The article says, "The majority of current restaurant meals consumed by American adults—70% of meals consumed from fast-food restaurants and 50% consumed from full-service restaurants—are of poor nutritional quality, and the remainder are only of intermediate nutritional quality, with very few being ideal."
That being the case, perhaps government policy ought to focus on food quality rather than menu calorie labelling. That would have to start back on the farm. Norwegian animal science researchers suggest this approach. In a 2011 article entitled 'Animal products, diseases and drugs: a plea for better integration between agricultural sciences, human nutrition and human pharmacology' the authors wrote, "It is shown how an unnaturally high omega-6/omega-3 fatty acid concentration ratio in meat, offal and eggs (because the omega-6/omega-3 ratio of the animal diet is unnaturally high) directly leads to exacerbation of pain conditions, cardiovascular disease and probably most cancers. It should be technologically easy and fairly inexpensive to produce poultry and pork meat with much more long-chain omega-3 fatty acids and less arachidonic acid than now, at the same time as they could also have a similar selenium concentration as is common in marine fish. The health economic benefits of such products for society as a whole must be expected vastly to outweigh the direct costs for the farming sector."[1]
The article says, "The majority of current restaurant meals consumed by American adults—70% of meals consumed from fast-food restaurants and 50% consumed from full-service restaurants—are of poor nutritional quality, and the remainder are only of intermediate nutritional quality, with very few being ideal."
That being the case, perhaps government policy ought to focus on food quality rather than menu calorie labelling. That would have to start back on the farm. Norwegian animal science researchers suggest this approach. In a 2011 article entitled 'Animal products, diseases and drugs: a plea for better integration between agricultural sciences, human nutrition and human pharmacology' the authors wrote, "It is shown how an unnaturally high omega-6/omega-3 fatty acid concentration ratio in meat, offal and eggs (because the omega-6/omega-3 ratio of the animal diet is unnaturally high) directly leads to exacerbation of pain conditions, cardiovascular disease and probably most cancers. It should be technologically easy and fairly inexpensive to produce poultry and pork meat with much more long-chain omega-3 fatty acids and less arachidonic acid than now, at the same time as they could also have a similar selenium concentration as is common in marine fish. The health economic benefits of such products for society as a whole must be expected vastly to outweigh the direct costs for the farming sector."[1]
Problem is, policy makers and their advisors seem to be unaware of the omega-6/omega-3 fatty acid aspect of food quality. Here is why that aspect is important. "The ω-6 series of fatty acids, which includes arachidonic acid (ARA, C20:4) and its precursor linoleic acid (LA), constitute a growing part of the lipid intake in western diets for the last 40 years. The first cause of this trend is the higher consumption of animal products. White meat especially provides the highest quantities of dietary ARA."[2]
In a 2020 BMJ article entitled 'What role should the commercial food system play in promoting health through better diet?' the authors said, A number of aspects of nutritionally poor processed foods, especially ultra-processed foods, are unhealthy (eg, excess salt or sugar). The mechanisms that lead to associations between processed foods and poor health remain largely unknown. Processed foods have some advantages—for example, their longer shelf life and convenience—and they may not inherently need to be unhealthy. Nevertheless, how to achieve healthier processed foods remains unclear.[3]
Clearly, food policy experts haven't figured out where the hurt is coming from. Canadian animal science researchers offer this insight. "Pork is the most widely eaten meat in the world, but typical feeding practices give it a high omega-6 (n-6) to omega-3 (n-3) fatty acid ratio and make it a poor source of n-3 fatty acids."[4]
In the United States animal science researchers are also trying to rebalance the omega-6/3 fatty acid profile of animal products. "With the incidence of obesity, heart disease and insulin resistance increasing toward epidemic proportions in the United States, people must make changes to improve their health," said Kevin Harvatine, associate professor of nutritional physiology in the Department of Animal Science. "Production of nutritionally enriched eggs and poultry meat will help consumers meet health goals and help egg and poultry producers to increase the value of their products."[5]
It took longer for grain-fed animal products to enter Siberia. Comment by Siberian Federal University researcher. “The dietary value of the Yakutian horse meat is very high precisely due to the ideal balance of polyunsaturated omega-3 and omega-6 acids,” Makhutova explains. “The 1:1 ratio of these acids is ideal for us, but civilization is steadily shifting the balance towards the predominance of omega-6 due to the dominance of vegetable oils, cheap pork and fast food in our daily diet. We also need omega-6 acids, but in combination with the omega-3 partners, which are found mainly in fatty fish. The horse meat we tested is also very good, especially for child nutrition and the diet of people suffering from cardiovascular diseases. If the population of Yakutia starts consuming mass-market products, which are now imported abundantly into the republic, and makes a choice in favor of, let us say, semi-finished pork products, this may drastically affect people’s health. This is just the case when you should not change a time-tested balanced diet.”[6]
In a 1996 Introduction to a symposium on arachidonic acid the authors noted that "Excessive signaling of AA metabolites has been associated with various chronic degenerative or autoimmune diseases, and intervention with the metabolism of AA is widely employed therapeutically in these afflictions. In essence, AA is the most biologically active unsaturated fatty acid in higher animals. Its concentration in membranes and its magnitude of effects depend on its amount, or that of its precursors and analogues, in the diet. The tendency of the field of nutrition to ignore the role of dietary AA will optimistically be reversed in the future."[7]
27 years have elapsed and the field of nutrition continues to ignore the most biologically active unsaturated fatty acid in higher animals. [
Per April 12th 2023, the sample size of the protocol was changed from 84 to 74 participants.
In the original design of the study, sample size was calculated using the following parameters: power 80%, anticipated effect difference 25%, alpha 5%. Sample size was calculated at 32 per group (allocation 1:1). Loss to follow-up was anticipated at 10 participants per group, leading to a sample size of 84 participants.
However, with 57 patients included and 21 patients who have completed follow-up, the researchers see no loss to follow-up. Therefore, the anticipated loss of follow-up of 10 per arm may be more than necessary.
A protocol amendement, anticipating 5 patients loss-to-follow-up per arm, has been proposed to the medical ethics committee, which has approved this change in protocol.
Thank you for this article on PMS - an important public health topic. There is an important typo in the introduction. The article states "Globally, 90% women of reproductive age experience severe premenstrual symptoms" (cited to Chumpalova doi: 10.1186/s12991-019-0255-1). The word 'severe' should be 'several' - an important definition for readers >>> "Globally, 90% of women of reproductive age experience several premenstrual symptoms".
BMJ Open thanks Dr Kilian and colleagues for their rapid response entitled "Serious flaws in article". The authors of the paper have been contacted and have been asked to provide their response.
Cerquera Jaramillo et al. conducted a cross-sectional study to evaluate the risk of primary open-angle glaucoma (POAG) in patients with obstructive sleep apnoea (OSA) (1). There was no dose-response relationship by measuring optic nerve information and the severity of OSA, although OSA contributed to the increased risk of POAG. I recently made comments regarding the increased risk of POAG in patients with OSA by considering the mechanism of association (2). There is a space of summing-up information for preventing POAG, and the understanding of pathophysiology regarding the comorbidity may contribute to new therapeutic approach for POAG (3).
References
1. Cerquera Jaramillo MA, Moreno Mazo SE, Toquica Osorio JE. Primary open-angle glaucoma in patients with obstructive sleep apnoea in a Colombian population: a cross-sectional study. BMJ Open 2023;13(2):e063506.
2. Kawada T. Obstructive sleep apnea and open-angle glaucoma. J Clin Sleep Med 2023 Feb 7. doi: 10.5664/jcsm.10494 [Epub ahead of print]
3. Goyal M, Tiwari US, Jaseja H. Pathophysiology of the comorbidity of glaucoma with obstructive sleep apnea: A postulation. Eur J Ophthalmol 2021;31(5):2776-2780.
I was greatly interested in the article by Peter Chai et al. 1 Additional considerations can be made with regard to STI prevention strategies. Condoms have allowed a massive reduction in the risks of STI, including HIV. In the West, HIV is no longer frightening; due to the advent of antiretroviral drugs, it has changed from a fatal disease to a chronic disease. This paradigm shift has led to a modification of sexual behavior and to the trivialization of condoms. Thus, new strategies are being developed (i.e., PrEP). 2 However, HIV remains a preventable STI in the same manner as gonorrhea, viral hepatitis, syphilis or emergent STI, and these STIs are on the rise with increased costs, antibiotic use and drug resistance. Although the data on PrEP are encouraging (few seroconversions), they are recent, and we do not have sufficient information available to include compliance as a factor limiting these results.3 Moreover, PrEP cannot compete with condoms. 4 All of these elements belong to an evolving sociocultural model, and it is essential to emphasize sexual responsibility (safer sex) to optimize STI prevention strategies.
References
1. Peter Chai, Dikkha De, Hannah Albrechta, Georgia R Goodman, Koki Takabatake, Amy Ben-Arieh, Jasper S Lee, Tiffany R Glynn, Kenneth Mayer, Conall O’Cleirigh, Celia Fisher. Attitudes towards participating in research involving digital pill systems to measure oral HIV pre-exposure chemoprophylaxis: a cross-sectional study among men wh...
I was greatly interested in the article by Peter Chai et al. 1 Additional considerations can be made with regard to STI prevention strategies. Condoms have allowed a massive reduction in the risks of STI, including HIV. In the West, HIV is no longer frightening; due to the advent of antiretroviral drugs, it has changed from a fatal disease to a chronic disease. This paradigm shift has led to a modification of sexual behavior and to the trivialization of condoms. Thus, new strategies are being developed (i.e., PrEP). 2 However, HIV remains a preventable STI in the same manner as gonorrhea, viral hepatitis, syphilis or emergent STI, and these STIs are on the rise with increased costs, antibiotic use and drug resistance. Although the data on PrEP are encouraging (few seroconversions), they are recent, and we do not have sufficient information available to include compliance as a factor limiting these results.3 Moreover, PrEP cannot compete with condoms. 4 All of these elements belong to an evolving sociocultural model, and it is essential to emphasize sexual responsibility (safer sex) to optimize STI prevention strategies.
References
1. Peter Chai, Dikkha De, Hannah Albrechta, Georgia R Goodman, Koki Takabatake, Amy Ben-Arieh, Jasper S Lee, Tiffany R Glynn, Kenneth Mayer, Conall O’Cleirigh, Celia Fisher. Attitudes towards participating in research involving digital pill systems to measure oral HIV pre-exposure chemoprophylaxis: a cross-sectional study among men who have sex with men with substance use. BMJ Open. 2023 Jan 30;13(1):e067549. doi: 10.1136/bmjopen-2022-067549
2. Guillemette Antoni et al. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV. 2020 Feb;7(2):e113-e120.
3. Jeanne M Marrazzo et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015 Feb 5;372(6):509-18.
4. Molina et al. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46.
Firstly, in this response to the earlier comments of Deborah L. Lokken and Beverley H. Johnson of February 24, 2023, we agree that patient participation in patient safety is of huge importance. Sorry that we may be gave you the wrong impression and we would like to apologize for this. We see it as a positive development towards a true partnership in healthcare between patient and professional, however, there can be also concerns or risks if patients participate. We therefore also need the negative effects of patient participation in patient safety to take the next step in the development of patient participation.
To take the next step in the contribution of patients and their families to patient safety, it is important to examine the full context and see which ‘gaps’ need to be addressed. Even if focusing only on negative effects could lead to a bias, identifying these gaps will us learn which ones there are and therefore also what we need to work on in order to make that positive contribution of patients in patient safety. For that reason, we have also indicated as a recommendation from this study that it is necessary to find the measures that need to be taken to either prevent these negative effects or address them ad hoc as soon as they occur.
We can understand that the authors have some questions about the initiatives mentioned or about the small sample size. We have included the small sample size as a limitation. However, as also described in our publi...
Firstly, in this response to the earlier comments of Deborah L. Lokken and Beverley H. Johnson of February 24, 2023, we agree that patient participation in patient safety is of huge importance. Sorry that we may be gave you the wrong impression and we would like to apologize for this. We see it as a positive development towards a true partnership in healthcare between patient and professional, however, there can be also concerns or risks if patients participate. We therefore also need the negative effects of patient participation in patient safety to take the next step in the development of patient participation.
To take the next step in the contribution of patients and their families to patient safety, it is important to examine the full context and see which ‘gaps’ need to be addressed. Even if focusing only on negative effects could lead to a bias, identifying these gaps will us learn which ones there are and therefore also what we need to work on in order to make that positive contribution of patients in patient safety. For that reason, we have also indicated as a recommendation from this study that it is necessary to find the measures that need to be taken to either prevent these negative effects or address them ad hoc as soon as they occur.
We can understand that the authors have some questions about the initiatives mentioned or about the small sample size. We have included the small sample size as a limitation. However, as also described in our published article, we only reached these conclusion by reaching saturation. The examples of initiatives cited in the research such as the participation in medication safety that you are refer to, are not new initiatives but rather demonstrated initiatives of patient participation in patient safety within an Obstetrics department. In this study, it was decided to offer a new insight based on the respondents from the professional- and patient side. We recognize that in the future it may be interesting to also include the families of pregnant woman in the study, to see and investigate what findings emerge.
Axel Skafte-Holm 1, Thomas Roland Pedersen 1 and Jørgen Skov Jensen 1*
1 Department of Bacteria, Parasites and Fungi, Research Unit for Reproductive Microbiology, Statens Serum Institut, Copenhagen, Denmark
*Corresponding author
Jørgen Skov Jensen
Consultant physician, MD, PhD, DMedSci.
Statens Serum Institute
5 Artillerivej
DK-2300 Copenhagen S
Denmark
Research Unit for Reproductive Microbiology.
Division of Diagnostic Infectious Disease Preparedness
Telephone +45 3268 3636 jsj@ssi.dk
To the Editor,
We read with interest the systematic review and meta-analysis by Jonduo et al. [1], investigating the association between Mycoplasma (M.) hominis, Ureaplasma (U.) urealyticum and U. parvum colonisation of the genital tract of pregnant women and adverse pregnancy outcomes. This is a highly relevant analysis, as this subject is a matter of ongoing debate, due to the complex interactions with other microbial and non-microbial factors. It is also a subject where enormous taxonomic confusion exists due to the re-classification of the ureaplasmas. We were, consequently, interested in the comprehensive analysis on the relative importance of the two Ureaplasma spp. Unfortunately, we detected some shortcomings, which need to be discussed.
(I) Culture-based studies. The review excluded articles published before the year 2000 if unspeciated U. urealyticum were re...
Axel Skafte-Holm 1, Thomas Roland Pedersen 1 and Jørgen Skov Jensen 1*
1 Department of Bacteria, Parasites and Fungi, Research Unit for Reproductive Microbiology, Statens Serum Institut, Copenhagen, Denmark
*Corresponding author
Jørgen Skov Jensen
Consultant physician, MD, PhD, DMedSci.
Statens Serum Institute
5 Artillerivej
DK-2300 Copenhagen S
Denmark
Research Unit for Reproductive Microbiology.
Division of Diagnostic Infectious Disease Preparedness
Telephone +45 3268 3636 jsj@ssi.dk
To the Editor,
We read with interest the systematic review and meta-analysis by Jonduo et al. [1], investigating the association between Mycoplasma (M.) hominis, Ureaplasma (U.) urealyticum and U. parvum colonisation of the genital tract of pregnant women and adverse pregnancy outcomes. This is a highly relevant analysis, as this subject is a matter of ongoing debate, due to the complex interactions with other microbial and non-microbial factors. It is also a subject where enormous taxonomic confusion exists due to the re-classification of the ureaplasmas. We were, consequently, interested in the comprehensive analysis on the relative importance of the two Ureaplasma spp. Unfortunately, we detected some shortcomings, which need to be discussed.
(I) Culture-based studies. The review excluded articles published before the year 2000 if unspeciated U. urealyticum were reported alone, as Ureaplasma spp. detected by culture previously were reported as U. urealyticum. In this matter, it is surprising that seven of the included articles [2-8] on U. urealyticum were culture-based. Although bacteriological culture is considered the gold standard it only identifies bacteria at the genus level, preventing differentiation between U. urealyticum (formerly biovar 2, T980, T960T or A) and U. parvum (formerly biovar 1, parvo or B). In the review, all results from culture-based articles were reported as U. urealyticum, probably because primary authors wrongly reported cultured ureaplasmas as U. urealyticum. Unless additional typing of isolates is performed, cultures should always be reported as Ureaplasma spp.
(II) Confusion on nomenclature. Harada et al. determined the biovar of colonies using PCR-based typing where they reported all U. urealyticum (i.e. Ureaplasma spp.) colonies as biovar type 1 i.e. U. parvum among 23 women experiencing preterm birth, but the systematic review reported findings as U. urealyticum [9]. Two other articles [10, 11] reported on biovar 1 and biovar 2, but were cited only as U. urealyticum and the review failed to include these results in the U. parvum analysis.
(III) Shortcomings in methodology. Most articles were based on real-time PCR and two articles [12, 13] used multiplex PCR to identify sexually transmitted infections. Some articles used conventional PCR, but one [14] failed to report information on PCR method and consequently evaluation of the species differentiation was not possible. In order to evaluate primers and probes in the studies included in the meta-analysis, we aligned sequences and queried them using the Basic Local Alignment Search Tool (BLAST) [15] against U. urealyticum serovar 8 (NCBI Reference Sequence: NZ_AAYN02000002.1) and U. parvum serovar 3 (NCBI Reference Sequence: NC_002162.1). Most studies correctly distinguished ureaplasmas at the species level. Unfortunately, we found methodological shortcomings in one paper [16], as primer/probe design did not allow discrimination of Ureaplasma spp. Two studies [17, 18] reported U. urealyticum, but alignment results indicated that the primers were 100% specific for U. parvum and contained several mismatches with the U. urealyticum sequence, thus, at best detecting Ureaplasma spp.
In general, Mollicutes are complicated pathogens and our assessment of the literature demonstrates a laissez-faire approach to nomenclature and methods applied. The diagnostic methodologies applied should be carefully evaluated when assessing studies to allow conclusions about the relation between Ureaplasma spp. and clinical outcomes. The taxonomic and methodological confusion in the literature is concerning, so an in-depth analysis of the area is warranted and we suggest that the review authors update their analysis of associations between the two Ureaplasma spp. and adverse pregnancy outcomes. The review conclusions may not change because the majority of the studies suffered from lack of control for major confounding factors, but at least the combined effect estimates will be more correct.
References
1. Jonduo ME, Vallely LM, Wand H, Sweeney EL, Egli-Gany D, Kaldor J, et al. Adverse pregnancy and birth outcomes associated with Mycoplasma hominis, Ureaplasma urealyticum and Ureaplasma parvum: a systematic review and meta-analysis. BMJ Open. 2022;12(8):e062990. DOI: 10.1136/bmjopen-2022-062990.
2. 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. DOI: 10.3349/ymj.2016.57.5.1271.
3. 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. DOI: 10.1111/j.1471-0528.2009.02364.x.
4. 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. DOI: 10.1515/jpm.2002.072.
5. 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. DOI: 10.3109/14767058.2013.818124.
6. 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. DOI: 10.1086/424505.
7. 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. DOI.
8. Kacerovský M, Pavlovský M, Tosner J. Preterm premature rupture of the membranes and genital mycoplasmas. Acta Medica (Hradec Kralove). 2009;52(3):117-20. DOI: 10.14712/18059694.2016.115.
9. 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. DOI: 10.1111/j.1348-0421.2008.00039.x.
10. 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. DOI: 10.1111/j.1447-0756.2005.00246.x.
11. 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. DOI: 10.1007/pl00011237.
12. Koucký M, Malíčková K, Cindrová-Davies T, Smíšek J, Vráblíková H, Černý A, et al. Prolonged progesterone administration is associated with less frequent cervicovaginal colonization by Ureaplasma urealyticum during pregnancy - Results of a pilot study. J Reprod Immunol. 2016;116:35-41. DOI: 10.1016/j.jri.2016.04.285.
13. Peretz A, Tameri O, Azrad M, Barak S, Perlitz Y, Dahoud WA, et al. Mycoplasma and Ureaplasma carriage in pregnant women: the prevalence of transmission from mother to newborn. BMC Pregnancy Childbirth. 2020;20(1):456. DOI: 10.1186/s12884-020-03147-9.
14. Schwab FD, Zettler EK, Moh A, Schötzau A, Gross U, Günthert AR. Predictive factors for preterm delivery under rural conditions in post-tsunami Banda Aceh. J Perinat Med. 2016;44(5):511-5. DOI: 10.1515/jpm-2015-0004.
15. Zhang Z, Schwartz S, Wagner L, Miller W. A greedy algorithm for aligning DNA sequences. J Comput Biol. 2000;7(1-2):203-14. DOI: 10.1089/10665270050081478.
16. Aaltone R, Jalava J, Laurikainen E, Kärkkäinen 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. DOI: 10.1080/00365540110077074.
17. Montenegro DA, Borda LF, Neuta Y, Gómez 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. DOI: 10.1111/jicd.12396.
18. 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. DOI.
We would like to thank the previous respondent (27.01.23) for their careful reading of our paper and for sharing their thoughts. Having considered it, the response assumes that our study included a manipulation check which was based on the emotion variable. However, this was not the case. We are not trying to manipulate how uncertain the participants actually feel – we expect them to feel uncertain after receiving conflicting information regardless of whether or not uncertainty is expressed in the vaccine announcement. The point of the paper is that when governments fail to express the uncertainty that people end up encountering, this reduces trust in them. How uncertain participants feel is therefore not a manipulation check as it is not conceptually linked to our manipulation, i.e. uncertainty expressed by the government. If we had wanted to include a manipulation check, it would have been about the perception that the government official is certain about the effectiveness of the vaccine.
Having said that, the question of experienced uncertainty is still an interesting research question. Although there was some evidence that the manipulation did affect the dynamics of uncertainty (i.e., there was a significantly larger increase in uncertainty in the “certain” than in the “uncertain” condition; F(1,326)=9.27, p=0.003)), this is not required for our conceptual model. Even if we were to use the uncertain emotion variable as a manipulation check, it would not be appr...
We would like to thank the previous respondent (27.01.23) for their careful reading of our paper and for sharing their thoughts. Having considered it, the response assumes that our study included a manipulation check which was based on the emotion variable. However, this was not the case. We are not trying to manipulate how uncertain the participants actually feel – we expect them to feel uncertain after receiving conflicting information regardless of whether or not uncertainty is expressed in the vaccine announcement. The point of the paper is that when governments fail to express the uncertainty that people end up encountering, this reduces trust in them. How uncertain participants feel is therefore not a manipulation check as it is not conceptually linked to our manipulation, i.e. uncertainty expressed by the government. If we had wanted to include a manipulation check, it would have been about the perception that the government official is certain about the effectiveness of the vaccine.
Having said that, the question of experienced uncertainty is still an interesting research question. Although there was some evidence that the manipulation did affect the dynamics of uncertainty (i.e., there was a significantly larger increase in uncertainty in the “certain” than in the “uncertain” condition; F(1,326)=9.27, p=0.003)), this is not required for our conceptual model. Even if we were to use the uncertain emotion variable as a manipulation check, it would not be appropriate to use it as an independent variable in a mediator model in a setting where it is influenced by numerous exogenous factors. We do not expect that an experimental manipulation of this nature would have a large effect on a variable like vaccine uncertainty, that has so many social determinants outside of the experimental setting. It makes sense that those who feel more uncertain about getting the vaccine are going to have lower intentions to get it, which is precisely why some public health communicators avoid expressing uncertainty. Our point here is that when communicators express uncertainty, rather than exacerbating the public’s uncertainty, this helps to protect them against a loss of trust if problems surface later and maintains vaccine intentions in the longer term.
Although we do not agree that the uncertainty emotion data are problematic for the interpretation of the paper, we thank the respondent for raising this interesting question about how the manipulation affects experienced uncertainty.
For more than 30 years, our organization, the Institute for Patient- and Family-Centered Care (IPFCC) has been a leader in helping other organizations develop and sustain effective partnerships with patients and families to improve the quality, safety, and the experience of care. During that same time, the patient safety movement has affirmed the important roles of patients and their families in safety.
We are concerned about the recent BMJ Open article, “Explaining the negative effects of patient participation in patient safety,” and the very different message it conveys. Our concerns center on the authors’ misunderstanding of what true partnership means in health care and the inherent bias in the structure of the research. Additionally, there was no patient or partner involvement in the “design, conducting, reporting, or dissemination plans of the research.”
The questions in the “topic guide” were leading and reflected bias; therefore, they could only elicit negative views from respondents. The sample size of 8 professionals and 8 patients is small in establishing such strong conclusions.
A patient in labor having the responsibility for checking the accuracy of medications was not an appropriate example of patient participation in safety nor of an understanding of partnership. Authentic partnership would entail a discussion about patient safety as a team responsibility and a determination from the patient on how she wishes to participate on that...
For more than 30 years, our organization, the Institute for Patient- and Family-Centered Care (IPFCC) has been a leader in helping other organizations develop and sustain effective partnerships with patients and families to improve the quality, safety, and the experience of care. During that same time, the patient safety movement has affirmed the important roles of patients and their families in safety.
We are concerned about the recent BMJ Open article, “Explaining the negative effects of patient participation in patient safety,” and the very different message it conveys. Our concerns center on the authors’ misunderstanding of what true partnership means in health care and the inherent bias in the structure of the research. Additionally, there was no patient or partner involvement in the “design, conducting, reporting, or dissemination plans of the research.”
The questions in the “topic guide” were leading and reflected bias; therefore, they could only elicit negative views from respondents. The sample size of 8 professionals and 8 patients is small in establishing such strong conclusions.
A patient in labor having the responsibility for checking the accuracy of medications was not an appropriate example of patient participation in safety nor of an understanding of partnership. Authentic partnership would entail a discussion about patient safety as a team responsibility and a determination from the patient on how she wishes to participate on that team. Further, the article made no mention of care partners/family members and their important, additional, role in patient safety.
Over the years, the BMJ has published many articles that have furthered the understanding of and commitment to sound patient safety practices and partnerships with patients and families. Many readers remember the 9/18/99 theme issue, “Embracing Patient Partnership,” and its dramatic cover of the tango dancers. Unfortunately, this current article seems like an anomaly.
The article says, "The majority of current restaurant meals consumed by American adults—70% of meals consumed from fast-food restaurants and 50% consumed from full-service restaurants—are of poor nutritional quality, and the remainder are only of intermediate nutritional quality, with very few being ideal."
That being the case, perhaps government policy ought to focus on food quality rather than menu calorie labelling. That would have to start back on the farm. Norwegian animal science researchers suggest this approach. In a 2011 article entitled 'Animal products, diseases and drugs: a plea for better integration between agricultural sciences, human nutrition and human pharmacology' the authors wrote, "It is shown how an unnaturally high omega-6/omega-3 fatty acid concentration ratio in meat, offal and eggs (because the omega-6/omega-3 ratio of the animal diet is unnaturally high) directly leads to exacerbation of pain conditions, cardiovascular disease and probably most cancers. It should be technologically easy and fairly inexpensive to produce poultry and pork meat with much more long-chain omega-3 fatty acids and less arachidonic acid than now, at the same time as they could also have a similar selenium concentration as is common in marine fish. The health economic benefits of such products for society as a whole must be expected vastly to outweigh the direct costs for the farming sector."[1]
Problem is, policy makers and the...
Show MorePer April 12th 2023, the sample size of the protocol was changed from 84 to 74 participants.
In the original design of the study, sample size was calculated using the following parameters: power 80%, anticipated effect difference 25%, alpha 5%. Sample size was calculated at 32 per group (allocation 1:1). Loss to follow-up was anticipated at 10 participants per group, leading to a sample size of 84 participants.
However, with 57 patients included and 21 patients who have completed follow-up, the researchers see no loss to follow-up. Therefore, the anticipated loss of follow-up of 10 per arm may be more than necessary.
A protocol amendement, anticipating 5 patients loss-to-follow-up per arm, has been proposed to the medical ethics committee, which has approved this change in protocol.
Thank you for this article on PMS - an important public health topic. There is an important typo in the introduction. The article states "Globally, 90% women of reproductive age experience severe premenstrual symptoms" (cited to Chumpalova doi: 10.1186/s12991-019-0255-1). The word 'severe' should be 'several' - an important definition for readers >>> "Globally, 90% of women of reproductive age experience several premenstrual symptoms".
BMJ Open thanks Dr Kilian and colleagues for their rapid response entitled "Serious flaws in article". The authors of the paper have been contacted and have been asked to provide their response.
Cerquera Jaramillo et al. conducted a cross-sectional study to evaluate the risk of primary open-angle glaucoma (POAG) in patients with obstructive sleep apnoea (OSA) (1). There was no dose-response relationship by measuring optic nerve information and the severity of OSA, although OSA contributed to the increased risk of POAG. I recently made comments regarding the increased risk of POAG in patients with OSA by considering the mechanism of association (2). There is a space of summing-up information for preventing POAG, and the understanding of pathophysiology regarding the comorbidity may contribute to new therapeutic approach for POAG (3).
References
1. Cerquera Jaramillo MA, Moreno Mazo SE, Toquica Osorio JE. Primary open-angle glaucoma in patients with obstructive sleep apnoea in a Colombian population: a cross-sectional study. BMJ Open 2023;13(2):e063506.
2. Kawada T. Obstructive sleep apnea and open-angle glaucoma. J Clin Sleep Med 2023 Feb 7. doi: 10.5664/jcsm.10494 [Epub ahead of print]
3. Goyal M, Tiwari US, Jaseja H. Pathophysiology of the comorbidity of glaucoma with obstructive sleep apnea: A postulation. Eur J Ophthalmol 2021;31(5):2776-2780.
I was greatly interested in the article by Peter Chai et al. 1 Additional considerations can be made with regard to STI prevention strategies. Condoms have allowed a massive reduction in the risks of STI, including HIV. In the West, HIV is no longer frightening; due to the advent of antiretroviral drugs, it has changed from a fatal disease to a chronic disease. This paradigm shift has led to a modification of sexual behavior and to the trivialization of condoms. Thus, new strategies are being developed (i.e., PrEP). 2 However, HIV remains a preventable STI in the same manner as gonorrhea, viral hepatitis, syphilis or emergent STI, and these STIs are on the rise with increased costs, antibiotic use and drug resistance. Although the data on PrEP are encouraging (few seroconversions), they are recent, and we do not have sufficient information available to include compliance as a factor limiting these results.3 Moreover, PrEP cannot compete with condoms. 4 All of these elements belong to an evolving sociocultural model, and it is essential to emphasize sexual responsibility (safer sex) to optimize STI prevention strategies.
Show MoreReferences
1. Peter Chai, Dikkha De, Hannah Albrechta, Georgia R Goodman, Koki Takabatake, Amy Ben-Arieh, Jasper S Lee, Tiffany R Glynn, Kenneth Mayer, Conall O’Cleirigh, Celia Fisher. Attitudes towards participating in research involving digital pill systems to measure oral HIV pre-exposure chemoprophylaxis: a cross-sectional study among men wh...
Firstly, in this response to the earlier comments of Deborah L. Lokken and Beverley H. Johnson of February 24, 2023, we agree that patient participation in patient safety is of huge importance. Sorry that we may be gave you the wrong impression and we would like to apologize for this. We see it as a positive development towards a true partnership in healthcare between patient and professional, however, there can be also concerns or risks if patients participate. We therefore also need the negative effects of patient participation in patient safety to take the next step in the development of patient participation.
To take the next step in the contribution of patients and their families to patient safety, it is important to examine the full context and see which ‘gaps’ need to be addressed. Even if focusing only on negative effects could lead to a bias, identifying these gaps will us learn which ones there are and therefore also what we need to work on in order to make that positive contribution of patients in patient safety. For that reason, we have also indicated as a recommendation from this study that it is necessary to find the measures that need to be taken to either prevent these negative effects or address them ad hoc as soon as they occur.
We can understand that the authors have some questions about the initiatives mentioned or about the small sample size. We have included the small sample size as a limitation. However, as also described in our publi...
Show MoreAxel Skafte-Holm 1, Thomas Roland Pedersen 1 and Jørgen Skov Jensen 1*
1 Department of Bacteria, Parasites and Fungi, Research Unit for Reproductive Microbiology, Statens Serum Institut, Copenhagen, Denmark
*Corresponding author
Jørgen Skov Jensen
Consultant physician, MD, PhD, DMedSci.
Statens Serum Institute
5 Artillerivej
DK-2300 Copenhagen S
Denmark
Research Unit for Reproductive Microbiology.
Division of Diagnostic Infectious Disease Preparedness
Telephone +45 3268 3636
jsj@ssi.dk
To the Editor,
We read with interest the systematic review and meta-analysis by Jonduo et al. [1], investigating the association between Mycoplasma (M.) hominis, Ureaplasma (U.) urealyticum and U. parvum colonisation of the genital tract of pregnant women and adverse pregnancy outcomes. This is a highly relevant analysis, as this subject is a matter of ongoing debate, due to the complex interactions with other microbial and non-microbial factors. It is also a subject where enormous taxonomic confusion exists due to the re-classification of the ureaplasmas. We were, consequently, interested in the comprehensive analysis on the relative importance of the two Ureaplasma spp. Unfortunately, we detected some shortcomings, which need to be discussed.
Show More(I) Culture-based studies. The review excluded articles published before the year 2000 if unspeciated U. urealyticum were re...
We would like to thank the previous respondent (27.01.23) for their careful reading of our paper and for sharing their thoughts. Having considered it, the response assumes that our study included a manipulation check which was based on the emotion variable. However, this was not the case. We are not trying to manipulate how uncertain the participants actually feel – we expect them to feel uncertain after receiving conflicting information regardless of whether or not uncertainty is expressed in the vaccine announcement. The point of the paper is that when governments fail to express the uncertainty that people end up encountering, this reduces trust in them. How uncertain participants feel is therefore not a manipulation check as it is not conceptually linked to our manipulation, i.e. uncertainty expressed by the government. If we had wanted to include a manipulation check, it would have been about the perception that the government official is certain about the effectiveness of the vaccine.
Having said that, the question of experienced uncertainty is still an interesting research question. Although there was some evidence that the manipulation did affect the dynamics of uncertainty (i.e., there was a significantly larger increase in uncertainty in the “certain” than in the “uncertain” condition; F(1,326)=9.27, p=0.003)), this is not required for our conceptual model. Even if we were to use the uncertain emotion variable as a manipulation check, it would not be appr...
Show MoreFor more than 30 years, our organization, the Institute for Patient- and Family-Centered Care (IPFCC) has been a leader in helping other organizations develop and sustain effective partnerships with patients and families to improve the quality, safety, and the experience of care. During that same time, the patient safety movement has affirmed the important roles of patients and their families in safety.
We are concerned about the recent BMJ Open article, “Explaining the negative effects of patient participation in patient safety,” and the very different message it conveys. Our concerns center on the authors’ misunderstanding of what true partnership means in health care and the inherent bias in the structure of the research. Additionally, there was no patient or partner involvement in the “design, conducting, reporting, or dissemination plans of the research.”
The questions in the “topic guide” were leading and reflected bias; therefore, they could only elicit negative views from respondents. The sample size of 8 professionals and 8 patients is small in establishing such strong conclusions.
A patient in labor having the responsibility for checking the accuracy of medications was not an appropriate example of patient participation in safety nor of an understanding of partnership. Authentic partnership would entail a discussion about patient safety as a team responsibility and a determination from the patient on how she wishes to participate on that...
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