Implementation effects of quality control circle in improving medication adherence of outpatient helicobacter pylori patients

Abstract

To evaluate the implementation effects of problem-solving Quality Control Circle (QCC) activities on medication adherence among outpatient Helicobacter pylori patients. Pharmacists collected data scales, guidance sheets, registration forms, and scoring sheets from outpatient H. pylori patients from January to March 2024. Through brainstorming, factors affecting medication adherence were identified and a series of specific measures were formulated. Implementation was carried out from April to July 2024, and the therapeutic effects of patients before and after implementing the QCC process were evaluated. The total score of patient medication adherence improved from 7.9 to 9.2, with statistically significant results (P < 0.001). The medication compliance rate increased from 57.46% to 87.62%; the adverse reaction incidence decreased from 39 to 11%; the C14 breath test positive rate decreased from 67.2% to 30.65%. All the above results showed statistically significant differences (P < 0.001). Implementing QCC can standardize and improve medication adherence measures for H. pylori patients, which has practical significance for patient treatment outcomes, while also enhancing pharmacists’ professional knowledge and skills.

Introduction

Helicobacter pylori (Hp) infection is a common digestive system disease that requires patients to strictly follow medical advice for medication during eradication therapy. However, poor patient medication adherence leads to increased treatment failure rates. Therefore, improving patient medication adherence is crucial for enhancing treatment outcomes [1]. H. pylori is very common, with more than half of the population infected, which represents a very high prevalence. The most important pharmaceutical intervention for H. pylori eradication is to accurately guide patients in medication use, improve patient medication adherence, and then implement tracking measures to ensure these measures can be effectively implemented [2]. First, as an important means of eradicating HP-related diseases, one of the important aspects is the rationality and standardization of patient medication use; second, HP infection has characteristics of wide transmission routes and easy recurrence [3]; third, the emergence of multiple ineffective medication cases in outpatient and clinical settings has raised doubts about our hospital’s medical care. Quality Control Circle (QCC) follows the “PDCA” (Plan-Do-Check-Act) process and is a comprehensive and scientific management model that has achieved good results in the field of pharmacy in China. Our hospital conducted QCC activities from January to July 2024 to standardize medication adherence management and achieved great success, with results as follows.

Materials and methods

Case data

We established a QCC named “Support Circle” aimed at conveying the concept of “people-oriented, patient-centered, supporting patients’ hopes and the hospital’s bright future.” Seven pharmacists and 2 clinical pharmacists were selected as QCC members. The head of the outpatient pharmacy was selected as the QCC leader. Weekly circle group meetings were held once a week, with all circle members reporting on activity progress and evaluating and scoring various processes in the activities.

In January 2024, through questionnaire surveys and medical record reviews, medication adherence surveys and assessments were conducted on patients receiving H. pylori eradication therapy. This study strictly adhered to relevant provisions of the Declaration of Helsinki, and patients and their families voluntarily signed informed consent forms. Inclusion criteria: ① Meeting diagnostic criteria for H. pylori infection; ② Patient age 20–70 years. Exclusion criteria: ① Patients with significant missing clinical data; ② Patients who discontinued contact midway; ③ Patients who voluntarily withdrew.

The main reasons for poor medication adherence include patient personal factors, iatrogenic factors, drug factors, economic factors, environmental factors, etc. Pharmacists evaluated the medication adherence of H. pylori patients. Pharmacists collected patients’ Medication Adherence Scale (MMAS-8): ① Do you sometimes forget to take your medication? ② In the past 2 weeks, was there a day or several days when you forgot to take your medication? ③ During treatment, when you felt symptoms worsened or other symptoms appeared, did you reduce the dosage or stop taking medication without informing your doctor? ④ When you travel or are away from home for long periods, do you sometimes forget to carry your medication with you? ⑤ Did you take your medication yesterday? ⑥ When you feel your condition is under control, have you ever stopped taking medication? ⑦ Do you find it difficult to stick to your treatment plan? ⑧ Do you find it difficult to remember to take your medication on time and in the correct amount? Each question was answered with “yes” or “no” selecting the most appropriate answer, with each question worth 1 point, total score 10 points. Scores ≥9 points indicate good adherence, scores ≤8 points indicate poor adherence. A total of 125 patients participated, with 38 scoring ≥9 points and 87 scoring ≤8 points, with an average score of 7.9, indicating poor adherence. Simultaneously, pharmacists received professional knowledge training on medication counseling and medication education for H. pylori patients. After implementing QCC, in July 2024, the adherence implementation of 137 H. pylori medication patients was analyzed. A total of 137 patients participated in the survey, with 109 scoring ≥9 points and 28 scoring ≤8 points, with an average score of 9.2.

Methods

Establishing QCC activity group

The QCC group proposed 5 topics through brainstorming, discussing, evaluating, and voting on each topic from four aspects: superior policies, importance, urgency, and circle capability. Finally, based on scores, the theme of this QCC activity was determined as "Improving Medication Adherence of Outpatient H. pylori Patients."

Formulating activity plan

Based on QCC processes and themes, implementation plans for various activities and personnel duration were plotted on a Gantt chart. The entire activity plan was approved by the pharmacy department. From January to March 2024, pharmacists collected data scales, guidance sheets, registration forms, and scoring sheets from outpatient H. pylori patients. Through brainstorming, factors affecting medication adherence were identified and a series of specific measures were formulated. Implementation was carried out from April to July 2024, and the therapeutic effects of patients before and after implementing the QCC process were evaluated.

Current status investigation and target setting

The Medication Adherence Scale (MMAS-8) was developed and compiled. Total score 10 points, scores ≥ 9 points indicate good adherence, scores ≤ 8 points indicate poor adherence. Before the survey, all QCC members received training on completing the checklist, and all subjects were scored according to unified standards. A total of 125 patients and 8 pharmacists participated in the survey. Among them, 87 patients had poor medication adherence and 38 patients had good medication adherence. Based on overall circle member experience, education, topic improvement ability, and QCC experience scoring, the calculated average score was 3.25 points out of 5 points, giving a circle capability of 65%. According to the target calculation formula: Target value = Current value + Improvement value = Current value + [(10-Current value) × Improvement focus × Circle capability] = 7.9 + (10–7.9) × 82.35% × 65% = 7.9 + 1.12 = 9.02. The target was to improve patient medication adherence scores to 9.02 points.

Cause analysis and root cause verification

Based on survey results, QCC members used brainstorming methods for personnel, drugs, environment, and methods, then constructed a fishbone diagram (Fig. 1).

Figure. 1.

Root cause verification fishbone diagram for poor medication adherence in H. pylori patients

Using the “5, 3, 1” method to score potential causes, according to the 80/20 rule, we selected 3 main causes, then re-applied on-site questionnaire surveys, telephone follow-up methods, and circle member scoring methods to investigate results. Cause determination—team consensus method, with 9 circle members scoring based on urgency, importance, and circle capability. Each item score: excellent = 5 points, good = 3 points, average = 1 point, total 45 points. According to the 80/20 rule, main causes ≥ 36 points. Eight root causes were identified, including: insufficient personal disease awareness and attention; poor lifestyle habits; inadequate medication guidance; failure to provide health education to patients; lack of standardized patient medication guidance; imperfect patient management and follow-up systems; multiple drug varieties with complex usage; multiple adverse drug reactions [4].

Strategy formulation and implementation

An evaluation method was used to evaluate proposed strategies from three aspects: feasibility, economy, and effectiveness, scoring each aspect as 5, 3, or 1 point. Based on total scores, 6 highly feasible and effective strategies were selected:

1. Addressing insufficient personal disease awareness and poor lifestyle habits: Regular health education, knowledge lectures, compilation of patient medication education manuals, distribution of health education materials, health education videos, and health education knowledge lectures to inform patients about potential disease harms, including H. pylori transmission routes, dangers, treatment plans, medication precautions, dietary and lifestyle adjustments, and how to prevent reinfection [5].

2. Addressing lack of patient medication education: Based on patients’ specific conditions, formulate individualized treatment plans to reduce medication complexity and inconvenience. Provide clear, detailed medication guidance, including drug dosage, usage time, and frequency. Emphasize the importance of regular medication to improve patients’ awareness and attention to treatment [6].

3. Addressing inadequate medical staff guidance and lack of standardized medication guidance: Utilize medication consultation windows to guide patients, while establishing telephone, WeChat, and other multi-channel consultation services.

4. Addressing imperfect patient management and follow-up systems: Establish follow-up systems with rotating shifts, implement follow-up measures, regularly follow up on patients’ medication use, standardize follow-up systems with proper documentation, and assess patients including general conditions, discomfort symptoms, lifestyle habits, economic and social support status, providing individualized guidance and psychological counseling [6].

5. Addressing multiple drug varieties and complex usage: After circle discussions, establish anti-H. pylori treatment management groups and outpatient pharmacy cross-department pharmaceutical management groups [7], improve and optimize medication distribution processes, establish standardized medication guidance sheets to guide patients in timely, appropriate dosage, and full-course medication use [8, 9] (Fig. 2).

6. Addressing adverse reactions: Strengthen medical staff knowledge and handling capacity for adverse drug reactions, promptly handle patient adverse reactions [10]. Invite pharmaceutical experts to conduct adverse drug reaction training, including common adverse reaction manifestations and treatment methods. Pharmacists closely monitor patient reactions during medication use, promptly provide solutions when adverse reactions occur, implement appropriate treatment measures, and maintain proper documentation [11]. Patients experiencing adverse reactions require close follow-up and regular pharmaceutical monitoring.

7. Simultaneously, standardized health education plans, medication reminder frequencies, and adverse drug reaction handling procedures developed in this QCC activity were incorporated into pharmacy department regulations and operational standards, implementing reward and punishment systems to form long-term effective mechanisms.

Figure. 2.

QCC intervention flow chart for improving H. pylori patient medication adherence

Evaluation methods

① Medication compliance rate: H. pylori treatment medication compliance rate = Total compliant medication doses during H. pylori patient treatment / Total medication doses during H. pylori patient treatment × 100%.

② Adverse drug reaction incidence rate: H. pylori treatment medication compliance rate = Adverse reaction occurrences during treatment / Total adverse reaction occurrences during treatment × 100%.

③ C14 breath test positive rate: H. pylori patient C14 breath test positive rate = Number of C14 breath test positive H. pylori patients after treatment / Total number of treated H. pylori patients × 100%.

All data were analyzed using SPSS 27.0 statistical software. Normally distributed quantitative data were expressed as mean ± standard deviation (x̄ ± s), with t-tests for inter-group comparisons; categorical data were expressed as frequencies and percentages (%), with χ² tests for inter-group comparisons. P < 0.05 was considered statistically significant.

Results

Tangible results

After QCC implementation, comparisons of tangible results before and after activities showed statistically significant differences (P < 0.05) (table 1). Post-activity patient C14 breath test positive rates were lower than pre-activity, with statistically significant differences (P < 0.05) (table 2). Pharmacist knowledge quiz average scores improved (table 3).

Table 1.

Comparison of tangible results before and after QCC implementation

Item	Adherence score	Non-compliant medication count	Adverse reaction count
Pre-activity	7.9 ± 0.74	297.6 ± 144.4	7.8 ± 6.76
Post-activity	9.2 ± 0.82	95 ± 45.4	2.2 ± 2.68
t value	13.54	15.02	8.67
P value	≈0.0001	≈0.0001	≈0.0001

Table 2.

Comparison of patient C14 breath test positive rates before and after QCC implementation

		C14 Breath test positive (Cases)		Positive Rate (%)
Time	Total cases	Positive	Negative
Pre-activity	125	84	41	67.2
Post-activity	137	42	95	30.65
χ2value	36.24
P value	P≈0.0001

Table 3.

Comparison of pharmacist knowledge quiz scores before and after QCC implementation

Time	Total number	Average score for H. pylori medication education knowledge quiz
Pre-activity	8	66
Post-activity	8	91

Intangible results

After QCC implementation, each member’s enthusiasm, problem-finding and problem-solving abilities, evidence-based capabilities, and quality and safety management awareness were greatly improved (figure 3).

Figure. 3.

Comparison of intangible results before and after QCC implementation

Discussion

Mastering H. pylori treatment pharmaceutical knowledge is very important. Before QCC activities, based on H. pylori medication-related knowledge survey results, some pharmacists lacked sufficient understanding of the seriousness of H. pylori medication-related professional knowledge and did not even know how to answer patient’ pharmaceutical professional questions. Pharmacists’ understanding of how to answer patients’ multiple drug combination-related questions was relatively superficial. Pharmacists could not fully utilize professional knowledge to flexibly serve patients.

After QCC activities, pharmacists transformed traditional treatment models into "proactive" prevention models, implementing measures to identify low-adherence patients, promptly communicating with patient families, and completing medication adherence assessment scales. Pharmacists developed standardized medication education and guidance thinking habits when patients collected medications. Pharmacists could apply professional knowledge and various professional reference books according to standardized processes to actively provide medication guidance and education for H. pylori patients based on patients’ individual conditions and underlying diseases, significantly improving patients’ overall medication adherence assessment, while improving H. pylori treatment effectiveness, reducing disease transmission, and improving patients’ quality of life. Pharmacists’ professional technical capabilities improved to some extent, also helping improve pharmaceutical service quality and satisfaction.

Even when low adherence and poor treatment outcomes inevitably occurred, this process improved understanding among patients and their families, reducing disputes between pharmacists and patients, alleviating pharmacists’ psychological burden, and enhancing their work enthusiasm and responsibility. This stimulated QCC members’ learning initiative and achieved pharmaceutical service transformation. However, this study has certain limitations: all members were outpatient pharmacists with unclear understanding of actual clinical medication guideline implementation effects, prone to misunderstandings and misjudgments during plan discussions and strategy implementation; some evaluation data in data analysis has subjective elements, requiring more scientific and rigorous evaluation standards.

In summary, QCC activities can improve outpatient H. pylori patient medication adherence, help patients take medications properly, reduce patient adverse reaction incidence, improve cure rates, while enhancing pharmacists’ self-management capabilities and improving patient treatment satisfaction.

Author contributions

HG: Wrote the main manuscript content. HDj: Prepared Figures 1–2.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Conflict of interest

The authors declare no competing interests.