Methodological quality and risk of bias of meta-analyses of pharmacy services: A systematic review

BackgroundA suboptimal meta-analysis with misleading conclusions, frequently published in the healthcare journals, can compromise decision making in clinical practice.ObjectiveTo evaluate the reporting quality, methodological quality, and risk of bias of meta-analyses of pharmacy services.MethodsSystematic searches to identify all the meta-analyses reporting the effect of pharmacy services were performed in PubMed, Scopus, and Web of Science. The reporting quality, the methodological quality, and the risk of bias of the included meta-analyses were evaluated using PRISMA checklist, R-AMSTAR, and ROBIS, respectively.ResultsA total of 109 meta-analyses were eligible for the study. The heterogeneity, the quality of evidence, and the quality analyses were poorly reported on authors’ conclusions (14.3%, 14.7%, and 17.4%, respectively). The median scores of PRISMA and R-AMSTAR tolls were 24 (IQR 21.75–25), and 30 (IQR 27–32.5), respectively. Additionally, most of the studies were considered as high risk of bias (n = 83, 76.1%). No association between the date of publication and guideline compliance exists. PRISMA score was higher in studies published in high impact factor journals (rho = 0.313; p = 0.002), in articles that reported the quality of evidence obtained (p = 0.018), and in those that stated the need for future studies in their conclusions (p = 0.011). R-AMSTAR score was higher in studies published in high impact factor journals (rho = 0.338; p = 0.001), in those which reported the quality of evidence (p = 0.002), and in articles that described the quality analyses in their conclusions (p = 0.046). An association between the risk of bias and the recognition of the need for further studies in their conclusions (p = 0.041) was also found.ConclusionThe rapid increase of the meta-analyses of pharmacy services was not associated with higher quality. Mechanistic meta-analyses with poor conclusions are commonly published. Quality of the analyses, strength of evidence, heterogeneity, and absence of confrontation with current guidelines are rarely considered when synthetizing evidence and making recommendations.     

Evaluation of a pharmacist vs. Haematologist-managed anticoagulation clinic: A retrospective cohort study

IntroductionWarfarin is the core component in the management of various thromboembolic disorders, which requires specialized expertise to optimize outcomes. There is limited data comparing a pharmacist vs. a haematologist-managed anticoagulation clinic in our setting, and in the Middle East. We aimed to evaluate the effectiveness and safety of a pharmacist vs. a haematologist-managed anticoagulation clinic in the Ambulatory Care Center at King Abdulaziz Medical City, Jeddah, Saudi Arabia.MethodsA retrospective cohort study was conducted from 2016 to 2018, which included adult patients who have been followed-up for at least six months and who received warfarin for an extended period. The primary outcome was the proportion of time the patients in the two arms were in the therapeutic range. The secondary outcomes were the differences in expanded time in the therapeutic range, as well as the frequency of bleeding and thromboembolic events between the two arms.ResultsWe enrolled 104 and 124 patients in the pharmacist and haematologist arms respectively. The median time in the therapeutic range for the pharmacist arm was 71.4%, IQR (60.8–83.8) vs. 65%, IQR (43.5–79.1), in the haematologist arm (p = 0.0049). The median expanded time in the therapeutic range was 86.4%, IQR (77.5–95.3) vs. 81.21%, IQR (67.1–93.3) in the pharmacist vs. haematologist arm (p = 0.015) respectively. Major bleeding events occurred in 5.7 % vs. 3.2 %, and thromboembolic events in 5.7% vs. 4%, in the pharmacist vs. haematologist arm respectively.ConclusionsOur results demonstrated that the time in the therapeutic range was significantly higher in the pharmacist arm, with no significant difference in bleeding and thromboembolic events compared to the haematologist arm.     

Changes in medication regimen complexity index following medication-related hospital admissions: A retrospective single-centre study

BackgroundMedication-related hospitalisations present an opportunity for de-prescribing and simplification of medication regimens. The Medication Regimen Complexity Index (MRCI) is a tool for measuring the complexity of medication regimens.ObjectivesTo evaluate whether MRCI changes following medication-related hospitalisations, and to evaluate the relationship between MRCI, length of stay (LOS) in hospital, and patient characteristics.MethodsA retrospective medical record review of patients admitted to a tertiary referral hospital in Australia for medication-related problems, January 2019 to August 2020. MRCI was calculated using pre-admission medication lists and discharge medication lists.ResultsThere were 125 patients who met inclusion criteria. The median (IQR) age was 64.0 years (45.0–75.0) and 46.4% were female. Median MRCI decreased by 2.0 following hospitalisation: from median (IQR) 17.0 (7.0–34.5) on admission vs 15.0 (3.0–29.0) on discharge (p < 0.001). Admission MRCI predicted LOS ≥2 days (OR 1.03, 95%CI 1.00–1.05, p = 0.022). Allergic reaction-related hospitalisations were associated with lower admission MRCI.ConclusionsThere was a decrease in MRCI following medication-related hospitalisation. Targeted medication reviews for high-risk patients (e.g., those with medication-related hospitalisations) could further reduce the burden of medication complexity following discharge from hospital and possibly prevent readmissions.     

Clinical and therapeutic characteristics and medical cost of managing cancer patients in Al-Anbar,Iraq: A cross-sectional study

BackgroundCancer is a complex disease that is one of the leading causes of death. This study aimed to investigate the clinical and therapeutic characteristics, as well as the medical cost of managing adult cancer patients in Al-Anbar city in Iraq from the patient's perspective.MethodThis was a prospective cross-sectional study that was carried out at the Al-Anbar Oncology Centre between September and December 2021. Direct medical cost data includes the cost of treatment, healthcare professional visits, laboratory tests, and surgery. Furthermore, patients were contacted and asked to estimate the direct non-medical costs (transportation costs) connected with their disease, as well as describe side effects of their cancer therapy. Logistic regression was used to identify variables associated with higher cancer management costs.ResultsThis study included 500 patients in total. The median overall management cost is 2,765.0 $ (IQR: 3,888.7$). The median cancer management cost differed statistically significantly depending on the stage of the disease, with stage two patients having a lower median cost than other patients (p < 0.05). Patients suffering from colon and brain cancer having significantly higher costs (p ≤ 0.05). The median duration of disease was 1.0 year (IQR: 1.0 year). More than half the patients (65.4 %) were at stages three and four. Breast cancer (among females), ovarian cancer (among females), and lymphoma were the most common types of cancer, accounting for 53.9 %, 10.5 %, and 8.6 %, respectively. Almost all patients (99.8 %) were undergoing chemotherapy. More than half of the patients (64.8 %) had surgery to manage their disease, and 16.6 % had radiotherapy as part of their treatment plan. The most widely utilized chemotherapy therapeutic classes were antimicrotubular and platinum analogues with 34.0 % and 33.6 %, respectively. The most common cancer therapy side effects were nausea and vomiting, hair loss, and appetite loss, with 85.2 %, 75.2 %, and 54.2 %, respectively.ConclusionBreast cancer (in females), ovarian cancer (in females), and lymphoma are the most common types of cancer in Iraq. More research on the risk factors for these types of cancer is needed. Furthermore, additional economic studies from other perspectives are required to highlight the economic burden of cancer in Iraq.     

Ki67检测在乳腺癌新辅助化疗疗效判断中的作用

目的 探讨Ki67检测在乳腺癌新辅助化疗临床疗效判断中的作用.方法 81例乳腺癌患者给予3个周期化疗后手术.化疗方案:环磷酰胺600 mg/m2,第1天;盐酸阿霉素100 mg/m2,第1天;5-氟尿嘧啶600 mg/m2,第1天;21 d为1个周期.用免疫组化方法检测患者新辅助化疗前后Ki67表达情况,并分析肿瘤组织化疗后反应.结果 Ki67在新辅助化疗前56例高表达,25例低表达,高表达率为69.1％.新辅助化疗后18例高表达,63例(77.8％)低表达,差异有统计学意义(x2=35.92,P＜0.05).新辅助化疗后Ki67高表达18例中,化疗有效5例,无效13例;63例低表达中有效43例,无效20例,差异有统计学意义(P＜0.05).新辅助化疗前后Ki67指数变化明显者化疗反应明显.结论 Ki67检测可以指导新辅助化疗用药,是一种判断化疗疗效的分子生物学指标.     

Discontinuation of antimicrobial therapy in adult neutropenic haematology patients: A prospective cohort

ObjectivesAntibiotics for febrile neutropenia (FN) in acute myeloid leukaemia (AML) patients undergoing intensive chemotherapy are usually maintained until neutropenia resolution, because of the risk of uncontrolled sepsis in this vulnerable population. This leads to unnecessarily prolonged antimicrobial therapy.MethodsBased on ECIL-4 recommendations, we modified our management strategy and discontinued antibiotics after a pre-established duration in patients treated for a first episode of FN between August 2014 and October 2017.ResultsAntibiotics were stopped during 62 FN episodes, and maintained in the control group (n = 13). Median age of patients was 54 years. A total of 39 (63%) patients received induction and 23 (37%) consolidation chemotherapy; 36 (58%) patients had fever of unknown origin. Median neutropenia length was 26 days (IQR 24–30). Antibiotics were started at day 9 (IQR 5–13). Most patients received piperacillin-tazobactam (56%) or cefepime (32%). Antimicrobial therapy was longer in the control group than in the policy compliant group, 10 (IQR 7–16) vs. 19 days (IQR 15–23), P = 0.0001. After antibiotics discontinuation, 20% patients experienced fever recurrence, within 5.5 days (IQR 3–7.5). None of these febrile episodes were severe and 80% patients remained afebrile, with neutrophil recovery occurring within 5 days (IQR 2–8.5). Overall, 287 antibiotics days were spared; this represents 49% of all days with antibiotics. No patient had died at day 30 from intervention; six died during late follow-up, two from graft-versus-host disease and four from relapsed or refractory leukaemia.ConclusionsDiscontinuing antibiotics in neutropenic AML patients treated for a first episode of FN is safe, and results in significant antibiotic sparing.     

Studying the impact of a medication use evaluation by the community pharmacist (Simenon): Patient-reported outcome measures

BackgroundIn the SIMENON study, medication use reviews were conducted for older polymedicated home-dwelling patients across 56 Belgian community pharmacies.ObjectiveTo evaluate the impact of the service on patient-reported outcome measures and patient-reported experience measures, and to evaluate the suitability of the chosen instruments.MethodsA before-after design was used to measure the impact of the medication use review in a subset of patients, participating in the SIMENON study. Patients completed self-report questionnaires before and 3 and 12 weeks after the intervention by letter, phone or e-mail. Six outcomes were evaluated: medication-related quality of life, adherence, self-management, patient satisfaction, fall incidents and use of emergency healthcare services.ResultsQuestionnaires at baseline and endpoint were available for 83 patients (median age 77 years; median of 7 drugs) of 24 pharmacies. The Living with Medicines Questionnaire showed low medication burden at baseline (84.8/205) which increased to 85.7 three weeks later (n = 57; p = 0.219). Scores significantly reduced to 81.9 at twelve weeks (p = 0.031). The Probabilistic Medication Adherence Scale (n = 67) showed high median adherence scores at baseline (14/18) which remained unaltered (p = 0.974). The patient activation measure found low self-management in one third of the sample at baseline and endpoint (35.5% and 37.1% respectively; p = 0.243). The Patient Satisfaction with Pharmacist Services Questionnaire (n = 66) demonstrated high patient satisfaction. The number of patients with a hospitalization in the last three months decreased non-significantly from 14.8% to 11.1% in the post-measurement after 12 weeks (p = 0.227). No effect was observed on emergency room visits and falls.ConclusionsThe medication use review reduced medication burden but did not impact the patient's adherence and self-management. However, adherence scores were high, medication burden was low at baseline and the sample size was limited. The Living with Medicines instrument is a promising instrument for future research to assess medication-related quality of life in older polymedicated patients.     

Effectivity and safety of PD-1/PD-L1 inhibitors for different level of PD-L1-positive,advanced NSCLC: A meta-analysis of 4939 patients from randomized controlled trials

BackgroundEffective improvement for the programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors had been shown in advanced non-small cell lung cancer (NSCLC) patients compared with traditional therapy. However, we do not have ample evidences to demonstrate the safety and effectivity in the treatment of PD-L1-positive, advanced NSCLC. The relation was controversial about the expression of PD-L1 and survival outcomes of PD-1/PD-L1 inhibitors.Materials and methodsElectronic databases (PubMed, EMBASE, and the Cochrane library) and major conference proceedings were systematically searched for all clinical trials in NSCLC using PD-1/PD-L1 inhibitors. Randomized controlled trials (RCTs) were included to compare PD-1/PD-L1 inhibitors with chemotherapy in advanced NSCLC patients reporting adverse events (AEs) and immune-related AEs (irAEs). The incidence, Hazard Ratio (HR), Odds Ratio (OR), and corresponding 95% confidence interval (CI) of outcomes were calculated.ResultsA total of 4939 patients from 10RCTs were included. In the group of PD-L1 ≥ 1%, PD-L1 ≥ 5%, PD-L1 ≥ 10%, PD-L1 ≥ 50%, the HR of OS is 0.31(95%CI 0.38–0.23; p < 0.0001), 0.47(95%CI 0.82–0.12; p = 0.008), 0.85(95%CI 1.17–0.53; p < 0.0001), 0.47(95%CI 0.59–0.36; p < 0.0001) respectively. The HR of PFS is 0.13(95%CI 0.01–0.24; p = 0.027), 0.31(95%CI 0.00–0.62; p < 0.0001), 0.62(95%CI 0.30–0.93; p < 0.0001), 0.40(95% CI 0.20–0.59; p < 0.0001) respectively. In terms of summary adverse events, PD-1/PD-L1 inhibitors groups had a significant lower risks in any treat-realated AEs than chemotherapy. About irAEs, PD-1/PD-L1 inhibitors groups had a significant higher risks in irAEs than chemotherapy.ConclusionPD-1/PD-L1 inhibitors are generally effected and safer than chemotherapy for patients with PD-L1-positive, advanced NSCLC. However, PD-1/PD-L1 inhibitors can generate a unique spectrum of irAEs, and even life-threatening.     

Continuous medication monitoring: A clinical model to predict adherence to medications among chronic kidney disease patients

BackgroundAn adherence model is required to optimise medication management among chronic kidney disease (CKD) patients, as current assessment methods overestimate the true adherence of CKD patients with complex regimens. An approach to assess adherence to individual medications is required to assist pharmacists in addressing non-adherence.ObjectiveTo develop an adherence prediction model for CKD patients.MethodsThis multi-centre, cross-sectional study was conducted in 10 tertiary hospitals in Malaysia using simple random sampling of CKD patients with ≥1 medication (sample size = 1012). A questionnaire-based collection of patient characteristics, adherence (defined as ≥80% consumption of each medication for the past one month), and knowledge of each medication (dose, frequency, indication, and administration) was performed. Continuous data were converted to categorical data, based on the median values, and then stratified and analysed. An adherence prediction model was developed through multiple logistic regression in the development group (n = 677) and validated on the remaining one-third of the sample (n = 335). Beta-coefficient values were then used to determine adherence scores (ranging from 0 to 7) based on the predictors identified, with lower scores indicating poorer medication adherence.ResultsMost of the 1012 patients had poor medication adherence (n = 715, 70.6%) and half had good medication knowledge (n = 506, 50%). Multiple logistic regression analysis determined 4 significant predictors of adherence: ≤7 medications (constructed score = 2, p < 0.001), ≤3 co-morbidities (constructed score = 1, p = 0.015), absence of complementary/alternative medicine use (constructed score = 1, p = 0.003), and knowledge score ≥80% (constructed score = 3, p < 0.001). A higher total constructed score from the prediction model indicated a higher likelihood of adherence (odds ratio [OR]: 2.41; 95% confidence interval [CI]: 2.112–2.744; p < 0.001). The area under the receiver operating characteristic (ROC) curve of the developed model (n = 677) had good accuracy (ROC: 0.867, 95% CI: 0.840–0.896; p < 0.001). The validated model (n = 335) also had good accuracy (ROC: 0.812, 95% CI: 0.765–0.859; p < 0.001). There was no significant difference between the development and validation groups (p = 0.11, Z-value:1.62, standard error: 0.034).ConclusionThe score constructed from the medication adherence prediction model for CKD patients had good accuracy and could be useful for identifying patients with a higher risk of non-adherence, to ensure optimised adherence management.     

Impact of a multidisciplinary medication reconciliation program on clinical outcomes: A pre-post intervention study in surgical patients

BackgroundPrevious studies have evaluated the effects of medication reconciliation (MR) and suggest that it is effective in decreasing medication discrepancies. Nevertheless, a recent overview of systematic reviews concluded that there is no clear evidence in favor of MR in patient-related outcomes and healthcare utilization, and further research about it is needed.ObjectiveTo evaluate the impact of a multidisciplinary MR program on clinical outcomes in patients with colorectal cancer presenting other chronic diseases, undergoing elective colorectal surgery.MethodsWe performed a pre-post study. Adult patients scheduled for elective colorectal cancer surgery were included if they presented at least one “high-risk” criteria. The MR program was developed by internists, pharmacists and surgeons, and ended with the obtention of the patient's pre-admission medication list and follow-up care until discharge. The primary outcome was the length of stay (LOS). Secondly, we evaluated mortality, preventable surgery cancellations and risk factors for complications.ResultsThree hundred and eight patients were enrolled. Only one patient in the pre-intervention group suffered a preventable surgery cancellation (p = 0.317). The mean LOS was 13 ± 12 vs. 11 ± 5 days in the pre-intervention and the intervention cohort, respectively (p = 0.435). A difference in favor of the intervention group in patients with cardiovascular disease (p = 0.038) and those >75 years old (p = 0.043) was observed. No difference was detected in the mortality rate (p = 0.999) neither most of the indicators of risk factors for complications. However, the management of preoperative systolic blood pressure of hypertensive patients (p = 0.004) and insulin reconciliation in patients with treated diabetes (p = 0.003) were statistically better in the intervention group.ConclusionsNo statistically significant change was observed in the mean global LOS. A statistically significant positive effect on LOS was observed in vulnerable populations: patients >75 years old and those with cardiovascular disease, who presented a 5-day reduction in the mean LOS.     

Thromboprophylaxis and clinical outcomes in moderate COVID-19 patients: A comparative study

BackgroundMany thrombotic complications are linked to coronavirus disease 2019 (COVID-19). Antithrombotic treatments are important for prophylaxis against these thrombotic events.ObjectivesThis study was designed to compare enoxaparin and rivaroxaban as prophylactic anticoagulants in moderate cases of COVID-19 in terms of efficacy, safety, and clinical outcomes.MethodsThe study involved 124 patients with moderate COVID-19 (pneumonia without hypoxia) divided into two groups. The first group (G1) comprised 66 patients who received enoxaparin subcutaneously at a dose of 0.5 mg/kg every 12 h until discharge from the hospital. The second group (G2) comprised 58 patients who received oral rivaroxaban at a dose of 10 mg once daily until discharge from the hospital. The outcomes evaluated in this study were as follows: intermediate care unit (IMCU) duration, the number of patients transferred from the IMCU to the intensive care unit (ICU), ICU duration, the total length of hospital stay, in-hospital mortality, and thrombotic and bleeding complications.ResultsNo significant differences in IMCU duration (p = 0.39), ICU duration (p = 0.96), and total length of hospital stay (p = 0.73) were observed between the two groups. The percentage of patients requiring ICU admission after hospitalization was 21.2% in G1 and 22.4% in G2 (p = 0.87). The mortality rate was 12.1% in G1 and 10.3% in G2 (p = 0.76). The proportion of patients who had thrombotic complications was 9.1% in G1 and 12.1% in G2 (p = 0.59). The incidence of mild bleeding was 3% in G1 and 1.7% in G2 (p = 0.64).ConclusionEither enoxaparin or rivaroxaban may be used as thromboprophylaxis agents in managing patients with moderate COVID-19. Either medication has no clear advantage over the other.     

Prognostic importance of markers for inflammation,angiogenesis and apoptosis in high grade glial tumors during temozolomide and radiotherapy

IntroductionAngiogenesis, inflammation and apoptosis have an important place in the carcinogenesis of high-grade gliomas (HGG). We evaluated the postoperative levels and the prognostic importance of tumor necrosis factor-alpha (TNFα), interleukin 6 (IL6), endoglin (CD105), vascular endothelial growth factor (VEGF), M65 and M30 as markers of inflammation, angiogenesis and apoptosis in patients with HGG.Methods and resultsPostoperative pretreatment sera were collected from 44 newly diagnosed patients with HGG. The control group was also consisted of 44 healthy people. The median age of all patients with HGG was 59 (range: 30–80). Temozolomide concurrent with radiotherapy was given to 37 patients. Thereafter 24 patients received consolidation temozolomide monotherapy. Mean chemotherapy cycle was 4.2. Progression free survival and overall survival were 6 (95% CI; 5.16–6.83) and 16 months (95% CI; 13.07–18.93) respectively in patients treated with concurrent chemoradiotherapy and consolidation chemotherapy. Relative to the control cohort endoglin (p = 0.000) and TNFα (p = 0.000) levels were significantly lower; however VEGF (p = 0.030) levels were higher in the patient group. In contrast, there were no significant change in IL-6 levels and the plasma apoptotic markers M65 (p = 0.085) and M30 (p = 0.292). In separate log rank tests, these biological markers did not correlate with survival.Discussion and conclusionIn HGG, a significant decrease in endoglin and TNFα levels was observed, while VEGF levels were significantly increased postoperatively. However, with the power from this patient population, no correlation with survival was observed.     

Efficacy and safety of dendritic cell vaccines for patients with glioblastoma: A meta-analysis of randomized controlled trials

BackgroundDendritic cell (DC)-based vaccination has been suggested to be promising for glioblastoma. However, the evidence in randomized controlled trials (RCTs) is inconsistent. We aimed to systematically evaluate the efficacy and safety of DC vaccine for glioblastoma via a meta-analysis of RCTs.MethodsRelated randomized controlled trials (RCTs) were identified via a search of PubMed, Embase, and Cochrane’s Library. We used a random-effect model to pool the results.ResultsSix phase II RCTs with 347 patients with newly diagnosed or recurrent glioblastoma that underwent conventional treatments were included. Compared to the control group with placebo or blank treatment, DC vaccine was associated with significantly improved overall survival in patients with glioblastoma (hazard ratio [HR]: 0.69, 95% confidence interval [CI]: 0.49 to 0.97, p = 0.03) with moderate heterogeneity (p for Cochrane’s Q test = 0.07, I² = 51%). A trend of improved progression-free survival was also detected in patients allocated to the DC vaccine group compared to those in the control group (HR: 0.76, 95% CI: 0.56 to 1.02, p = 0.07), with no significant heterogeneity (I² = 0%). Moreover, the incidence of adverse events was not significant between patients treated with DC vaccine or control (odds ratio = 1.52, 95% CI: 0.88 to 2.62, p = 0.14; I² = 0%).ConclusionsEvidence based on phase II RCTs suggests that DC vaccine may improve the survival of patients with glioblastoma. Large-scale RCTs are needed to validate the findings and determine the optimal regimens for DC vaccine.     

Effectiveness and cost-effectiveness of a people-centred care model for community-living older people versus usual care ─ A randomised controlled trial

BackgroundThere is a need for effective and cost-effective interprofessional care models that support older people to maintain their quality of life (QoL) and physical performance to live longer independently in their own homes.ObjectivesThe objectives were to evaluate effectiveness, QoL and physical performance, and cost-utility of a people-centred care model (PCCM), including the contribution of clinically trained pharmacists, compared with that of usual care in primary care.MethodsA randomised controlled trial (RCT) with a two-year follow-up was conducted. The participants were multimorbid community-living older people, aged ≥75 years. The intervention comprised an at-home patient interview, health review, pharmacist-led clinical medication review, an interprofessional team meeting, and nurse-led care coordination and health support. At the baseline and at the 1-year and 2-year follow-ups, QoL (SF-36, 36-Item Short-Form Health Survey) and physical performance (SPPB, Short Performance Physical Battery) were measured. Additionally, a physical dimension component summary in the SF-36 was calculated. The SF-36 data were transformed into SF-6D scores to calculate quality-adjusted life-years (QALYs). Healthcare resource use were collected and transformed into costs. A healthcare payer perspective was adopted. Incremental cost-effectiveness ratio (ICER) was calculated, and one-way sensitivity analysis was performed.ResultsNo statistically or clinically significant differences were observed between the usual care (n = 126) and intervention group (n = 151) patients in their QoL; at the 2-year follow-up the mean difference was ?0.02, (95 % CI -0.07; 0.04,p = 0.56). While the mean difference between the groups in physical performance at the 2-year follow-up was ?1.02, (?1.94;-0.10,p = 0.03), between the physical component summary scores it was ?7.3, (?15.2; 0.6,p = 0.07). The ICER was ?73 638€/QALY, hence, the developed PCCM dominated usual care, since it was more effective and less costly.ConclusionsThe cost-utility analysis showed that the PCCM including pharmacist-led medication review dominated usual care. However, it had no effect on QoL and the effect towards physical performance remained unclear.     

Impact of pharmacist insulin injection re-education on glycemic control among type II diabetic patients in primary health clinics

BackgroundInsulin injection technique re-education and diabetes knowledge empowerment has led to improved glycemic control.ObjectivesTo evaluate the impact of pharmacist’s monthly re-education on insulin injection technique (IT), lipohypertrophy, patients’ perception on insulin therapy and its effect on glycaemic control.MethodsThis randomized controlled, multi-centered study was conducted among type 2 diabetics from 15 government health clinics. 160 diabetics with baseline HbA1_C ≥ 8% and unsatisfactory IT technique were randomized into control or intervention group. Control group received standard pharmacist counselling during initiation and at 4th month. Intervention group received monthly counselling and IT re-education for 4 months. Assessment of diabetes, IT knowledge, adherence and perception towards diabetes were conducted using validated study tools Insulin Treatment Appraisal Scale (ITAS) and Medication Compliance Questionnaire (MCQ)).Results139 patients completed the study; control group (69), intervention group (70). In control group, all outcomes shown improvement except for patient’s perception. Mean HbA1_C decreased 0.79% ± 0.24 (p = 0.001). In intervention group, all outcomes improved significantly. HbA1c reduces significantly by 1.19% ± 0.10 (p < 0.001). Monthly re-education improved patient’s perception towards insulin therapy (ITAS score reduced 1.44 ± 2.36; p = 0.021). Between groups, interventional arm shown significantly better improvement in all outcomes. Improvement was shown in IT technique (+2.02 score; p < 0.001), medication adherence (+1.48 score; p < 0.001) and ITAS (−1.99 score; p = 0.037). Mean HbA1_C reduced an additional of 0.63% (p = 0.008) compared to control arm.ConclusionRe-education is more effective in increasing adherence, reducing lipohypertrophy, improving injection technique and patient’s perception on insulin therapy, thereby providing better glycaemic control.     

Assessing adherence to infusion-based biologic therapies in patients with inflammatory bowel disease

BackgroundThe intravenous biologics infliximab and vedolizumab are effective long-term therapies for inflammatory bowel disease (IBD). Though highly effective, suboptimal adherence may result in loss of response and adverse sequelae. The extent and outcomes of suboptimal adherence with intravenous biologics, including in IBD, requires further evaluation.ObjectivesTo ascertain adherence to infliximab and vedolizumab infusions, and determine factors associated with poorer adherence within an IBD cohort.MethodsA retrospective single-centre cohort study of IBD patients, assessing adherence to infliximab and vedolizumab over 2 years (July 1, 2017 to June 30, 2019) was conducted. Medical and pharmacy dispensing records were used to determine date of infusion. Adherence was assessed using the continuous, multiple interval measure of medication gaps (CMG). Objectively measured disease remission was achieved if one or more of endoscopic remission, faecal calprotectin <100 μg/mL and/or CRP <5 mg/mL occurred within 3 months of end of follow-up. Bivariate analysis and multiple linear regression elucidated factors associated with poorer adherence.ResultsOf 193 IBD patients, 132 (68.4%) had Crohn's disease. One hundred and thirty six (70.5%) patients received infliximab and 57 (29.5%) received vedolizumab with a median 13 [IQR 11–14] doses administered per patient over 2 years. Adherence according to CMG was similar between infliximab and vedolizumab groups (median 1.5% vs 1.2%, p = 0.31). In multiple linear regression analysis male sex, shorter IBD duration and clinic non-attendances were each associated with poorer adherence (Beta 4.69, 3.90, 3.56 respectively, p < 0.05) and objective disease remission was inversely associated with poorer adherence (Beta ?3.27, p < 0.05).ConclusionThere was a wide range of adherence to biologic infusions in this IBD cohort with poorer adherence associated with patient related factors. Conversely, objectively measured remission was strongly associated with adherence. This emphasises the need for targeted interventions to improve adherence and monitoring, and mitigate treatment delays.     

穴位按摩对新生儿缺氧缺血性脑病病儿生长发育和睡眠的影响

目的探究穴位按摩应用于新生儿缺氧缺血性脑病病儿中对生长发育及睡眠的影响。方法选取 2016年 4月至 2017年 4月无锡市儿童医院收治的给予常规干预的新生儿缺氧缺血性脑病病儿 47例作为对照组,给予病儿吸氧,酸中毒纠正及控制脑水肿抗惊厥等措施,同时采用国内改良简易按摩法,对病儿头、腹、手腕及踝足等部位进行揉按。另选取 2017年 5月至 2018年 5月无锡市儿童医院收治的给予穴位按摩的新生儿缺氧缺血性脑病病儿 47例作为观察组;在对照组基础上给予穴位按摩,按背部 -臀部 -四肢 -头面部 -胸腹部顺序进行按摩。两组干预时间均为 1个月。对比两组前后病儿生长发育、睡眠质量及新生儿行为神经测定情况。结果观察组 1个月后体质量、身高及摄入奶量分别为( 5043.72±425.36)g、(56.37±2.54)cm,(605.67±43.81)mL,均优于对照组,差异有统计学意义( P＜0.05);观察组 1个月后入睡时间、睡眠时间、睡眠效率、睡眠紊乱、睡眠质量、辅助药物及日间功能障碍评分分别为( 3.25±1.65)分、(0.69±0.52)分、(3.26±1.46)分、(7.58±1.68)分、(0.64±0.49)分、(1.15±0.95)分、(3.25±0.26)分,均低于对照组,差异有统计学意义( P＜0.05);观察组 7d后、护理 1个月后新生儿行为神经评分分别为( 28.06±1.94)分和( 37.76±2.83)分,均高于对照组,差异有统计学意义( P＜0.05)。结论穴位按摩应用于新生儿缺氧缺血性脑病病儿中能有效促进病儿生长发育,提高其睡眠质量,改善其行为神经,值得推广。     

Phase II trial of vinorelbine and trastuzumab in patients with HER2-positive metastatic breast cancer. A prospective, open label, non-controlled, multicenter phase II trial (to investigate efficacy and safety of this combination chemotherapy)

Summary  The purpose of this study was to evaluate the efficacy (progression free survival (PFS) and response rate) and safety of vinorelbine and trastuzumab combination chemotherapy in patients with HER2-overexpressing, metastatic breast cancer as a first line chemotherapy regimen. Patients with histologically confirmed, HER2-positive (immunohistochemistry (ICH) 3+, or 2+ and FISH+) metastatic breast cancer who had nor received prior vinorelbine or anti-HER2 therapy in the adjuvant setting, received at least eight weeks of vinorelbine i.v. (25 mg/g weekly) and trastuzumab (4 mg/kg on day 1 followed by 2 mg/kg weekly). Forty-one women from six participating centers were enrolled into the trial. The overall response rate, was 43.9% (18 of 41 patients), (CI 28–60.3%), 30% of patients were progression free after 1 year. Four patients reached complete remission, 14 partial remission and five had stable disease for at least 18 weeks. Six patients developed primary progression. 35 patients (85%) experienced progression after a median time of 235 days. Therapy was in general well-tolerated. There were two CTC grade 4 infusion syndromes and two patients experienced cardiotoxicity at least grade 2. This phase II trial of vinorelbine and trastuzumab demonstrated an effective and well-tolerated regimen with a favourable safety profile.