Why Should You Consider Collecting a Family of Measures When Undertaking an Improvement?

Globe J Nephrol. 2014 Nov 6; iii(4): 249–255.

Clinical audit, a valuable tool to ameliorate quality of care: General methodology and applications in nephrology

Received 2014 Jun xiii; Revised 2014 Aug ane; Accepted 2014 Sep iv.

Abstract

Evaluation and improvement of quality of intendance provided to the patients are of crucial importance in the daily clinical do and in the health policy planning and financing. Different tools accept been developed, including incident analysis, health technology assessment and clinical audit. The clinical audit consist of measuring a clinical outcome or a process, against well-defined standards attack the principles of evidence-based medicine in order to identify the changes needed to better the quality of care. In particular, patients suffering from chronic renal diseases, nowadays many bug that have been set as topics for clinical audit projects, such every bit hypertension, anaemia and mineral metabolism direction. Although the results of these studies have been encouraging, demonstrating the effectiveness of audit, overall the present evidence is not clearly in favour of clinical inspect. These findings call attending to the need to further studies to validate this methodology in unlike operating scenarios. This review examines the principle of clinical audit, focusing on experiences performed in nephrology settings.

Keywords: Clinical audit, Evidence-based medicine, Quality improvement, Nephrology, Hemodialysis

Core tip: Clinical inspect is a office of the continuous quality improvement process. It consists in measuring a clinical outcome or a procedure against well-defined standards, established using the principles of bear witness-based medicine. The comparison between clinical practise and standards leads to the formulation of strategies, in order to improve daily care quality. This review examines the basis of clinical audit and the data about the efficacy of this methodology, focusing on nephrology problems. We think that clinical audit could offer to the modern Nephrologists a useful tool to monitor and advance their clinical exercise.

INTRODUCTION

"Audit" is a Latin word, and the verb audio ('hear') indicates both active listening and the action of investigation and interrogation of the judiciary. Transferred to the English vocabulary "audit" takes on a significant of "an official inspection of an organisation's accounts, typically by an independent body"[1].

The term is nowadays widely used in unlike settings (economic, business, etc.) referring to procedures aiming to ensure that the activities carried out for a purpose are consistent and effective for the achievement of objectives. Clinical (or medical) audits are part of the continuous quality improvement process that focus on specific problems or aspects of health intendance and clinical practice.

They consist of measuring a clinical outcome or a process, against well-divers standards set on the principles of evidence-based medicine. Aim of the audit is to highlight the discrepancies betwixt bodily practice and standard in lodge to place the changes needed to improve the quality of care. A peculiar characteristic of the clinical audit is the "professionalism" of the initiative, which is expressed by some typical ingredients: clinical specific competence of the participants, the confidentiality of the results, the object strongly connected to the "quality" of professionals. From a methodological betoken of view, clinical audit consists of a "quality loop" (Figure ​ i): one time chosen a topic and set up shared and measurable criteria and standards, current clinical exercise is evaluated, especially in terms of procedure or outcome, and suggestions for improvement are developed and applied, so the bicycle can brainstorm again[2].

The audit should non be confused with information collection activities (i.due east., benchmarking) or clinical research: the latter, in fact, aims to define the characteristics of good practice on a unknown land, while the audit compares the electric current exercise against well-divers and established standards[three]. The final aim of the clinical inspect is ever improving the intendance provided to the patient.

This achievement may be reach through different actions: (1) Increase the civilization of clinicians; (2) Solve a problem; (3) Reduce the variability of professional conduct (standardize); and (4) Reduce the gap betwixt theoretical standards and real life.

PRINCIPLES OF THE CLINICAL Audit

Pace i: Preparing for the audit

Good grooming is crucial for the success of an inspect project.

The key elements to design valuable clinical audits are: choosing the topic, defining a clear purpose and providing the necessary organisation in terms of audit staff and resource.

The first footstep that must be achieved in designing a clinical audit is to identify the topic (Table ​ one). The topic of the audit tin can be loosely identified in clinical practice and may relate to the adequacy of a care procedure or that of the results[4]. An audited theme should have specific characteristics: it should be of cracking clinical importance, of easy collection and assay, and source of of import consequences. The personnel involved in the audit have a fundamental role in setting priorities amid clinical bug to bargain with. By choosing a suitable theme various aspects should exist considered.

Table 1

Factors to consider in the conclusion on a topic for a clinical inspect

For the option of an appropriate theme for a clinical inspect, appraise that:

The problem to be audited has an of import impact in terms of costs, resources, or chance

There is some strong scientific evidence bachelor (guidelines, systematic reviews)

The improvements made on the discipline in question can be hands evaluated and source of important clinical/organisational consequence.

In particular, it would be a good choice to face up a trouble that involves the clinician in terms of: (1) High volumes of work; (2) High costs in terms of health and/or economic; (3) High run a risk; (four) Loftier variability; (five) High complexity; and (6) Loftier innovation.

Rare events, such as complex clinical cases or sporadic adverse events, are non an advisable topic for a clinical audit, and should exist analysed with more acceptable methodologies (i.due east., Root Case Analysis)[5]. Once the topic has been selected, the purpose of the project must be defined, then that a proper audit methodology can be chosen and designed.

The aim of an audit projection could include the implementation of new processes (for case laboratory protocols, surgical procedures, etc.) and/or the improvement of current strategies[half dozen].

Moreover, before start a clinical inspect, organisations should clearly declare the resource allocated to support the projection direction (data drove, hardware and software required) and for the training of the clinical staff, including education on clinical inspect techniques, facilitation and data management[vii,viii].

Regarding the inspect projection squad, information technology is advisable that it be customised for the specific audit project, with team members providing many of the skills needed. For example, if the topic of the inspect is the management of vascular access in patients undergoing haemodialysis, it volition be useful to include nephrologists, vascular surgeons and dialysis nurses in the audit team[nine].

Step two: Selection of indicators, criteria and standards and definition of intervention strategies

One time the preliminary issues of the audit have been defined, the next step is to gear up the standards, which the current clinical exercise will be compared to. At this point, it is important to clarify some definitions: (1) Indicator: a variable that allows to describe circuitous phenomena and to measure changes in relation to defined criteria, in order to guide the decisions aiming at obtaining or maintaining the changes. It can exist expressed as absolute number, percentage, rate, or average; (2) Criterion: it is a definable and measurable aspect of health intendance that describes its quality. The audit criteria are explicit statements that ascertain an effect to be measured. In a clinical inspect, it is a proclamation of what should happen on the footing of expert do, and it should exist prove-based[10]; and (3) Standard: it is the standard of care to be achieved for each specific criterion, usually expressed as a percentage. It represents the threshold of acceptability, that is, the value that defines the upper or lower limit, so that the quality of care is considered to exist appropriate[11]. Some indicators are so of import that the standards must be achieved in 100% of patients (e.one thousand., use of masks during the dressing of central venous catheters), simply in general information technology is sufficient to meet the standard in a lower percentage (for example, in eighty% of patients)[4].

The choice of criteria and standards is one of the most critical points in the design of a clinical audit and information technology requires the collaboration of all participants in the audit. Indeed, the quality of care provided (i.east., the terminal result of the audit) will be evaluated just on the basis of a comparing with these parameters.

The sources where criteria and standards can be drawn from may be: international guidelines, scientific literature, expert consensus, data obtained past other health care facilities and personal case studies[12-14]. The stronger the evidence taken as a reference volition be, the more than the results of the comparison with daily clinical exercise will be reliable. However, to design an effective clinical audit, information technology is important that the standard and criteria exist shared with colleagues prior to the review of the collected data, since they should not be object of rearrangement in the class of verification, nor be changed retrospectively, in the lite of the findings derived from the audit itself.

Finally, the audit squad should also define the intervention strategies to be implemented in case of of import discrepancies betwixt standards and bodily clinical exercise. These strategies should be discussed, shared, articulate and piece of cake feasible according to a structured algorithm.

Step 3: Information collection

In clinical audit data tin can exist nerveless prospectively or retrospectively[15]. Taking into consideration past clinical documentation, the latter method is certainly faster, but often the quality of the collected information is not optimal.

Perspective audits are more expensive in terms of time, merely they allow a more authentic blueprint, while offering a more realistic description of the current clinical practice. Before proceeding with data collection, it is necessary to advisedly programme the variables to be recorded, and ascertain the type of analysis to be conducted on the collected data. These points are important to preclude the collection of useless information or, conversely, the lack of essential data. A specific-designed form or a database should be arranged to collect patient records[16].

Moreover, it may be advisable to carry out a sampling (preferably using randomized methods) if there is a very large number of patients to exist examined, also in relation to the degree of conviction that 1 wants to reach and the resources really available (time, coin, personnel)[17].

Nerveless data can be quantitative or qualitative, such as interviews, questionnaires or comments and data sources can be various, including medical records, results of biochemical and instrumental evaluations and/or other different archives[18,19]. The medical tape is certainly the main source of information, but it is often incomplete. In this regard, highlighting the inadequacies of data management, already in the preliminary phase of information collection, the audit improves the existing information flow. Finally, it is worth pointing out that in every moment of data collection and assay, patient privacy must be protected, making the information nerveless bearding and explaining the reasons for the data collection, in case of straight interest of patients themselves[20].

Step 4: Comparison of collected data with the standards and evolution of corrective deportment

This is the cardinal stage of clinical audit. In this phase, the team of professionals interested in the audit analyses the data and compares them with the pre-set standards. Information technology is important to note that the critical nature of this moment lies in the fact that the professionals involved in the audit process can interpret the audit as an inspection of their clinical action, thus becoming, unconsciously, an obstacle to an constructive information analysis (Table ​ 2)[21].

Table ii

Facilitating factors and barriers for effective clinical audit

Facilitating factors	Obstacles
Clarity of design and data drove	Not articulate objectives and planning
Good planning	Lack of resources-heavy workload
Organization back up	Lack of clarity on the method
Defended staff	Lack of organizational support
Collective analysis of the results	Unwillingness to alter

For this reason, the meeting where the results of the audit will be discussed must be carefully prepared, paying particular attention to all aspects of communication and social skills[22,23].

Moreover, these contents must be pre-emptively shared with those who have proposed the inspect. From the comparison of bodily data with the theoretical standards different results might emerge, and the standard could be reached or not. In the consequence that the standard is non met, it should be assessed whether or not there is the possibility of a real improvement. In fact, if the data are non in line with the standards but they are sufficiently shut, one might decide that any further improvement is difficult to achieve, and therefore information technology would be useful to invest resources in the assessment of other problems. In the instance in that location is a significant difference betwixt information gleaned from the clinical documentation and standards, collegial give-and-take should highlight the barriers to the achievement of the standard[24]. Afterwards, inspect methodology requires that the audit squad elaborate intervention strategies and recommendations, according to the indications preliminarily set up[25]. Such advices or recommendations should take into account organizational factors (in terms of economical resources, timing, dedicated staff) and the context in which the audit takes place. For this reason it is imperative that the developed recommendations be clear, explicit and shared[26]. The mere dissemination of educational materials, such every bit guidelines, has picayune event if they are not accompanied by selected methods of implementation, such as training seminars or discussions amid peers[27].

Instead, in instance the results obtained from the inspect can be considered satisfactory, it is as indispensable to provide a course of monitoring. Finally, all the findings drawn from data analysis and the subsequent word, including strategies to implement modify, should be reported in a detailed account to be distributed to all participants of the audit, as feedback and reminder of the work done.

Step 5: Check and maintenance of improvements

The audit bike ends with the stage of verification and monitoring of implemented strategies[2,4].

Indeed, it is essential for a proper procedure of clinical inspect to schedule periodic verifications of the effects of the changes introduced. It would be advisable to use a data collection and an organizational strategy similar to that used for the previous analysis, so that the results are comparable.

If it emerges that the objectives have not been achieved and the plan of improvements was non effective or sufficient, it could be necessary to make changes to planned strategies.

However, besides in case of success, a monitoring plan should be equally scheduled in order to maintain the improvements made.

EFFICACY OF THE CLINICAL Audit

There is alien evidence on the effectiveness of clinical audit[28]. A systematic review of the Cochrane Study Group has considered 140 studies in which clinical audit and the corresponding feedback were tested alone or in comparison to other types of interventions (meetings, distribution of printed materials, etc.). In the studies included in this review, the results produced by the audit were widely variable, from a negative to a very positive consequence. When the inspect was effective, the effects generally ranged from small to moderate. The review concluded that the relative effectiveness of an audit is likely to be greater when baseline adherence to recommended practise is low and when feedback is carried out with greater intensity[29]. Therefore, at the moment, scientific bear witness does not provide clear back up about the real effectiveness of clinical inspect. This finding could be a starting point to pattern studies and analyses to validate clinical inspect in different operating contexts[30].

CLINICAL AUDIT IN NEPHROLOGY

Medical literature offers several studies on audits conducted in the field of clinical nephrology, especially in patients on haemodialysis (Hard disk). The reported studies have evaluated different aspects of organizational direction and clinical research, such as the problems associated with belatedly referral, vascular admission, the management of hypertension and anaemia[31-33]. A conscientious assay of these studies shows that the research has been mainly focused on the comparison between data collected from several instance studies and indications of the guidelines. Therefore, the majority of these studies lack in the processes of cyclicity and verification that, as aforesaid, are the distinctive and characteristic features of clinical audit. An example of a well-conducted audit has been reported in a paper of an Australian group that has performed an audit in order to assess the effect of a multi-disciplinary intervention on the choice of dialysis vascular access, aiming at reducing the use of primal venous catheters[34]. The outset information collection on 184 incident dialysis patients was useful to recognize the issues in limiting the use of arteriovenous fistula, such as communication difficulties with patients or organizational shortcomings. Then, basing on the difficulties identified, the audit team developed specific intervention strategies (i.e., promotion of educational skills, facilitated access to the operating room, direct nurse involvement, etc.), that resulted, 12 mo later, in a meaning increase in the number of patients starting dialysis with an arteriovenous fistula (75% vs 56 % of command baseline, P < 0.01).

Many inspect projects accept been as well focused on management of hypertension in HD patients and different aspects take been investigated, such every bit the function of sodium dialysate concentration and dialysate temperature in the determining claret force per unit area (BP) levels[35,36].

Interestingly, in a contempo written report we tested whether a clinical inspect in se is effective in improving BP command in a population of patients on regular Hard disk drive.

Nosotros studied 177 adult prevalent Hd patients, recording data on factors affecting BP and anti-hypertensive drug regimen at months -1 (Pre), 0 (the date of the audit- Inspect), and +1 and +6 after the audit.

Hypertensive patients were identified, cases were discussed and recommendations for improving BP management were recorded, and so returned to each physician as a reminder and a feedback of the inspect process.

The interventions included the reduction of extracellular fluid volume in patients with fluid overload, use of interdialytic convalescent blood pressure monitoring and bioimpedance, initiatives aimed to increase patient compliance and modulation of dialysis sodium content or temperature. Interestingly, the announcement of the audit by itself was associated with a decreased prevalence of hypertension (Pre 64.4% to Audit 58.vii%) and a further subtract followed the audit (Post-1 51.1%, Postal service-vi 47.6%, P < 0.05 vs Audit). Systolic BP in hypertensive patients also decreased (mean decrease was -viii.v and -14.1; P = 0.007 and P < 0.001 at Post-1 and Mail-6), beingness also associated with a reduced number of drugs assumed, thus proving that clinical inspect is an effective tool to improve BP control in Hd patients[37].

Mineral metabolism disorders in Chronic Kidney Affliction (CKD-MBD) are an instance of a suitable topic for a clinical audit. Indeed, they are common in Hd patients and are associated with a number of clinical symptoms and complications, including cardiovascular diseases[38].

However, although MBD in Hard disk patients are the object of intense research activity, their prevention and treatment still remain unsatisfactory[39]. In this view, we performed two large multicentre audits aiming to enlighten the obstacles that hamper the successful command of MBD by a straightforward "patient-oriented" approach[40,41].

Overall, we collected information and discussed the cases of nigh 700 prevalent Hd adult patients co-ordinate to the audit methodology.

Showtime of all, we confirmed the data regarding the difficulty to achieve therapeutic targets, showing that just 15%-20% of the evaluated patients presented Ca, P and PTH values simultaneously controlled[42].

And then, evaluating the factors related to unsatisfactory results, we found that low compliance with treatment was the major determinant of failure (43.five% of the cases).

All the same, we observed a discrepancy between the assay of factors accounting for therapeutic failure and the interventions planned. In fact, while the low compliance was recognized equally the main cause of therapeutic failure, most of the interventions were focused on pharmacological therapy. Consequently, six months later the audit nosotros found that, against a pregnant increase in the amount of drugs prescribed, the command of MBD parameters did not improve.

Therefore, the results of the audit suggested that low compliance with treatments is a main only yet neglected cause of failure in the accomplishment of MBD control in Hard disk patients, while increase of drug administration, regardless the awareness to the compliance to the therapy, is insufficient to obtain an overall satisfactory rate of therapeutic success.

This finding is particularly important, since indicates that future therapeutic strategies, beyond the evolution of new drugs, should include the implementation of feasible educational programmes addressed to both health personnel and patients. This kind of study shows the potentiality of a clinical audit that allows to effectively compare theoretical standards with daily clinical exercise, providing suggestions to ameliorate quality of care.

Futurity APPLICATIONS

Audit methodology could be potentially extended to several other issues in the setting of clinical nephrology.

For instance, it could exist useful to evaluate the causes of handling failure in patients undergoing peritoneal dialysis, such as to implement protocols to reduce the rate of cardinal venous catheter-related infections. Moreover, clinical audit could be a feasible tool to solve organizational problems, such every bit the delays on the waiting listing for kidney transplantation.

Finally, a clinical audit could be used to face more than general topics, which may involve also renal patients, such as direction of dyslipidaemia (for example, evaluating the appropriateness of statin prescription) and implementation of lifestyle change.

Conclusion

Quality control, and consequently the correct allocation of resource, is condign a cardinal issue in the management of Health Intendance Systems. Several tools are deployed to provide a monitoring of the levels of care and amend its quality. Among them, clinical audit is one of the most popular and widespread. In the specific field of clinical nephrology, this method has proven its effectiveness in facing unlike issues, such as hypertension and mineral metabolism command. Nonetheless, it still seems necessary to spread the understanding of clinical audit and promote its systematic application both nationally and locally, so that it can be function of the expertise of each health intendance provider, together with other quality improvement techniques. In Tabular array ​ iii nosotros present a checklist for the planning of a clinical audit.

Table 3

Checklist for the planning and validation of a clinical audit

Particular	Yes/ No
Promoting a clinical audit	The audit topic has been decided according to the needs of the working group.
	The objectives are clearly specified.
	Indicators, criteria and reference standards have been set according to literature, guidelines and/or the consensus amongst experts.
Design and planning	The audit has been organized in different stages and times, assigning specific responsibilities.
	Necessary resources have been allocated.
	The population/reference sample has been defined.
	Tools for data drove take been designed, preliminarily defining information management methods.
	The whole textile has been proposed in advance to the participants.
Data collection	Those who participated in the preventive phase have been involved.
	The established phases have been met.
	Information have been correctly collected.
Data analysis Interventions	The results take been discussed with the participants to the audit and other interested parties.
	A structured strategy to implement changes has been defined.
	Written reports of the results take been made and sent to all the participants.
Checking the audit effectiveness	A bank check of the effectiveness of the changes introduced has been planned.
	The verification has been formally documented.

ACKNOWLEDGMENTS

We thank Marina Nazzaro for the English editing.

Footnotes

P- Reviewer: Nakhoul FM, Stavroulopoulos A, Showkat Hi, Watanabe T S- Editor: Ji FF L- Editor: A

E- Editor: Lu YJ

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