Dear Editor,
Thank you for drawing our attention to this rapid response by Condon L, which was published on the 6th December 2023.
In response to the author’s comments on the inclusion of one of her studies - (Reference #52: Condon L, Rhodes C, Warren S, et al. ‘But is it a normal thing?’ Teenage mothers’ experiences of breastfeeding promotion and support. Health Education Journal 2013; 72: 156–62) in our review. We will take each point in turn.
Comment: It is unclear why our article has been included in this systematic review. In their Methods section, Malouf et al. describe their study selection criteria as follows: “‘Studies were eligible for inclusion if they involved women with low-risk pregnancies [...] and gave birth in hospitals or birth centres in the UK’. Our study explored experiences of breastfeeding promotion and support among pregnant teenagers and teenage mothers, and does not provide information about risk in pregnancy or place of birth. Our study therefore does not meet the eligibility criteria and should not have been included.
Response: We have clearly stated our approach to the eligibility criteria highlighted by Condon in our strengths and limitations sections:
‘Although we set out to review the literature relating to postnatal care for women at low risk of complications to explore routine practice, this was not always possible. Most of the studies reported results undifferentiated by risk and without excluding those wom...
Dear Editor,
Thank you for drawing our attention to this rapid response by Condon L, which was published on the 6th December 2023.
In response to the author’s comments on the inclusion of one of her studies - (Reference #52: Condon L, Rhodes C, Warren S, et al. ‘But is it a normal thing?’ Teenage mothers’ experiences of breastfeeding promotion and support. Health Education Journal 2013; 72: 156–62) in our review. We will take each point in turn.
Comment: It is unclear why our article has been included in this systematic review. In their Methods section, Malouf et al. describe their study selection criteria as follows: “‘Studies were eligible for inclusion if they involved women with low-risk pregnancies [...] and gave birth in hospitals or birth centres in the UK’. Our study explored experiences of breastfeeding promotion and support among pregnant teenagers and teenage mothers, and does not provide information about risk in pregnancy or place of birth. Our study therefore does not meet the eligibility criteria and should not have been included.
Response: We have clearly stated our approach to the eligibility criteria highlighted by Condon in our strengths and limitations sections:
‘Although we set out to review the literature relating to postnatal care for women at low risk of complications to explore routine practice, this was not always possible. Most of the studies reported results undifferentiated by risk and without excluding those women at high risk. Similarly, this review has focused on postnatal care in hospital, but for some outcomes, particularly those relating to infant feeding, it was not possible to separate hospital from community care. These studies were included for completeness.’ Malouf et al 2019
The inclusion of the study in question was one that was discussed and decided on by the whole research team as the relevance of the study in regard to sample was unclear. We decided to include because one of the themes highlighted health professional care in hospital just after birth. For example under this theme the following statement was made:
‘Feeding decisions made in pregnancy were not necessarily followed through when the baby was born, demonstrating the influence of health professional promotion and support at birth. Despite wishing to breastfeed, one mother was directed towards the hospital stocks of formula milk and subsequently bottle fed her baby.’ Condon et al 2013
This theme was deemed to be relevant to the review objectives to comprehensively report on women’s experiences of the immediate postnatal care received in hospitals and birth centres. Based on this information and in the absence of risk data or evidence of specialist services related to breast feeding around birth we decided to include.
Comment: The erroneous inclusion of our article leads the authors to make inaccurate claims about the quality of our study. In Table 2, Malouf et al. list the characteristics of qualitative studies included in their review. For our study, the ‘Sample characteristics’ column states that details were not reported for the postnatal sample. This is misleading, as Table 1 of our article presents the characteristics for our overall sample of teenage mothers and pregnant teenagers; however, as laid out above, our study did not include a separate postnatal sample Furthermore, in their Results section, under the heading ‘Risk of bias in qualitative studies’, Malouf et al. have claimed that the study population was “not described” in our article, “limiting transferability”. This gives the impression that our article fails to appropriately disclose the sample characteristics, which is untrue.
Response: These are statements of fact in regard to the description of the 23 teenage mothers in the sample. Such descriptions are common in systematic reviews and are not a judgement on the paper. They are included for complete transparency on what data could be extracted from the paper using our data extraction protocol.
Comment: Malouf et al. provide a quality assessment of the qualitative studies included in their review. In final column of this table, titled ‘Is the research valuable?’, it is unclear whether the authors are referring to the value of the research for their review, or to the field in general. Our study has been deemed not valuable, but the authors do not disclose the methodology used to reach this apparently subjective judgement. Of note, our study meets almost all of the quality assessment criteria listed in Table 4, while other studies considered valuable meet fewer of these criteria
Response: To assess the study quality we used the CASP risk of bias assessment for qualitative studies. The CASP tool is widely used to quality assess qualitative studies in qualitative reviews and the reporting that we provided for each domain is standard. Condon’s study has performed well using this tool, with seven ‘yes’ ratings out of ten questions. This was a reflection on the clarity of the study aims, the appropriate qualitative methodology and design to achieve the study aims, the transparency of the study recruitment strategy, the adequacy of the data collection (focus group and interviews), sufficient details on the ethical approval and the explicit findings of Condon’s study. The study was rated ‘unclear’ on one question – ‘Was the data analysis sufficiently rigorous?’. We could not find enough information in the paper on the analysis process or sufficient details on how the coding for the thematic analysis was done and by whom (whether done by e.g. two researchers or independently). The final question on the CASP is ‘is the research valuable?’. The terminology used is that of CASP’s and not ours and we completely understand how this could cause offence and we agree that many of the questions can be subjective. A key component of this final question is whether the researchers findings can be transferred to the local/other populations. In this study a rating of ‘no’ was given as the study findings cannot be transferred to other similar populations. This was stated by the authors in their study’s limitations section– ‘rates of breastfeeding initiation and continuation were higher among the study sample than nationally’ and ‘study sample may have been highly atypical of pregnant teenagers and teenage mothers in other UK cities’. The ‘no’ rating is for this one domain and is not a global assessment of study quality which is why other studies could be considered ‘valuable’ but did not perform well on other domains.
Comment: We recognise that this systematic review has been published for some time; however, it has recently been brought to our attention, and based on the points laid out above we would consider it appropriate for the article to be corrected to remove the misleading claims regarding our work. Furthermore, we strongly recommend that the authors consider whether the study selection and eligibility criteria have been correctly applied across all studies included in their review, and how this might affect the credibility of their findings.
Response: This review followed a rigorous methodology, decision making and reporting process. We greatly value the contribution of Condon et al’s paper in this review on this particularly under researched group. We do not believe that the data included in the review misrepresents the study within the context of the review question. We stand over our decision to include the paper in the review, the data extracted from the paper and quality assessment made.
RE. Penicillin allergy status and its effect on antibiotic prescribing, patient outcomes and antimicrobial resistance (ALABAMA): protocol for a multicentre, parallel-arm, open-label, randomised pragmatic trial. https://bmjopen.bmj.com/content/13/9/e072253
The issue of incorrect penicillin allergy records and their impact on antibiotic prescribing remains an internationally important issue that lacks randomised controlled trials to guide optimal management.
Since submission of this protocol paper, the funder (UK National Institute for Health and Care Research Programme Grants for Applied Research) has undertaken a review of trial progress and decided not to provide additional funds to compensate for slow recruitment caused by COVID-19. Although a steady rate of recruitment was achieved during the pandemic, it was not at the rate anticipated pre-COVID-19. The funder recognised the value of the trial but maintained that the financial climate has changed within the context of the UK Department of Health and Social Care’s wider ‘Research Reset’ initiative. As a result of this funding review a revised primary trial outcome has been agreed. This will allow us to provide a powered study with a revised (reduced) sample size.
NHS Research Ethics Committee and Health Research Authority approval has been granted for the protocol amendment outlined in this correspondence and clinical tri...
RE. Penicillin allergy status and its effect on antibiotic prescribing, patient outcomes and antimicrobial resistance (ALABAMA): protocol for a multicentre, parallel-arm, open-label, randomised pragmatic trial. https://bmjopen.bmj.com/content/13/9/e072253
The issue of incorrect penicillin allergy records and their impact on antibiotic prescribing remains an internationally important issue that lacks randomised controlled trials to guide optimal management.
Since submission of this protocol paper, the funder (UK National Institute for Health and Care Research Programme Grants for Applied Research) has undertaken a review of trial progress and decided not to provide additional funds to compensate for slow recruitment caused by COVID-19. Although a steady rate of recruitment was achieved during the pandemic, it was not at the rate anticipated pre-COVID-19. The funder recognised the value of the trial but maintained that the financial climate has changed within the context of the UK Department of Health and Social Care’s wider ‘Research Reset’ initiative. As a result of this funding review a revised primary trial outcome has been agreed. This will allow us to provide a powered study with a revised (reduced) sample size.
NHS Research Ethics Committee and Health Research Authority approval has been granted for the protocol amendment outlined in this correspondence and clinical trials registration remains in place. Patient follow-up continues and analysis of outcomes is planned for April 2024.
Summary of the changes to the protocol:
1. The primary outcome has been changed to:
The proportion of participants who receive prescriptions for a penicillin when attending for predefined conditions where a penicillin is the first-line recommended antibiotic (as per supplemental appendix A) during the course of routine primary care, up to 12 months post randomisation.
2. A new power calculation has been carried out:
A total sample size of 848 to 656 are estimated to provide a 90% and 80% power, respectively, to detect an increase in the proportion of penicillin prescriptions from 4% (Usual care) to 14% (Penicillin allergy assessment pathway) over the year after randomisation at 5% level of significance (2-sided) and 10% attrition.
3. The previous primary outcome of treatment response failure has become a secondary outcome.
4. Additional secondary outcomes have been added to measure penicillin allergy de-labelling and relabelling rates:
a) The proportion of ALABAMA participants whose labels are removed from the medical electronic health record allergy section at 3 months post randomisation and b) the proportion of these participants labels that remain removed from the medical electronic health record allergy section up to 12 months post-randomisation.
5. Cost-effectiveness analysis has been expanded:
The economic evaluation will estimate the incremental cost per quality-adjusted life years (QALY) for the penicillin allergy assessment pathway (PAAP) intervention versus usual care from the perspective of the NHS. Changes relate to data, methods and scope of analysis.
• Data will be collected via: (i) SystmOne (primary/community care); (ii) Linked Hospital episode statistics (HES) (secondary care: inpatient, A&E, outpatient and critical care datasets) and Office of National Statistics mortality data; (iii) The linked HES data will facilitate a directed search for prescribing data in secondary care, from electronic prescribing systems or by the trial team through hand searching patient records (if available/accessible) for patients receiving secondary care.
• Model based extrapolation beyond the 12 month-trial endpoint.
A Markov model will be developed to project the differences in costs and QALYs that are likely to accrue beyond the period of trial follow-up. The model will be informed by a review of the health economic and epidemiological literature of incidence of bacterial infections in patient cohorts drawn from the same reference patient population as that of the ALABAMA trial. The model will be based on the rate of amended primary care patient records at the end of ALABAMA follow-up and transitions of members of the trial patient cohort between susceptible and states of infection up to 5 years after randomisation.
• Costs and QALYs will be discounted at an annual rate of 3.5% from the second year onwards. Probabilistic sensitivity analysis will be conducted to account for sampling uncertainty in the epidemiological, costs and utility model parameters. Results will be presented in terms of the probability of PAAP being cost-effective after 5 years.
• Value of Information Analysis
Based on the probabilistic Markov model, the value of conducting further research in key uncertain outcomes will be determined using the Expected Value of Perfect Partial Information. This analysis will determine whether the costs of conducting further research on uncertain parameters is justified by the expected costs associated with the risk of making the wrong decision on the basis of the state of the evidence base at the end of ALABAMA.
The author team would like to inform the readers of a recent amendment to the original protocol as published here.
The ARON trial was planned before the COVID-19 pandemic. Though, the trial actually started in the initial part of the pandemic, just as the Delta variant (second wave) was first emerging in early 2021. The ARON trial kept going through all subsequent COVID-19 waves and is currently still ongoing. The COVID-19 pandemic has shown that antibiotic prescribing has (for the better) declined during the pandemic, as shown by several studies and reports:
- Gillies, MB, Burgner, DP, Ivancic, L, et al. Changes in antibiotic prescribing following COVID-19 restrictions: Lessons for post-pandemic antibiotic stewardship. Br J Clin Pharmacol. 2022; 88( 3): 1143- 1151.
- https://www.ecdc.europa.eu/en/news-events/reported-decrease-antibiotic-c...
- Colliers, A.; De Man, J.; Adriaenssens, N.; Verhoeven, V.; Anthierens, S.; De Loof, H.; Philips, H.; Coenen, S.; Morreel, S. Antibiotic Prescribing Trends in Belgian Out-of-Hours Primary Care during the COVID-19 Pandemic: Observational Study Using Routinely Collected Health Data. Antibiotics 2021, 10, 1488. https://doi.org/ 10.3390/antibiotics10121488
This has urged us to revise our sample size calculation, based on the overall prevalence...
The author team would like to inform the readers of a recent amendment to the original protocol as published here.
The ARON trial was planned before the COVID-19 pandemic. Though, the trial actually started in the initial part of the pandemic, just as the Delta variant (second wave) was first emerging in early 2021. The ARON trial kept going through all subsequent COVID-19 waves and is currently still ongoing. The COVID-19 pandemic has shown that antibiotic prescribing has (for the better) declined during the pandemic, as shown by several studies and reports:
- Gillies, MB, Burgner, DP, Ivancic, L, et al. Changes in antibiotic prescribing following COVID-19 restrictions: Lessons for post-pandemic antibiotic stewardship. Br J Clin Pharmacol. 2022; 88( 3): 1143- 1151.
- https://www.ecdc.europa.eu/en/news-events/reported-decrease-antibiotic-c...
- Colliers, A.; De Man, J.; Adriaenssens, N.; Verhoeven, V.; Anthierens, S.; De Loof, H.; Philips, H.; Coenen, S.; Morreel, S. Antibiotic Prescribing Trends in Belgian Out-of-Hours Primary Care during the COVID-19 Pandemic: Observational Study Using Routinely Collected Health Data. Antibiotics 2021, 10, 1488. https://doi.org/ 10.3390/antibiotics10121488
This has urged us to revise our sample size calculation, based on the overall prevalence found in the first patients recruited, given the start of our trial during the pandemic.
This amendment concerns a clarification of the impact the COVID-19 pandemic has had on recruitment as well as the overall prevalence of our primary outcome, the antibiotic prescribing rate in children.
With this amendment, we aim to:
- (1) investigate the influence of the COVID-19 pandemic on antibiotic prescribing rates in practices included in the ARON trial and (2) redetermine the required sample size for the ARON trial.
- (3) monitor whether inclusions were done consecutively, as per the study protocol, in order to minimize selection bias.
The following methods are described in this amendment to achieve the above aims:
1. Audit of antibiotic prescribing rate before and during the COVID-19 pandemic:
An audit is an official methodical examination and review, typically of an organisation’s or individual’s accounts or financial situation . In the context of this appendix, we aim to audit practices’ antibiotic prescribing rates in a time-matched before-after manner. We will compare the rate before the COVID-19 pandemic and during the COVID-19 pandemic, in an identical period during the year. A statistically significant change from baseline quantified by odds ratios will indicate a change in antibiotic prescribing behaviour due to COVID-19. This audit will be executed by the study coordinator (SC) that manages the practice.
2. Adjusted sample size calculation:
The original sample size calculation was based on previous data, assuming an overall prescribing rate of 26.5% in those children recruited for our trial.
The overall prevalence was found to be 18% overall in children recruited in the first 4938 patients recruited in the ARON trial.
If we were to assume a reduction of 5.3% (proportionate to our original reduction) between the usual care group and the intervention group, using a 5% significance level (alpha 0.05), an intracluster correlation coefficient (ICC) of 0.063 (based on data from the ERNIE2 study in the exact same population), and power of 90% (beta 0.1), this would require 63 clusters of 50 patients in both arms, resulting in 6300 children.
R code:
We used the n4props-function in the R package CRTSize, using the following command:
n4props(0.2065,0.1435,50,0.063, alpha = 0.05, power=0.9, AR=1, two.tailed=TRUE, digits=3)
Considering the pragmatic nature of this trial and in correspondence with the 10% of practices performing non-consecutive inclusion of patients (high risk of selection bias) during the ERNIE2 trial, we will perform sensitivity analyses only considering physicians who have recruited in a consecutive way. Taking into account the required sample size for this analysis of the primary study outcome, these assumptions result in a total sample size of 7000 patients for the primary study outcome.
3. Explore non-consecutive recruitment:
In the protocol, we have specified: “The participating physicians will be asked to consecutively recruit children with an acute illness over the recruitment period covering two winter seasons.”
We wanted to further clarify what is meant by non-consecutive recruitment, by stating that GPs are likely to breach this assumption if:
- They recruit less than 10 patients per year
- They perform a point-of-care CRP test on nearly all (>90%) of the included children
- They deliberately only include children (>90%) that do not need antibiotics and exclude those that might need antibiotic treatment.
All of the above circumstances introduce significant selection bias and reduce the generalisability of our findings. Although we plan to perform an intention-to-treat analysis given the pragmatic nature of our trial, protocol violations caused by the inappropriate inclusion/exclusion of patients will be far more detrimental for the validity of our trial. Apart from the intention-to-treat analysis a per protocol sensitivity analysis will be performed.
The above-mentioned assumptions can be tested, based on:
- the qualitative sub-study (semi-structured interviews with parents and physicians) in a selection of the recruiting practices as described in the original protocol
- the audit as described above
- monitoring visits by the clinical trial centre supporting data monitoring of the ARON trial
The above changes as part of the amendment have been approved by the Funder (KCE), the Ethical Review Board of UZ/KU Leuven (Belgium) and adapted in the registered protocol on Clinicaltrials.gov (NCT04470518).
Yours sincerely,
Prof Dr Jan Y Verbakel, on behalf of the author team of the ARON trial protocol.
I am the lead author of an article cited in this systematic review (Reference #52: Condon L, Rhodes C, Warren S, et al. ‘But is it a normal thing?’ Teenage mothers’ experiences of breastfeeding promotion and support. Health Education Journal 2013;72:156–62.) and would like to draw your attention to the inaccurate and misleading way in which the authors have presented our work.
It is unclear why our article has been included in this systematic review. In their Methods section, Malouf et al. describe their study selection criteria as follows: “‘Studies were eligible for inclusion if they involved women with low-risk pregnancies [...] and gave birth in hospitals or birth centres in the UK’. Our study explored experiences of breastfeeding promotion and support among pregnant teenagers and teenage mothers, and does not provide information about risk in pregnancy or place of birth. Our study therefore does not meet the eligibility criteria and should not have been included.
The erroneous inclusion of our article leads the authors to make inaccurate claims about the quality of our study. In Table 2, Malouf et al. list the characteristics of qualitative studies included in their review. For our study, the ‘Sample characteristics’ column states that details were not reported for the postnatal sample. This is misleading, as Table 1 of our article presents the characteristics for our overall sample of teenage mothers and pregnant teenagers; however,...
I am the lead author of an article cited in this systematic review (Reference #52: Condon L, Rhodes C, Warren S, et al. ‘But is it a normal thing?’ Teenage mothers’ experiences of breastfeeding promotion and support. Health Education Journal 2013;72:156–62.) and would like to draw your attention to the inaccurate and misleading way in which the authors have presented our work.
It is unclear why our article has been included in this systematic review. In their Methods section, Malouf et al. describe their study selection criteria as follows: “‘Studies were eligible for inclusion if they involved women with low-risk pregnancies [...] and gave birth in hospitals or birth centres in the UK’. Our study explored experiences of breastfeeding promotion and support among pregnant teenagers and teenage mothers, and does not provide information about risk in pregnancy or place of birth. Our study therefore does not meet the eligibility criteria and should not have been included.
The erroneous inclusion of our article leads the authors to make inaccurate claims about the quality of our study. In Table 2, Malouf et al. list the characteristics of qualitative studies included in their review. For our study, the ‘Sample characteristics’ column states that details were not reported for the postnatal sample. This is misleading, as Table 1 of our article presents the characteristics for our overall sample of teenage mothers and pregnant teenagers; however, as laid out above, our study did not include a separate postnatal sample. Furthermore, in their Results section, under the heading ‘Risk of bias in qualitative studies’, Malouf et al. have claimed that the study population was “not described” in our article, “limiting transferability”. This gives the impression that our article fails to appropriately disclose the sample characteristics, which is untrue.
In Table 4, Malouf et al. provide a quality assessment of the qualitative studies included in their review. In final column of this table, titled ‘Is the research valuable?’, it is unclear whether the authors are referring to the value of the research for their review, or to the field in general. Our study has been deemed not valuable, but the authors do not disclose the methodology used to reach this apparently subjective judgement. Of note, our study meets almost all of the quality assessment criteria listed in Table 4, while other studies considered valuable meet fewer of these criteria.
We recognise that this systematic review has been published for some time; however, it has recently been brought to our attention, and based on the points laid out above we would consider it appropriate for the article to be corrected to remove the misleading claims regarding our work. Furthermore, we strongly recommend that the authors consider whether the study selection and eligibility criteria have been correctly applied across all studies included in their review, and how this might affect the credibility of their findings.
Dear Editor,
I am writing regarding the article titled "Adverse childhood experiences, the risk of pregnancy complications and adverse pregnancy outcomes: a systematic review and meta-analysis." I would like to provide a critical evaluation and methodological assessment of the paper.
The authors conducted a thorough systematic review and meta-analysis to explore the association between adverse childhood experiences (ACEs) and the risk of pregnancy complications and adverse pregnancy outcomes. The study's strength lies in its comprehensive search strategy, inclusion criteria, and quality assessment of the selected studies.
The meta-analysis revealed compelling findings. The pooled analyses demonstrated that exposure to ACEs increased the risk of pregnancy complications and adverse pregnancy outcomes, such as gestational diabetes mellitus, antenatal depression, low offspring birth weight, and preterm delivery. The association was particularly pronounced for women with four or more ACEs.
However, it is essential to discuss some limitations of the study. Firstly, the majority of included studies were conducted in high-income western countries, which raises concerns about the generalizability of the findings to other populations. Additionally, the analysis did not consider item-specific ACEs due to a lack of data, limiting the ability to assess the impact of specific ACE types on pregnancy outcomes. Moreover, the dose-response relationship...
Dear Editor,
I am writing regarding the article titled "Adverse childhood experiences, the risk of pregnancy complications and adverse pregnancy outcomes: a systematic review and meta-analysis." I would like to provide a critical evaluation and methodological assessment of the paper.
The authors conducted a thorough systematic review and meta-analysis to explore the association between adverse childhood experiences (ACEs) and the risk of pregnancy complications and adverse pregnancy outcomes. The study's strength lies in its comprehensive search strategy, inclusion criteria, and quality assessment of the selected studies.
The meta-analysis revealed compelling findings. The pooled analyses demonstrated that exposure to ACEs increased the risk of pregnancy complications and adverse pregnancy outcomes, such as gestational diabetes mellitus, antenatal depression, low offspring birth weight, and preterm delivery. The association was particularly pronounced for women with four or more ACEs.
However, it is essential to discuss some limitations of the study. Firstly, the majority of included studies were conducted in high-income western countries, which raises concerns about the generalizability of the findings to other populations. Additionally, the analysis did not consider item-specific ACEs due to a lack of data, limiting the ability to assess the impact of specific ACE types on pregnancy outcomes. Moreover, the dose-response relationship between ACEs and adverse pregnancy outcomes couldn't be thoroughly examined due to variations in screening tools and cut-off values used across studies.
The methodological approach of the study, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines and utilizing a quality effects model for bias adjustment, enhances the reliability of the findings. The authors also acknowledge the limitations and provide a comprehensive discussion on the potential biological and psychosocial pathways connecting ACEs to adverse pregnancy outcomes.
The implications of this research are substantial. The results emphasize the need for preventive strategies, screening, and trauma-informed care to improve maternal and child health. Routine ACEs screening during pregnancy, coupled with trauma-informed approaches in clinical practice, may play a vital role in identifying at-risk women and providing appropriate support. The discussion also highlights the importance of addressing ACEs upstream through policy interventions, community-level initiatives, and efforts to create positive family and social environments.
In conclusion, the article contributes valuable insights into the relationship between ACEs and pregnancy outcomes. The strength of the study lies in its rigorous methodology and significant findings. Addressing the limitations pointed out and conducting further research in diverse populations would enhance the generalizability and impact of this important area of study. The integration of trauma-informed care and preventive measures into clinical practice can potentially lead to improved maternal and child health outcomes.
The final CRISP Statement and CRISP Checklist are published at:
Phillips WR, Sturgiss E, Glasziou P, olde Hartman TC, Orkin AM, Prathivadi P, Reeve J, Russell GM, van Weel C. Improving the reporting of primary care research: Consensus Reporting Items for Studies in Primary Care—the CRISP Statement. Annals of Family Medicine 2023, 21(6):549-555; DOI: https://doi.org/10.1370/afm.3029
We appreciate the authors for their interesting article, but we want to highlight issues regarding the interpretation and reproducibility of the research results. The key problems lie in the documentation of measurements and the reporting of essential aspects of the study.
First, the article does not provide sufficient detail on how ventilation in the participating daycare centers is implemented – whether it is mechanical, gravity-based, or reliant solely on window ventilation. Fundamental information concerning the baseline ventilation is crucial for evaluating and reproducing the study results. When assessing the effectiveness of air purification against airborne infections, it is necessary to establish 1) what is the baseline ventilation capacity which dictates the reference airborne infection risk level and 2) what is the augmented ventilation capacity after introducing air purifiers which, in turn, dictate the expected reduction in the risk level (Rehva 2020; Auvinen et al. 2022; Buonanno et al. 2022). Without knowing the baseline ventilation rates and how they differ between intervention and control groups, it is impossible to assess whether the introduced air purification improves the overall ventilation performance sufficiently to bring the risk level low enough to justify expectations for an observable improvement. After all, it is possible that even after introducing air purifiers the infection risk levels remain high nonetheless (Rehva 2023).
We appreciate the authors for their interesting article, but we want to highlight issues regarding the interpretation and reproducibility of the research results. The key problems lie in the documentation of measurements and the reporting of essential aspects of the study.
First, the article does not provide sufficient detail on how ventilation in the participating daycare centers is implemented – whether it is mechanical, gravity-based, or reliant solely on window ventilation. Fundamental information concerning the baseline ventilation is crucial for evaluating and reproducing the study results. When assessing the effectiveness of air purification against airborne infections, it is necessary to establish 1) what is the baseline ventilation capacity which dictates the reference airborne infection risk level and 2) what is the augmented ventilation capacity after introducing air purifiers which, in turn, dictate the expected reduction in the risk level (Rehva 2020; Auvinen et al. 2022; Buonanno et al. 2022). Without knowing the baseline ventilation rates and how they differ between intervention and control groups, it is impossible to assess whether the introduced air purification improves the overall ventilation performance sufficiently to bring the risk level low enough to justify expectations for an observable improvement. After all, it is possible that even after introducing air purifiers the infection risk levels remain high nonetheless (Rehva 2023).
Second, the study introduces unpredictability through variable factors such as window ventilation. Depending on opening rate, and e.g. on window placement and weather conditions, window ventilation can significantly enhance overall ventilation (Park et al. 2021). The use of window ventilation was significantly higher in the control group as reported, possibly biasing the conclusion on the effectiveness of air purifiers.
Third, the article mentions a baseline test aerosol experiment, but lacks documentation on the test conditions and results. Information on the test space size, baseline ventilation, added ventilation, and measurement configuration is essential. However, it is not reported whether or not the clean air delivery rates (CADR) used in the test scenarios were equivalent or comparable with the study conditions.
For the monitoring period, understanding the effect of designed air purifier capacity is crucial for the interpretation and reproducibility. Was the decision for the chosen air purifier capacity based on their maximum CADR (and assumed maximum noise levels) or were the purifiers operated at lower CADR for operational comfort? What was the targeted gain of the added ventilation? This directly determines the expected reduction in infection risk, and whether this is in line with the presented 15% reduction in the significance estimation? Additionally, knowing if the designed CADR capacity aligned with the actual usage is vital. While acknowledging the challenge of for example noise levels, the pandemic has seen the emergence of effective, cost-efficient, and quiet air purifiers.
To interpret the study results, documentation of the above information is necessary. Unfortunately, the manuscript offers little analysis and omits crucial pieces of information relating to the baseline risk levels and obtained risk levels after augmenting the ventilation with air purifiers. This leaves the reader with the responsibility to guess whether there ever was a good reason to expect a significant change between the test and control groups. Appeal to real-world scenarios and their complexity does not negate the need to lay down the underlying assumptions and hypothesized outcomes. Without this information and analysis, the study cannot substantiate its claim that intervention daycares had a relatively lower viral load while showing no change in infections.
References
Auvinen, Mikko, Joel Kuula, Tiia Grönholm, Matthias Sühring, and Antti Hellsten. 2022. “High-Resolution Large-Eddy Simulation of Indoor Turbulence and Its Effect on Airborne Transmission of Respiratory Pathogens-Model Validation and Infection Probability Analysis.” Physics of Fluids (Woodbury, N.Y.: 1994) 34 (1): 015124.
Buonanno, Giorgio, Luca Ricolfi, Lidia Morawska, and Luca Stabile. 2022. “Increasing Ventilation Reduces SARS-CoV-2 Airborne Transmission in Schools: A Retrospective Cohort Study in Italy’s Marche Region.” Frontiers in Public Health 10 (December): 1087087.
Park, Sowoo, Younhee Choi, Doosam Song, and Eun Kyung Kim. 2021. “Natural Ventilation Strategy and Related Issues to Prevent Coronavirus Disease 2019 (COVID-19) Airborne Transmission in a School Building.” The Science of the Total Environment 789 (October): 147764.
Rehva. 2020. “COVID-19 Guidance Document: How to Operate HVAC and Other Building Service Systems to Prevent the Spread of the Coronavirus (SARS-CoV-2) Disease ….” Federation of European Heating, Ventilation and Air Conditioning Associations. https://www.rehva.eu/fileadmin/user_upload/REHVA_COVID-19_guidance_docum....
Rehva. 2023. “Health-Based Target Ventilation Rates and Design Method for Reducing Exposure to Airborne Respiratory Infectious Diseases.” Rehva - Federation of European Heating, Ventilation and Air Conditioning Associations. https://www.rehva.eu/activities/post-covid-ventilation.
The authors have conducted a thorough analysis of the existing literature on this crucial topic and have provided valuable insights into the effectiveness of various interventions for improving mental health outcomes among adolescents in sub-Saharan Africa (SSA).
The systematic review employed the Grades of Recommendation, Assessment, Development, and Evaluation approach, ensuring a robust evaluation of the evidence. The researchers conducted a comprehensive search across multiple databases, including Cochrane Library, MEDLINE, EMBASE, PSYCINFO, and Web of Science, and identified 30 studies for inclusion in the review.
The findings of this review highlight the significance of multi-level interventions in addressing mental health disorders among adolescents in SSA. The synthesis of the studies revealed that interventions comprising economic empowerment, peer support, and cognitive behavioral therapy (CBT) were particularly effective in improving mental health outcomes among vulnerable adolescents. Moreover, community-level interventions delivered to community groups demonstrated significant positive changes in mental health outcomes.
While the results of this review are promising, the authors acknowledge the need for further research to understand the reliability and sustainability of these interventions in different African contexts. They rightfully point out the variability in intervention components and study participants among the included studies, emp...
The authors have conducted a thorough analysis of the existing literature on this crucial topic and have provided valuable insights into the effectiveness of various interventions for improving mental health outcomes among adolescents in sub-Saharan Africa (SSA).
The systematic review employed the Grades of Recommendation, Assessment, Development, and Evaluation approach, ensuring a robust evaluation of the evidence. The researchers conducted a comprehensive search across multiple databases, including Cochrane Library, MEDLINE, EMBASE, PSYCINFO, and Web of Science, and identified 30 studies for inclusion in the review.
The findings of this review highlight the significance of multi-level interventions in addressing mental health disorders among adolescents in SSA. The synthesis of the studies revealed that interventions comprising economic empowerment, peer support, and cognitive behavioral therapy (CBT) were particularly effective in improving mental health outcomes among vulnerable adolescents. Moreover, community-level interventions delivered to community groups demonstrated significant positive changes in mental health outcomes.
While the results of this review are promising, the authors acknowledge the need for further research to understand the reliability and sustainability of these interventions in different African contexts. They rightfully point out the variability in intervention components and study participants among the included studies, emphasizing the importance of scaling up these interventions and evaluating their long-term impact.
One noteworthy aspect of the review is the focus on individual needs when designing interventions for highly vulnerable populations, such as adolescents affected by HIV, war-affected adolescents, and orphans. Engaging young people in the development of these interventions can help ensure their relevance and effectiveness. However, the authors also stress the limited application of youth engagement approaches in SSA and advocate for its increased utilization.
The review highlights the varied nature of community-level interventions, with economic empowerment interventions, family coaching or parenting interventions, and theory-based interventions such as CBT and interpersonal therapy (IPT) being particularly effective. Schools are identified as favorable settings for implementing interventions relevant to adolescents, and previous research supports the integration of school-based mental health interventions into education programs. Nonetheless, it is essential to avoid excluding out-of-school youth by overly targeting efforts on school settings. Peer-led community-based and digital mental health interventions, including internet-based CBT, are presented as potential solutions to reach a broader range of young people.
However, there are some limitations to consider in this review. The reliance on published studies and the exclusion of unpublished and qualitative studies may have resulted in some valuable evidence being overlooked. The heterogeneity in intervention components, study participants, and duration prevented the reporting of summary effect measures. Additionally, the absence of studies focusing on individual-level interventions restricted the ability to compare them with multi-level interventions. The age range limitation to adolescents aged 10-24 years may have also excluded important information.
In conclusion, this systematic review provides compelling evidence for the effectiveness of multi-level interventions in improving mental health outcomes among young people in SSA. The authors recommend combining individual-level and community or family-level interventions, tailoring them to the specific needs of adolescents. Economic empowerment, peer support, and CBT interventions have demonstrated positive results, either when delivered alone or in combination with other interventions.
However, further research is needed to replicate these promising interventions in different settings and ascertain their long-term effects and reliability under varied circumstances. Preventive interventions focused on universal mental health in SSA, such as economic empowerment and family strengthening interventions, are deemed crucial for reducing the social determinants of poor mental health in adolescents.
Overall, this review enhances our understanding of mental health interventions for adolescents and emphasizes the importance of addressing mental health in SSA's vulnerable youth population. It serves as a valuable resource for researchers, practitioners, and policymakers working towards supporting the mental well-being of young people in sub-Saharan Africa.
Eine interessante Studie mit einem klaren Ergebnis
Zur Schlußfolgerung: "Es ist bekannt, dass die Ansteckung hauptsächlich über den direkten Luftaustausch von Angesicht zu Angesicht während des Spiels erfolgt und dass die kontaminierte Luft nicht unbedingt vor dem Luftaustausch zwischen Kindern durch den Filter strömt. Die Verwendung von HEPA-Filtern kann auch zu einem Sicherheitsgefühl führen, was zu einem verringerten vorbeugenden Verhalten führt."
Die Studie enthält keine Untersuchung über den Verhaltensvergleich in den Kindergärten der zwei Kohorten (Mit/Ohne Filter).
Insofern vermisse ich in der Schlußfolgerung diese Aussage als eine Vermutung kenntlich zu machen.
Ich finde, daß "Ergebnis" und "Schlußfolgerung" zwei verschiedene Themen sind. Die Schlußfolgerung müßte meines Erachtens lauten: HEPA Filter bringen keinen Vorteil.
Ich finde die Schlußfolgerung eher in Brosa formuliert und somit abweichend vom vorhergehenden Text der Studie. Für mich macht dies die Qualität der Studie zunichte wenn Vermutungen angestellt werden welche nicht Umfang der Studie waren. Mithin viele Studien nur nach Abstrakt, Ergebnis & Schlußfolgerung lesen.
Wenn die Studienverfasser einen Beweis nahelegen, dann muß das Verhalten der Kinder in den Kohorten überprüft und nachgewiesen werden.
We appreciate the interest and questions posed by Professor Richards regarding the FORGE trial. The PREVENTT trial was a well-designed and executed trial, however the primary limitation of the trial is the “Two-week rule” described by the author in their letter and discussed in our introduction. It is well known that the biochemical response to all iron replacement improves with time, with most studies noting a larger response at 3 to 4 weeks post infusion[1,2]. In the PREVENTT study, the median time from infusion to surgery was 14 days in the iron infusion group, with an interquartile range (IQR) of 12-21 days. This is perhaps an explanation as to why the study demonstrated a hemoglobin increase of only 4.7g/L while other studies with median time from infusion to surgery demonstrated greater responses[1]. The study by Derman and colleagues found that at 2 weeks only 30% of patients obtained an increase of hemoglobin concentration greater than 20g/L in response to IV ferric derisomaltose (FDI), while at 3 weeks this increased to nearly 50% of patients[2]. Similarly, the work by Froessler and colleagues in 2016 found only an 8g/L difference in hemoglobin when IV iron (ferric carboxymaltose) was administered a median of 8 days (IQR 6-13 days) prior to surgery[3].
Although expedited surgery for malignancies is often the ideal, in many jurisdictions, this is not feasible, or advisable based on patient, disease, and health system factors. The COVID-19 pandemic afforded a...
We appreciate the interest and questions posed by Professor Richards regarding the FORGE trial. The PREVENTT trial was a well-designed and executed trial, however the primary limitation of the trial is the “Two-week rule” described by the author in their letter and discussed in our introduction. It is well known that the biochemical response to all iron replacement improves with time, with most studies noting a larger response at 3 to 4 weeks post infusion[1,2]. In the PREVENTT study, the median time from infusion to surgery was 14 days in the iron infusion group, with an interquartile range (IQR) of 12-21 days. This is perhaps an explanation as to why the study demonstrated a hemoglobin increase of only 4.7g/L while other studies with median time from infusion to surgery demonstrated greater responses[1]. The study by Derman and colleagues found that at 2 weeks only 30% of patients obtained an increase of hemoglobin concentration greater than 20g/L in response to IV ferric derisomaltose (FDI), while at 3 weeks this increased to nearly 50% of patients[2]. Similarly, the work by Froessler and colleagues in 2016 found only an 8g/L difference in hemoglobin when IV iron (ferric carboxymaltose) was administered a median of 8 days (IQR 6-13 days) prior to surgery[3].
Although expedited surgery for malignancies is often the ideal, in many jurisdictions, this is not feasible, or advisable based on patient, disease, and health system factors. The COVID-19 pandemic afforded an opportunity to assess and standardize timeframes for surgery for gynecologic oncology. Our health system, in line with The Society of Gynecologic Oncology guidelines, has targeted surgery for the majority of gynecologic malignancies within a 4-week time frame[4]. This affords an opportunity for patient optimization, which we hope to explore in FORGE. With our listed inclusion criteria of 21 day minimum from time to surgery, nearly three quarters of the patients from PREVENTT would not be eligible. As this is a pilot trial, we hope to demonstrate that in our population, and with sufficient time for onset of action, that FDI can be feasibly administered to these patients in this window of opportunity, with subsequent trials planned and powered for patient-centered outcomes including those suggested by the secondary results of the PREVENTT study.
Regarding the dosage of ferric derisomaltose, the regulatory approval from FDI in Canada for simplified fixed dosing based on patient weight is a maximum of 1000mg with reassessment in 4 weeks with a recommendation that a single dose not exceed 1500mg. This also coincides with the dose used in the PREVENTT trial and although the improved response found by Keeler and colleagues may be related solely to an increased dose of iron, the other studies listed above as well as the FERWON-IDA trial by Auerbach and colleagues would suggest that a sufficient (>10g/L) response can be obtained at 21 days from 1000mg of FDI[5]. As a pilot/feasibility study, FORGE will assess clinical and laboratory effects of repletion of iron stores in the perioperative course and will yield information as to whether further iron repletion/redosing might be needed in subsequent studies.
Based on the results of PREVENTT many have questioned the usefulness of preoperative iron infusions, suggesting instead postoperative treatment. Our goal, as a mature Enhanced Recovery After Surgery program[7] is to improve surgical outcomes for our patients; providing patients with proven iron deficiency with timely iron repletion has the potential to improve their surgical outcomes beyond improving hemoglobin concentration and rates of allogenic blood transfusion alone. The FORGE trial has the potential to clarify the role of preoperative iron repletion in the gynecologic oncology population prior to abandoning the practice entirely, as has been suggested following the results of the PREVENTT study[8,9]. Furthermore, Professor Richards suggested this line of research in the reference provided “Other future trials might examine particular diagnoses, such as surgery for cancer, and focus on cancer outcomes, such as tolerance on adjuvant treatment or patient-reported outcomes, as well as rate of recurrence” in addition to suggesting further studies on postoperative and patient-reported outcomes[9]. We hope that the FORGE trial can answer some of these unanswered questions.
[1] Keeler BD, Simpson JA, Ng O, Padmanabhan H, Brookes MJ, Acheson AG, et al. Randomized clinical trial of preoperative oral versus intravenous iron in anaemic patients with colorectal cancer. Br J Surg 2017;104:214–21. https://doi.org/10.1002/bjs.10328.
[2] Derman R, Roman E, Modiano MR, Achebe MM, Thomsen LL, Auerbach M. A randomized trial of iron isomaltoside versus iron sucrose in patients with iron deficiency anemia. Am J Hematol 2017;92:286–91. https://doi.org/10.1002/ajh.24633.
[3] Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The important role for intravenous iron in perioperative patient blood management in major abdominal surgery. Ann Surg 2016;264:41–6. https://doi.org/10.1097/SLA.0000000000001646.
[4] Fader AN, Huh WK, Kesterson J, Pothuri B, Wethington S, Wright JD, et al. When to Operate, Hesitate and Reintegrate: Society of Gynecologic Oncology Surgical Considerations during the COVID-19 Pandemic. Gynecol Oncol 2020;158:236–43. https://doi.org/10.1016/j.ygyno.2020.06.001.
[5] Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Am J Hematol 2019;94:1007–14. https://doi.org/10.1002/ajh.25564.
[6] Wolf M, Rubin J, Achebe M, Econs MJ, Peacock M, Imel EA, et al. Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials. JAMA - J Am Med Assoc 2020;323:432–43. https://doi.org/10.1001/jama.2019.22450.
[7] Bisch SP, Wells T, Gramlich L, Faris P, Wang X, Tran DT, et al. Enhanced Recovery After Surgery (ERAS) in gynecologic oncology: System-wide implementation and audit leads to improved value and patient outcomes. Gynecol Oncol 2018;151:117–23. https://doi.org/10.1016/j.ygyno.2018.08.007.
[8] Miles LF. The end of the beginning: pre‐operative intravenous iron and the PREVENTT trial. Anaesthesia 2021;76:6–10. https://doi.org/10.1111/anae.15268.
[9] Richards T, Baikady RR, Clevenger B, Butcher A, Abeysiri S, Chau M, et al. Preoperative intravenous iron for anaemia in elective major open abdominal surgery: the PREVENTT RCT. Health Technol Assess (Rockv) 2021;25:1–58. https://doi.org/10.3310/hta25110.
Dear Editor,
Thank you for drawing our attention to this rapid response by Condon L, which was published on the 6th December 2023.
In response to the author’s comments on the inclusion of one of her studies - (Reference #52: Condon L, Rhodes C, Warren S, et al. ‘But is it a normal thing?’ Teenage mothers’ experiences of breastfeeding promotion and support. Health Education Journal 2013; 72: 156–62) in our review. We will take each point in turn.
Comment: It is unclear why our article has been included in this systematic review. In their Methods section, Malouf et al. describe their study selection criteria as follows: “‘Studies were eligible for inclusion if they involved women with low-risk pregnancies [...] and gave birth in hospitals or birth centres in the UK’. Our study explored experiences of breastfeeding promotion and support among pregnant teenagers and teenage mothers, and does not provide information about risk in pregnancy or place of birth. Our study therefore does not meet the eligibility criteria and should not have been included.
Response: We have clearly stated our approach to the eligibility criteria highlighted by Condon in our strengths and limitations sections:
Show More‘Although we set out to review the literature relating to postnatal care for women at low risk of complications to explore routine practice, this was not always possible. Most of the studies reported results undifferentiated by risk and without excluding those wom...
Dear Editor,
RE. Penicillin allergy status and its effect on antibiotic prescribing, patient outcomes and antimicrobial resistance (ALABAMA): protocol for a multicentre, parallel-arm, open-label, randomised pragmatic trial. https://bmjopen.bmj.com/content/13/9/e072253
The issue of incorrect penicillin allergy records and their impact on antibiotic prescribing remains an internationally important issue that lacks randomised controlled trials to guide optimal management.
Since submission of this protocol paper, the funder (UK National Institute for Health and Care Research Programme Grants for Applied Research) has undertaken a review of trial progress and decided not to provide additional funds to compensate for slow recruitment caused by COVID-19. Although a steady rate of recruitment was achieved during the pandemic, it was not at the rate anticipated pre-COVID-19. The funder recognised the value of the trial but maintained that the financial climate has changed within the context of the UK Department of Health and Social Care’s wider ‘Research Reset’ initiative. As a result of this funding review a revised primary trial outcome has been agreed. This will allow us to provide a powered study with a revised (reduced) sample size.
NHS Research Ethics Committee and Health Research Authority approval has been granted for the protocol amendment outlined in this correspondence and clinical tri...
Show MoreThe author team would like to inform the readers of a recent amendment to the original protocol as published here.
The ARON trial was planned before the COVID-19 pandemic. Though, the trial actually started in the initial part of the pandemic, just as the Delta variant (second wave) was first emerging in early 2021. The ARON trial kept going through all subsequent COVID-19 waves and is currently still ongoing. The COVID-19 pandemic has shown that antibiotic prescribing has (for the better) declined during the pandemic, as shown by several studies and reports:
- Gillies, MB, Burgner, DP, Ivancic, L, et al. Changes in antibiotic prescribing following COVID-19 restrictions: Lessons for post-pandemic antibiotic stewardship. Br J Clin Pharmacol. 2022; 88( 3): 1143- 1151.
- https://www.ecdc.europa.eu/en/news-events/reported-decrease-antibiotic-c...
- Colliers, A.; De Man, J.; Adriaenssens, N.; Verhoeven, V.; Anthierens, S.; De Loof, H.; Philips, H.; Coenen, S.; Morreel, S. Antibiotic Prescribing Trends in Belgian Out-of-Hours Primary Care during the COVID-19 Pandemic: Observational Study Using Routinely Collected Health Data. Antibiotics 2021, 10, 1488. https://doi.org/ 10.3390/antibiotics10121488
This has urged us to revise our sample size calculation, based on the overall prevalence...
Show MoreDear Editor,
I am the lead author of an article cited in this systematic review (Reference #52: Condon L, Rhodes C, Warren S, et al. ‘But is it a normal thing?’ Teenage mothers’ experiences of breastfeeding promotion and support. Health Education Journal 2013;72:156–62.) and would like to draw your attention to the inaccurate and misleading way in which the authors have presented our work.
It is unclear why our article has been included in this systematic review. In their Methods section, Malouf et al. describe their study selection criteria as follows: “‘Studies were eligible for inclusion if they involved women with low-risk pregnancies [...] and gave birth in hospitals or birth centres in the UK’. Our study explored experiences of breastfeeding promotion and support among pregnant teenagers and teenage mothers, and does not provide information about risk in pregnancy or place of birth. Our study therefore does not meet the eligibility criteria and should not have been included.
The erroneous inclusion of our article leads the authors to make inaccurate claims about the quality of our study. In Table 2, Malouf et al. list the characteristics of qualitative studies included in their review. For our study, the ‘Sample characteristics’ column states that details were not reported for the postnatal sample. This is misleading, as Table 1 of our article presents the characteristics for our overall sample of teenage mothers and pregnant teenagers; however,...
Show MoreDear Editor,
Show MoreI am writing regarding the article titled "Adverse childhood experiences, the risk of pregnancy complications and adverse pregnancy outcomes: a systematic review and meta-analysis." I would like to provide a critical evaluation and methodological assessment of the paper.
The authors conducted a thorough systematic review and meta-analysis to explore the association between adverse childhood experiences (ACEs) and the risk of pregnancy complications and adverse pregnancy outcomes. The study's strength lies in its comprehensive search strategy, inclusion criteria, and quality assessment of the selected studies.
The meta-analysis revealed compelling findings. The pooled analyses demonstrated that exposure to ACEs increased the risk of pregnancy complications and adverse pregnancy outcomes, such as gestational diabetes mellitus, antenatal depression, low offspring birth weight, and preterm delivery. The association was particularly pronounced for women with four or more ACEs.
However, it is essential to discuss some limitations of the study. Firstly, the majority of included studies were conducted in high-income western countries, which raises concerns about the generalizability of the findings to other populations. Additionally, the analysis did not consider item-specific ACEs due to a lack of data, limiting the ability to assess the impact of specific ACE types on pregnancy outcomes. Moreover, the dose-response relationship...
The final CRISP Statement and CRISP Checklist are published at:
Phillips WR, Sturgiss E, Glasziou P, olde Hartman TC, Orkin AM, Prathivadi P, Reeve J, Russell GM, van Weel C. Improving the reporting of primary care research: Consensus Reporting Items for Studies in Primary Care—the CRISP Statement. Annals of Family Medicine 2023, 21(6):549-555; DOI: https://doi.org/10.1370/afm.3029
We appreciate the authors for their interesting article, but we want to highlight issues regarding the interpretation and reproducibility of the research results. The key problems lie in the documentation of measurements and the reporting of essential aspects of the study.
First, the article does not provide sufficient detail on how ventilation in the participating daycare centers is implemented – whether it is mechanical, gravity-based, or reliant solely on window ventilation. Fundamental information concerning the baseline ventilation is crucial for evaluating and reproducing the study results. When assessing the effectiveness of air purification against airborne infections, it is necessary to establish 1) what is the baseline ventilation capacity which dictates the reference airborne infection risk level and 2) what is the augmented ventilation capacity after introducing air purifiers which, in turn, dictate the expected reduction in the risk level (Rehva 2020; Auvinen et al. 2022; Buonanno et al. 2022). Without knowing the baseline ventilation rates and how they differ between intervention and control groups, it is impossible to assess whether the introduced air purification improves the overall ventilation performance sufficiently to bring the risk level low enough to justify expectations for an observable improvement. After all, it is possible that even after introducing air purifiers the infection risk levels remain high nonetheless (Rehva 2023).
Sec...
Show MoreThe authors have conducted a thorough analysis of the existing literature on this crucial topic and have provided valuable insights into the effectiveness of various interventions for improving mental health outcomes among adolescents in sub-Saharan Africa (SSA).
Show MoreThe systematic review employed the Grades of Recommendation, Assessment, Development, and Evaluation approach, ensuring a robust evaluation of the evidence. The researchers conducted a comprehensive search across multiple databases, including Cochrane Library, MEDLINE, EMBASE, PSYCINFO, and Web of Science, and identified 30 studies for inclusion in the review.
The findings of this review highlight the significance of multi-level interventions in addressing mental health disorders among adolescents in SSA. The synthesis of the studies revealed that interventions comprising economic empowerment, peer support, and cognitive behavioral therapy (CBT) were particularly effective in improving mental health outcomes among vulnerable adolescents. Moreover, community-level interventions delivered to community groups demonstrated significant positive changes in mental health outcomes.
While the results of this review are promising, the authors acknowledge the need for further research to understand the reliability and sustainability of these interventions in different African contexts. They rightfully point out the variability in intervention components and study participants among the included studies, emp...
Eine interessante Studie mit einem klaren Ergebnis
Zur Schlußfolgerung: "Es ist bekannt, dass die Ansteckung hauptsächlich über den direkten Luftaustausch von Angesicht zu Angesicht während des Spiels erfolgt und dass die kontaminierte Luft nicht unbedingt vor dem Luftaustausch zwischen Kindern durch den Filter strömt. Die Verwendung von HEPA-Filtern kann auch zu einem Sicherheitsgefühl führen, was zu einem verringerten vorbeugenden Verhalten führt."
Die Studie enthält keine Untersuchung über den Verhaltensvergleich in den Kindergärten der zwei Kohorten (Mit/Ohne Filter).
Insofern vermisse ich in der Schlußfolgerung diese Aussage als eine Vermutung kenntlich zu machen.
Ich finde, daß "Ergebnis" und "Schlußfolgerung" zwei verschiedene Themen sind. Die Schlußfolgerung müßte meines Erachtens lauten: HEPA Filter bringen keinen Vorteil.
Ich finde die Schlußfolgerung eher in Brosa formuliert und somit abweichend vom vorhergehenden Text der Studie. Für mich macht dies die Qualität der Studie zunichte wenn Vermutungen angestellt werden welche nicht Umfang der Studie waren. Mithin viele Studien nur nach Abstrakt, Ergebnis & Schlußfolgerung lesen.
Wenn die Studienverfasser einen Beweis nahelegen, dann muß das Verhalten der Kinder in den Kohorten überprüft und nachgewiesen werden.
We appreciate the interest and questions posed by Professor Richards regarding the FORGE trial. The PREVENTT trial was a well-designed and executed trial, however the primary limitation of the trial is the “Two-week rule” described by the author in their letter and discussed in our introduction. It is well known that the biochemical response to all iron replacement improves with time, with most studies noting a larger response at 3 to 4 weeks post infusion[1,2]. In the PREVENTT study, the median time from infusion to surgery was 14 days in the iron infusion group, with an interquartile range (IQR) of 12-21 days. This is perhaps an explanation as to why the study demonstrated a hemoglobin increase of only 4.7g/L while other studies with median time from infusion to surgery demonstrated greater responses[1]. The study by Derman and colleagues found that at 2 weeks only 30% of patients obtained an increase of hemoglobin concentration greater than 20g/L in response to IV ferric derisomaltose (FDI), while at 3 weeks this increased to nearly 50% of patients[2]. Similarly, the work by Froessler and colleagues in 2016 found only an 8g/L difference in hemoglobin when IV iron (ferric carboxymaltose) was administered a median of 8 days (IQR 6-13 days) prior to surgery[3].
Although expedited surgery for malignancies is often the ideal, in many jurisdictions, this is not feasible, or advisable based on patient, disease, and health system factors. The COVID-19 pandemic afforded a...
Show MorePages