospitalisation being in the hundreds of thousands for young ‘no risk’ groups.3 It would appear to be an unacceptable risk, at least for certain groups, for this one adverse effect alone. The risk of vaccine-induced myocarditis may indeed be very small, but the risk of serious COVID in the young and healthy is smaller still.
There are also increasing questions over the vaccines’ effectiveness, such as those concerning statistical biases in observational studies raised in the Journal of Evaluation in Clinical Practice by Fung, Jones, and Doshi;4 and by myself.5 Should we now adm...
The striking findings by Alami et al., published in The BMJ, that their “meta-analysis indicates that within 30-day follow-up period, vaccinated individuals were twice as likely to develop myo/pericarditis in the absence of SARS-CoV-2 infection compared to unvaccinated individuals, with a rate ratio of 2.05 (95% CI 1.49–2.82)” adds to the recent spate of evidence on the not-so-insignificant risk of COVID-19 vaccine-induced myocarditis.1 For example, Cho et al., publishing in the European Heart Journal, found a COVID vaccine-induced myocarditis incidence rate of around 1 in 100,000, and around 1 in 19,000 for males between the ages of 12 and 17 years; also finding that a significant number of vaccine-induced myocarditis sufferers (around 5%) end up dying soon afterwards.2
Contrast this with the UK government’s determination of numbers needed to vaccinate to prevent a severe COVID hospitalisation being in the hundreds of thousands for young ‘no risk’ groups.3 It would appear to be an unacceptable risk, at least for certain groups, for this one adverse effect alone. The risk of vaccine-induced myocarditis may indeed be very small, but the risk of serious COVID in the young and healthy is smaller still.
There are also increasing questions over the vaccines’ effectiveness, such as those concerning statistical biases in observational studies raised in the Journal of Evaluation in Clinical Practice by Fung, Jones, and Doshi;4 and by myself.5 Should we now admit that, at least at this point in time, the benefits of the COVID-19 vaccines do not outweigh the risks?
References
1. Alami A, Krewski D, Farhat N, et al. Risk of myocarditis and pericarditis in mRNA COVID-19-vaccinated and unvaccinated populations: a systematic review and meta-analysis. BMJ Open. 2023;13:e065687. https://bmjopen.bmj.com/content/13/6/e065687.
2. Cho JY, Kim KH, Lee N, et al. COVID-19 vaccination-related myocarditis: a Korean nationwide study. European Heart Journal. 2023;44: 2234-43. https://doi.org/10.1093/eurheartj/ehad339.
3. Department of Health & Social Care. Appendix 1: estimation of number needed to vaccinate to prevent a COVID-19 hospitalisation for primary vaccination, booster vaccination (3rd dose), autumn 2022 and spring 2023 booster for those newly in a risk group. 2023. https://assets.publishing.service.gov.uk/government/uploads/system/uploa....
4. Fung K, Jones M, Doshi P. Sources of bias in observational studies of covid-19 vaccine effectiveness. Journal of Evaluation in Clinical Practice. 2023;1-7. https://doi.org/10.1111/jep.13839.
5. Lataster R. Reply to Fung et al. on COVID-19 vaccine case-counting window biases overstating vaccine effectiveness. Journal of Evaluation in Clinical Practice. 2023;1-4. https://doi.org/10.1111/jep.13892.
Dear authors: Toshinari Kaku, Masahiro Banno and Takahiro Tsuge,
We are delighted that our article took your attention and we appreciate the time that you spent reviewing our study. We hope the prepared response can solve your concerns.
First, you mentioned an issue about not implementing face-to-face training properly. As you can see, in the method section, under the participants' headline, we considered not attending the face-to-face training for over three sessions as an exclusion criterion, which means that it was important for us to observe this group closely. No one missed the sessions which means that they were eager to learn and all the participants received the prepared content. Besides, the reason why we designed each session for only about 10 minutes was that the result of previous studies showed long training sessions distract patients’ attention and reduce the outcome. Therefore, we stuck to the mentioned duration to avoid adversely affecting the face-to-face training. Furthermore, in the intervention section, we mentioned that this group was trained by one of the researchers. It means that we directly observed all the participants of this group. There was a chance for the participants of this group to ask their questions by the end of each session while the other group had no access to any source to ask their questions. Moreover, the written training content was handed to the patients of this group to review whenever they wanted.
Second...
Dear authors: Toshinari Kaku, Masahiro Banno and Takahiro Tsuge,
We are delighted that our article took your attention and we appreciate the time that you spent reviewing our study. We hope the prepared response can solve your concerns.
First, you mentioned an issue about not implementing face-to-face training properly. As you can see, in the method section, under the participants' headline, we considered not attending the face-to-face training for over three sessions as an exclusion criterion, which means that it was important for us to observe this group closely. No one missed the sessions which means that they were eager to learn and all the participants received the prepared content. Besides, the reason why we designed each session for only about 10 minutes was that the result of previous studies showed long training sessions distract patients’ attention and reduce the outcome. Therefore, we stuck to the mentioned duration to avoid adversely affecting the face-to-face training. Furthermore, in the intervention section, we mentioned that this group was trained by one of the researchers. It means that we directly observed all the participants of this group. There was a chance for the participants of this group to ask their questions by the end of each session while the other group had no access to any source to ask their questions. Moreover, the written training content was handed to the patients of this group to review whenever they wanted.
Second, you implied that the mHealth group received advanced treatment. The treatment was hemodialysis which was the same in both groups. If you mean the intervention (using the app), it was the goal of this study to compare an up-to-date intervention with one of the most common training methods. As a result, it relates to the nature of the method and we could not do anything with that.
Third, it was asked about exchanging views between two groups. In the last paragraph of the method section, it is written that “To avoid contamination information among the HD patients in both groups, they were explained the study objectives and asked not to swap information until the study completion”. Besides, to use the app, users had to log in by their phone number and their name. These data were sent immediately to the server of the app and we checked regularly if the participants of the face-to-face group used it, which did not happen during the study.
We tried to answer your concerns. Please feel free to ask any other related questions.
Sincerely yours
Abstract: Objective: This article critically examines the study "Comparing the effects of mHealth application based on micro-Learning method and face-to-face training on treatment adherence and perception in haemodialysis patients: A randomised clinical trial" by Mohsen Torabi Khah, Zahra Farsi, and Seyedeh Azam Sajadi. Summary of the argument: There are two concerns that the intervention effect may be overestimated and one that the intervention effect may be underestimated. Conclusion: While the study indicates innovative use of mHealth applications in enhancing treatment adherence, it also highlights potential biases that may have resulted in an overestimation and an underestimation of the intervention's effect.
Full References: Torabi Khah M, Farsi Z, Sajadi SA. Comparing the effects of mHealth application based on micro-learning method and face-to-face training on treatment adherence and perception in haemodialysis patients: A randomised clinical trial. BMJ Open 2023;13:e071982. doi:10.1136/bmjopen-2023-071982
Authors’ Contributions: The author of this communication article critically analysed the referenced study and authored the article.
Funding Statement: This research did not receive any specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Competing Interests Statement: The author declares no competing interests.
We read the article by Torabi Khah et al. with great interest and app...
Abstract: Objective: This article critically examines the study "Comparing the effects of mHealth application based on micro-Learning method and face-to-face training on treatment adherence and perception in haemodialysis patients: A randomised clinical trial" by Mohsen Torabi Khah, Zahra Farsi, and Seyedeh Azam Sajadi. Summary of the argument: There are two concerns that the intervention effect may be overestimated and one that the intervention effect may be underestimated. Conclusion: While the study indicates innovative use of mHealth applications in enhancing treatment adherence, it also highlights potential biases that may have resulted in an overestimation and an underestimation of the intervention's effect.
Full References: Torabi Khah M, Farsi Z, Sajadi SA. Comparing the effects of mHealth application based on micro-learning method and face-to-face training on treatment adherence and perception in haemodialysis patients: A randomised clinical trial. BMJ Open 2023;13:e071982. doi:10.1136/bmjopen-2023-071982
Authors’ Contributions: The author of this communication article critically analysed the referenced study and authored the article.
Funding Statement: This research did not receive any specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Competing Interests Statement: The author declares no competing interests.
We read the article by Torabi Khah et al. with great interest and appreciate the authors' efforts to assess the effectiveness of mHealth application based on the micro-learning method on treatment adherence in haemodialysis patients. However, we have two concerns about the article. First, the study did not assess whether the face-to-face training was properly implemented. This oversight could mean that the face-to-face training group included participants for whom the training was improperly implemented, potentially leading to worse outcome for this group. Second, participants in the mHealth group may have been more motivated to learn than those in the face-to-face group because they were receiving an advanced treatment. The above two points could have biased the results, leading to an overestimation of the intervention's effect. Third, there is no mention from this paper of whether or not the two groups of participants exchanged views, and if they did, the content of the two groups of interventions would be effectively similar, which may underestimate the intervention effect.
While we agree with the conclusion of this research that mHealth application is effective in improving treatment adherence and awareness in hemodialysis patients. We are afraid that data of the present study was not able to support that mHealth applications is more effective than face-to-face training. The study provides valuable insights into the potential of mHealth applications in improving treatment adherence, further research is needed to address potential biases and ensure the validity of the findings.
【cover-letter】
June 24th, 2023
Adrian Aldcroft
Editor-in-Chief
BMJ Open
Dear Editor:
I wish to submit a letter for publication in BMJ open, titled "Questioning the superiority of mHealth applications over face-to-face training in treatment adherence of hemodialysis patients." The paper is co-authored by Masahiro Banno and Takahiro Tsuge.
In this communication we compared the study by Mohsen Torabi Khah, Zahra Farsi, and Seyedeh, "Comparison of the effects of microlearning methods and mHealth applications based on face-to-face training on treatment adherence and cognition in hemodialysis patients: a randomized clinical trial" A critical review. Azam Sajadi. We discuss concerns that intervention effects may be overestimated or underestimated, which could affect the validity of the results.
This manuscript has not been published or presented elsewhere in part or in whole and is not under consideration by another journal.We have read and understand your journal’s policies, and believe that neither the manuscript nor the study violates any of these.
We have no conflicts of interest to declare.
Thank you for your consideration. I look forward to hearing from you.
Sincerely,
Toshinari Kaku, MD
Department of general medicine, Minami-Satsuma Municipal Bonotsu Hospital
19, Tomari, Minamisatsuma city, Kagoshima, 898-0102, Japan
E-mail: m09029tk@icloud.com
TEL: +81-993-67-1141; FAX: +81-993-67-2180
Martin JC van Gemert,*1 Marianne Vlaming,2 Peter J van Koppen,3 Aeilco H Zwinderman,4 HA Martino Neumann5
1Department of Biomedical Engineering & Physics, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Amsterdam, The Netherlands
2Private Practice, Criminal Psychology and Law, Doetinchem, The Netherlands
3Department of Criminal Law and Criminology, Faculty of Law, VU University Amsterdam, The Netherland
4Department of Clinical Epidemiology & Bio-Statistics, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Amsterdam, The Netherlands
5ZBC-Multicare, Hilversum-The Netherlands
Van Rijn et al1 described the implementation and first output data of the Dutch expertise centre for child abuse (LECK: Landelijk Expertise Centrum Kindermishandeling). LECK's methodology aims to be easily accessible for giving anonymous advice when health care professionals suspect potential cases of physical child abuse.1 LECK physicians do not see the patient nor talk to the parents and are neither involved in further treatment or follow-up. LECK works with Bayes' statistics,2,3 and uses likelihood ratios, part of Bayes' theorem, in their conclusions.1
Bayes' theorem, named after the 18th century English statistician, philosopher and Presbyterian minister Thomas Bayes,2,3 updates the relative probability of an hypothesis (here, physical child abuse caused the symptoms),...
Martin JC van Gemert,*1 Marianne Vlaming,2 Peter J van Koppen,3 Aeilco H Zwinderman,4 HA Martino Neumann5
1Department of Biomedical Engineering & Physics, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Amsterdam, The Netherlands
2Private Practice, Criminal Psychology and Law, Doetinchem, The Netherlands
3Department of Criminal Law and Criminology, Faculty of Law, VU University Amsterdam, The Netherland
4Department of Clinical Epidemiology & Bio-Statistics, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Amsterdam, The Netherlands
5ZBC-Multicare, Hilversum-The Netherlands
Van Rijn et al1 described the implementation and first output data of the Dutch expertise centre for child abuse (LECK: Landelijk Expertise Centrum Kindermishandeling). LECK's methodology aims to be easily accessible for giving anonymous advice when health care professionals suspect potential cases of physical child abuse.1 LECK physicians do not see the patient nor talk to the parents and are neither involved in further treatment or follow-up. LECK works with Bayes' statistics,2,3 and uses likelihood ratios, part of Bayes' theorem, in their conclusions.1
Bayes' theorem, named after the 18th century English statistician, philosopher and Presbyterian minister Thomas Bayes,2,3 updates the relative probability of an hypothesis (here, physical child abuse caused the symptoms), as more evidence becomes available (expressed in the form of a likelihood ratio). The updated outcome, the relative probability of the hypothesis being true if the symptoms are present, is given by the product of likelihood ratio and physical child abuse incidence,4 where the likelihood ratio expresses how more frequent the symptoms develop if abuse indeed occurred versus the non-abuse situation.
We previously estimated the Dutch incidence of physical child abuse for infants as about 0.0026.4 For older Dutch children it is likely that the physical abuse incidence decreases even further, based on the yearly published child abuse data for USA children.5
Implication of these exceedingly low physical abuse incidences is that Bayesian statistics predicts a virtually zero probability for USA and Dutch children that physical abuse-mimicking-symptoms are indeed caused by physical abuse. Nevertheless, LECK claims the use of Bayes' theorem, e.g. in its first 4 years in 761 cases.1 The solution to this conundrum is given in the Abstract of their paper,1,4 that LECK "works with Bayes' theorem and uses likelihood ratios in their conclusions." Even though they correctly explained Bayes' theorem in words,1 we showed4 that LECK literally used the likelihood ratio to represent the probability that the observed symptoms are due to physical abuse. That invalid use of Bayes' theorem obviously produces physical abuse probabilities that can be orders of magnitude too large, not only for <1 year old infants,4 but also for all other child ages.
A Bayesian probability of >3 that observed symptoms could be physical abuse-related, a minimum value of possible statistical significance, requires likelihood ratios of approximately >1,200 for children below 1 year, >2,700 for 1-8 year old children, and >4,500 for 11-18 year old children, which numbers are far beyond any reasonable likelihood ratio.
In conclusion, Bayes' theorem, when correctly used (which obviously should occur), includes such exceedingly low physical abuse incidences, that this statistical method is too insensitive to assess potential physical child abuse cases convincingly, not only in the USA and the Netherlands, but possibly also worldwide. Finally, LECK creates by their approach an unsafe situation Finally, LECK creates by its approach an unsafe situation for e.g. Dutch parents when presenting their child that has a rare or inheritable medical disorder that gives symptoms mimicking child abuse.4 Such a methodology will likely increase the number of invalid physical child abuse convictions, including the number of temporary as well as permanent foster care placements.4 In our opinion, therefore, LECK should refrain from applying Bayesian statistics in cases of child abuse suspicion and use differential diagnostic procedures, the general accepted medical method of care.
REFERENCES
1. van Rijn RR, Affourtit MJ, Karst WA, Kamphuis M, de Bock LC, van de Putte E. Implementation of the Dutch Expertise Centre for Child Abuse: descriptive data from the first 4 years. BMJ Open 2019;9:e031008 (1-7).
2. Bayes T. An Essay Toward Solving a Problem in the Doctrine of Chances. Philosoph Trans Roy Soc London 1764;53:370-418.
3. https://en.wikipedia.org/wiki/Bayesian statistics.
4. van Gemert MJC, Zwinderman AH, van Koppen PJ, Neumann HAM, Vlaming M. Child Abuse, misdiagnosed by an Expertise Center. Part II. Misuse of Bayes' Theorem. Children 2023;10(5):(1-11).
5. US Department of He
Persistent systemic neo-colonialism in academic publication
The recent publication of the paper, Clinical emergency care quality indicators in Africa: a scoping review and data summary(1) has triggered much discussion within our network of emergency care academics and clinicians from various countries across Africa.
The subject matter explored in the publication is crucial, and we would congratulate the authors on tackling this issue. We agree that in many settings of nascent African emergency care systems, it is key to build quality indicators and to use them to improve and measure emergency care. Yet, for a paper that concludes that more needs to be done to improve published work on quality indicators in African emergency care, not including any authors living and working within African emergency care, is a significant oversight.
The problem of excluding African voices
Analysing the African emergency care health system from outside Africa is problematic. Africa is not a country, and we find the approach to dealing with Africa as one unit troubling. Although the authors rightly point out that emergency care systems and resources are at profoundly different ends of the spectrum in different settings within the continent, they chose to perform their search looking for evidence from Africa.(1) Much research done within African settings is done without collaboration or active engagement with the African emergenc...
Persistent systemic neo-colonialism in academic publication
The recent publication of the paper, Clinical emergency care quality indicators in Africa: a scoping review and data summary(1) has triggered much discussion within our network of emergency care academics and clinicians from various countries across Africa.
The subject matter explored in the publication is crucial, and we would congratulate the authors on tackling this issue. We agree that in many settings of nascent African emergency care systems, it is key to build quality indicators and to use them to improve and measure emergency care. Yet, for a paper that concludes that more needs to be done to improve published work on quality indicators in African emergency care, not including any authors living and working within African emergency care, is a significant oversight.
The problem of excluding African voices
Analysing the African emergency care health system from outside Africa is problematic. Africa is not a country, and we find the approach to dealing with Africa as one unit troubling. Although the authors rightly point out that emergency care systems and resources are at profoundly different ends of the spectrum in different settings within the continent, they chose to perform their search looking for evidence from Africa.(1) Much research done within African settings is done without collaboration or active engagement with the African emergency care community working locally. Emergency Medicine is well established in many countries on the continent, which is described by Sawe et al(2), and many countries have established academic and research capacities.(3, 4) Conducting a scoping review is certainly within the capacities and resources of many African emergency care academics, and we are sceptical of the authors’ statement that structural barriers such as internet connection and institutional library access are barriers to inclusion. There are undoubtedly African researchers who would have been able to and would have welcomed the opportunity to contribute to a scoping review on matters that directly affect them.
The need for decolonising global health
There has been much written about decolonising global health and the lack of Southern voices in publications. There is widespread criticism for the lack of representative authorship from low- and middle-income countries on papers about these settings, generated from high-income settings.(5-7) Another BMJ title, BMJ Global Health, has acknowledged the need for equity in Board representation as a component of decolonising academia in low- and middle-income settings.(8) As contended by other publications, some of the responsibility for publishing without due authorship representation rests with the editorial board.(6, 9) The African Journal of Emergency Medicine specifically requires proportional inclusion of African authors on all submissions to be eligible for peer review.
We recognise several authors in this paper with a significant background in global health, specifically in African emergency care. Given that global health is effectively the global discipline of inclusiveness and equity, choosing not to involve any African affiliated authorship, especially for authors so well connected within African emergency care, was a missed opportunity.
The African Federation for Emergency Medicine acknowledges that even as a regional collective, there exist local power differentials and clusters of privilege that facilitate research and publication from a few centres. The organisation has committed to strengthening mechanisms which acknowledge indigenous perspectives and promote equity and inclusivity in research representation.(6, 10) In transforming away from colonialist research and publication systems, it is imperative to engage with the composition of authors reporting on locations outside of their own, and consider systems designed to promote long-term equitable research relationships with appropriate representativity.(10)
1. Pickering AE, Malherbe P, Nambuba J, et al. Clinical emergency care quality indicators in Africa: a scoping review and data summary. BMJ Open 2023;13(5):e069494. doi: 10.1136/bmjopen-2022-069494 [published Online First: 20230502]
2. Sawe HR, Akomeah A, Mfinanga JA, et al. Emergency medicine residency training in Africa: overview of curriculum. BMC Medical Education 2019;19:1-6.
3. Kannan V, Tenner A, Sawe H, et al. Emergency care systems in Africa: a focus on quality. African Journal of Emergency Medicine 2020;10:S65-S72.
4. Rybarczyk MM, Ludmer N, Broccoli MC, et al. Emergency medicine training programs in low-and middle-income countries: a systematic review. Annals of Global Health 2020;86(1)
5. Contractor SQ, Dasgupta J. Is decolonisation sufficient? BMJ Global Health 2022;7(12) doi: 10.1136/bmjgh-2022-011564
6. Horn L, Alba S, Gopalakrishna G, et al. The Cape Town Statement on fairness, equity and diversity in research. Nature 2023;615(7954):790-93.
7. Naidoo AV, Hodkinson P, Lai King L, et al. African authorship on African papers during the COVID-19 pandemic. BMJ Global Health 2021;6(3):e004612. doi: 10.1136/bmjgh-2020-004612
8. Nafade V, Sen P, Pai M. Global health journals need to address equity, diversity and inclusion. BMJ Glob Health 2019;4(5):e002018. doi: 10.1136/bmjgh-2019-002018 [published Online First: 20191018]
9. Saleh S, Masekela R, Heinz E, et al. Equity in global health research: A proposal to adopt author reflexivity statements. PLOS Global Public Health 2022;2(3):e0000160. doi: 10.1371/journal.pgph.0000160 [published Online First: 20220330]
10. TRUST. Global Code of Conduct for Research in Resource-Poor Settings. 2018; doi: 10.48508/GCC/2018.05
Telemonitoring is an emerging field which uses information technologies to transmit information on patient’s health to the selected healthcare facility. We have read the article by Gijsbers et al al with great interest [1] In addition to these arguments, we would like to express some vital issues regarding the viability of telemonitoring in enhancing triabl health. The effectiveness of telemonitoring in managing health issues was tested in a small number (and very few among tribals) of randomized control trials because it is a new field. These trials found that telemonitoring is beneficial in controlling chronic illness conditions. Telemonitoring has the potential to help with the management of chronic illnesses like hypertension since it enables continuous monitoring of vital signs, which lowers the number of trips to medical facilities [2].
TASHMINH-4 trial study proved to be a milestone in establishing the effectiveness in the management of Telemonitoring in chronic condition like hypertension. The study done by Richard McManus and colleagues, shows that self-monitoring of blood pressure with Telemonitoring used by general practitioner in poorly controlled individuals has significantly help in improving control over the blood pressure. This study emphasize that self-monitoring of blood pressure by individual helps in better control over of high blood pressure [3][4].
Telemonitoring provides a platform which makes healthcare services accessible through home...
Telemonitoring is an emerging field which uses information technologies to transmit information on patient’s health to the selected healthcare facility. We have read the article by Gijsbers et al al with great interest [1] In addition to these arguments, we would like to express some vital issues regarding the viability of telemonitoring in enhancing triabl health. The effectiveness of telemonitoring in managing health issues was tested in a small number (and very few among tribals) of randomized control trials because it is a new field. These trials found that telemonitoring is beneficial in controlling chronic illness conditions. Telemonitoring has the potential to help with the management of chronic illnesses like hypertension since it enables continuous monitoring of vital signs, which lowers the number of trips to medical facilities [2].
TASHMINH-4 trial study proved to be a milestone in establishing the effectiveness in the management of Telemonitoring in chronic condition like hypertension. The study done by Richard McManus and colleagues, shows that self-monitoring of blood pressure with Telemonitoring used by general practitioner in poorly controlled individuals has significantly help in improving control over the blood pressure. This study emphasize that self-monitoring of blood pressure by individual helps in better control over of high blood pressure [3][4].
Telemonitoring provides a platform which makes healthcare services accessible through home or other remote area. It as well aids in providing “point of care” of care service for chronic condition [4].
As Telemonitoring has the potential to serve large group of population, population residing in the remote areas, vulnerable population like geriatrics population [5].
The applications of Telemonitoring in hypertension management need to be focused, as India accounts for largest tribal population of the world. According to census 2011, approximately 67.8 million tribal population spread across India and about 90% resides in rural area. Tribal population considered to be vulnerable in terms of poor health indicator as compare to general population which can be influenced by their low literacy level, poverty and their scattered geographical distribution. Due to which these population has little access to healthcare services, causes high burden of disease morbidity and mortality. A report by Tribal health expert committee headed by Dr Abhay Bang, , there is a shift in disease trend from communicable to non-communicable diseases which will raise the demand for Telemonitoring for monitoring and management of chronic condition [6].
The study by Chakma et al (2017), found the burden of Hypertension was approx. 30% among the tribal population of central India. The study shows that, 28.2% of males and 23.6% of females had either stage-I or stage-II hypertension [7]. Also study had done by Meshram et al (2013) shows the increasing burden of hypertension among tribal population of Maharashtra [8]. A Meta-Analysis done by Rizwan et al (2014), illustrates that there is an increasing burden of hypertension among the tribal people [9].
These are the marginalized population which usually resides in the remote areas, if these population to be self-monitored with Telemonitoring by simple free text SMS in local language or a designated nurse trained with the mobile-health tool at the nearest facility will be given driver’s seat in monitoring of blood pressure of the local population through Telemonitoring and antihypertensive dose adjusted by General Physician. Similar to TASHMIN-4 trial, suggestive of better control over high blood pressure can be achieved in Indian context with limited resources a large geographical population can be covered.
How it be beneficial if implemented at tribal areas:
• Telemonitoring helps in diagnosing new hypertensive cases, which will eventually add on increasing control over high blood pressure.
• Due to low literacy level among tribal’s, Telemonitoring can be used as a tool for screening of disease using specific symptom.
• Telemonitoring allows early detection of chronic disease conditions which in turn reduces complications and financial burden.
• Telemonitoring can also be beneficial for the aging population, as these population had to face challenges while assessing to nearest health facilities.
References
1. Gijsbers H, Feenstra TM, Eminovic N, et alEnablers and barriers in upscaling telemonitoring across geographic boundaries: a scoping reviewBMJ Open 2022;12:e057494. doi: 10.1136/bmjopen-2021-057494
2.Hanley J, Pinnock H, Paterson M, McKinstry B. Implementing telemonitoring in primary care: learning from a large qualitative dataset gathered during a series of studies. BMC family practice. 2018 Dec;19(1):118.
3. McManus RJ, Mant J, Franssen M, et al. Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): unmasked randomised controlled trial.Lancet 2018; published online Feb 27. http://dx.doi.org/10.1016/S0140-6736(18)30309-X.
4. Rietzschel ER, De Buyzere ML. Hypertension: time for doctors to switch the driver's seat?. The Lancet. 2018 Mar 10;391(10124):914-6.
5. Hovey L, Kaylor MB, Alwan M, Resnick HE. Community-based telemonitoring for hypertension management: Practical challenges and potential solutions. Telemedicine and e-Health. 2011 Oct 1;17(8):645-51.
6. Tribal Health Expert Committee report [Internet]. Tribal health in India- Bridging the gap and a roadmap for the future; 2018 [Cited 2019 August 2]. Available form: https://mohfw.gov.in/sites/default/files/Tribal%20Health%20Expert%20Comm...
7. Chakma T, Kavishwar A, Sharma RK, Rao PV. High prevalence of hypertension and its selected risk factors among adult tribal population in Central India. Pathogens and global health. 2017 Oct 3;111(7):343-50.
8. Meshram II, Laxmaiah A, Mallikharjun RK, Arlappa N, Balkrishna N, Reddy CG. Prevalence of hypertension and its correlates among Adult Tribal Population (≥ 20 years) of Maharashtra state, India. Int J Health Sci Res. 2014;4(1):130-9.
9. Rizwan SA, Kumar R, Singh AK, Kusuma YS, Yadav K, Pandav CS. Prevalence of hypertension in Indian tribes: a systematic review and meta-analysis of observational studies. PLoS one. 2014 May 5;9(5):e95896.
We invited the authors of the STAR*D study to provide a response to this article, but they declined.
Thank you for your response to my concerns and comments on the article. I wish to correct an apparent misunderstanding about concomitant use of SSRIs and stimulants. I did not state that SSRIs have any indication for treating ADHD, I am aware of research to the contrary and have never used SSRIs to treat ADHD. My statement that "SSRIs have FDA-indications for treating both conditions" was intended to refer to the conditions of anxiety and depression; upon re-reading the statement when looking to see how a conclusion was made that I was treating ADHD with SSRIs I can see how it could be mis-construed. Regarding studies of the safety of the combination of stimulants and SSRIs (or other anti-depressants), I also am not aware of any. A prospective study would be challenging to do, to say the least. A retrospective analysis with inclusion of diagnosis-specific information and directly correlating diagnosis, treatment including dosages and duration, and outcomes would probably be challenging as well but I think that degree of detail and specificity is necessary before drawing conclusions about the safety of combinations of medications (drugs) used to treat any condition.
Show MoreThank you again for your careful consideration of my initial comments.
Respectfully,
David P. Pomeroy MD
Regarding my statement that "stimulants and SSRIs are basically safe" I was not contesting the fact that each has Black Box warnings and serious side effects and...
To the editor,
We are grateful to Axel Skafte-Holm et al. for their careful reading of our systematic review and for highlighting challenges in the classification of Ureaplasma species. We aimed to include studies that identified U. urealyticum or U. parvum using appropriate microbiological methods to examine associations with adverse pregnancy outcomes. For the 14 articles highlighted by Skafte-Holm et al. [1-14], we acknowledge that we used data that the authors of the included studies reported, but which were not consistent with the actual microbiological methods used.
There is inconsistent reporting of Ureaplasma species owing to changes made to their taxonomy; the resulting misclassification of these species compounds the shortcomings of epidemiological methods of studies in this systematic review. As such, it reinforces our conclusion, that “The currently available literature does not allow conclusions about the role of mycoplasmas in adverse pregnancy and birth outcomes”.
We updated our analysis of associations between the two Ureaplasma spp. and adverse pregnancy outcomes, following Skafte-Holm and colleagues’ investigations. We removed data from meta-analyses if identification of U. urealyticum was ambiguous and we amended data from studies that identified biovars of Ureaplasma spp. but reported them incorrectly.
The original systematic review included 57 articles. Of the 14 articles highlighted by Skafte-Holm et al., 10 would remain; 2...
Show MoreThe persistent effort towards making India defecation free have met with mixed success that is defining characteristics linked with this adversity and regions with greater failures in this regard. An exercise that uses the most recently obtained data to investigate the correlates of open defecation places the obvious i.e. socio-economic adversity being responsible for this failure. While this phenomenon has a dual bearing of deprivation on one hand and behavioral dimension on the other, a mere provisioning may not translate into changed behavior. But then OD as a practice needs to be read in association with the cultural belief system on ideal hygiene practice and circumstantial convenience. Most enquiries on this subject may well be finding a contesting force between beliefs and practice and convenience together that sustains and justifies OD despite provisioning and promotion of modern sanitary practice. In all these attempts, a variable that perhaps facilitates convenience is the density ( i.e availability of open space) remains overlooked. Owing to inconvenience, it has gained greater success in urban space compared with the rural hinterland. In addition, realization of its success/failure and its geography will also have a systematic connect with population density. Finally, a unidimensional focus on provisioning of sanitation infrastructure may not achieve the dream goal of OD free India rather than it being a part of improving living environment in its entirety that...
Show MoreThe striking findings by Alami et al., published in The BMJ, that their “meta-analysis indicates that within 30-day follow-up period, vaccinated individuals were twice as likely to develop myo/pericarditis in the absence of SARS-CoV-2 infection compared to unvaccinated individuals, with a rate ratio of 2.05 (95% CI 1.49–2.82)” adds to the recent spate of evidence on the not-so-insignificant risk of COVID-19 vaccine-induced myocarditis.1 For example, Cho et al., publishing in the European Heart Journal, found a COVID vaccine-induced myocarditis incidence rate of around 1 in 100,000, and around 1 in 19,000 for males between the ages of 12 and 17 years; also finding that a significant number of vaccine-induced myocarditis sufferers (around 5%) end up dying soon afterwards.2
Contrast this with the UK government’s determination of numbers needed to vaccinate to prevent a severe COVID hospitalisation being in the hundreds of thousands for young ‘no risk’ groups.3 It would appear to be an unacceptable risk, at least for certain groups, for this one adverse effect alone. The risk of vaccine-induced myocarditis may indeed be very small, but the risk of serious COVID in the young and healthy is smaller still.
There are also increasing questions over the vaccines’ effectiveness, such as those concerning statistical biases in observational studies raised in the Journal of Evaluation in Clinical Practice by Fung, Jones, and Doshi;4 and by myself.5 Should we now adm...
Show MoreDear authors: Toshinari Kaku, Masahiro Banno and Takahiro Tsuge,
Show MoreWe are delighted that our article took your attention and we appreciate the time that you spent reviewing our study. We hope the prepared response can solve your concerns.
First, you mentioned an issue about not implementing face-to-face training properly. As you can see, in the method section, under the participants' headline, we considered not attending the face-to-face training for over three sessions as an exclusion criterion, which means that it was important for us to observe this group closely. No one missed the sessions which means that they were eager to learn and all the participants received the prepared content. Besides, the reason why we designed each session for only about 10 minutes was that the result of previous studies showed long training sessions distract patients’ attention and reduce the outcome. Therefore, we stuck to the mentioned duration to avoid adversely affecting the face-to-face training. Furthermore, in the intervention section, we mentioned that this group was trained by one of the researchers. It means that we directly observed all the participants of this group. There was a chance for the participants of this group to ask their questions by the end of each session while the other group had no access to any source to ask their questions. Moreover, the written training content was handed to the patients of this group to review whenever they wanted.
Second...
Abstract: Objective: This article critically examines the study "Comparing the effects of mHealth application based on micro-Learning method and face-to-face training on treatment adherence and perception in haemodialysis patients: A randomised clinical trial" by Mohsen Torabi Khah, Zahra Farsi, and Seyedeh Azam Sajadi. Summary of the argument: There are two concerns that the intervention effect may be overestimated and one that the intervention effect may be underestimated. Conclusion: While the study indicates innovative use of mHealth applications in enhancing treatment adherence, it also highlights potential biases that may have resulted in an overestimation and an underestimation of the intervention's effect.
Show MoreFull References: Torabi Khah M, Farsi Z, Sajadi SA. Comparing the effects of mHealth application based on micro-learning method and face-to-face training on treatment adherence and perception in haemodialysis patients: A randomised clinical trial. BMJ Open 2023;13:e071982. doi:10.1136/bmjopen-2023-071982
Authors’ Contributions: The author of this communication article critically analysed the referenced study and authored the article.
Funding Statement: This research did not receive any specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Competing Interests Statement: The author declares no competing interests.
We read the article by Torabi Khah et al. with great interest and app...
Martin JC van Gemert,*1 Marianne Vlaming,2 Peter J van Koppen,3 Aeilco H Zwinderman,4 HA Martino Neumann5
1Department of Biomedical Engineering & Physics, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Amsterdam, The Netherlands
2Private Practice, Criminal Psychology and Law, Doetinchem, The Netherlands
3Department of Criminal Law and Criminology, Faculty of Law, VU University Amsterdam, The Netherland
4Department of Clinical Epidemiology & Bio-Statistics, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Amsterdam, The Netherlands
5ZBC-Multicare, Hilversum-The Netherlands
Van Rijn et al1 described the implementation and first output data of the Dutch expertise centre for child abuse (LECK: Landelijk Expertise Centrum Kindermishandeling). LECK's methodology aims to be easily accessible for giving anonymous advice when health care professionals suspect potential cases of physical child abuse.1 LECK physicians do not see the patient nor talk to the parents and are neither involved in further treatment or follow-up. LECK works with Bayes' statistics,2,3 and uses likelihood ratios, part of Bayes' theorem, in their conclusions.1
Bayes' theorem, named after the 18th century English statistician, philosopher and Presbyterian minister Thomas Bayes,2,3 updates the relative probability of an hypothesis (here, physical child abuse caused the symptoms),...
Show MoreLetter to the Editor BMJ Open
Persistent systemic neo-colonialism in academic publication
The recent publication of the paper, Clinical emergency care quality indicators in Africa: a scoping review and data summary(1) has triggered much discussion within our network of emergency care academics and clinicians from various countries across Africa.
The subject matter explored in the publication is crucial, and we would congratulate the authors on tackling this issue. We agree that in many settings of nascent African emergency care systems, it is key to build quality indicators and to use them to improve and measure emergency care. Yet, for a paper that concludes that more needs to be done to improve published work on quality indicators in African emergency care, not including any authors living and working within African emergency care, is a significant oversight.
The problem of excluding African voices
Show MoreAnalysing the African emergency care health system from outside Africa is problematic. Africa is not a country, and we find the approach to dealing with Africa as one unit troubling. Although the authors rightly point out that emergency care systems and resources are at profoundly different ends of the spectrum in different settings within the continent, they chose to perform their search looking for evidence from Africa.(1) Much research done within African settings is done without collaboration or active engagement with the African emergenc...
Telemonitoring is an emerging field which uses information technologies to transmit information on patient’s health to the selected healthcare facility. We have read the article by Gijsbers et al al with great interest [1] In addition to these arguments, we would like to express some vital issues regarding the viability of telemonitoring in enhancing triabl health. The effectiveness of telemonitoring in managing health issues was tested in a small number (and very few among tribals) of randomized control trials because it is a new field. These trials found that telemonitoring is beneficial in controlling chronic illness conditions. Telemonitoring has the potential to help with the management of chronic illnesses like hypertension since it enables continuous monitoring of vital signs, which lowers the number of trips to medical facilities [2].
Show MoreTASHMINH-4 trial study proved to be a milestone in establishing the effectiveness in the management of Telemonitoring in chronic condition like hypertension. The study done by Richard McManus and colleagues, shows that self-monitoring of blood pressure with Telemonitoring used by general practitioner in poorly controlled individuals has significantly help in improving control over the blood pressure. This study emphasize that self-monitoring of blood pressure by individual helps in better control over of high blood pressure [3][4].
Telemonitoring provides a platform which makes healthcare services accessible through home...
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