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.
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.
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.
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.
To Prof Forrest and the authors of the Chaudhary et al paper(1): Thank you for your response to our review(2) in which you highlight that there was a significant reduction in alcohol-related liver disease (ALD) discharges following the introduction of minimum unit pricing (MUP) at your unit. This is an important point to highlight as a misrepresentation of the Chaudhary et al study in our review.
In our review, we reported the outcome measure of mean weekly ALD discharges before and after MUP for 'All hospital episodes' which did not reach pre-defined significance (6.2 versus 5.2; p = 0.123) in the Chaudhary et al study, however the outcomes for 'individual patients' and those 'actively drinking' did indeed reach pre-defined significance and should have been included in our review. These outcomes from the Chaudhary et al study would certainly be consistent with the overall conclusion of our review, adding further support to the impact of MUP reducing alcohol-related hospital burden as you have highlighted.
We would also like to correct the reference to your study in the main text of our review which should read “Chaudhary et al” and not “Ferguson et al” (found under ‘Results’, subheading ‘Natural experiments’).
References
1. Chaudhary S, MacKey W, Duncan K, Forrest EH. Changes in Hospital Discharges with Alcohol-Related Liver Disease in a Gastroenterology and General Medical Unit Following the...
To Prof Forrest and the authors of the Chaudhary et al paper(1): Thank you for your response to our review(2) in which you highlight that there was a significant reduction in alcohol-related liver disease (ALD) discharges following the introduction of minimum unit pricing (MUP) at your unit. This is an important point to highlight as a misrepresentation of the Chaudhary et al study in our review.
In our review, we reported the outcome measure of mean weekly ALD discharges before and after MUP for 'All hospital episodes' which did not reach pre-defined significance (6.2 versus 5.2; p = 0.123) in the Chaudhary et al study, however the outcomes for 'individual patients' and those 'actively drinking' did indeed reach pre-defined significance and should have been included in our review. These outcomes from the Chaudhary et al study would certainly be consistent with the overall conclusion of our review, adding further support to the impact of MUP reducing alcohol-related hospital burden as you have highlighted.
We would also like to correct the reference to your study in the main text of our review which should read “Chaudhary et al” and not “Ferguson et al” (found under ‘Results’, subheading ‘Natural experiments’).
References
1. Chaudhary S, MacKey W, Duncan K, Forrest EH. Changes in Hospital Discharges with Alcohol-Related Liver Disease in a Gastroenterology and General Medical Unit Following the Introduction of Minimum Unit Pricing of Alcohol: The GRI Q4 Study. Alcohol and Alcoholism 2022; 57(4): 477–482.
2. Maharaj T, Angus C, Fitzgerald N, et al. Impact of minimum unit pricing on alcohol-related hospital outcomes: systematic review. BMJ Open 2023; 13: e065220. doi: 10.1136/bmjopen-2022-065220
I'm a 68 year old male with parox AF so am very interested in ablation data. I applaud the authors for their work and look forward to the results. One sentence in this paper confused me---" The benefits of ablation may not be fully realised among elderly patients." I wasn't sure what they meant by that. Elderly patients may be unable to appreciate the benefits? There may not be any benefits in elderly patients? Something else?
Again, very good work, thanks to the authors.
Declan Fox
Family physician
Dear Editor,
The article by Yang et al. (2022) is fundamentally flawed due to a number of serious methodological shortcomings. These deficits are of such crucial relevance that it is in our view highly doubtful whether the conclusions the authors draw from their research are valid.
1) Data extraction is not transparent and sometimes false:
We were not able to replicate any of the values included in the main analysis of pain (Figure 4). In at least one study, values were extracted from the wrong group. In two further studies, the given values are incompatible with the values reported in the study. In at least three studies, sample sizes were falsely extracted.
Specifically:
Only in one of the included studies (Bishop et al., 2016) the values given in Figure 4 (Mean, SD) were found (Table 6, Bishop et al., 2016). However, the values of the control group were extracted from the false group (see below). For all other included studies, the values (Mean, SD) given in Figure 4 were not found. We were not able to find a description of how the authors may have transformed the values to explain the disagreement. In some studies, the given values in Figure 4 are not only not replicable but are incompatible with the values reported in the studies:
o In Bishop et al. (2016), values were extracted from the false group. Values were taken from standard care group but Yang et al. stated in Table 1 to have used the placebo acupuncture group as control g...
Dear Editor,
The article by Yang et al. (2022) is fundamentally flawed due to a number of serious methodological shortcomings. These deficits are of such crucial relevance that it is in our view highly doubtful whether the conclusions the authors draw from their research are valid.
1) Data extraction is not transparent and sometimes false:
We were not able to replicate any of the values included in the main analysis of pain (Figure 4). In at least one study, values were extracted from the wrong group. In two further studies, the given values are incompatible with the values reported in the study. In at least three studies, sample sizes were falsely extracted.
Specifically:
Only in one of the included studies (Bishop et al., 2016) the values given in Figure 4 (Mean, SD) were found (Table 6, Bishop et al., 2016). However, the values of the control group were extracted from the false group (see below). For all other included studies, the values (Mean, SD) given in Figure 4 were not found. We were not able to find a description of how the authors may have transformed the values to explain the disagreement. In some studies, the given values in Figure 4 are not only not replicable but are incompatible with the values reported in the studies:
o In Bishop et al. (2016), values were extracted from the false group. Values were taken from standard care group but Yang et al. stated in Table 1 to have used the placebo acupuncture group as control group. The placebo acupuncture group actually had better pain scores than the experimental group. This is the opposite effect of what is used in Figure 4.
o Elden et al. (2005) reported morning and evening pain values post treatment in three groups. For all three groups and both measures (morning, evening), Elden et al. (2005) reported different medians. However, in Figure 4, equal means are given for experimental and control group for Elden et al. (2008) (which is a follow-up publication of the same study as Elden et al., 2005; see below).
o Lund et al. (2006) compared deep and superficial acupuncture. They did not report mean values but concluded that, regarding pain levels, "according to our study, there is not enough evidence of different treatment effects between the two stimulation modes of acupuncture". However, in Figure 4, the effect estimate presented for Lund et al. (2006) strongly favors the experimental group und the confidence interval does not include 0.
o In at least three studies, the extracted sample sizes were too large. Here, Yang et al. seemed to have used the number of participants that were included in the beginning of the study but failed to recognize that the analysis was done for a smaller number of patients. In the following, actual and falsely reported numbers are given for the groups Yang et al. presented in Table 1 (experimental group / control group): Bishop et al. (2016) reported 32 / 27, Yang et al. used 42 / 41; Ekdahl and Petersson (2010) reported 16 / 16, Yang et al. used 20 / 20; Elden et al. (2005) reported 107 / 108, Yang et al. used 130 / 125.
2) The same study is included twice:
Yang et al. included two publications of the same study (Elden et al., 2008; Elden et al., 2005) and presented them as two different studies in Table 1 and throughout the manuscript. Elden et al. (2005) reported pain endpoints whereas Elden et al. (2008) did not report values of pain. In contrast to that, in Figure 4, pain values are assigned to Elden et al. (2008).
3) The choices of the comparator group are not comprehensible:
Five of the nine included studies analyzed more than two groups (e.g. true acupuncture, placebo acupuncture, and standard care). Yang et al. did not give reasons for their choices of which group is used as control group. When three- or four-armed studies included both a placebo acupuncture group and a standard care group, Yang et al. sometimes chose the placebo acupuncture group as control (Bishop et al., 2016) and sometimes the standard care group (Jorge et al., 2019; Wang et al., 2009). One study (Ekdahl and Petersson, 2010) compared two acupuncture groups where the intervention was equal but began at different gestational weeks. It is not transparent why one of the groups was chosen as experimental group and the other one as control group.
3) Effects were pooled and interpreted as significant results with staggering heterogeneity and scarcity of data:
Despite the major heterogeneity observed, studies were pooled and effects were presented as statistically significant. This is contrary to the Cochrane recommendations for dealing with large heterogeneity (Cochrane Handbook Section 10.10.3 “Strategies for addressing heterogeneity” (https://training.cochrane.org/handbook/current/chapter-10#section-10-10-3): “1. Check again that the data are correct / 2. Do not do a meta-analysis”)
4) Choice between fixed-effect-model and random-effects-model was done in hindsight:
The authors stated “If p<0.1 or I**2 >50% we combined results using a random-effect model (29).” This is considered as bad practice, see, e.g. Borenstein et al. (2010) (https://doi.org/10.1002/jrsm.12): “In some circles, researchers tend to start with the fixed-effect model, and then switch to the random-effects model if there is a compelling reason to do so. Usually, this means that the test for heterogeneity across studies is statistically significant. This is a bad idea for many reasons.”
Furthermore, the cited reference (29) gives no justification for the applied approach.
In addition to the above points, some further issues came to our attention:
Figure 6 is falsely labelled. The left side of the forest plot should favor experimental.
The choice of the pain endpoint is not transparent: The included studies collected multiple different measures of VAS-pain. Two studies (Wedenberg et al., 2000; Elden et al., 2005) collected morning and evening values. One study (Kvorning et al., 2004) collected minimal and maximal pain. Yang et al. did not describe or explain which values they used.
In summary, due to its serious weaknesses in conduct, methods, and reporting, the article by Yang et al. does in our view not contribute to clarify the value of acupuncture for low back and/or pelvic pain during pregnancy but is misleading and thus does a disservice to physicians and patients.
Dear Editor,
The recent systematic review by Maharaj et al on the impact of minimum unit pricing on alcohol-related hospital outcomes is a welcome addition to the literature on this subject1. The mirroring of real-world experience of minimum pricing of alcohol with modelling studies provides yet further support for this public health measure.
As part of their review, the authors cite our study which assessed the impact of minimum pricing of alcohol specifically on alcohol-related liver disease hospital episodes2. In the review it is stated that our study showed ‘no change in ALD hospital discharge rate’ after the introduction of minimum pricing. This conclusion is reiterated in the discussion. However I fear this is a misrepresentation of our study. When we reviewed patients discharged from the specialist Gastroenterology wards at Glasgow Royal Infirmary before and after the introduction of minimum unit pricing, we did find that there was a significant reduction in alcohol-related liver disease discharges. What did not change was the proportion of those patients with specific complications of liver disease such as ascites, hepatic encephalopathy or alcoholic hepatitis. Neither was there any change in mortality. Whilst accepting the limitations of our study as raised in the discussion, these results indicate that minimum unit pricing did reduce the number of hospital episodes with alcohol-related liver disease. However for those fewer patients who did require ho...
Dear Editor,
The recent systematic review by Maharaj et al on the impact of minimum unit pricing on alcohol-related hospital outcomes is a welcome addition to the literature on this subject1. The mirroring of real-world experience of minimum pricing of alcohol with modelling studies provides yet further support for this public health measure.
As part of their review, the authors cite our study which assessed the impact of minimum pricing of alcohol specifically on alcohol-related liver disease hospital episodes2. In the review it is stated that our study showed ‘no change in ALD hospital discharge rate’ after the introduction of minimum pricing. This conclusion is reiterated in the discussion. However I fear this is a misrepresentation of our study. When we reviewed patients discharged from the specialist Gastroenterology wards at Glasgow Royal Infirmary before and after the introduction of minimum unit pricing, we did find that there was a significant reduction in alcohol-related liver disease discharges. What did not change was the proportion of those patients with specific complications of liver disease such as ascites, hepatic encephalopathy or alcoholic hepatitis. Neither was there any change in mortality. Whilst accepting the limitations of our study as raised in the discussion, these results indicate that minimum unit pricing did reduce the number of hospital episodes with alcohol-related liver disease. However for those fewer patients who did require hospitalisation, their outcomes and presentations were similar to hospital episodes prior to the introduction of minimum pricing.
Therefore our study is supportive of the conclusions of the systematic review rather than being ‘inconsistent’ with the other studies.
Prof Ewan Forrest
Consultant Hepatologist and Honorary Professor, Department of Gastroenterology, Glasgow Royal Infirmary and University of Glasgow.
References
1. Maharaj T, Angus C, Fitzgerald N, et al. Impact of minimum unit pricing on alcohol-related hospital outcomes: systematic review. BMJ Open 2023; 13: e065220. doi: 10.1136/bmjopen-2022-065220
2. Chaudhary S, MacKey W, Duncan K, Forrest EH. Changes in Hospital Discharges with Alcohol-Related Liver Disease in a Gastroenterology and General Medical Unit Following the Introduction of Minimum Unit Pricing of Alcohol: The GRI Q4 Study. Alcohol and Alcoholism 2022; 57(4): 477–482.
Most of the studies in the literature propagate that the incidence of frozen shoulder is higher in people with diabetes. According to the American Diabetic Association, the average age of people with frozen shoulder is 52 years. Among people 40 and over, the condition affects 2 to 4 percent of the general population and up to 25 percent of people with diabetes. But no definite pathophysiological mechanism to support the data has been postulated.
Several questions remain unanswered.
Do people with diabetes experience worse outcomes from frozen shoulders than those without diabetes?
Does uncontrolled diabetes have a higher risk or severity of disease?
Do people with diabetes develop frozen shoulder at an earlier age than non-diabetics?
Does Diabetes delay the recovery from a frozen shoulder?
Answers to the above questions may be yes in several studies in scientific literature. However, the certainty in evidence in most such studies is moderate to low. In our experience of more than 30 years, we also don't find any such correlation.
Frozen shoulder undoubtedly has a higher incidence among patients with Myocardial Infarction, but the incidence, duration of disability, severity of symptoms, and age of onset are not remarkably different from the general population.
Most of the studies in the literature propagate that the incidence of frozen shoulder is higher in people with diabetes. According to the American Diabetic Association, the average age of people with frozen shoulder is 52 years. Among people 40 and over, the condition affects 2 to 4 percent of the general population and up to 25 percent of people with diabetes. But no definite pathophysiological mechanism to support the data has been postulated.
Several questions remain unanswered.
Do people with diabetes experience worse outcomes from frozen shoulders than those without diabetes?
Does uncontrolled diabetes have a higher risk or severity of disease?
Do people with diabetes develop frozen shoulder at an earlier age than non-diabetics?
Does Diabetes delay the recovery from a frozen shoulder?
Answers to the above questions may be yes in several studies in scientific literature. However, the certainty in evidence in most such studies is moderate to low. In our experience of more than 30 years, we also don't find any such correlation.
Frozen shoulder undoubtedly has a higher incidence among patients with Myocardial Infarction, but the incidence, duration of disability, severity of symptoms, and age of onset are not remarkably different from the general population.
This research by Mooghali and team provide valuable and disturbing data on the problem of financial conflicts of interest (COI) in clinical practice guidelines.(1) Failure of authors and committee members to accurately disclose potential COI raises concerns about lack of transparency in the process, bias in the resulting guidelines, and ultimately harm to patients.
The pioneering work in this area was done by the American Academy of Family Physicians, which published in 1994 the first international call for an explicit declaration of conflicts of interest in the development of clinical practice guidelines.(2) This has been followed by policies on COI by other groups of primary care physicians in the US(3,4), the UK(5,6) and Canada(7,8).
Primary care physicians have been early champions of evidence-based medicine and explicit clinical practice guidelines. They are also the clinicians working at the point of care, partnering with patients to make shared decisions. The best in care requires the best guidance based on the best evidence. Therefore, potential COIs must be fully disclosed and critically managed by all involved in producing, disseminating, and implementing clinical practice guidelines.
REFERENCES
1.Mooghali M, Glick L, Ramachandran R, et al. Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross- sectional study. BMJ Open 2023;13:e069115. doi:10.1136/ bmjopen-2022-069115
2. Phillips...
This research by Mooghali and team provide valuable and disturbing data on the problem of financial conflicts of interest (COI) in clinical practice guidelines.(1) Failure of authors and committee members to accurately disclose potential COI raises concerns about lack of transparency in the process, bias in the resulting guidelines, and ultimately harm to patients.
The pioneering work in this area was done by the American Academy of Family Physicians, which published in 1994 the first international call for an explicit declaration of conflicts of interest in the development of clinical practice guidelines.(2) This has been followed by policies on COI by other groups of primary care physicians in the US(3,4), the UK(5,6) and Canada(7,8).
Primary care physicians have been early champions of evidence-based medicine and explicit clinical practice guidelines. They are also the clinicians working at the point of care, partnering with patients to make shared decisions. The best in care requires the best guidance based on the best evidence. Therefore, potential COIs must be fully disclosed and critically managed by all involved in producing, disseminating, and implementing clinical practice guidelines.
REFERENCES
1.Mooghali M, Glick L, Ramachandran R, et al. Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross- sectional study. BMJ Open 2023;13:e069115. doi:10.1136/ bmjopen-2022-069115
2. Phillips WR. Clinical policies: making conflicts of interest explicit. JAMA 1994; 272(19):1479. doi:10.1001/jama.1994.03520190021010
3. Schünemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB, et al. Guidelines International Network: Principles for disclosure of interests and management of conflicts in guidelines. Ann Intern Med. 2015;163:548-553. doi:10.7326/M14-1885Ann Int Med 2016
4. Phillips WR. American Academy of Family Physicians pioneered full disclosure in clinical
guidelines. (eLetter 7 January) Ann Intern Med. 2015;163:548-553. doi:10.7326/M14-1885Ann Int Med 2016
5. Moore, Ainsley, et al. Financial conflict of interest among clinical practice guideline-producing organisations. British J General Practice 70.700 (2020): 530-531. Web. 30 Oct. 2020. doi: 10.3399/bjgp20X713177
6. Phillips WR. General practice leads in transparency of clinical guidelines. (eLetter 30 OPct 2020) British J General Practice 70.700 (2020): 530-531. https://bjgp.org/content/70/700/530/tab-e-letters
7. Allan GM, Cauchon M, Katz A, Kuling PJ, Moore S, Scrimshaw C, Stalker P. Endorsement of clinical practice guidelines. Criteria from the College of Family Physicians of Canada. Can Fam Physician 2021;67:499-502. doi: 10.46747/cfp.6707499
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 MoreWe 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 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...
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...
Show MoreDear Editor,
To Prof Forrest and the authors of the Chaudhary et al paper(1): Thank you for your response to our review(2) in which you highlight that there was a significant reduction in alcohol-related liver disease (ALD) discharges following the introduction of minimum unit pricing (MUP) at your unit. This is an important point to highlight as a misrepresentation of the Chaudhary et al study in our review.
In our review, we reported the outcome measure of mean weekly ALD discharges before and after MUP for 'All hospital episodes' which did not reach pre-defined significance (6.2 versus 5.2; p = 0.123) in the Chaudhary et al study, however the outcomes for 'individual patients' and those 'actively drinking' did indeed reach pre-defined significance and should have been included in our review. These outcomes from the Chaudhary et al study would certainly be consistent with the overall conclusion of our review, adding further support to the impact of MUP reducing alcohol-related hospital burden as you have highlighted.
We would also like to correct the reference to your study in the main text of our review which should read “Chaudhary et al” and not “Ferguson et al” (found under ‘Results’, subheading ‘Natural experiments’).
References
Show More1. Chaudhary S, MacKey W, Duncan K, Forrest EH. Changes in Hospital Discharges with Alcohol-Related Liver Disease in a Gastroenterology and General Medical Unit Following the...
I'm a 68 year old male with parox AF so am very interested in ablation data. I applaud the authors for their work and look forward to the results. One sentence in this paper confused me---" The benefits of ablation may not be fully realised among elderly patients." I wasn't sure what they meant by that. Elderly patients may be unable to appreciate the benefits? There may not be any benefits in elderly patients? Something else?
Again, very good work, thanks to the authors.
Declan Fox
Family physician
Dear Editor,
The article by Yang et al. (2022) is fundamentally flawed due to a number of serious methodological shortcomings. These deficits are of such crucial relevance that it is in our view highly doubtful whether the conclusions the authors draw from their research are valid.
1) Data extraction is not transparent and sometimes false:
Show MoreWe were not able to replicate any of the values included in the main analysis of pain (Figure 4). In at least one study, values were extracted from the wrong group. In two further studies, the given values are incompatible with the values reported in the study. In at least three studies, sample sizes were falsely extracted.
Specifically:
Only in one of the included studies (Bishop et al., 2016) the values given in Figure 4 (Mean, SD) were found (Table 6, Bishop et al., 2016). However, the values of the control group were extracted from the false group (see below). For all other included studies, the values (Mean, SD) given in Figure 4 were not found. We were not able to find a description of how the authors may have transformed the values to explain the disagreement. In some studies, the given values in Figure 4 are not only not replicable but are incompatible with the values reported in the studies:
o In Bishop et al. (2016), values were extracted from the false group. Values were taken from standard care group but Yang et al. stated in Table 1 to have used the placebo acupuncture group as control g...
Dear Editor,
Show MoreThe recent systematic review by Maharaj et al on the impact of minimum unit pricing on alcohol-related hospital outcomes is a welcome addition to the literature on this subject1. The mirroring of real-world experience of minimum pricing of alcohol with modelling studies provides yet further support for this public health measure.
As part of their review, the authors cite our study which assessed the impact of minimum pricing of alcohol specifically on alcohol-related liver disease hospital episodes2. In the review it is stated that our study showed ‘no change in ALD hospital discharge rate’ after the introduction of minimum pricing. This conclusion is reiterated in the discussion. However I fear this is a misrepresentation of our study. When we reviewed patients discharged from the specialist Gastroenterology wards at Glasgow Royal Infirmary before and after the introduction of minimum unit pricing, we did find that there was a significant reduction in alcohol-related liver disease discharges. What did not change was the proportion of those patients with specific complications of liver disease such as ascites, hepatic encephalopathy or alcoholic hepatitis. Neither was there any change in mortality. Whilst accepting the limitations of our study as raised in the discussion, these results indicate that minimum unit pricing did reduce the number of hospital episodes with alcohol-related liver disease. However for those fewer patients who did require ho...
Most of the studies in the literature propagate that the incidence of frozen shoulder is higher in people with diabetes. According to the American Diabetic Association, the average age of people with frozen shoulder is 52 years. Among people 40 and over, the condition affects 2 to 4 percent of the general population and up to 25 percent of people with diabetes. But no definite pathophysiological mechanism to support the data has been postulated.
Several questions remain unanswered.
Do people with diabetes experience worse outcomes from frozen shoulders than those without diabetes?
Does uncontrolled diabetes have a higher risk or severity of disease?
Do people with diabetes develop frozen shoulder at an earlier age than non-diabetics?
Does Diabetes delay the recovery from a frozen shoulder?
Answers to the above questions may be yes in several studies in scientific literature. However, the certainty in evidence in most such studies is moderate to low. In our experience of more than 30 years, we also don't find any such correlation.
Frozen shoulder undoubtedly has a higher incidence among patients with Myocardial Infarction, but the incidence, duration of disability, severity of symptoms, and age of onset are not remarkably different from the general population.
References: 1.https://www.sciencedirect.com/science/article/pii/S259010952100051...
Show MoreThis research by Mooghali and team provide valuable and disturbing data on the problem of financial conflicts of interest (COI) in clinical practice guidelines.(1) Failure of authors and committee members to accurately disclose potential COI raises concerns about lack of transparency in the process, bias in the resulting guidelines, and ultimately harm to patients.
The pioneering work in this area was done by the American Academy of Family Physicians, which published in 1994 the first international call for an explicit declaration of conflicts of interest in the development of clinical practice guidelines.(2) This has been followed by policies on COI by other groups of primary care physicians in the US(3,4), the UK(5,6) and Canada(7,8).
Primary care physicians have been early champions of evidence-based medicine and explicit clinical practice guidelines. They are also the clinicians working at the point of care, partnering with patients to make shared decisions. The best in care requires the best guidance based on the best evidence. Therefore, potential COIs must be fully disclosed and critically managed by all involved in producing, disseminating, and implementing clinical practice guidelines.
Show MoreREFERENCES
1.Mooghali M, Glick L, Ramachandran R, et al. Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross- sectional study. BMJ Open 2023;13:e069115. doi:10.1136/ bmjopen-2022-069115
2. Phillips...
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