Management of Patients with Chronic Obstructive Pulmonary Disease Attended at Primary Care in Granada: A Clinical Audit

1. Introduction

Highlights

What are the main findings?

• The uptake of COPD clinical practice guidelines among primary care facilities in Granada is low
• This is specially true for the assessment of the symptom burden of this disease with evidence- based recommended questionnaires such as mMRC and CAT.

What is the implication of the main finding?

• There is a room for improvement in COPD management at the primary care level
• Efforts should be made to increase evidence- base management in this disease at the primary care level.

Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent respiratory disease. National prevalence data from EPISCAN ¹ study showed that this disease affects more than 10% of the Spanish adult population aged between 40 and 80 years- old. Moreover, COPD is the third leading cause of death worldwide ² and the fifth leading cause of years lived with disability ³.

There are several clinical practice guidelines (CPGs) in our country aiming to organise clinical care of this patients with COPD, and quality of care standards have been developed by Spanish National Respiratory Society (SEPAR), which have allowed clinicians to improve the quality of healthcare by summarising the scientific evidence and offering consistency in clinical proceedings⁴. In Spain, the most followed recommendations are the Spanish Guidelines for COPD -GesEPOC⁵(which were endorsed by both the patients associations and scientific societies involved in COPD care, but also by the Spanish Ministry of Health) and the GOLD strategy document for COPD management ⁶.

However, adherence to such recommendations is far away from ideal ⁷. Several studies have detected a deficient compliance and heavy deviations between professionals, which ultimately derives in unequal quality of care even in the same healthcare system.

Along with this previous experience, a recent audit of clinical records from Spanish respiratory specialist clinics has been carried out, kwon as EPOCONSUL study audit. This study has also shown a large variability in healthcare resources as well as patient profiles, adherence to national clinical guidelines and international recommendations and pharmacological and non-pharmacological management of patients with stable COPD. As a result of this findings, scientific societies with interest in healthcare attention to COPD have designed and implemented improvement strategies focusing clinical efforts in those areas where more deficiencies and variability were observed ^8–11. For example, although spirometry is the keystone for COPD diagnosis ¹², it is worldwide kwon that access to spirometry is limited for patients, as a recent survey in Spain highlighted showing low rates of spirometries performed in primary care centers in Spain¹³. This gives a room for improvement in COPD and its implementation in primary care.

Nevertheless, although COPD is a frequent cause of primary care consultation in Spain (more than 10% of visits in primary care are due to COPD) because of its high prevalence and chronic nature, there is scarce data about primary healthcare attention to COPD in Spain and particularly in Andalusia. This has led to this proposal of clinical audits of primary care consultations for COPD patients. An audit is a quality process aiming to improve patient healthcare and its results by a systematic review of disease management with explicit criteria and changes implementation.

Therefore, our aim was to audit the management and care for patients with COPD along the same healthcare system in primary care centers in Granada, to describe the overall adherence to guidelines and suggest changes to improve the management of this population.

2. Materials and Methods

This study is a clinical retrospective audit of clinical histories from patients with a diagnostic code for COPD recruited at 19 primary care centres for 12 months from March 2021 to March 2022. The distribution and selection of primary care centres was performed to reflect the entire population of Granada province. Collected information was retrospective for clinical data (clinical history and related documents) and concurrent for that scheduled attention in primary care as well as for primary healthcare resources.

To avoid selection bias, recruitment was performed prospectively including the first 10 patients each month scheduled for an appointment in the primary care centre with a diagnostic code for COPD

2.1. Inclusion and Exclusion Criteria

Patients were included if they had fulfilled inclusion criteria: adults (men or women) aged more than 40 years old, diagnostic code in Andalusian clinical records (Diraya) in accordance with ICD-9 (Diagnostic codes 496, 492.8, 494.0, 491.20, 493.2), were current of former smokers of at least 10 pack- years, had a minimum follow up of 1 year, and had been assisted in a scheduled primary care appointment at inclusion date. Exclusion criteria included those without information related with COPD in the previous year, those involved in any clinical trial or research study related with COPD.

2.2. Outcomes

The main outcome of the study was to audit public healthcare for patients with COPD in primary care offices in Granada, evaluating variability and possible determinant factors. Secondary outcomes were to describe clinical profile of patients with COPD attended at primary care offices in Granada, to describe the quality of care for COPD patients and its variability, to evaluate the adherence and implementation of clinical guidelines for COPD and the performance of healthcare and to describe current available resources for COPD healthcare in the primary care level in Granada.

2.3. Study Variables

Collected data were divided in 4 groups: a) available resources and primary care centre model, b) clinical practice models, c) data regarding clinical process, patient profile and primary care consultation and d) evaluation of database quality.

2.4. Statistical Methods

A descriptive analysis of data values was performed for the entire study population as well as for each primary care centre and a comparison with mean values of similar centres. Statistical descriptives analysis were arranged using means, standard deviations for quantitative data and proportions for qualitative data.

Analysis of clinical practice models, types of primary care centres, seasonal and geographical variability were carried on to detect their influence in COPD healthcare.

Significance of variability by area/ primary care center were explored by Kruskal–Wallis or chi-square tests, depending on the nature of the variable between the different participant centers. Data was processed using the the Jamovi software (Jamovi version 2.3, The Jamovi project). P-values 0.05 will be considered statistically significant.

To evaluate the degree of clinical practice guidelines implementation, criteria of good clinical practice and quality standards were classified into 3 categories: clinical evaluation of the patient, disease evaluation, and therapeutic interventions.

2.5. Ethical Aspects

The study was evaluated by a Clinical Scientific Ethics Committee (CSEC) to guaranty all the ethical issues and safe confidentiality of included patients. During study evaluations principles of Helsinki Declaration on biomedical research were followed. In accordance with Biomedical Research Spanish Law 14/2007 dated 3/July/2007 and the Organic Law on Patient Data Protection, it was not deemed necessary to obtain informed consent from included patients as it is stated in this legislation that retrospective evaluation of data obtained in routinely clinical practice with research aims precludes informed consent obtanining. An autorisation to participate was requested to local healthcare authorities. All the primary care centre directors and healthcare authorities were informed of starting dates.

2.6. Patient Data Protection

Protocol procedures were performed accordingly with Spanish Law of Patient Data Protection. Data about participant were collected codified, keeping confidentiality according to current legislation. Patients were identified by correlative number which were assigned by computer application. Registry did not store personal data allowing a concrete patient identification. A dissociation mechanism was launched between clinical history information and data recorded in the study in order not to provide individual information. The study was registered in clinicaltrials.gov with the identifier NCT04691752.

3. Results

2970 patients attending primary care centres in Granada were detected and assessed for eligibility, of whom 2283 patients were finally included in the study from March 2021 to March 2022 at 19 primary care centres in Granada. Figure 1 describes the flowchart of study participants. Main reasons for exclusion from the study were having a non-diagnostic code for COPD, lack of smoking history and patients attended at primary care centres who were from other regions of Spain.

Table 1 describes the overall characteristics of the 19 primary care centres including patients in the study. They were centres which attended more than 10000 people on average, most of them had resources for a basic COPD diagnosis (spirometry, blood test, chest X ray) and were authorised for medical internal residents’ formation in primary care.

Table 2 describes the overall characteristics of study population. It consisted of 7th decade men, with almost a quarter of them current smokers and moderate lung function impairment. Notably, there were very few patients with information about symptoms via CAT questionnaire and dyspnoea via mMRC. A very few of them had exacerbations in the previous year and a little proportion were admitted to the hospital due to severe episodes.

Figure 2 shows the proportion of patients included in the study who were assessed correctly by the CPGs divided by the location of the primary care center (PCC). Rural and city PCC patients had a low proportion of assessment by either GOLD o GesEPOC CPGs. There were no differences between both rural and city PCC in terms of correct assessment by CPGs.

Figure 3 shows the prescribed inhaled therapies for the entire population regarding if a correct assessment based on the CPGs was made or not. The most frequent inhaled therapy was LAMA, and there were differences between groups in the use of long acting broncodilators (either monotherapy or dual bronchodilation) with those patients with an assessment based in CPGs being treated more frequently with bronchodilators and less frequently with LABA/ICs.

4. Discussion

The results of this study show that the management of patients with COPD does not usually follow up recommendations and this leads to an increase of the prescription of non-preferable inhaled therapies options for patients, which could determine not only a reduced perception of efficacy by the patients but an increase in long term adverse events and increased costs.

The results from our study do not differ from many other studies in our country or outside Spain, where a low adherence to CPGs has been detected14–16. This is not a sole problem in the field of primary care because similar problems have been detected in specialized care too, although in different magnitudes. Mainly the overall proportion of patients with a reported assessment of symptoms was very low, especially for the CAT questionnaire. This low adherence to symptom evaluation limits the overall adherence to CPGs and therefore it impacts the way a primary care physician prescribes inhaled therapies17,18.

Our results emphazise the need for a global quality standard for COPD assessment, with clear criteria for primary care physicians and easy orders to improve the management of this disease. While there are other ongoing initiatives 19regarding this issue, it will be needed a collaboration from medical authorities and healthcare directors to include some of them in the primary care deals in order to receive funding.

Our study has some limitations, the most important being a local study which could not reflect the overall quality of assessment of COPD patients. However, it should reflect at least the entire population of the province, which should not differ from other provinces with the same healthcare system. This means that our results could not be extrapolated to countries with different health systems.

In conclusion, our work indicate that there is an overall room for improvement regarding the management of COPD patients in primary care. There is a need for symptom registry in health records and a increased uptake of CPGs.

5. Conclusions

In conclusion, our work indicate that there is an overall room for improvement regarding the management of COPD patients in primary care. There is a need for symptom registry in health records and a increased uptake of CPGs.