Recent eLetters

Dear Editor,

We welcome the recent Original Viewpoint paper by Foy et al1, titled The role of theory in research to develop and evaluate the implementation of patient safety practices. We strongly support the recommendations in this paper, and in particular, the application of behavioural change theory in the design, implementation and evaluation of Patient Safety Practices (PSPs).

However, on reading this paper, one could be forgiven for believing that the use of such behavioural theory as the basis for the design, implementation and evaluation of PSPs is novel. Reference to the application of the Theory of Planned Behaviour (TPB) in the paper, was restricted to taking intra-oral radiographs, managing upper respiratory tract infections with antibiotics and disclosure of dementia: hardly mainstream PSPs.

We are therefore perplexed at the apparent 'blind spot' of the authors for citing relevant research in this area. Pubmed and even a simple Google search using search string "TPB and patient safety behaviours" will produce original published work which has been omitted.

The first article in this Google search is a paper which explored the use of TPB in understanding hand hygiene behaviour and design of interventions to improve compliance2. We have been using such theory for more than ten years, to design, implement and evaluate important PSPs including the recent pivotal PSP of hand hygiene.2,3 As hand hygiene was used as a core example of PSP by Foy et al1, we were left wondering why such relevant and highly cited3 research was not included.

Another citation on page one of the Google search related to an original research paper published in 2010 in Quality and Safety in Health Care (the same journal now called BMJ Quality and Safety). This paper titled Patient Safety Culture: factors that influence clinician involvement in patient safety behaviours4, applied TPB to a range of patient safety behaviours including incident reporting and speaking up when witnessing a colleague making a mistake. This paper has for the first time in the literature identified predictive factors for these PSPs, establishing unique models for differing professional sub-groups such as junior and senior doctors; junior and senior nurses; and, allied health practitioners. Again, it is hard to understand why such research, published in the same journal, was not cited.

For the past decade behavioural theory has been successful in predicting patients' non compliant antiviral therapy to prevent wide- spread resistance8 as well as other central public safety issues of the time.5-9

Perhaps the root cause of the issues identified by Foy et al, is that the focus has been on identifying an evidence base for what PSPs to implement, rather than how best to change behaviour and practice. The former, is founded in traditional biosciences, reductionist research paradigms and pedagogy, wheras the latter is far more the domain of public health, behavioural and social sciences. Perhaps if we were to re-state the problem of patient safety as public health, then we would start to employ the appropriate scientific endeavours to design, implement and evaluate interventions.

Finally, we welcome the increased focus on behavioural theory driven interventions in patient safety, and congratulate the authors and journal for shining a light on this important issue. However, we believe that the authors have been selective in their review of the relevant literature on the use of behavioural theory applied to PSPs, both at a general level, and in relation to specific examples in the paper.

1. Foy R, Ovretveit J, Shekelle PG, et al. The role of theory in research to develop and evaluate the implementation of patient safety practices. BMJ Qual Saf bmjqs.2010.047993Published Online First: 11 February 2011 doi:10.1136/bmjqs.2010.047993.

2. Whitby M, McLaws ML, Ross MW. Why healthcare workers don't wash their hands: a behavioural explanation. Infect Control Hosp Epidemiol 2006; 27: 484-492.

3. Whitby M, Pessoa-Silva CL, McLaws ML, Allegranzi B, Sax H, Larson E, Seto WH, Donaldson L, Pittet D. Behavioural considerations for hand hygiene practices: the basic building blocks. J Hosp Infect 2006; 65(1):1-8.

4. Wakefield J, McLaws ML, Whitby M, Patton L, Blake S. Patient Safety Culture: Factors that influence clinician involvement in patient safety behaviour. Quality and Safety in Healthcare 2010 Aug 19 (6): 585-91.

5. Begely K, McLaws ML, Ross MW, Gold J. Adherence behavior of patients on long term protease inhibitor therapy: insight for the treating clinician. Clinical Psychologist 2008;12(1):9-17.

6. McLaws ML, Irwig LM, Oldenburg B, Mock P, Ross MW. Predicting intention to use condoms in homosexual men: an application and extension of the theory of reasoned action. Psychol Health 1996;11(5):745-55.

7. McLaws ML, Oldenburg B, Ross MW. Application of the Theory of Reasoned Action to measurement of condom use among gay men. In: The Theory of Reasoned Action: Its Application to AIDS-Preventive Behaviour. Terry DJ, Gallois C, McCamish M (Eds). Chapter 10. Pergamon Press. Oxford, 1993.

8. Ross MW, McLaws ML. Attitudes towards condoms and the Theory of Reasoned Action. In: The Theory of Reasoned Action: Its Application to AIDS-Preventive Behaviour. Terry DJ, Gallois C, McCamish M (Eds). Chapter 5. Pergamon Press. Oxford, 1993.

9. Ross MW, McLaws ML. Subjective norms about condoms are better predictors of use and intention to use than attitudes. Health Educ Research 1992; 7 (3): 335-339.

Conflict of Interest:

None declared

Most Intensive Care Units (ICU) collect comprehensive data relating to patient demographics, diagnoses and complications and some use this information to benchmark and guide quality improvement activities aimed at improving patient outcomes and reducing iatrogenic complications. Ayas et. al. are to be commended for using routine information they collect in an attempt to identify trends and possible contributing factors to one of the potential complications related to insertion of Central Venous Catheters (CVCs), development of a pneumothorax. Their retrospective review did not confirm their suspicions that the incidence of pneumothorax would increase with the introduction of new trainees to their area, which is surprising, however they have suggested that decreased supervision as the ICU rotation progresses may contribute to this. CVCs are widely used in ICUs around the world, and pneumothoraces are a significant potential complication of insertion of CVCs into the internal jugular and subclavian veins (SCV). There is high level evidence to support the insertion of CVCs into neck veins, particularly the SCV, as opposed to femoral veins to reduce the incidence of blood stream infections that contribute to significant morbidity and mortality, and increased length and cost of hospital stay.1 Sheretz et. al. demonstrated that providing targeted training for physicians in relation to methods to reduce infection related to vascular device insertion resulted in improved knowledge and retention that translated into practice. In their study, compliance with evidence based procedures improved and resulted in a reduction in the incidence of CVC bloodstream infections. They provided a detailed cost-benefit analysis of their training program that supports such an approach to improving quality and safety of patient care.2 Ault described an approach to training inexperienced practitioners that used tissue models for practice, the use of ultrasound devices, a focus on use of large drapes and improved sharps handling that resulted in improved accuracy and safety of CVC insertion.3 Ayas et. al. refer to the use of ultrasound guidance to assist in CVC placement as being sporadic in their study settings, which could contribute to the trends they are identifying, however the evidence to support the routine use of such devices is to date not strong.4 The only training method referred to by Ayas et. al. is supervision by more experienced practitioners in the clinical field. Perhaps they could consider introducing more formalized training, as described above, to reduce the incidence of pneumothorax and other complications related to CVC insertion for their patients. The routine data they are currently collecting could assist in assessing the efficacy of such an approach. Ros MacLeod, BN, Grad Cert CCN, Grad Dip Nursing, Nurse Unit Manager, ICU, Western Health, Footscray, Australia, Ros.MacLeod@wh.org.au References: 1. O’Grady, N. P., Alexander, M., Dellinger, E. P., Gerberding, J.L., Heard, S. O., Maki, D. G., Maur, H., McCormick, R. D., Mermel. L.A., Person, M. L., Raad, I. I., Randolph, A., Weinstein., R. A.. Guidelines for the Prevention of Intravascular Catheter-Related Infections. National Center for Infectious Diseases. 2002. www.cdc.gov/mmwr/preview/mmwrhtml/rr5110al.htm 2. Sherertz, R. J., Ely, E., Wesley M. D., Westbrook, D. M., RN, Gledhill, K. S., Streed, S. A., Kiger, B., Flynn, L., Hayes, S., Strong, S., Cruz, J., Bowton, D. L., Hulgan, T. & Haponik, E. Education of Physicians-in -Training Can Decrease the Risk for Vascular Catheter Infection. Annals of Internal Medicine: 2000: 132(8): 641-648. 3. Ault, M. J. The Use of Tissue Models for Vascular Access Training: Phase 1 of the Procedural Safety Initiative. Academic Emergency Medicine. 2007: 14(1):13. 4. Stone, M.B. Identification and correction guide wire malposition during internal jugular cannulation with ultrasound. Journal of the Canadian Association of Emergency Physicians. 2007:p(2):131.

Recently Neuhauser and Dias raised an important question [1]: are randomised clinical trials (RCT) necessary in quality improvement?

They conclude that “RCTs need to be embedded in generalized replicatable theory. Otherwise it is a scientific house without foundation” and argue that RCTs comparing drugs cannot be replicated for two reasons: (1) after a decade or two the control arm has changed and (2) replication may be considered unethical if the original trial showed a difference. Thus it is tempting to draw the conclusion that the authors suggest that RCT should not be used when the effect of a new drug is to be tested.

Why is it so important that an experiment can be replicated? Say drug B is shown to be superior to drug A, and later drug C is shown to be superior to drug B. Then, who really cares whether the experiment comparing drug A and B can be replicated or not?

The authors’ claim that RCTs cannot be replicated may be challenged. If the conditions for the control arm has changed then the intervention arm conditions are likely to have changed in parallel over time. Then we expect to be able to replicate the findings. But we have no way of knowing this. In fact, given that the same drug is used over the years, it is unethical not to replicate the experiments regularly, according to paragraph 6 in the introduction to the Helsinki Declaration (www.wma.net/e/policy/b3.htm).

We agree with the authors that statistical process control (SPC) has an important role to play in medicine [2]. But we feel that the use of SPC for the comparison of drugs is quite risky due to the potential for the introduction of all kinds of bias [2,3]. Another reason why SPC may be inferior to RCTs is that the application of SPC requires the processes studied to be brought in statistical control prior to the intervention [2]. This may not be possible to achieve because the patient mix may vary over time. It may be argued, then, that statistical risk adjustment may take care of this problem. However, it is well known that this approach is fraud with problems [2,3]. By contrast, the attainment of statistical control is not an issue in the case of RCTs, precisely due to the random assignment of patients to the intervention groups.

References 1. Neuhauser D, Dias M. Quality improvement research: are randomized trials necessary? Qual Saf Health Care 2007; 16:77-80. 2. Winkel P, Zhang NF. Statistical Development of Quality in Medicine. John Wiley and Sons Inc, 2007; 1 – 263. 3. Deeks JJ, Dinnes J, D’Amico R, Sowdon AJ, Sakarovitch C, Song F, Petticrew M, Altman DG. Evaluating non-randomised intervention studies. Health Technol Assess 2003;7:1-173.

Dear Editor,

As a retired USAF pilot-physician, I commend Singh et al. for their excellent use of aviation Situational Awareness as an analysis tool. I wish only to add a subtle dimension to their illustration of situational awareness: "LSA" - loss of situational awareness – began as a universally recognized NATO acronym. But…one can not lose what one never had. SA in military and air carrier aviation universally begins at a maximum, and may deteriorate backwards from Level 3 of Endsley’s model. Maximal SA at the outset of a mission is achieved by all team members studying all environmental factors that might affect the outcome; mentally rehearsing the mission timeline, actions, and threats; and planning for contingencies during the preflight briefing. The team begins with a high level, mental model of what is to come. Sadly, pre-event reviews are vanishingly rare in medicine, and physicians begin with very limited, or absent SA, as illustrated by the outpatient case in the paper. Further, SA in outpatient medicine, if it exists at all, is compromised by the fragmentation and time displacement of cues and communications. Ironically, is easier to discern SA, good and bad, in the confines of the high risk areas of inpatient care: the OR, Labor and Delivery, and ED. Medical team training courses emphasize the value of briefings in setting the stage for good SA, and train high risk team leaders to conduct them.

Thus far team training is not widely deployed or accepted. Nor are briefings cited in such patient safety resources as the AHRQ Web M&M.1 Another fundamental, but subtle, difference between aviation and medicine is decision making. The hapless primary care physician was "flying solo" and making independent judgments. Despite the Hollywood images, fighter pilots rarely make solo decisions. Flying in multiples for "mutual support," air combat teams operate with strong, visible, designated leadership, but simultaneously practice collaborative, consensus decision making. Similarly, "cockpit resource management," the progenitor of medical team training, reversed decades of left-seat, hierarchical, autocratic decisions that placed passengers at the same risk level as the described patient in favor of collaborative decision making after inputs by all, even passengers.2 Lastly, the authors omit any discussion of a post-event debriefing of this adverse outcome. Thus, learning was not captured, nor system improvements made. Debriefings – as short as 30s or lasting for hours – are mandatory in aviation and result in real-time, actual, lasting CQI. Early efforts to use traditional M&M conferences offer some promise in debriefings.3 Medicine has much to adopt and adapt from other high risk professions, aviation, nuclear power, and even mining. The authors have advanced that journey significantly.

References

1. http://webmm.ahrq.gov/

2. Foushee HC. Dyads and triads at 25 000 feet: factors affecting group process and aircrew performance. American Psychologist 1984; 39: 885-993.

3. http://www.patientsafety.gov.

No conflicting interests: Government employee only.

Dear Editor,

According to MM Bismark et Al (1) complaints that are brought to a Commissioner in NZ offer a potentially valuable “window” on serious threats to patient safety. In Italy, the consultative and conciliatory commissions (“Commissioni miste conciliative”) and the ombudsmen (second level organisations) supply unsatisfactory results or are not even established (2). Furthermore, epidemiological data like those of the NZQHS are very scarce. We had only a possibility in this field: to carry out a survey to explore if an independent patient’s agency could facilitate local learning and action to improve the quality of health services.

Two hundred forty complaints and accounts of presumed untoward events presented by people to our voluntary Patients Agency in Milan (Cittadinanzattiva) were analysed. Every complaint enclosed one or more clinical records. Our aim was to compare allegations contained in the written complaints and the results of a retrospective case records review. An expert physician examined all the clinical records produced and identified when an “avoidable adverse event” was present (3). A medicolegal expert independently reviewed 89 complaints. According to the patients the cause of the complaint was: *A delay in diagnosis and treatment (89 cases). *The failure or a complication in the technical performance of an indicated operation (82 cases), or of an indicated invasive procedure (24 cases ). *Lack of care or attention, failure to attend, lack in monitoring of a patient (19 cases). *Delay or failure in treatment (9 cases). *Others (9 cases). In the physician record review, 87 out of 240 complaints were associated with a preventable adverse event (mainly occurring in hospital); 22 were serious and preventable, 12 of them from a failure or a complication of an indicated operation.

We know that there are a number of potential shortcomings in our study. Nevertheless, the survey confirm what kind of useful information about substandard medical care we can gather also from this type of documentation. With no patient lawyer or representative (4) present in the hospital, and with claim management firmly controlled by the medical experts, who wishes to complain will be more motivated if the management of the claims was supported by an independent Agency to ensure objectivity before the disputes, taking on responsibility for reporting the incident to the interested organization and for feed-back to the citizen. But, in my opinion, the Italian voluntary Patients Agencies have a very weak voice.

Roberto Natangelo
Retired Physician
Cittadinanzattiva (Active Citizenship. Via Mecenate n. 25. 20138 Milan. Italy)
e-mail: roberto.natangelo @ libero.it

References

1. – Bismark MM, Brennan TA, Paterson RJ, Davis PB, Studdert DM. Relationship between complaints and quality of care in New Zealand: a descriptive analysis of complainants and non-complainants following adverse events. Qual Saf Health Care 2006;15:17-22.

2. – Convegno: “La comunicazione pubblica in sanità” (Meeting: Public communication in health service) Associazione Stampa Medica Italiana. Atti interventi. Roma 6-10 maggio 2002.

3. - Wilson RM , Runciman WB, Gibberd RW, Harrison BT, Newby L, Hamilton JD. The quality in Australian Health Care Study. Med J Aust 1995;153:458- 471.

4. - Entwistle VA, Andrew JE, Emslie MJ, Walker KA, Dorrian C, Angus VC, Conniff AO. Public opinion on systems for feeding back views to the National Health Service. Qual Saf Health Care 2003;12:435-442.