We are writing in response to Abraham et al.’s recent review of systematic reviews (SR) targeting the impact of computerised provider order entry (CPOE) on clinical and safety outcomes [1]. We commend the authors’ inclusion of medication errors and adverse drug events (ADE) among the outcomes assessed. This is particularly timely given the World Health Organisation’s 2017 announcement of the third Global Patient Safety Challenge to motivate actions to reduce medication errors causing actual patient harm by half in five years [2]. Abraham et al. concluded that, based on the evidence reported by three SR of inpatient populations, pooled studies showed significant reduction in ADEs with CPOE use, with considerable variation in the magnitude of relative risk reduction [1]. However, there are significant limitations to the studies on which this conclusion is based, and we believe a more cautious approach should be taken when assessing the current evidence.
Firstly, as the authors acknowledged, there was variation in the definitions of ADE across the three SR and the 18 studies they included. We agree that these are significant limitations when trying to summarise the impact of CPOE on ADE. To be clear, the included studies assessed preventable ADEs (10 studies) and/or potential ADEs (15 studies), and three studies did not specify the type of ADE. An ADE can be preventable, non-preventable, or potential [3]. A preventable ADE refers to a medication error which reached th...
We are writing in response to Abraham et al.’s recent review of systematic reviews (SR) targeting the impact of computerised provider order entry (CPOE) on clinical and safety outcomes [1]. We commend the authors’ inclusion of medication errors and adverse drug events (ADE) among the outcomes assessed. This is particularly timely given the World Health Organisation’s 2017 announcement of the third Global Patient Safety Challenge to motivate actions to reduce medication errors causing actual patient harm by half in five years [2]. Abraham et al. concluded that, based on the evidence reported by three SR of inpatient populations, pooled studies showed significant reduction in ADEs with CPOE use, with considerable variation in the magnitude of relative risk reduction [1]. However, there are significant limitations to the studies on which this conclusion is based, and we believe a more cautious approach should be taken when assessing the current evidence.
Firstly, as the authors acknowledged, there was variation in the definitions of ADE across the three SR and the 18 studies they included. We agree that these are significant limitations when trying to summarise the impact of CPOE on ADE. To be clear, the included studies assessed preventable ADEs (10 studies) and/or potential ADEs (15 studies), and three studies did not specify the type of ADE. An ADE can be preventable, non-preventable, or potential [3]. A preventable ADE refers to a medication error which reached the patient and resulted in actual patient harm. A non-preventable ADE, or adverse drug reaction, is defined as harm resulting from an unexpected reaction to a drug where there was no medication error. A potential ADE, or near-miss, is typically defined as a medication error with the potential for harm but in which no harm occurred due to patient circumstance or an intervention [3]. In the wider medication safety literature, many studies which assess ADEs do not delineate whether this harm was, the much more frequently occurring, potential harm or the relatively rare actual harm [4].
Further limitations of the studies of ADEs and CPOEs not discussed were the data collection methods. There is significant variation in the methods undertaken by the included studies to identify ADEs. Firstly, there were eight studies using voluntary incident reports as the only source for identifying ADEs. Incident reports are known to result in significant under-estimation of errors and ADEs [5]. Eight studies used the more rigorous chart and record review. Finally, the study designs do not allow for drawing causal conclusions. That is, there were no randomised controlled trials. Except for one cohort study, all the studies used before-after designs, only one of which included a control.
In conclusion, only half the studies (n=10) included assessed the impact of CPOE on actual patient harm resulting from a medication error. Of these studies, only three reported a significant reduction in patient harm, with the most recent data collection completed in 2010. Five studies reported no significant effect and two studies reported an increase. Of the six studies identifying preventable ADE by chart review, three studies reported a significant reduction (a pooled total of 157 events compared to 139 events) and three studies reported no significant effect.
Considering the very significant limitations across studies, we believe there is not yet convincing evidence of the direct impact of CPOE on actual patient harm. This conclusion remains consistent with two earlier umbrella reviews [6, 7].
References:
1. Abraham, J., et al., Effects of CPOE-based medication ordering on outcomes: an overview of systematic reviews. BMJ Quality & Safety, 2020: p. bmjqs-2019-010436.
2. Donaldson, L.J., et al., Medication without harm: WHO's Third Global Patient Safety Challenge. The Lancet, 2017. 389(10080): p. 1680-1681.
3. Bates, D.W., et al., Relationship between medication errors and adverse drug events. J Gen Intern Med, 1995. 10(4): p. 199-205.
4. Gates, P.J., et al., Standardising the Classification of Harm Associated with Medication Errors: The Harm Associated with Medication Error Classification (HAMEC). Drug Safety, 2019. 42(8): p. 931-939.
5. Westbrook, J.I., et al., What are incident reports telling us? A comparative study at two Australian hospitals of medication errors identified at audit, detected by staff and reported to an incident system. Int J Qual Health Care, 2015. 27(1): p. 1-9.
6. Ranji, S.R., S. Rennke, and R.M. Wachter, Computerised provider order entry combined with clinical decision support systems to improve medication safety: a narrative review. BMJ Qual Saf, 2014. 23(9): p. 773-80.
7. Weir, C.R., N. Staggers, and T. Laukert, Reviewing the impact of computerized provider order entry on clinical outcomes: The quality of systematic reviews. International Journal of Medical Informatics, 2012. 81(4): p. 219-231.
Adherence Issues in Population with Intellectual Disabilities
Bernadette Flood PhD MPSI, Pharmacist, Daughters of Charity Disability Support Services
Link to Original article: Medication non-adherence: an overlooked target for quality improvement interventions
Commentary on: Medication non-adherence: an overlooked target for quality improvement interventions, Bryony Dean Franklin, Gary Abel, Kaveh G Shojania (2019-12-20). 10.1136/bmjqs-2019-009984
Non adherence to prescribed medication is a complex problem. The complexity is increased in vulnerable population groups such as the population with intellectual disabilities. A person with an intellectual disability may often be dependent on ‘healthcare by proxy’ where another person makes healthcare decisions on their behalf. People with intellectual disabilities may also be ‘invisible’ to pharmacists dispensing prescribed medicines. Many pharmacists may have little experience of the challenges faced by this high risk group of patients [1] who may be prescribed high risk medications such as diabetic medicines including insulin and anti-epileptic medications. People with intellectual disabilities and their family carers, support workers etc. may be unaware of the consequences of poor adherence to prescribed medicines. The difficulties of involving a parent proxy in a three-way relationship involving an adult at risk of lacking decision-making capacity, their proxy, and a treating clinician have been ra...
Adherence Issues in Population with Intellectual Disabilities
Bernadette Flood PhD MPSI, Pharmacist, Daughters of Charity Disability Support Services
Link to Original article: Medication non-adherence: an overlooked target for quality improvement interventions
Commentary on: Medication non-adherence: an overlooked target for quality improvement interventions, Bryony Dean Franklin, Gary Abel, Kaveh G Shojania (2019-12-20). 10.1136/bmjqs-2019-009984
Non adherence to prescribed medication is a complex problem. The complexity is increased in vulnerable population groups such as the population with intellectual disabilities. A person with an intellectual disability may often be dependent on ‘healthcare by proxy’ where another person makes healthcare decisions on their behalf. People with intellectual disabilities may also be ‘invisible’ to pharmacists dispensing prescribed medicines. Many pharmacists may have little experience of the challenges faced by this high risk group of patients [1] who may be prescribed high risk medications such as diabetic medicines including insulin and anti-epileptic medications. People with intellectual disabilities and their family carers, support workers etc. may be unaware of the consequences of poor adherence to prescribed medicines. The difficulties of involving a parent proxy in a three-way relationship involving an adult at risk of lacking decision-making capacity, their proxy, and a treating clinician have been rarely considered[2] .
The international trend to deinstitutionalise the care of people with intellectual disabilities will require that this complex group of patients receive support from care givers and health and social care professionals in the community setting to ensure quality medication use. Pharmacists have a role to play.
Pharmacists and Adherence in Population with Intellectual Disabilities
It is thought that only around half of medicines for long-term conditions are taken as prescribed in developed countries, and there is little evidence of any improvement in adherence rates over the past 50 years[4] . Some factors that can impact adherence in the population with intellectual disabilities have been identified in USA [5] :
1. Patients with intellectual disabilities may not have the ability to fully understand the importance or impact of the medications they’re given. This altered perception or ability may have profound effects on treatment, particularly for chronic conditions.
2. Patients with intellectual disabilities can also have various living situations, which can impart more challenges to medication therapy and adherence. These living arrangements can range from total independence to residing in group homes. It was found that patients with intellectual disabilities living in group homes had higher adherence rates compared with those who lived independently or in a family home.
3. Socioeconomic factors may impact these individuals’ ability to adhere to a medication regimen. Medicaid enrolment and minority race/ethnicity have been associated with reduced medication adherence in individuals with intellectual disabilities.
Almost all of the interventions found to be effective for long-term care are complex, including combinations of more convenient care, information, reminders, self-monitoring, reinforcement, counselling, family therapy, psychological therapy, crisis intervention, manual telephone follow-up, and supportive care. Even the most effective interventions have not led to large improvements in adherence and treatment outcomes [6]. More frequent interaction with patients with attention to adherence in every healthcare encounter appears to be a common thread in all interventions.
Pharmacists and others involved must work out how to match patients to the interventions already available. Individual interventions may only be effective when directed at the subset of the population whose reason for non-adherence is targeted by the particular intervention. This is an area in which pharmacists with specialist knowledge of adherence and other medicine related issues in the population with intellectual disabilities can play a role.
References:
[1].Flood, B. and Henman, M.C. (2015), Case study: hidden complexity of medicines use: information provided by a person with intellectual disability and diabetes to a pharmacist. Br J Learn Disabil, 43: 234-242. doi:10.1111/bld.12121 https://onlinelibrary.wiley.com/action/showCitFormats?doi=10.1111%2Fbld....
[2].Redley, M., Prince, E., Bateman, N., et al. (2013), The involvement of parents in healthcare decisions where adult children are at risk of lacking decision‐making capacity: a qualitative study of treatment decisions in epilepsy. Journal of Intellectual Disability Research, 57: 531-538. doi:10.1111/j.1365-2788.2012.01556.x
[3].Hom, C.L., Touchette, P., Nguyen, V., et al. (2015), Living arrangement and medication non‐adherence. J Intellect Disabil Res, 59: 48-54. doi:10.1111/jir.12123
[4].Nieuwlaat R, Wilczynski N, Navarro T et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2014; issue 11. Art. No: CD000011.doi:10.1002/14651858.CD000011.pub4
[5].Factors Affecting Adherence in Patients with Intellectual Disabilities. 2016-11-07 09:54:07 Erik Hefti, Pharm D, MS https://www.pharmacytimes.com/contributor/erik-hefti-pharmd-ms/2016/11/f...
[6]. Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD000011. DOI: 10.1002/14651858.CD000011.pub3
Conflict of Interest
None declared
In their editorial commenting on our paper “Association of registered nurse and nursing support staffing with inpatient hospital mortality,” [1] Aiken and Sloane misrepresent our study results, conclusions and implications. They characterize our study as examining the impact of substitution of nursing support staff for professional nurses or registered nurses (RNs) (commonly described as skill mix). This is done despite acknowledging that we stated our findings should not be interpreted to mean that nursing aides can safely substitute for RNs. Furthermore, as Aiken and Sloane acknowledge each of us have published multiple studies [2 3] showing efforts to deskill the nursing work force will increase deaths, adverse events and costs. This conclusion was also restated in a recent editorial in this journal by one of us. [4]
Aiken and Sloane discuss the paper as though it is about skill mix, characterizing our findings as “counter” to our earlier published papers that did analyze skill mix. However, the current paper and the recent Griffith’s paper Aiken and Sloane also reference[5], “examine nursing support staffing not as a substitute for RNs, as studies of skill mix do, but …rather examine the impact of shortfalls in support staffing given established RN- nursing support staffing models.” What our paper and Griffiths paper do is examine shortfalls from established levels of nurse support staffing as a complement of typical RN staffing withi...
In their editorial commenting on our paper “Association of registered nurse and nursing support staffing with inpatient hospital mortality,” [1] Aiken and Sloane misrepresent our study results, conclusions and implications. They characterize our study as examining the impact of substitution of nursing support staff for professional nurses or registered nurses (RNs) (commonly described as skill mix). This is done despite acknowledging that we stated our findings should not be interpreted to mean that nursing aides can safely substitute for RNs. Furthermore, as Aiken and Sloane acknowledge each of us have published multiple studies [2 3] showing efforts to deskill the nursing work force will increase deaths, adverse events and costs. This conclusion was also restated in a recent editorial in this journal by one of us. [4]
Aiken and Sloane discuss the paper as though it is about skill mix, characterizing our findings as “counter” to our earlier published papers that did analyze skill mix. However, the current paper and the recent Griffith’s paper Aiken and Sloane also reference[5], “examine nursing support staffing not as a substitute for RNs, as studies of skill mix do, but …rather examine the impact of shortfalls in support staffing given established RN- nursing support staffing models.” What our paper and Griffiths paper do is examine shortfalls from established levels of nurse support staffing as a complement of typical RN staffing within established unit-level nurse staffing models. Both papers find these shortfalls also increase patient risk of death. In our article, we posit two complementary mechanisms through which low nurse support staffing might increase patient risk – by adding to the workload of RNs who have to take on the support staff work, and decreasing the direct observation of patients. Regardless of mechanism, we and Griffiths conclude that providing adequate nursing support staff as well as adequate RN staffing may be necessary to assure safe and reliable care. This is not a skill mix-staffing model issue, but an issue of having adequate staffing.
There is no question that patients are kept safe and care delivered reliably only when there are adequate numbers of RNs. Our paper’s finding on the impact on mortality of shortfalls in RN staffing from established, typical levels reinforce this conclusion. Assuring these levels needs to be a priority of health system administrators, regulators and payers. But this paper also indicates that assuring adequate support for RNs is also important for patient safety. It is disappointing that Aiken and Sloane did not understand the distinction between supporting RNs and substituting for them with lower skilled staff. It is an important distinction that the readers of BMJQS should understand and the editorial should have made clear.
References
1. Needleman J, Liu J, Shang J, Larson EL, Stone PW. Association of registered nurse and nursing support staffing with inpatient hospital mortality. BMJ Qual Saf 2020;29(1):10-18 doi: 10.1136/bmjqs-2018-009219[published Online First: Epub Date]|.
2. Needleman J, Buerhaus PI, Stewart M, Zelevinsky K, Mattke S. Nurse staffing in hospitals: is there a business case for quality? Health affairs (Project Hope) 2006;25(1):204-11 doi: 10.1377/hlthaff.25.1.204[published Online First: Epub Date]|.
3. Glance LG, Dick AW, Osler TM, Mukamel DB, Li Y, Stone PW. The association between nurse staffing and hospital outcomes in injured patients. BMC Health Serv Res 2012;12:247 doi: 10.1186/1472-6963-12-247[published Online First: Epub Date]|.
4. Needleman J. Nursing skill mix and patient outcomes. BMJ Qual Saf 2017;26(7):525-28 doi: 10.1136/bmjqs-2016-006197[published Online First: Epub Date]|.
5. Griffiths P, Maruotti A, Recio Saucedo A, et al. Nurse staffing, nursing assistants and hospital mortality: retrospective longitudinal cohort study. BMJ Qual Saf 2018 doi: 10.1136/bmjqs-2018-008043[published Online First: Epub Date]|.
I write in response to the article published in your journal “Passing the acid test? Evaluating the impact of national education initiatives to reduce proton pump inhibitor use in Australia” (Bruno C et al., BMJ Qual Saf 2019). I am writing as NPS MedicineWise evaluation found a significant impact on general practitioner prescribing of proton pump inhibitors (PPIs) following their educational programs in 2009 and 2015. I acknowledge that the article is well written, the methods are well described, and the approach includes a number of sensitivity analyses. However, I would like to highlight some key points on the analysis methods used that differ from the approach taken by NPS MedicineWise and about which I have some concerns.
The 2015 NPS MedicineWise educational program on PPIs was part of a larger educational strategy over a decade to support best-practice prescribing of PPIs by general practitioners (GPs) and included Pharmaceutical Benefits Scheme (PBS) feedback to GPs in Australia. This consists of a letter that includes information of the individual GP’s prescribing of PPIs compared to their peers. Programs launched in 2009 and 2018 on PPI prescribing for GPs also included face-to-face educational visits to GP practices. The 2015 campaign, which did not include these face-to-face visits, aimed to reinforce the impact of the earlier 2009 campaign.
NPS MedicineWise has conducted an evaluation of the 2009 and 2015 education programs on GP prescribing o...
I write in response to the article published in your journal “Passing the acid test? Evaluating the impact of national education initiatives to reduce proton pump inhibitor use in Australia” (Bruno C et al., BMJ Qual Saf 2019). I am writing as NPS MedicineWise evaluation found a significant impact on general practitioner prescribing of proton pump inhibitors (PPIs) following their educational programs in 2009 and 2015. I acknowledge that the article is well written, the methods are well described, and the approach includes a number of sensitivity analyses. However, I would like to highlight some key points on the analysis methods used that differ from the approach taken by NPS MedicineWise and about which I have some concerns.
The 2015 NPS MedicineWise educational program on PPIs was part of a larger educational strategy over a decade to support best-practice prescribing of PPIs by general practitioners (GPs) and included Pharmaceutical Benefits Scheme (PBS) feedback to GPs in Australia. This consists of a letter that includes information of the individual GP’s prescribing of PPIs compared to their peers. Programs launched in 2009 and 2018 on PPI prescribing for GPs also included face-to-face educational visits to GP practices. The 2015 campaign, which did not include these face-to-face visits, aimed to reinforce the impact of the earlier 2009 campaign.
NPS MedicineWise has conducted an evaluation of the 2009 and 2015 education programs on GP prescribing of PPIs and found a significant decrease in the volume of high and standard PPIs prescribed to concessional patients.
There are a number of ways in which our analysis differs to that described in the Bruno et al. article:
• Our analysis found a reduction in high/standard PPI dispensed volumes from GP prescriptions for concessional patients over four times that found in the Bruno et al. article. Our analysis was focussed on GP prescribing, as they were the target prescribers for our education programs. In contrast, the Bruno et al. article includes all dispensed prescriptions including those by specialists. Specialists may be prescribing PPIs more frequently for people with more complicated conditions for which long-term PPI use is appropriate.
• The authors of the Bruno et al. article have used a novel approach by looking at a sample of 10% of individual longitudinal PBS patient data and used novel data analysis methods. In contrast, we use the complete PBS data for concessional patients and analyse dispensing volumes using best practice time series analysis.
• We analyse trends over multiple years, whereas the Bruno et al. analysis used data from one year before and after the 2015 NPS MedicineWise program, although they did adjust for seasonality. Benefits of a multiple year analysis include taking into account additional factors such as the impacts of previous programs, consumers stockpiling medicines once they reach the PBS safety net and other environmental factors.
• In the Bruno et al. article they only assessed a change in the dispensing levels after the interventions although there is a clear upward trend in PPI prescriptions over the years prior to the intervention. They did not assess a change in slope (i.e. change in trend) which NPS MedicineWise considers in evaluation work using time series analysis. One possible reason for an upward trend is a continual increase in the size of the population with gastro-oesophageal reflux disease (GORD) due to population growth, and this is particularly strong in older populations. I would recommend assessing total dispensing over time as an age-standardised or age-specific population rate to control for change in the size of the population at risk of being prescribed PPIs.
Since NPS MedicineWise launched the Choosing Wisely Australia initiative in April 2015, three recommendations from medical colleges and societies about the use of PPIs have been published – from the Royal Australian College of General Practitioners (RACGP) in April 2015, the Gastroenterological Society of Australia (GESA) in October 2016 and the Royal Australasian College of Physicians’ Paediatrics & Child Health Division in September 2017. The 2018 NPS MedicineWise educational program included recommendations on PPIs from RACGP and GESA. One of the program’s aims was to grow GP awareness of the RACGP recommendation and GPs were encouraged to regularly review patients with GORD on PPIs, with the aim of reducing or ceasing PPIs altogether.
A GP survey conducted in February 2019 asked GPs to rate their agreement with the RACGP statement before and after participating in the NPS MedicineWise program. The result was a significant 13% increase in GP awareness of the RACGP recommendation after participating, demonstrating that educational activities do have an important role in behaviour change.
There is a need for further research into the impact of reducing PPI use on GORD symptom control. Further evaluation is planned and the MedicineInsight dataset provides a unique opportunity to explore the reasons general practitioners prescribe PPIs to patients. MedicineInsight, managed by NPS MedicineWise with support funding from the Australian Government Department of Health, is a large-scale national general practice dataset that extracts and collates longitudinal, de-identified patient health records from general practice clinical information systems.
We thank the French Society of Emergency Medicine for such a large study. However it is difficult to conclude regarding a number of limitations due to the observational cross-sectional study scheme.
The main critics concern the 3 measurements tools allowing to decide appropriateness of ED visits or not. Appropriate Use Score Method: the authors decide a cut-off based on Italian litterature data which is not French sounded; Possible GP Use Method : it would be more accurate to have an external evaluation instead of a judge and part one ; Resource Utilisation Method : the elephant in the room is the result of consultation and the final diagnostic as well.
I don’t discuss here the relevance of a number of items as distance between home and ED Departments, medical density and so far.
Specifically I doubt it is possible to interpret socioeconomic and territorial factors results without diagnostics and diagnostic frequency on June, 11, 2013
We are looking forward for more studies informing use of ED departments.
As a non-physician often working as a researcher with physicians, I didn't know whether to laugh or cry at the explanation in this article as to why certain specialties might get lower patient satisfaction scores than internists. Yes, it may well be that the episodic nature of the encounter with a non-chosen physician leads to lower satisfaction. But given the long history of jokes within medicine based on the personality type differences among specialties, and, one would think, given the authors' personal experiences in say, their last dermatology appointment, might not differences among doctors rather than patient issues be at least be presented as a hypothesis? The briefest of Googling finds a post in the KevinMD blog, directed towards physicians, on "remarkably distinct" cultures. (The blog is here: https://www.kevinmd.com/blog/2018/07/what-personality-type-fits-your-med.... One of the literature links is here: https://onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2923.2011.04099.x)
I admire the question and rigor the researchers used in answering it. But, in the Discussion, simply assuming "differences in perception must be due to the patient" fails to meet the test of common sense.
We can only reiterate the points brought forward by Carl Macrae in “The problem with incident reporting”. In our own work with incident reporting systems in the UK and Austria we observe that an estimated 50% of incident reports are eliminated without further consideration due to their non-clinical nature, even if they may affect patient safety. The remaining clinical reports are then pigeonholed to fit existing medical categories of expertise for further investigation. Hence, current incident reporting practices do not truly reflect the systemic complexities of medical errors, which are composed of both clinical and non-clinical elements. Incident reporting systems in healthcare need to either use more stringent reporting criteria to exclude non-clinical incidents upfront (even if they affect patient safety), but this would mean cutting themselves short of opportunities for whole system improvement. Alternatively, non-clinical reports should be further investigated to determine their potential contribution to (un)safe practice. This is likely to require the inclusion of non-clinical, organisational experts in the analysis of incident reports.
We appreciate the concerns raised and agree that accurately presenting the findings of our study regarding patient-reported possible PICC-related complications is important. We took several steps to ensure transparency in how we presented our data. First, we were vigilant about consistently defining our outcomes as “possible complications” in all key areas of the paper including the main outcomes and conclusions section of the abstract, study measures section in the methods, main findings in the results section and in the discussion. The fact that the term “possible” or “potential” was not always used or some terms appeared to be used interchangeably was to improve readability of the article. In general, however, we were conscientious about clearly noting that we asked patients about signs or symptoms of a potential complication or adverse effect. Second, we purposefully chose to not present the data as complication rates (implying that these were actual events), but as the percentage of patients reporting a given event – thus we faithfully represented what we were told by patients during follow-up assessments. Third, we took these approaches because our primary objective was to accurately present the data collected from our patients; if something mattered enough to a patient to tell us about it, then it should matter to us as healthcare professionals regardless of internal standards that we may use to define serious medical complications. While that’s not to say that f...
We appreciate the concerns raised and agree that accurately presenting the findings of our study regarding patient-reported possible PICC-related complications is important. We took several steps to ensure transparency in how we presented our data. First, we were vigilant about consistently defining our outcomes as “possible complications” in all key areas of the paper including the main outcomes and conclusions section of the abstract, study measures section in the methods, main findings in the results section and in the discussion. The fact that the term “possible” or “potential” was not always used or some terms appeared to be used interchangeably was to improve readability of the article. In general, however, we were conscientious about clearly noting that we asked patients about signs or symptoms of a potential complication or adverse effect. Second, we purposefully chose to not present the data as complication rates (implying that these were actual events), but as the percentage of patients reporting a given event – thus we faithfully represented what we were told by patients during follow-up assessments. Third, we took these approaches because our primary objective was to accurately present the data collected from our patients; if something mattered enough to a patient to tell us about it, then it should matter to us as healthcare professionals regardless of internal standards that we may use to define serious medical complications. While that’s not to say that future work to better understand how patient reported outcomes relate to ascertainable or medically defined outcomes isn’t needed, our reporting was accurate and achieved the primary objective of this study - which was to highlight PICC-associated patient concerns and opportunities for care improvement.
"What is needed now is an understanding of what is the threshold of professional nurse staff and complementary staff needed to achieve optimal outcomes, and how are these levels influenced by patient nursing acuity and the education, experience, organisation and work environment of the nurse workforce." --- I agree with you. Further, this study may be approached by Park's Optimized Nurse Staffing (Sweet Spot) Estimation Theory (Park, 2017): https://onlinelibrary.wiley.com/doi/full/10.1111/jan.13284. I am doing the research now.
Krein, et al (Patient-Reported Complications Related to Peripherally Inserted Central Catheters: A Multicenter Prospective Cohort Study; Feb 2019) should be commended for sharing the results of this very interesting study. After reading it a few times, I am compelled to share the following concerns with you and the research team. The knowledge regarding PICC-related complications is indeed incomplete, but I am not sure if the main outcome(s) of your study are clearly represented to the reader.
The word “possible” is critical to correctly interpreting the results of this study. The term “complication” implies a medical diagnosis or medical confirmation – which your study attempted to do by conducting the chart reviews to confirm the presence or absence of a PICC complication, with limited success. Terms such as signs, symptoms, issues, adverse effects, and complications are used interchangeably throughout the paper to describe the patients’ self-reported experience, but without the benefit of operational definitions. These are not synonyms. Definitions help us to have a common understanding of a word or topic; they help us get on the same page when reading about an issue.
The word “possible” seems appropriate in the main outcome(s) statement, but is curiously missing from the report title. The phrase “medical complications” is used in the title of Table 2 – which clearly reports predominantly patient self-reported symptoms. The same bias is exhibited...
Krein, et al (Patient-Reported Complications Related to Peripherally Inserted Central Catheters: A Multicenter Prospective Cohort Study; Feb 2019) should be commended for sharing the results of this very interesting study. After reading it a few times, I am compelled to share the following concerns with you and the research team. The knowledge regarding PICC-related complications is indeed incomplete, but I am not sure if the main outcome(s) of your study are clearly represented to the reader.
The word “possible” is critical to correctly interpreting the results of this study. The term “complication” implies a medical diagnosis or medical confirmation – which your study attempted to do by conducting the chart reviews to confirm the presence or absence of a PICC complication, with limited success. Terms such as signs, symptoms, issues, adverse effects, and complications are used interchangeably throughout the paper to describe the patients’ self-reported experience, but without the benefit of operational definitions. These are not synonyms. Definitions help us to have a common understanding of a word or topic; they help us get on the same page when reading about an issue.
The word “possible” seems appropriate in the main outcome(s) statement, but is curiously missing from the report title. The phrase “medical complications” is used in the title of Table 2 – which clearly reports predominantly patient self-reported symptoms. The same bias is exhibited in the paragraph titled “Change in patient-reported complications over time”. The study limitations clearly note that the signs and symptoms reported could not be interpreted within the context of comorbidities, nor could the complications be confirmed without evidence in the medical record.
Study titles and terms will influence the readers – who in this case are clinicians and patients. It seems irresponsible to use the term “complication” without the qualifying word “possible” to accurately represent the findings and import of this study.
Krein et al have the best of intentions as they try to develop the body of knowledge around vascular access devices. However, an analysis of self-reported symptoms should not be represented as a complication rate.
We are writing in response to Abraham et al.’s recent review of systematic reviews (SR) targeting the impact of computerised provider order entry (CPOE) on clinical and safety outcomes [1]. We commend the authors’ inclusion of medication errors and adverse drug events (ADE) among the outcomes assessed. This is particularly timely given the World Health Organisation’s 2017 announcement of the third Global Patient Safety Challenge to motivate actions to reduce medication errors causing actual patient harm by half in five years [2]. Abraham et al. concluded that, based on the evidence reported by three SR of inpatient populations, pooled studies showed significant reduction in ADEs with CPOE use, with considerable variation in the magnitude of relative risk reduction [1]. However, there are significant limitations to the studies on which this conclusion is based, and we believe a more cautious approach should be taken when assessing the current evidence.
Firstly, as the authors acknowledged, there was variation in the definitions of ADE across the three SR and the 18 studies they included. We agree that these are significant limitations when trying to summarise the impact of CPOE on ADE. To be clear, the included studies assessed preventable ADEs (10 studies) and/or potential ADEs (15 studies), and three studies did not specify the type of ADE. An ADE can be preventable, non-preventable, or potential [3]. A preventable ADE refers to a medication error which reached th...
Show MoreAdherence Issues in Population with Intellectual Disabilities
Bernadette Flood PhD MPSI, Pharmacist, Daughters of Charity Disability Support Services
Link to Original article: Medication non-adherence: an overlooked target for quality improvement interventions
Commentary on: Medication non-adherence: an overlooked target for quality improvement interventions, Bryony Dean Franklin, Gary Abel, Kaveh G Shojania (2019-12-20). 10.1136/bmjqs-2019-009984
Non adherence to prescribed medication is a complex problem. The complexity is increased in vulnerable population groups such as the population with intellectual disabilities. A person with an intellectual disability may often be dependent on ‘healthcare by proxy’ where another person makes healthcare decisions on their behalf. People with intellectual disabilities may also be ‘invisible’ to pharmacists dispensing prescribed medicines. Many pharmacists may have little experience of the challenges faced by this high risk group of patients [1] who may be prescribed high risk medications such as diabetic medicines including insulin and anti-epileptic medications. People with intellectual disabilities and their family carers, support workers etc. may be unaware of the consequences of poor adherence to prescribed medicines. The difficulties of involving a parent proxy in a three-way relationship involving an adult at risk of lacking decision-making capacity, their proxy, and a treating clinician have been ra...
Show MoreTo the editor,
In their editorial commenting on our paper “Association of registered nurse and nursing support staffing with inpatient hospital mortality,” [1] Aiken and Sloane misrepresent our study results, conclusions and implications. They characterize our study as examining the impact of substitution of nursing support staff for professional nurses or registered nurses (RNs) (commonly described as skill mix). This is done despite acknowledging that we stated our findings should not be interpreted to mean that nursing aides can safely substitute for RNs. Furthermore, as Aiken and Sloane acknowledge each of us have published multiple studies [2 3] showing efforts to deskill the nursing work force will increase deaths, adverse events and costs. This conclusion was also restated in a recent editorial in this journal by one of us. [4]
Aiken and Sloane discuss the paper as though it is about skill mix, characterizing our findings as “counter” to our earlier published papers that did analyze skill mix. However, the current paper and the recent Griffith’s paper Aiken and Sloane also reference[5], “examine nursing support staffing not as a substitute for RNs, as studies of skill mix do, but …rather examine the impact of shortfalls in support staffing given established RN- nursing support staffing models.” What our paper and Griffiths paper do is examine shortfalls from established levels of nurse support staffing as a complement of typical RN staffing withi...
Show MoreI write in response to the article published in your journal “Passing the acid test? Evaluating the impact of national education initiatives to reduce proton pump inhibitor use in Australia” (Bruno C et al., BMJ Qual Saf 2019). I am writing as NPS MedicineWise evaluation found a significant impact on general practitioner prescribing of proton pump inhibitors (PPIs) following their educational programs in 2009 and 2015. I acknowledge that the article is well written, the methods are well described, and the approach includes a number of sensitivity analyses. However, I would like to highlight some key points on the analysis methods used that differ from the approach taken by NPS MedicineWise and about which I have some concerns.
The 2015 NPS MedicineWise educational program on PPIs was part of a larger educational strategy over a decade to support best-practice prescribing of PPIs by general practitioners (GPs) and included Pharmaceutical Benefits Scheme (PBS) feedback to GPs in Australia. This consists of a letter that includes information of the individual GP’s prescribing of PPIs compared to their peers. Programs launched in 2009 and 2018 on PPI prescribing for GPs also included face-to-face educational visits to GP practices. The 2015 campaign, which did not include these face-to-face visits, aimed to reinforce the impact of the earlier 2009 campaign.
NPS MedicineWise has conducted an evaluation of the 2009 and 2015 education programs on GP prescribing o...
Show MoreWe thank the French Society of Emergency Medicine for such a large study. However it is difficult to conclude regarding a number of limitations due to the observational cross-sectional study scheme.
The main critics concern the 3 measurements tools allowing to decide appropriateness of ED visits or not. Appropriate Use Score Method: the authors decide a cut-off based on Italian litterature data which is not French sounded; Possible GP Use Method : it would be more accurate to have an external evaluation instead of a judge and part one ; Resource Utilisation Method : the elephant in the room is the result of consultation and the final diagnostic as well.
I don’t discuss here the relevance of a number of items as distance between home and ED Departments, medical density and so far.
Specifically I doubt it is possible to interpret socioeconomic and territorial factors results without diagnostics and diagnostic frequency on June, 11, 2013
We are looking forward for more studies informing use of ED departments.
As a non-physician often working as a researcher with physicians, I didn't know whether to laugh or cry at the explanation in this article as to why certain specialties might get lower patient satisfaction scores than internists. Yes, it may well be that the episodic nature of the encounter with a non-chosen physician leads to lower satisfaction. But given the long history of jokes within medicine based on the personality type differences among specialties, and, one would think, given the authors' personal experiences in say, their last dermatology appointment, might not differences among doctors rather than patient issues be at least be presented as a hypothesis? The briefest of Googling finds a post in the KevinMD blog, directed towards physicians, on "remarkably distinct" cultures. (The blog is here: https://www.kevinmd.com/blog/2018/07/what-personality-type-fits-your-med.... One of the literature links is here: https://onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2923.2011.04099.x)
I admire the question and rigor the researchers used in answering it. But, in the Discussion, simply assuming "differences in perception must be due to the patient" fails to meet the test of common sense.
We can only reiterate the points brought forward by Carl Macrae in “The problem with incident reporting”. In our own work with incident reporting systems in the UK and Austria we observe that an estimated 50% of incident reports are eliminated without further consideration due to their non-clinical nature, even if they may affect patient safety. The remaining clinical reports are then pigeonholed to fit existing medical categories of expertise for further investigation. Hence, current incident reporting practices do not truly reflect the systemic complexities of medical errors, which are composed of both clinical and non-clinical elements. Incident reporting systems in healthcare need to either use more stringent reporting criteria to exclude non-clinical incidents upfront (even if they affect patient safety), but this would mean cutting themselves short of opportunities for whole system improvement. Alternatively, non-clinical reports should be further investigated to determine their potential contribution to (un)safe practice. This is likely to require the inclusion of non-clinical, organisational experts in the analysis of incident reports.
We appreciate the concerns raised and agree that accurately presenting the findings of our study regarding patient-reported possible PICC-related complications is important. We took several steps to ensure transparency in how we presented our data. First, we were vigilant about consistently defining our outcomes as “possible complications” in all key areas of the paper including the main outcomes and conclusions section of the abstract, study measures section in the methods, main findings in the results section and in the discussion. The fact that the term “possible” or “potential” was not always used or some terms appeared to be used interchangeably was to improve readability of the article. In general, however, we were conscientious about clearly noting that we asked patients about signs or symptoms of a potential complication or adverse effect. Second, we purposefully chose to not present the data as complication rates (implying that these were actual events), but as the percentage of patients reporting a given event – thus we faithfully represented what we were told by patients during follow-up assessments. Third, we took these approaches because our primary objective was to accurately present the data collected from our patients; if something mattered enough to a patient to tell us about it, then it should matter to us as healthcare professionals regardless of internal standards that we may use to define serious medical complications. While that’s not to say that f...
Show More"What is needed now is an understanding of what is the threshold of professional nurse staff and complementary staff needed to achieve optimal outcomes, and how are these levels influenced by patient nursing acuity and the education, experience, organisation and work environment of the nurse workforce." --- I agree with you. Further, this study may be approached by Park's Optimized Nurse Staffing (Sweet Spot) Estimation Theory (Park, 2017): https://onlinelibrary.wiley.com/doi/full/10.1111/jan.13284. I am doing the research now.
Krein, et al (Patient-Reported Complications Related to Peripherally Inserted Central Catheters: A Multicenter Prospective Cohort Study; Feb 2019) should be commended for sharing the results of this very interesting study. After reading it a few times, I am compelled to share the following concerns with you and the research team. The knowledge regarding PICC-related complications is indeed incomplete, but I am not sure if the main outcome(s) of your study are clearly represented to the reader.
The word “possible” is critical to correctly interpreting the results of this study. The term “complication” implies a medical diagnosis or medical confirmation – which your study attempted to do by conducting the chart reviews to confirm the presence or absence of a PICC complication, with limited success. Terms such as signs, symptoms, issues, adverse effects, and complications are used interchangeably throughout the paper to describe the patients’ self-reported experience, but without the benefit of operational definitions. These are not synonyms. Definitions help us to have a common understanding of a word or topic; they help us get on the same page when reading about an issue.
The word “possible” seems appropriate in the main outcome(s) statement, but is curiously missing from the report title. The phrase “medical complications” is used in the title of Table 2 – which clearly reports predominantly patient self-reported symptoms. The same bias is exhibited...
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