Normal Daily Practice Research Articles

Changes in Attitudes to Medical Care among Pharmacy Pharmacists before and after the COVID-19 Pandemic: A Questionnaire Survey

The coronavirus disease 2019 (COVID-19) pandemic has had a major negative effect on the number of patients visiting pharmacies in Japan. The decrease in pharmacy visits during the pandemic compared with the pre-pandemic period may have increased the likelihood of adverse health outcomes; thus, it is important that pharmacy pharmacists take measures to prevent health disadvantages. In this study, we distributed a questionnaire survey to 104 pharmacy pharmacists (mainly in Kagoshima and Kumamoto Prefectures), and investigated changes in the extent of implementation and perceptions of measures considered necessary to protect patients' health between the pre-pandemic and pandemic period. The results showed that the proportions of respondents "sharing patient information between primary care doctors and pharmacy pharmacists" and conducting "follow-up after prescribing medications mainly via telephone" increased between the pre-pandemic period and September 2022. The perceived necessity of the above two measures, as well as "online medication instructions" and "a prescription refill system," increased during the same period. However, the proportion of respondents who perceived "0410 correspondence," which was introduced during the pandemic, as a necessity did not change. Moreover, many pharmacists indicated that, at their own discretion, they continued to correspond with patients in relation to the above, and to respond to specific requests during normal daily practice. Our results could help community-based pharmacists tackle serious public health problems, such as COVID-19.

Coping with the residency program during COVID-19: Hematology oncology pharmacy residents' perspective.

The COVID-19 pandemic has led to significant changes in all governmental activities in Saudi Arabia including training and teaching, with the majority of such activities suspended in response to the COVID-19 pandemic. We aim to share the challenges that Hematology Oncology Pharmacy (HOP) residents faced during the quarantine period and provide recommendations on how to cope with the residency journey. We followed a qualitative methodological approach in March 2020 using a structured virtual group discussion for data generation. All six PGY2 hematology oncology pharmacy (HOP) residents were included in the group discussion. The group agreed that the need for HOP services during this pandemic is beyond the scope of oncology pharmacists' normal daily practice. The group recognized two fundamental points. First, the goal of the current training should be customized to the most pressing need and recognized at the national level. Second, the current training system should be improved to ensure efficient use of current resources. On this basis, the group developed six main recommendations for action. The current situation is a challenge for all healthcare providers, and the majority of the nation's current generation never dealt with such a situation in days gone by. This paper presents the challenges that should be addressed at the national level and provide a fundamental consensus recommendation for practical approaches to maximize learning and minimize disruption to trainees' progression while maintaining patient-pharmacy quality of care.

Success Rate of Colonoscopies and Reasons That Prevent Procedure Completion - Retrospective Study

Abstract Background. Colonoscopy is a common performed procedure in Gastroenterology, and it’s widely used for diagnosis, treatment and surveillance of a wide range of conditions and symptoms. Properly performed, it’s generally safe, more accurate than a virtual colonoscopy and well-tolerated by patients. The completion of a colonoscopy is defined by cecal intubation with the visualization of colonic mucosa and distal terminal ileum when it’s possible. Patients and methods. We reviewed retrospectively all consecutive endoscopies database of the lower digestive tract, done over a period from 2014-2017 in our clinic. The recommended completion based on the latest guidelines ranges from 90-95% completion rate according to the indication. Results. 11214 consecutive colonoscopies were done. Overall cecal intubation was successful in 9456 procedures (87.3%). If we exclude the interventional procedures (414 procedures), where cecal intubation was not necessary, the main reasons of non-intubation were due to intolerance of the patients (388 patients), followed on the second place by patients with obstructive cancer (299 patients). The presence of diverticulosis, poor preparation for colonoscopy and post-surgical adhesions were significant findings in non-successful procedures. Conclusions. In normal daily practice, colonoscopy is completed in 88.01% of the procedures but we think that this result will stimulate the efforts to incorporate more quality measures and time in our endoscopy laboratory.

The incidence of colorectal cancer in patients with previously removed polyp(s)-a cross-sectional study.

Years ago, it was established that removal of adenomas will lead to a lower incidence of colorectal cancer. This study aims to establish the occurrence of colorectal cancer in unselected patients after index colonoscopy with polyp removal. A prospectively collected dataset on colonoscopy covering 25 consecutive years was used. Patients in who during the index (first) procedure a polyp(s) was removed were included. Excluded were patients with colorectal cancer and patients belonging to Lynch families. In case of cancer time after the index and previous procedure, tumor stage, histology of earlier removed polyps, localization of the tumor and demographics were noted. In 1,617 patients polyp(s) were removed. Thirty (1.9%) patients developed colorectal cancer. In 18 cases adenomas were removed during prior endoscopies. Five patients only had hyperplastic polyp(s). Nine patients with cancer already were older than 75 years when the previous endoscopy was done. Patients with adenomas prior to the cancer were older compared with patients with hyperplastic polyps [mean (SD): 71.6 (5.8) versus 64.2 (10.5) years, P=0.046]. The majority of cancers were located in the proximal colon (75%). The time between diagnosing cancer and the previous colonoscopy was mean 70.6 months with a median of 60.0 months (range, 12.0-167.0 months). It is concluded that follow-up after removal of polyps in normal daily practice is associated with a low incidence of developing colorectal cancer.

Fluorescence cystoscopy: the end of biopsies for carcinoma in situ detection?

The present prospective study by Palou et al. 1, conducted in eight Spanish centres, documents the use of hexaminolevulinate fluorescence cystoscopy (FC)-guided bladder tumour resection and biopsies in 283 patients with non-muscle-invasive bladder cancer (NMIBC). It is an inpatient comparison between white-light cystoscopy and FC. The study presents data from routine practice in Spain and the results show an improvement in diagnosis of NMIBC, especially Ta tumours and carcinoma in situ (CIS) with FC-guided resections. These results are confirmation of reports in the literature, including a number of randomized controlled trials and a recent large meta analysis 2. Although the magnitude of the difference between FC and white-light cystoscopy was somewhat lower in the present study, apparently even in normal daily practice the difference was significant. Moreover, as the rate of CIS in Spain is very high, up to 19% in a large Spanish series 3, I can imagine that the use of FC is of specific interest in this country. Apart from the confirmation of the better detection rate (75.5 and 93.2% for white-light cystoscopy and FC, respectively, figures similar to those in the recent literature) and confirmation of safety of hexaminolevulinate FC, there are two particular points regarding the present study that I would like to highlight. The first item that deserves some discussion is mucosal biopsies. In this study the number of false-positive results (948/1569; 60.4%) was very high. This was predominantly explained by the inclusion or mucosal biopsies from ‘normal appearing urothelium’ in these calculations. Only 36 lesions were detected with biopsies, which suggests a very low detection rate. Assuming that >800 random biopsies were taken (apparently six biopsies were taken per patient, and biopsies were taken in 49.1% of the 283 patients), the detection rate was <4%, and one might ask whether it was still worthwhile to take these biopsies. Even though 26.7% of patients with CIS were only diagnosed by biopsies in this study, the number was small. The authors also indicate that it was surprising that CIS was not found more often with FC, but they blame it on the learning curve for FC. The value of mucosal biopsies was also questioned by some reviewers, and in fact by the present authors too. In their introduction they explain the biopsy policy by the high rate of CIS in Spain; however, they also indicate that this incidence seems to be decreasing. Taking together the disappointing detection rate of mucosal biopsies and the high detection rate of CIS with FC, the message should be clear: stop taking mucosal biopsies from normal-looking urothelium. As a matter of fact, this had already been suggested before the era of FC by the authors of other large studies, such as an analysis by the European Organisation for the Research and Treatment of Cancer 4 and a large Dutch study 5. The false-positive rate for FC was not very high (15.7%, similar to the more recent studies with hexaminolevulinate FC). And I assume that these figures would even be much lower if biopsies of normal urothelium were to be excluded from these calculations. The second point that deserves attention is the learning curve for FC and its impact on the results. The authors indeed mention as an important limitation of this study ‘the investigators’ lack of experience’ with FC. They point out that this might be the reason that the advantage of FC for the detection of CIS seemed to be less pronounced than in published series, although still significantly better than with white light. In their cohort, 27 of 36 patients with CIS (75%) were detected with FC. The impact of the learning curve and the limited experience of some of the centres is also illustrated by the wide range between centres in, for example, the false-positive rates. Indeed, some training with this FC technique is mandatory. Unfortunately, however, the authors were not able to provide details of the relationship between experience and detection of CIS or false-positive rates. In conclusion, even in routine practice, FC significantly improves the detection of NMIBC. The advantage is seen especially in Ta tumours and CIS, similarly to recent publications. The use of FC can, in my view, replace the use of random mucosal biopsies of normal-looking urothelium with white light because the detection rate of these biopsies is only a few percent. Finally, the present study also shows that a learning curve significantly improves the detection rate of NMIBC with FC and decreases the rate of false-positives. This should probably be somewhere between 5 (the number used in some of the registration studies for hexaminolevulinate) and 20 as suggested by a recent Canadian study 6. J.A.W. has been an investigator for Photocure and has been an advisor for and has received honoraria from Photocure and Ipsen.

Individual polyp detection rate in routine daily endoscopy practice depends on case-mix.

The adenoma detection rate (ADR), a marker of endoscopic quality, is confounded by selection bias. It is not known what the ADR is in normal daily practice. To study the polyp detection rate (PDR) in different endoscopists in the course of years. All consecutive endoscopies of the colon done in 11 years were included. Endoscopies in the regular surveillance programme after polyp removal and after surgery because of colorectal cancer or diverticular disease were scored separately. The number of yearly procedures per endoscopist and presence of polyps, anastomoses, surveillance and cancer were noted. In the period of 11 years, 14,908 consecutive endoscopies of colon and rectum were done by four endoscopists. Two endoscopists had a significantly lower PDR than the other two (p < 0.001), these two had the longest careers in endoscopy. The two younger endoscopists did significantly less often procedures in patients with anastomoses and because of surveillance (p < 0.001, respectively). One endoscopist detected significantly less colorectal cancers than the other three endoscopists (p < 0.001). This study presents the PDR in normal routine daily endoscopy practice. It can be concluded that the PDR, implicating the ADR, in unselected patients can be lower in individual endoscopists than recommended in the literature. This highly depends on the case-mix of patients presented for endoscopy. This result debates the use of the ADR as quality indicator for individual endoscopists.

Multicenter Study of Contraceptive Vaginal Ring (NuvaRing(®)) in Normal Daily Practice in Indian Women.

This was the first Indian multicenter study at six specialty hospitals, to assess the real-life usage of the vaginal ring in daily clinical practice. This open-label, prospective, single-arm, nonrandomized, interventional study enrolled 252 women aged >18years, seeking contraception with no contraindications to the use of combined hormonal contraceptive. Women were provided the ring with a monthly follow-up schedule for three cycles. Cycle control, acceptability, tolerability, and safety assessments were recorded at each visit. Regular menstrual bleeding was reported by 76.2% (192/252) at baseline. In study completers, regular bleeding was seen in 94.1% (192/204), 97.5% (199/204), and 98% (200/204) in the 1st, the 2nd, and the 3rd cycles, respectively. Most (94.2% [195/207]) women were very satisfied or satisfied with the ring, and 93.2% (193/207) would recommend it to others. No pregnancies or serious adverse events were reported. The study demonstrated that NuvaRing(®) is a highly effective contraceptive method with an excellent cycle control. It is well tolerated and accepted by Indian women.

Patient-reported outcome measures after endoscopic retrograde cholangiopancreatography: a prospective, multicentre study

Objective. While patient-reported outcome measures (PROMs) in ERCP are scarce, these reports are important for making improvements in quality of care. This study sought to document patient satisfaction and specifically pain related to endoscopic retrograde cholangiopancreatography (ERCP) procedures and to identify predictors for these experiences. Methods. From 2007 through 2009, prospective data from consecutive ERCP procedures at 11 hospitals during normal daily practice were recorded. Information regarding undesirable events that occurred during a 30-day follow-up period was also reported. The patient-reported pain, discomfort and general satisfaction with the ERCP were recorded. Results. Data from 2808 ERCP procedures were included in this study. Patient questionnaires were returned for 52.6% of the procedures. Moderate or severe pain was experienced in 15.5% and 14.0% of the procedures during the ERCP and in 10.8% and 7.7% of the procedures after the ERCP, respectively. In addition, female gender, endoscopic sphincterotomy (EST), and longer procedure times served as independent predictors of increased pain during the ERCP. The performing hospitals and sedation regimens were independent predictors of the procedural pain experience. In 90.9% of the procedures, the patients were satisfied with the information overall, and in 98.3% of the procedures, the patients were satisfied with the treatment provided. Independent predictors of dissatisfaction with the treatment included the occurrence of specific complications after ERCP and pain during or after the procedure. Conclusions. Female gender, the performance of EST and longer procedure times were independent predictors for increased procedure-related pain. The individual hospital and sedation regimen predicts the patient's pain experience.

Palliative stenting of the digestive tract: a case series of a single centre.

Obstruction of the gastrointestinal tract due to cancer can be treated with stenting. The aim was to review the local experience with endoscopic stenting. All patients treated with stenting in a ten years period from 2001-2010 were studied. Fifty one patients received 57 stents because of oesophageal cancer. Mean survival after stent placement was 141 days. No case of perforation occurred. In nine cases (17%) clogging with food occurred. Tumour overgrowth was noted in four cases. Twenty four patients received 28 stents in their colon or rectum. The stents were placed in the rectum (n=6), the sigmoid (n=14), the descending colon (n=1), and the transverse colon (n=3). Mean survival was 276 days. Perforation did not occur. Tumour ingrowth was seen in two patients. One patient received a second stent. Dislocation occurred in two cases. There were two cases of clogging (8%) by stool. Fourteen patients received a total of 18 stents because of obstructing stomach cancer. Mean survival after placement was 121 days. There was no perforation, one case of clogging, and four cases of tumour ingrowth. Eight patients had stent placement in their duodenum. Mean survival after stent placement was 84 days. No perforation or clogging occurred. But three cases of tumour ingrowth were seen. The present series shows that placement of expandable stents in the digestive tract in normal daily practice is feasible, safe, with a low number of complications, and provides good palliation for their remaining life.

The Completion Rate of Colonoscopy in Normal Daily Practice: Factors Associated with Failure

Background: Colonoscopy is an important diagnostic procedure for screening as well as for patients presenting with complaints. The completion of a colonoscopy is defined as cecal intubation. A large single center study was done in order to evaluate the completion rate of colonoscopy and identify reasons for failure. Patients and Methods: We reviewed all consecutive endoscopies of the lower digestive tract done over a period of 15 years by 2 endoscopists. The main outcome measure was a successful cecal intubation. Results: 14,139 consecutive colonoscopies were done. Overall cecal intubation was successful in 11,787 procedures (83.3%). Three hundred and sixty-one of the nonsuccessful procedures were due to insufficient colon cleansing, and no significant abnormalities were seen in 362 procedures. In the remaining 1,629 endoscopies, significant diagnoses were made. The presence of colorectal cancer, diverticula and inflammatory bowel disease were significant findings in nonsuccessful procedures. Conclusion: In normal daily practice, colonoscopy is completed in 83.3% of the procedures. Reasons for failure are obstructing tumors, diverticula and insufficient colon cleansing.

Are many colorectal cancers due to missed adenomas?

Background An unknown number of colorectal cancers could be due to missed adenomas during previous endoscopy. Data in the literature are sparse. A large cross-sectional study was done in a prospective database of all patients diagnosed with colorectal cancer. Methods All consecutive endoscopies over a period of 15 years, in which colorectal cancer was diagnosed were included. All patients who underwent more than one endoscopy and in whom ultimately cancer was diagnosed were studied separately. Results Colorectal cancer was diagnosed in 835 patients. Twenty-five patients underwent a previous endoscopy without a cancer diagnosis. These 25 patients were divided into three groups according to the time between the endoscopy in which the cancer was detected and the previous endoscopy. Five out of these 25 patients underwent regular surveillance. Only 11 patients had no argument for regular follow-up. Assuming that these cancers developed from an adenoma than only 11 out of 835 (1.3%) cancers were missed in the adenoma phase. There was no difference in the size of the tumour between the three groups of patients. Conclusion In normal daily practice, only a small number of clinically important adenomas are missed. The problem of missed adenomas probably is being exaggerated.

Efficacy and safety of nifedipine GITS in Chinese patients with hypertension – A post‐marketing surveillance study

Purpose. This post‐marketing surveillance study assessed the efficacy, safety and tolerability of the treatment with nifedipine GITS (gastro‐intestinal therapeutic system) in hypertensive patients under normal daily practice conditions in China. Patients and methods. A total of 3003 patients were included in 174 outpatient clinics. Patients received 30 mg or 60 mg of nifedipine GITS. Data were collected at up to three follow‐up visits. Results. At the end of the observation period, mean treatment duration was 13.3 weeks. Mean blood pressure reduction was 27.6/13.6 mmHg, 62.1% of patients had a systolic blood pressure <140 mmHg, and 82.2% had a diastolic blood pressure <90 mmHg. Blood pressure control according to international guidelines was achieved in 45.0% of all patients. A total of 1515 patients received additional antihypertensive medications, of which angiotensin‐converting enzyme (ACE) inhibitors were mostly used (42.2%) followed by beta‐blockers (33.7%). Twenty‐two patients (0.7%) experienced 27 adverse events. Physicians' assessments of efficacy, tolerability and patient acceptance had ratings of “very good” and “good” in 88.7% (efficacy), 92.8% (tolerability) and 89.1% (patient acceptance) of patients. Conclusions. Nifedipine GITS proved to be effective and well tolerated for the treatment of hypertension in 3003 Chinese patients. The results confirm the findings of previously performed clinical studies.

Efficacy and Safety of Nifedipine GITS in Asians with Hypertension

This post-marketing surveillance study assessed the efficacy, safety and tolerability of treatment with nifedipine GITS (gastrointestinal therapeutic system) in hypertensive patients with different risk profiles under normal daily practice conditions in China. A total of 7395 patients were included in 564 outpatient clinics. Patients received 30mg or 60mg of nifedipine GITS, which could be up- and down-titrated if necessary. Efficacy, safety and tolerability data were collected at up to three follow-up visits. Patient documentation was completed using standardised and barcoded case report forms. Descriptive and explorative analyses of the data were performed. At endpoint, 93% of patients were receiving 30mg of nifedipine GITS and 7% were taking 60mg of nifedipine GITS. The mean observation period was 9 +/- 7 weeks. At endpoint, the mean BP reduction was 27.7/14.8mm Hg; 43% of patients had a systolic BP <140mm Hg, and 58% had a diastolic BP <90mm Hg. BP control as recommended by international guidelines was achieved in 43.5% of all patients. A total of 3163 patients (42.8%) received additional antihypertensive medication, of which ACE inhibitors were most commonly used (40.7%), followed by beta-adrenoceptor antagonists (25.8%).Twenty-nine patients (0.4%) experienced a total of 39 adverse events. Subjective physicians' assessments of efficacy, tolerability and patient acceptance of nifedipine GITS treatment returned ratings of 'very good' and 'good' in 91-95% of each category. Nifedipine GITS proved to be effective and well tolerated for the treatment of hypertension in 7395 Chinese patients under normal daily practice conditions. The results confirm the findings and experience of previously performed clinical studies.

Effect of Add-On Acarbose to Insulin Therapy in Routine Clinical Practice

This post-marketing surveillance study collected data on the efficacy and tolerability of acarbose in patients with insulin-treated type 2 diabetes mellitus and, in particular, on its effect on postprandial blood glucose under normal daily practice conditions. A total of 1142 patients were included in this observational study in which the treating physicians had sole responsibility for determining acarbose doses and other therapeutic measures. Efficacy parameters consisted of fasting and postprandial blood glucose and glycosylated haemoglobin (HbA(1c)). Additionally, cholesterol, triglycerides and weight were analysed. All patient data had to be recorded by the attending physician on a case report form. Patients were asked to self-monitor blood glucose daily after breakfast (1h) and to keep a diary. Mean HbA(1c) improved by 0.9%, fasting blood glucose by 32.4 mg/dL, and postprandial hyperglycaemia by 49.7 mg/dL during the observation period compared with baseline. Comparable results were obtained in combination with conventional, functional or intensive insulin therapy. Mean weight was reduced by 0.7kg. The incidence of acarbose-related side effects was low (6.9%) and consisted mostly of gastrointestinal complaints. The majority of patients assessed acarbose treatment positively. The addition of acarbose to different insulin regimens provided an efficacious and safe treatment for better glycaemic and weight control.

Diagnosis and therapy in pre-school children with asthma or asthma-like symptoms

Diagnosing asthma in pre-school children with asthma or asthma-like symptoms is a major problem because of the similarity of the symptoms. The initial treatment of these young patients is often performed by general practitioners. Currently very much attention is paid to the use of inhalation corticosteroids (ICS) in these young children while optimal treatment regiments are still unclear. The precise place of ICS has yet to be clarified in children with recurrent wheezing. Although several studies have shown that ICS is effective in the treatment of asthma we do not know which of these children should be given maintenance therapy with inhaled corticosteroids and which not.Only a small percentage of early wheezers go on to develop classic asthma. It is possible that children with transient wheeze do not respond to ICS in the same way true asthmatics do. The ability to predict accurately those wheezy pre-school children who will develop asthma eludes us. To focus on these diagnostic and therapeutic dilemmas. A multicentre, parallel group, randomised, double blind study to investigate the efficacy of ICS in 1 to 5 year old children with asthma or asthma-like symptoms. Study population: children with asthma or asthma-like symptoms in which in normal daily practice the general practitioner considers treatment with ICS because of symptoms. In this study we try to answer the question which children will benefit from maintenance treatment with ICS; as part of this study we have developed an Asthma Diagnostic Questionnaire. By using this questionnaire and by collecting additional lung function data (Forced Oscillation Technique and Resistance Interrupter Technique) we try to distinguish children with probably asthma from children with probably non-asthma. The results of our study may lead to an improvement in the diagnosis and treatment of asthma or asthma-like symptoms in pre-school children.