{"title":"Evaluation of the clinical pharmacist's effect on achieving treatment goals in patients with hypothyroidism: a randomized controlled trial.","authors":"Yunus Emre Ayhan, Muhammed Yunus Bektay, Dilek Gogas Yavuz, Mesut Sancar","doi":"10.1186/s12902-025-01914-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and aim: </strong>Hypothyroidism (HoT) treatment involves lifelong thyroxine replacement therapy and regular monitoring. The objective of this study was to assess the impact of clinical pharmacist (CP) intervention in managing drug-related problems (DRPs) on outcomes among patients with HoT receiving levothyroxine (LT4) therapy.</p><p><strong>Method: </strong>A randomized controlled trial involved patients with HoT attending a university hospital's endocrinology and metabolism outpatient clinic from March 2022 to September 2022. Participants were randomly assigned to control (CG) and intervention groups (IG). CP identified and classified DRPs based on Pharmaceutical Care Network Europe (PCNE) v9.1 criteria. The validated version of the Morisky-Green-Levine (MGL) 4-question scale was used to measure adherence. All patients included in the study were assessed during their first visit and again two months later at their second visit.</p><p><strong>Results: </strong>43 patients were assigned to the CG (n = 25) and IG (n = 18). Diabetes (21.6 vs. 20.5%) and hypertension (16.2% vs. 11.7%) were the most prevalent comorbidities in both the CG and IG, respectively. A total of 118 DRPs belonging to both groups were detected. In the IG group, the total number of DRPs significantly decreased from 66 to 24, and the total potential drug-drug interactions (pDDIs) decreased from 21 to 0 between the first and second visits (p < 0.001). CG and IG patients had no difference in adherence levels at the first and second visits (p > 0.05). A statistically significant increase in adherence to the time of taking the medication was observed between the first and second visits in IG (55.5% vs. 94.4%, p = 0.008).</p><p><strong>Conclusion: </strong>This study highlights the frequent occurrence of DRPs and LT4 therapy adherence problems in patients with HoT. The findings suggest that the intervention of CPs, by increasing adherence to LT4 therapy and decreasing DRPs, could significantly contribute to improving patients' treatment outcomes.</p><p><strong>Trial registration: </strong>This study protocol has been retrospectively registered at ClinicalTrials.gov (NCT06408909) at 06/05/2024.</p>","PeriodicalId":9152,"journal":{"name":"BMC Endocrine Disorders","volume":"25 1","pages":"94"},"PeriodicalIF":2.8000,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Endocrine Disorders","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12902-025-01914-3","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
引用次数: 0
Abstract
Background and aim: Hypothyroidism (HoT) treatment involves lifelong thyroxine replacement therapy and regular monitoring. The objective of this study was to assess the impact of clinical pharmacist (CP) intervention in managing drug-related problems (DRPs) on outcomes among patients with HoT receiving levothyroxine (LT4) therapy.
Method: A randomized controlled trial involved patients with HoT attending a university hospital's endocrinology and metabolism outpatient clinic from March 2022 to September 2022. Participants were randomly assigned to control (CG) and intervention groups (IG). CP identified and classified DRPs based on Pharmaceutical Care Network Europe (PCNE) v9.1 criteria. The validated version of the Morisky-Green-Levine (MGL) 4-question scale was used to measure adherence. All patients included in the study were assessed during their first visit and again two months later at their second visit.
Results: 43 patients were assigned to the CG (n = 25) and IG (n = 18). Diabetes (21.6 vs. 20.5%) and hypertension (16.2% vs. 11.7%) were the most prevalent comorbidities in both the CG and IG, respectively. A total of 118 DRPs belonging to both groups were detected. In the IG group, the total number of DRPs significantly decreased from 66 to 24, and the total potential drug-drug interactions (pDDIs) decreased from 21 to 0 between the first and second visits (p < 0.001). CG and IG patients had no difference in adherence levels at the first and second visits (p > 0.05). A statistically significant increase in adherence to the time of taking the medication was observed between the first and second visits in IG (55.5% vs. 94.4%, p = 0.008).
Conclusion: This study highlights the frequent occurrence of DRPs and LT4 therapy adherence problems in patients with HoT. The findings suggest that the intervention of CPs, by increasing adherence to LT4 therapy and decreasing DRPs, could significantly contribute to improving patients' treatment outcomes.
Trial registration: This study protocol has been retrospectively registered at ClinicalTrials.gov (NCT06408909) at 06/05/2024.
背景和目的：甲状腺功能减退症（HoT）的治疗包括终身甲状腺素替代治疗和定期监测。本研究的目的是评估临床药师（CP）干预药物相关问题（DRPs）对接受左旋甲状腺素（LT4）治疗的HoT患者预后的影响。方法：随机对照试验纳入2022年3月至2022年9月在某大学附属医院内分泌代谢门诊就诊的HoT患者。参与者随机分为对照组（CG）和干预组（IG）。CP根据欧洲药品保健网络（PCNE） v9.1标准对drp进行识别和分类。采用Morisky-Green-Levine （MGL）四题量表来测量依从性。所有参与研究的患者在第一次就诊时进行评估，两个月后在第二次就诊时再次进行评估。结果：43例患者分为CG组（n = 25）和IG组（n = 18）。糖尿病（21.6% vs. 20.5%）和高血压（16.2% vs. 11.7%）分别是CG组和IG组最常见的合并症。共检测到两组共118个drp。IG组第一次和第二次就诊时，drp总数从66个减少到24个，总潜在药物相互作用（pddi）从21个减少到0个（p 0.05）。在IG第一次和第二次就诊期间，依从服药时间有统计学意义的增加（55.5% vs. 94.4%, p = 0.008）。结论：本研究突出了HoT患者中常见的DRPs和LT4治疗依从性问题。研究结果表明，CPs的干预，通过增加对LT4治疗的依从性和降低DRPs，可以显著改善患者的治疗结果。试验注册：本研究方案已于2024年6月5日在ClinicalTrials.gov （NCT06408909）上回顾性注册。
期刊介绍：
BMC Endocrine Disorders is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of endocrine disorders, as well as related molecular genetics, pathophysiology, and epidemiology.
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