The effect of Thiazolidinedione therapy on the risk of Parkinson’s disease is controversial. One article by Wu and colleagues in Taiwan reported that pioglitazone use was not associated with the risk of Parkinson’s disease in people with diabetes mellitus (hazard ratio 0.90, 95% CI 0.68-1.18).1 To the contrary, another article by Lin and colleagues in Taiwan reported that thiazolidinedione use was associated with a 60% reduced risk of Parkinson’s disease in people with diabetes mellitus.2 Similarly, conflicting results were also found in Western countries.3,4 There was no measure of the hemoglobin A1c in the above studies. We cannot determine whether the risk of Parkinson’s disease is associated with good glycemic control or poor control among people on thiazolidinedione therapy. Therefore, any study exploring the association between anti-diabetic medications and Parkinson’s disease should estimate the hemoglobin A1c levels.
Theoretically, a study should be designed to compare people on thiazolidinedione therapy only with those people not taking any medication. However, according to the recommendation of the American Diabetes Association, metformin is the first-line therapy for type 2 diabetes mellitus.5 People with diabetes mellitus usually take metformin alone or use combined therapy with other anti-diabetic medications. Thiazolidinedione is usually recommended as combined therapy with metformin for type 2 diabetes mellitus. So it is difficult to identify peo...
The effect of Thiazolidinedione therapy on the risk of Parkinson’s disease is controversial. One article by Wu and colleagues in Taiwan reported that pioglitazone use was not associated with the risk of Parkinson’s disease in people with diabetes mellitus (hazard ratio 0.90, 95% CI 0.68-1.18).1 To the contrary, another article by Lin and colleagues in Taiwan reported that thiazolidinedione use was associated with a 60% reduced risk of Parkinson’s disease in people with diabetes mellitus.2 Similarly, conflicting results were also found in Western countries.3,4 There was no measure of the hemoglobin A1c in the above studies. We cannot determine whether the risk of Parkinson’s disease is associated with good glycemic control or poor control among people on thiazolidinedione therapy. Therefore, any study exploring the association between anti-diabetic medications and Parkinson’s disease should estimate the hemoglobin A1c levels.
Theoretically, a study should be designed to compare people on thiazolidinedione therapy only with those people not taking any medication. However, according to the recommendation of the American Diabetes Association, metformin is the first-line therapy for type 2 diabetes mellitus.5 People with diabetes mellitus usually take metformin alone or use combined therapy with other anti-diabetic medications. Thiazolidinedione is usually recommended as combined therapy with metformin for type 2 diabetes mellitus. So it is difficult to identify people on thiazolidinedione therapy alone without using metformin in a study using claim data. Whether the medication effect on the risk of Parkinson’s disease is associated with thiazolidinedione alone or metformin-thiazolidinedione combination should be addressed in future studies. Currently, there is no definite evidence to prove thiazolidinedione having a neuroprotective effect against the development of Parkinson’s disease.
Contributors
Shih-Wei Lai contributed to the conception of the article and initiated the draft of the article.
Competing interests
The author report no conflicts of interest.
REFERENCES
1. Wu HF, Kao LT, Shih JH, et al. Pioglitazone use and Parkinson's disease: a retrospective cohort study in Taiwan. BMJ Open 2018;8:2018-023302.
2. Lin HL, Lin HC, Tseng YF, Chao JC, Hsu CY. Association of thiazolidinedione with a lower risk of Parkinson's disease in a population with newly-diagnosed diabetes mellitus. Ann Med 2018;50:430-6.
3. Connolly JG, Bykov K, Gagne JJ. Thiazolidinediones and Parkinson Disease: A Cohort Study. Am J Epidemiol 2015;182:936-44.
4. Brakedal B, Flones I, Reiter SF, et al. Glitazone use associated with reduced risk of Parkinson's disease. Mov Disord 2017;32:1594-9.
5. Pharmacologic Approaches to Glycemic Treatment. Diabetes Care 2017;40:S64-S74.
The Editor of BMJ Open has received the comments from Albert Donnay on this paper. The authors of the paper have been contacted and have been asked to provide a response.
We read with interest the paper by Hansen et al1 and commend the authors on their work, however we would like to point out some significant limitations of the study
First, it is unclear whether the reported deaths are related to arrhythmic events resulting from QT prolongation or any other cause. While it is intuitive to that patients with abnormal heart tracings or underlying channelopathies are at a higher risk of death compared to healthy individuals, the association demonstrated in this study is far from causation. Additionally, the authors do not report pertinent clinical information such as electrolyte imbalances or the use of medications know to prolong the QT interval. Such preventable and reversible causes of QT prolongation theoretically should not affect 30-day mortality if adequately addressed. Finally, despite the use of the term “transnational” in title of the paper, patients included are from four different hospitals located in close geographical area and are likely more genetically homogenous than patients in single urban teaching hospital in a major US city. Thus the absence of demographic data severely limits the applicability of their findings to a global environment.
In conclusion, while this topic is of significant interest, methodological and analytical flaws limit the validity and applicability of the authors’ conclusions.
1-Schade Hansen C, Pottegård A, Ekelund U, et al. Association between QTc prolongati...
We read with interest the paper by Hansen et al1 and commend the authors on their work, however we would like to point out some significant limitations of the study
First, it is unclear whether the reported deaths are related to arrhythmic events resulting from QT prolongation or any other cause. While it is intuitive to that patients with abnormal heart tracings or underlying channelopathies are at a higher risk of death compared to healthy individuals, the association demonstrated in this study is far from causation. Additionally, the authors do not report pertinent clinical information such as electrolyte imbalances or the use of medications know to prolong the QT interval. Such preventable and reversible causes of QT prolongation theoretically should not affect 30-day mortality if adequately addressed. Finally, despite the use of the term “transnational” in title of the paper, patients included are from four different hospitals located in close geographical area and are likely more genetically homogenous than patients in single urban teaching hospital in a major US city. Thus the absence of demographic data severely limits the applicability of their findings to a global environment.
In conclusion, while this topic is of significant interest, methodological and analytical flaws limit the validity and applicability of the authors’ conclusions.
1-Schade Hansen C, Pottegård A, Ekelund U, et al. Association between QTc prolongation and mortality in patients with suspected poisoning in the emergency department: a transnational propensity score matched cohort study. BMJ Open 2018;8:e020036. doi:10.1136/ bmjopen-2017-020036
Thank you for your response...The first step to change is raising awareness I think a powerful next motivator might be sufficient funding to get the work done well! The value of reporting PPI is to increase good methods and reproducibility. It is a challenge to learn any new form of reporting for research. When RCTs, statistics and epidemiology were first introduced they were not well reported or funding, it does take time. You touch on an interesting point in terms of funding. We could ask if researchers are granted sufficient dedicated PPI funding to deliver training and impact.
"If user involvement remains an international policy imperative with little if any support at the vital stage of bid development, policy‐makers, service user organizations, researchers, health service providers and commissioners will need to recognize the limited nature of involvement that may result and the impact this would have on the evidence base. Researchers will need to recognize the resource implications of involvement at this point, and user groups will need to decide whether to participate when there is the greatest chance of influencing research but little or no funding (p. 175)"
This was a quote from 2007 and the question is still open!
Staniszewska S, Jones N, Newburn M, Marshall S. User involvement in the development of research bid: barriers, enablers and impacts. Health Expectations, 2007; 10: 173–183. [PubMed]
In the study of Huang C, et al. on BMJ Open 2018;8:e018070. doi:10.1136/bmjopen-2017-018070: “ MicroRNA-17 and the prognosis of human carcinomas: a systematic review and meta-analysis” the manuscript from Robaina et al. entitled “miR-17-92 cluster components analysis in Burkitt lymphoma: overexpression of miR-17 is associated with poor prognosis. Ann Hematol 2016;95:881–91.” was mentioned (citation number 38). We would like to point out some mistakes regarding the citation of our study as below:
1.Table 1 on page 4, the assay performed in our study was quantitative RT-PCR (q-PCR) instead of ISH assay as described on the table 1 and 2 of the Huang et al. publication. The same mistake is observed on the figure 3 C.
2. Discussion on page 7: The sentence: In the subgroup analysis, we found that the potential heterogeneity may have originated from the Caucasian group in the study conducted by Robaina et al.38 Unlike the commonly used RT-PCR, ISH technique was used to detect miR-17 .
There is a great misunderstanding on this sentence. Neither our Brazilian patients were classified by race as " Caucasian ", nor the analysis of miR-17 expression levels in our study was performed by ISH. All the assays were performed by qRT-PCR.
It is important to mention that the term " Caucasian " is not applied in Brazilian for race/ethnicity classification. The Brazilian population is formed by extensive admixture from three different ances...
In the study of Huang C, et al. on BMJ Open 2018;8:e018070. doi:10.1136/bmjopen-2017-018070: “ MicroRNA-17 and the prognosis of human carcinomas: a systematic review and meta-analysis” the manuscript from Robaina et al. entitled “miR-17-92 cluster components analysis in Burkitt lymphoma: overexpression of miR-17 is associated with poor prognosis. Ann Hematol 2016;95:881–91.” was mentioned (citation number 38). We would like to point out some mistakes regarding the citation of our study as below:
1.Table 1 on page 4, the assay performed in our study was quantitative RT-PCR (q-PCR) instead of ISH assay as described on the table 1 and 2 of the Huang et al. publication. The same mistake is observed on the figure 3 C.
2. Discussion on page 7: The sentence: In the subgroup analysis, we found that the potential heterogeneity may have originated from the Caucasian group in the study conducted by Robaina et al.38 Unlike the commonly used RT-PCR, ISH technique was used to detect miR-17 .
There is a great misunderstanding on this sentence. Neither our Brazilian patients were classified by race as " Caucasian ", nor the analysis of miR-17 expression levels in our study was performed by ISH. All the assays were performed by qRT-PCR.
It is important to mention that the term " Caucasian " is not applied in Brazilian for race/ethnicity classification. The Brazilian population is formed by extensive admixture from three different ancestral roots: Amerindians, Europeans and Africans. For more details see (Pena SD, Di Pietro G, Fuchshuber-Moraes M, et al. PLoS One. 2011 F;6 (2):e17063. In addition, The Instituto Brasileiro de Geografia e Estatıstica (IBGE) classifies the racial groups in Brazil by self-report as White (‘‘branca’’), Brown (‘‘parda’’), Black (‘‘preta’’), Yellow (“amarela”) and Indigenous (‘‘indigena”), based on a subjective phenotypic evaluation according to the skin pigmentation, and also hair pigmentation and type, eye melanization and facial features such as nose and lip shape. See details in IBGE:https://www.ibge.gov.br/.
Thus, the correction of the online article version is required because the results presented by Huang et al. on BMJ Open provided incorrect information of our study.
It would be satisfying if all papers gave a summary of the part played by PPI in the work. It is clear that they do not, despite it being editorial policy to seek it. We may conclude that either PPI does not occur to the extent foreseen, or that the authors do not rate it highly reportable in comparison to the rest of the content. Given the increased requirement to build PPI into grant applications, it seems likely that it is the second scenario that is predominant, and this leads to a consideration of the authors' motivation in writing. Ideally, the prime mover would be the altruism of wishing to get knowledge or a change in practice into the public arena, where it will have the greatest chance of creating patient benefit. Then would come the personal spur of academic reputation and all that follows from that. Maybe an up-coming REF exercise is being thought about in some cases. Whatever these motivations are, PPI appears to have no place among them, except that good manners require it should be acknowledged, along with other help received. If reporting PPI has no discernible utility, it will not generally happen without an enforceable requirement.
We would like to congratulate de Groot et al. for having performed this cost of illness study regarding hypoglycaemic events in insulin-treated diabetic patients in the Netherlands, which is a great step forward to a broader perspective on the hypoglycaemic burden specifically for the Netherlands [1]. In this study, Groot et al. use data from self-assessment questionnaires in type 1 (T1DM) and type 2 diabetes mellitus (T2DM) patients in the Netherlands during a 4-week follow up period, to assess the costs of hypoglycaemic events. The article sheds light on the substantial impact which direct and indirect costs related to hypoglycaemia have on the total economic burden of diabetes. Accordingly, the study suggests that preventing hypoglycaemia can lead to an increase in quality of life, but also lead to a reduction in DM-related health care costs. We would like to elaborate on the results of this study to stimulate debate, and encourage further research.
Using self-reported data on hypoglycaemic events due to insulin treatment, de Groot et al. estimated that the total annual costs of hypoglycaemia, lies between a range of €112.5 million to €590.8 million in the Netherlands. Further research could support the conclusions reached in this study, for example, using alternative sources and methods to estimate costs. In addition, further research could be conducted on the incidence and frequency of hypoglycaemia and its potential consequences. To furthe...
We would like to congratulate de Groot et al. for having performed this cost of illness study regarding hypoglycaemic events in insulin-treated diabetic patients in the Netherlands, which is a great step forward to a broader perspective on the hypoglycaemic burden specifically for the Netherlands [1]. In this study, Groot et al. use data from self-assessment questionnaires in type 1 (T1DM) and type 2 diabetes mellitus (T2DM) patients in the Netherlands during a 4-week follow up period, to assess the costs of hypoglycaemic events. The article sheds light on the substantial impact which direct and indirect costs related to hypoglycaemia have on the total economic burden of diabetes. Accordingly, the study suggests that preventing hypoglycaemia can lead to an increase in quality of life, but also lead to a reduction in DM-related health care costs. We would like to elaborate on the results of this study to stimulate debate, and encourage further research.
Using self-reported data on hypoglycaemic events due to insulin treatment, de Groot et al. estimated that the total annual costs of hypoglycaemia, lies between a range of €112.5 million to €590.8 million in the Netherlands. Further research could support the conclusions reached in this study, for example, using alternative sources and methods to estimate costs. In addition, further research could be conducted on the incidence and frequency of hypoglycaemia and its potential consequences. To further elucidate the total burden of hypoglycaemia in diabetic patients, additional data during an extended follow-up period could be collected to provide a more comprehensive view of hypoglycaemia related costs. Additional data could include hypoglycaemia related adverse events, such as: falls, fractures, and corresponding hospitalisations.
Hypoglycaemia may cause dizziness, visual disturbances, confusion or even loss of consciousness in severe cases, which can lead to falls, and associated fractures, other injuries and hospitalizations [2–5]. To further elucidate the total burden of hypoglycaemia in diabetic patients, additional data during an extended follow-up period could be collected to provide a more comprehensive view of hypoglycaemia related costs. Furthermore, it is important to consider that 74% of T2DM patients in the Netherlands is 65-years or older [6]. Elderly T2DM patients often have multiple comorbidities and therefore polypharmacy, resulting in a higher rate of frailty. As such, fractures due to hypoglycaemia in T2DM patients may be frequent, and represent a significant adverse outcome with associated costs, in T2DM patients.
A disadvantage of self-reported assessments used in the study by de Groot et al. is that these reports can only be completed by patients in an outpatient care setting. This means that ill, frail or non-ambulatory diabetes patients would be excluded from the self-report assessment, which eventually leads to partial mapping of the hypoglycaemia burden. Further research focussing on complications and hospitalizations due to hypoglycaemic events, would support the identification of additional consequences and costs that are part of the total burden of hypoglycaemia.
The study by De Groot et al. focuses on insulin-treated T1DM and T2DM patients. The outcome of the study reflects the total burden of disease in T1DM patients in the Netherlands, as these patients are treated with insulin upon diagnosis. Nevertheless, only a proportion of patients with T2DM are actually treated with insulin. In the Netherlands insulin will only be prescribed to T2DM patients once oral treatment is insufficient, which means that prior to insulin, they have often already been treated with other drugs for years. Whereas many oral drugs are not related to hypoglycaemic risks, some oral treatments, like sulphonylurea derivatives, do have such risk [7]. Further research could evaluate the impact of these oral drugs on the economic burden of hypoglycaemia. As patients that use oral treatments are on average younger than patients on insulin, costs related to productivity losses could be measured alongside healthcare costs.
De Groot et al. based the costs of hypoglycaemia on a subanalysis of the Global Hypoglycaemia Assessment Tool (HAT) study [8]. This subanalysis indicates that 15% of Dutch patients had a severe event, which is considered reasonably high compared to other international studies and guidelines [1]. For example, the Dutch primary care guideline for T2DM refers to Schopman et al., which mentions a lower incidence of severe hypoglycaemic events in T2DM [7,9]. Varying definitions for hypoglycaemia and severe hypoglycaemia could partially explain this difference. Notably, De Groot et al. defined a severe event as “hypoglycaemia requiring assistance from another person to administer carbohydrate and/or glucagon”(p.2), whereas Schopman et al. refer to a severe event as hypoglycaemia requiring help of a third party or medical assistance [1,9]. Consensus on the definition of a hypoglycaemic event, and a consistent application of this definition, can facilitate the identification of hypoglycaemia at a higher level of granularity and consistency. Furthermore, we would suggest to make a distinction between mild, moderate and severe events, following the definitions of the AACE/ACE guidelines [10]. These guidelines provide a clear definition of severity states, and are commonly used in international health economic studies.
Considering our review and suggestions on the article of de Groot et al., we recommend that further research is conducted to help identify, broaden and complete the knowledge on the economic burden of hypoglycaemia in the Netherlands. This will require research that includes a longer follow-up period, the inclusion of T2DM patients that are not using insulin, and the application of a common definition and categorization of hypoglycaemia. Throughout the next four years, a recently launched EU project Hypo-RESOLVE aims to identify the burden of hypoglycaemia in Europe, including the Netherlands [11]. The start of this project underlines the critical need for more data and knowledge in this area, and the importance of the study published by de Groot et al. In the meantime, we would recommend performing additional analyses to assess the incidence of hypoglycaemic events and its consequences in terms of falls, fractures and hospitalizations as reported in different (Western) countries in T2DM patients, to complement the study of de Groot et al. This knowledge will further broaden the perspective and strengthen the evidence base of the total burden of hypoglycaemia for T2DM population in the Netherlands.
References
1. de Groot S, Enters-Weijnen CF, Geelhoed-Duijvestijn PH, Kanters TA. A cost of illness study of hypoglycaemic events in insulin-treated diabetes in the Netherlands. BMJ Open. 2018 Mar 25;8(3):e019864.
2. Mattishent K, Loke YK. Meta-analysis: Association between hypoglycaemia and serious adverse events in older patients. J Diabetes Complications. 2016 Jul;30(5):811–8.
3. Pijpers E, Ferreira I, de Jongh RT, Deeg DJ, Lips P, Stehouwer CDA, et al. Older individuals with diabetes have an increased risk of recurrent falls: analysis of potential mediating factors: the Longitudinal Ageing Study Amsterdam. Age Ageing. 2012 May;41(3):358–65.
4. Kachroo S, Kawabata H, Colilla S, Shi L, Zhao Y, Mukherjee J, et al. Association Between Hypoglycemia and Fall-Related Events in Type 2 Diabetes Mellitus: Analysis of a U.S. Commercial Database. J Manag Care Spec Pharm. 2015 Mar;21(3):243–53.
5. Hartholt KA, Polinder S, Van der Cammen TJM, Panneman MJM, Van der Velde N, Van Lieshout EMM, et al. Costs of falls in an ageing population: A nationwide study from the Netherlands (2007–2009). Injury. 2012 Jul 1;43(7):1199–203.
6. Dutch Institute for Public Health and Environment (RIVM). Volksgezondheid Toekomst Verkenning - Aandoeningen - Diabetes [Internet]. 2018 [cited 2018 Feb 21]. Available from: https://www.vtv2018.nl/aandoeningen
7. Rutten G, De Grauw W, Nijpels G, Houweling S, Van de Laar F, Bilo H, et al. NHG-Standaard Diabetes mellitus type 2 (Vierde (partiële) herziening). Huisarts Wet [Internet]. 2018 [cited 2018 Feb 28]; Available from: https://www.nhg.org/standaarden/volledig/nhg-standaard-diabetes-mellitus...
8. Khunti K, Alsifri S, Aronson R, Cigrovski Berković M, Enters-Weijnen C, Forsén T, et al. Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study. Diabetes Obes Metab [Internet]. 2016 Sep [cited 2018 Jun 5];18(9):907–15. Available from: http://doi.wiley.com/10.1111/dom.12689
9. Schopman JE, Simon ACR, Hoefnagel SJM, Hoekstra JBL, Scholten RJPM, Holleman F. The incidence of mild and severe hypoglycaemia in patients with type 2 diabetes mellitus treated with sulfonylureas: a systematic review and meta-analysis. Diabetes Metab Res Rev. 2014 Jan;30(1):11–22.
10. Handelsman Y, Bloomgarden ZT, Grunberger G, Umpierrez G, Zimmerman RS, Bailey TS, et al. AACE/ACE Guidelines AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY – CLINICAL PRACTICE GUIDELINES FOR DEVELOPING A DIABETES MELLITUS COMPREHENSIVE CARE PLAN – 2015 AACE TAsk ForCE For DEvEloping A DiAbETEs ComprEhEnsivE CArE plAn WriTing CommiTTEE. Endocr Pract Endocr Pr. 2015;21.
11. Hypoglycaemia - REdefining SOLutions for better liVEs | Hypo-RESOLVE [Internet]. [cited 2018 Jun 5]. Available from: https://hypo-resolve.eu/
This is a very useful study which confirms higher usage and DNA rates already documented among the more deprived. However, more recent research suggests that social group, as determined by the output area classification, may be more powerful in determining which groups among the deprived are associated with particular diseases [1-3]. After adjusting for social group there appears to be a very little role for deprivation per se, i.e. deprivation merely sets a broad context for the social health behaviours among different social groups.
1. Beeknoo N, Jones R (2016) Factors influencing A&E attendance, admissions and waiting times at two London hospitals. British Journal of Medicine and Medical Research 17(10): 1-29. doi : 10.9734/BJMMR/2016/28783
2. Beeknoo N, Jones R (2016) Using Social Groups to Locate Areas with High Emergency Department Attendance, Subsequent Inpatient Admission and Need for Critical Care. British Journal of Medicine and Medical Research 18(6): 1-23. doi: 10.9734/BJMMR/2016/29208
3. Beeknoo N, Jones R (2016) Using social groups to locate areas of high utilization of critical care. British Journal of Healthcare Management 22(11): 551-560.
We agree with Shah et al. that caring for patients with acute kidney injury (AKI) is complicated, particularly when it comes to medication management (1). It is important to remember that AKI is a heterogenous condition with multiple etiologies and different degrees of severity. In some cases then, prioritization of other chronic diseases over AKI may be reasonable and even beneficial for patients.
On this background, we would caution against the conclusion that physicians view AKI as a low priority concern. More qualitative research is needed first to understand physician experiences with AKI during both the inpatient and outpatient setting. This information is necessary to develop and support the use of quality improvement tools for patients with AKI, such as the medication checklists referenced by Shah et al (2).
References:
1. Phipps DL, Morris RL, Blakeman T, Ashcroft DM. What is involved in medicines management across care boundaries? A qualitative study of healthcare practitioners' experiences in the case of acute kidney injury. BMJ Open 2017;7:e011765.
2. Griffith K, Ashley C, Blakeman T, Fluck R, Lewington A, Selby N, et al. ‘Sick day’ guidance in patients at risk of Acute Kidney Injury: An Interim Position Statement from the Think Kidneys Board 2015.
The effect of Thiazolidinedione therapy on the risk of Parkinson’s disease is controversial. One article by Wu and colleagues in Taiwan reported that pioglitazone use was not associated with the risk of Parkinson’s disease in people with diabetes mellitus (hazard ratio 0.90, 95% CI 0.68-1.18).1 To the contrary, another article by Lin and colleagues in Taiwan reported that thiazolidinedione use was associated with a 60% reduced risk of Parkinson’s disease in people with diabetes mellitus.2 Similarly, conflicting results were also found in Western countries.3,4 There was no measure of the hemoglobin A1c in the above studies. We cannot determine whether the risk of Parkinson’s disease is associated with good glycemic control or poor control among people on thiazolidinedione therapy. Therefore, any study exploring the association between anti-diabetic medications and Parkinson’s disease should estimate the hemoglobin A1c levels.
Show MoreTheoretically, a study should be designed to compare people on thiazolidinedione therapy only with those people not taking any medication. However, according to the recommendation of the American Diabetes Association, metformin is the first-line therapy for type 2 diabetes mellitus.5 People with diabetes mellitus usually take metformin alone or use combined therapy with other anti-diabetic medications. Thiazolidinedione is usually recommended as combined therapy with metformin for type 2 diabetes mellitus. So it is difficult to identify peo...
The Editor of BMJ Open has received the comments from Albert Donnay on this paper. The authors of the paper have been contacted and have been asked to provide a response.
To the editor:
We read with interest the paper by Hansen et al1 and commend the authors on their work, however we would like to point out some significant limitations of the study
First, it is unclear whether the reported deaths are related to arrhythmic events resulting from QT prolongation or any other cause. While it is intuitive to that patients with abnormal heart tracings or underlying channelopathies are at a higher risk of death compared to healthy individuals, the association demonstrated in this study is far from causation. Additionally, the authors do not report pertinent clinical information such as electrolyte imbalances or the use of medications know to prolong the QT interval. Such preventable and reversible causes of QT prolongation theoretically should not affect 30-day mortality if adequately addressed. Finally, despite the use of the term “transnational” in title of the paper, patients included are from four different hospitals located in close geographical area and are likely more genetically homogenous than patients in single urban teaching hospital in a major US city. Thus the absence of demographic data severely limits the applicability of their findings to a global environment.
In conclusion, while this topic is of significant interest, methodological and analytical flaws limit the validity and applicability of the authors’ conclusions.
1-Schade Hansen C, Pottegård A, Ekelund U, et al. Association between QTc prolongati...
Show MoreThank you for your response...The first step to change is raising awareness I think a powerful next motivator might be sufficient funding to get the work done well! The value of reporting PPI is to increase good methods and reproducibility. It is a challenge to learn any new form of reporting for research. When RCTs, statistics and epidemiology were first introduced they were not well reported or funding, it does take time. You touch on an interesting point in terms of funding. We could ask if researchers are granted sufficient dedicated PPI funding to deliver training and impact.
"If user involvement remains an international policy imperative with little if any support at the vital stage of bid development, policy‐makers, service user organizations, researchers, health service providers and commissioners will need to recognize the limited nature of involvement that may result and the impact this would have on the evidence base. Researchers will need to recognize the resource implications of involvement at this point, and user groups will need to decide whether to participate when there is the greatest chance of influencing research but little or no funding (p. 175)"
This was a quote from 2007 and the question is still open!
Staniszewska S, Jones N, Newburn M, Marshall S. User involvement in the development of research bid: barriers, enablers and impacts. Health Expectations, 2007; 10: 173–183. [PubMed]
In the study of Huang C, et al. on BMJ Open 2018;8:e018070. doi:10.1136/bmjopen-2017-018070: “ MicroRNA-17 and the prognosis of human carcinomas: a systematic review and meta-analysis” the manuscript from Robaina et al. entitled “miR-17-92 cluster components analysis in Burkitt lymphoma: overexpression of miR-17 is associated with poor prognosis. Ann Hematol 2016;95:881–91.” was mentioned (citation number 38). We would like to point out some mistakes regarding the citation of our study as below:
1.Table 1 on page 4, the assay performed in our study was quantitative RT-PCR (q-PCR) instead of ISH assay as described on the table 1 and 2 of the Huang et al. publication. The same mistake is observed on the figure 3 C.
2. Discussion on page 7: The sentence: In the subgroup analysis, we found that the potential heterogeneity may have originated from the Caucasian group in the study conducted by Robaina et al.38 Unlike the commonly used RT-PCR, ISH technique was used to detect miR-17 .
There is a great misunderstanding on this sentence. Neither our Brazilian patients were classified by race as " Caucasian ", nor the analysis of miR-17 expression levels in our study was performed by ISH. All the assays were performed by qRT-PCR.
It is important to mention that the term " Caucasian " is not applied in Brazilian for race/ethnicity classification. The Brazilian population is formed by extensive admixture from three different ances...
Show MoreIt would be satisfying if all papers gave a summary of the part played by PPI in the work. It is clear that they do not, despite it being editorial policy to seek it. We may conclude that either PPI does not occur to the extent foreseen, or that the authors do not rate it highly reportable in comparison to the rest of the content. Given the increased requirement to build PPI into grant applications, it seems likely that it is the second scenario that is predominant, and this leads to a consideration of the authors' motivation in writing. Ideally, the prime mover would be the altruism of wishing to get knowledge or a change in practice into the public arena, where it will have the greatest chance of creating patient benefit. Then would come the personal spur of academic reputation and all that follows from that. Maybe an up-coming REF exercise is being thought about in some cases. Whatever these motivations are, PPI appears to have no place among them, except that good manners require it should be acknowledged, along with other help received. If reporting PPI has no discernible utility, it will not generally happen without an enforceable requirement.
บทคัดย่อ
Show Moreบทนำ การใช้ยาปฏิชีวนะในประเทศที่มีรายได้น้อยและปานกลางยังคงเพิ่มขึ้นถึงแม้จะทราบว่าการใช้ยาปฏิชีวนะมากเกินไปอาจทำให้เกิดความดื้อยาปฏิชีวนะได้ ซึ่งข้อมูลรายละเอียดเหล่านี้มีความเกี่ยวข้องกับการใช้ยาปฏิชีวนะในหน่วยบริการปฐมภูมิที่มีอยู่อย่าง จำกัด
วัตถุประสงค์ อธิบายถึงอาการและอาการแสดงของการติดเชื้อเฉียบพลันและข้อบ่งชี้สำหรับการสั่งยาปฏิชีวนะ
รูปแบบการศึกษา การทบทวนข้อมูลที่เก็บเป็นประจำย้อนหลัง 2 ปี
ขอบเขตการศึกษา หน่วยบริการปฐมภูมิทั้งหมด 32 แห่งในอำเภอแห่งหนึ่ง ของภาคเหนือ ประเทศไทย
ผู้เข้าร่วมการศึกษา ผู้ป่วยที่เข้ารับการบริการหน่วยปฐมภูมิที่มีประวัติไข้ มีการบันทึกอุณหภูมิ และระบุ ICD 10 สำหรับการติดเชื้อหรือการสั่งยาปฏิชีวนะในระบบโดยไม่รวมผู้ป่วยที่เข้าร่วมทำการศึกษาเกี่ยวกับการทดสอบ C-reactive protein ใน หน่วยปฐมภูมิ 4 แห่ง
ผลลัพธ์ที่ได้ คือ สัดส่วนของผู้ป่วยที่ได้รับยาปฏิชีวนะและความถี่ของอาการและอาการแสดงทางคลินิก
ผู้ป่วยที่เข้ารับการรักษาที่หน่วยบริการสุขภาพ 762,868 คน ซึ่งอยู่ในเกณฑ์การคัดเลือก จำนวน 103,196 ราย และไม่เข้าเกณฑ์จำนวน 5,966 รายทำให้เหลือจำนวนผู้ป่วย 97,230 ราย ประกอบด้วย 83,661 ครั้งที่มีการเจ็บป่วย
ผู้ป่วย 46.9% (39,242 ราย) ได้รับยาปฏิชีวนะในช่วงป่วย ซึ่งค่าดัชนีของการใช้ยาปฏิชีวนะในการวิเคราะห์ถดถอยโลจิสติก ในหลายตัวแปร ได้แก่ เพศชาย(aOR 1.21 [CI 1.16-1.28], p <0.001), ผู้ใหญ่ (aOR 1.77 [CI 1.57-2, p <0.001]) และอุณหภูมิ> 37.5 องศาเซลเซียส (aOR 1.24 [CI 1.03-1.48, p 0.020]) 77.9% ของการศึกษานี้ แสดงให้เห็นถึง ความสัมพันธ์กับโรคระบบทางเดินหายใจ ซึ่ง 98.6% เป็นการติดเชื้อทางเดิ...
Dear editor,
We would like to congratulate de Groot et al. for having performed this cost of illness study regarding hypoglycaemic events in insulin-treated diabetic patients in the Netherlands, which is a great step forward to a broader perspective on the hypoglycaemic burden specifically for the Netherlands [1]. In this study, Groot et al. use data from self-assessment questionnaires in type 1 (T1DM) and type 2 diabetes mellitus (T2DM) patients in the Netherlands during a 4-week follow up period, to assess the costs of hypoglycaemic events. The article sheds light on the substantial impact which direct and indirect costs related to hypoglycaemia have on the total economic burden of diabetes. Accordingly, the study suggests that preventing hypoglycaemia can lead to an increase in quality of life, but also lead to a reduction in DM-related health care costs. We would like to elaborate on the results of this study to stimulate debate, and encourage further research.
Using self-reported data on hypoglycaemic events due to insulin treatment, de Groot et al. estimated that the total annual costs of hypoglycaemia, lies between a range of €112.5 million to €590.8 million in the Netherlands. Further research could support the conclusions reached in this study, for example, using alternative sources and methods to estimate costs. In addition, further research could be conducted on the incidence and frequency of hypoglycaemia and its potential consequences. To furthe...
Show MoreThis is a very useful study which confirms higher usage and DNA rates already documented among the more deprived. However, more recent research suggests that social group, as determined by the output area classification, may be more powerful in determining which groups among the deprived are associated with particular diseases [1-3]. After adjusting for social group there appears to be a very little role for deprivation per se, i.e. deprivation merely sets a broad context for the social health behaviours among different social groups.
1. Beeknoo N, Jones R (2016) Factors influencing A&E attendance, admissions and waiting times at two London hospitals. British Journal of Medicine and Medical Research 17(10): 1-29. doi : 10.9734/BJMMR/2016/28783
2. Beeknoo N, Jones R (2016) Using Social Groups to Locate Areas with High Emergency Department Attendance, Subsequent Inpatient Admission and Need for Critical Care. British Journal of Medicine and Medical Research 18(6): 1-23. doi: 10.9734/BJMMR/2016/29208
3. Beeknoo N, Jones R (2016) Using social groups to locate areas of high utilization of critical care. British Journal of Healthcare Management 22(11): 551-560.
Dear Editor,
We agree with Shah et al. that caring for patients with acute kidney injury (AKI) is complicated, particularly when it comes to medication management (1). It is important to remember that AKI is a heterogenous condition with multiple etiologies and different degrees of severity. In some cases then, prioritization of other chronic diseases over AKI may be reasonable and even beneficial for patients.
On this background, we would caution against the conclusion that physicians view AKI as a low priority concern. More qualitative research is needed first to understand physician experiences with AKI during both the inpatient and outpatient setting. This information is necessary to develop and support the use of quality improvement tools for patients with AKI, such as the medication checklists referenced by Shah et al (2).
References:
1. Phipps DL, Morris RL, Blakeman T, Ashcroft DM. What is involved in medicines management across care boundaries? A qualitative study of healthcare practitioners' experiences in the case of acute kidney injury. BMJ Open 2017;7:e011765.
2. Griffith K, Ashley C, Blakeman T, Fluck R, Lewington A, Selby N, et al. ‘Sick day’ guidance in patients at risk of Acute Kidney Injury: An Interim Position Statement from the Think Kidneys Board 2015.
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