Pub Date : 2016-01-28eCollection Date: 2016-01-01DOI: 10.2147/POR.S94456
Olga K Lutzko, Helen Schifferle, Marita Ariola, Antonia Rich, Khen Meng Kon
Purpose: The purpose of this study was to evaluate the optimization of fasting blood glucose (FBG) levels in patients with type 2 diabetes mellitus newly initiated on insulin glargine who were enrolled in the Australian Diabetes CoStars Patient Support Program (PSP).
Patients and methods: A retrospective analysis of data from 514 patients with type 2 diabetes mellitus who completed the 12-week Diabetes CoStars PSP was performed. All patients were initiated on insulin glargine in primary care and enrolled by their general practitioner, who selected a predefined titration plan and support from a local Credentialled Diabetes Educator. The data collected included initial and final insulin dose, self-reported FBG, and glycated hemoglobin (A1c) levels.
Results: The insulin dose increased in 81% of patients. Mean FBG was reduced from 208.8 mg/dL (11.6 mmol/L) to 136.8 mg/dL (7.6 mmol/L) after 12 weeks. Initial and final A1c values were available for 99 patients; mean A1c was reduced from 9.5% (80 mmol/mol) to 8.1% (65 mmol/mol). The reductions in mean FBG and A1c were similar irrespective of titration plan. Overall, 27.2% of patients achieved FBG levels within the titration plan target range of 72-108 mg/dL (4-6 mmol/L) and an additional 43.4% of patients achieved FBG within the range recommended by current Australian guidelines (110-144 mg/dL [6.1-8.0 mmol/L]). Overall, 23.3% of patients achieved the A1c target of ≤7%.
Conclusion: These data demonstrate that the majority of patients enrolled in the Diabetes CoStars PSP achieved acceptable FBG levels 12 weeks after starting insulin therapy irrespective of titration plan.
{"title":"Optimizing insulin initiation in primary care: the Diabetes CoStars patient support program.","authors":"Olga K Lutzko, Helen Schifferle, Marita Ariola, Antonia Rich, Khen Meng Kon","doi":"10.2147/POR.S94456","DOIUrl":"10.2147/POR.S94456","url":null,"abstract":"<p><strong>Purpose: </strong>The purpose of this study was to evaluate the optimization of fasting blood glucose (FBG) levels in patients with type 2 diabetes mellitus newly initiated on insulin glargine who were enrolled in the Australian Diabetes CoStars Patient Support Program (PSP).</p><p><strong>Patients and methods: </strong>A retrospective analysis of data from 514 patients with type 2 diabetes mellitus who completed the 12-week Diabetes CoStars PSP was performed. All patients were initiated on insulin glargine in primary care and enrolled by their general practitioner, who selected a predefined titration plan and support from a local Credentialled Diabetes Educator. The data collected included initial and final insulin dose, self-reported FBG, and glycated hemoglobin (A<sub>1c</sub>) levels.</p><p><strong>Results: </strong>The insulin dose increased in 81% of patients. Mean FBG was reduced from 208.8 mg/dL (11.6 mmol/L) to 136.8 mg/dL (7.6 mmol/L) after 12 weeks. Initial and final A<sub>1c</sub> values were available for 99 patients; mean A<sub>1c</sub> was reduced from 9.5% (80 mmol/mol) to 8.1% (65 mmol/mol). The reductions in mean FBG and A<sub>1c</sub> were similar irrespective of titration plan. Overall, 27.2% of patients achieved FBG levels within the titration plan target range of 72-108 mg/dL (4-6 mmol/L) and an additional 43.4% of patients achieved FBG within the range recommended by current Australian guidelines (110-144 mg/dL [6.1-8.0 mmol/L]). Overall, 23.3% of patients achieved the A<sub>1c</sub> target of ≤7%.</p><p><strong>Conclusion: </strong>These data demonstrate that the majority of patients enrolled in the Diabetes CoStars PSP achieved acceptable FBG levels 12 weeks after starting insulin therapy irrespective of titration plan.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"7 1","pages":"3-10"},"PeriodicalIF":8.9,"publicationDate":"2016-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5085308/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68457131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
[This corrects the article on p. 47 in vol. 6, PMID: 27774032.].
[这更正了第6卷第47页的文章,PMID: 27774032]。
{"title":"Efficacy and effectiveness trials have different goals, use different tools, and generate different messages [Corrigendum]","authors":"F. Porzsolt, N. G. Rocha, A. C. Toledo-Arruda","doi":"10.2147/POR.S100784","DOIUrl":"https://doi.org/10.2147/POR.S100784","url":null,"abstract":"[This corrects the article on p. 47 in vol. 6, PMID: 27774032.].","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"7 1","pages":"1 - 1"},"PeriodicalIF":8.9,"publicationDate":"2016-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S100784","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68454980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-11-04eCollection Date: 2015-01-01DOI: 10.2147/POR.S89946
Franz Porzsolt, Natália Galito Rocha, Alessandra C Toledo-Arruda, Tania G Thomaz, Cristiane Moraes, Thais R Bessa-Guerra, Mauricio Leão, Arn Migowski, André R Araujo da Silva, Christel Weiss
The discussion about the optimal design of clinical trials reflects the perspectives of theory-based scientists and practice-based clinicians. Scientists compare the theory with published results. They observe a continuum from explanatory to pragmatic trials. Clinicians compare the problem they want to solve by completing a clinical trial with the results they can read in the literature. They observe a mixture of what they want and what they get. None of them can solve the problem without the support of the other. Here, we summarize the results of discussions with scientists and clinicians. All participants were interested to understand and analyze the arguments of the other side. As a result of this process, we conclude that scientists tell what they see, a continuum from clear explanatory to clear pragmatic trials. Clinicians tell what they want to see, a clear explanatory trial to describe the expected effects under ideal study conditions and a clear pragmatic trial to describe the observed effects under real-world conditions. Following this discussion, the solution was not too difficult. When we accept what we see, we will not get what we want. If we discuss a necessary change of management, we will end up with the conclusion that two types of studies are necessary to demonstrate efficacy and effectiveness. Efficacy can be demonstrated in an explanatory, ie, a randomized controlled trial (RCT) completed under ideal study conditions. Effectiveness can be demonstrated in an observational, ie, a pragmatic controlled trial (PCT) completed under real-world conditions. It is impossible to design a trial which can detect efficacy and effectiveness simultaneously. The RCTs describe what we may expect in health care, while the PCTs describe what we really observe.
{"title":"Efficacy and effectiveness trials have different goals, use different tools, and generate different messages.","authors":"Franz Porzsolt, Natália Galito Rocha, Alessandra C Toledo-Arruda, Tania G Thomaz, Cristiane Moraes, Thais R Bessa-Guerra, Mauricio Leão, Arn Migowski, André R Araujo da Silva, Christel Weiss","doi":"10.2147/POR.S89946","DOIUrl":"10.2147/POR.S89946","url":null,"abstract":"<p><p>The discussion about the optimal design of clinical trials reflects the perspectives of theory-based scientists and practice-based clinicians. Scientists compare the theory with published results. They observe a continuum from explanatory to pragmatic trials. Clinicians compare the problem they want to solve by completing a clinical trial with the results they can read in the literature. They observe a mixture of what they want and what they get. None of them can solve the problem without the support of the other. Here, we summarize the results of discussions with scientists and clinicians. All participants were interested to understand and analyze the arguments of the other side. As a result of this process, we conclude that scientists tell what they see, a continuum from clear explanatory to clear pragmatic trials. Clinicians tell what they want to see, a clear explanatory trial to describe the expected effects under ideal study conditions and a clear pragmatic trial to describe the observed effects under real-world conditions. Following this discussion, the solution was not too difficult. When we accept what we see, we will not get what we want. If we discuss a necessary change of management, we will end up with the conclusion that two types of studies are necessary to demonstrate efficacy and effectiveness. Efficacy can be demonstrated in an explanatory, ie, a randomized controlled trial (RCT) completed under ideal study conditions. Effectiveness can be demonstrated in an observational, ie, a pragmatic controlled trial (PCT) completed under real-world conditions. It is impossible to design a trial which can detect efficacy and effectiveness simultaneously. The RCTs describe what we may expect in health care, while the PCTs describe what we really observe.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"6 1","pages":"47-54"},"PeriodicalIF":8.9,"publicationDate":"2015-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5045025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68457091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michihiro Takahashi, N. Nakahara, S. Fujikoshi, M. Iyo
Purpose To compare the rates of antipsychotic response, remission, and relapse in patients with schizophrenia treated with olanzapine or other antipsychotics in usual clinical care in Japan. Patients and methods This analysis of a 12-month, prospective, noninterventional study examined outcomes for 1,089 inpatients and outpatients with schizophrenia who initiated antipsychotic monotherapy. All treatment decisions, including medication choice, were left to the discretion of the treating physician. The rates of treatment response, relapse, and 6-month sustained remission were compared between olanzapine monotherapy (OLZ) and other anti-psychotic monotherapy (OAN), and between OLZ and other atypical antipsychotic monotherapy (OAT). Visit-wise comparisons of treatment response and remission were examined using repeated-measures logistic regressions. Propensity scores were used to control for potential baseline differences between groups. Results Response rates were higher for OLZ patients and relapse rates were consistently lower for OLZ patients, however the differences were not statistically significant. Rates of 6-month sustained remission were significantly higher for OLZ than OAN patients (P=0.032) and for OLZ than OAT patients (P=0.041). An exploratory analysis of OLZ and OAN comparison found outpatients treated with OLZ or OAN had similar sustained remission rates (OLZ: 22.2%, OAN: 22.8%), while inpatients treated with OLZ had significantly higher sustained remission rates than inpatients treated with OAN (OLZ: 17.1%, OAN: 6.6%, odds ratio [95% confidence interval] =3.54 [2.00–6.25]). Conclusion In usual care in Japan, treating the acute symptoms of schizophrenia with olanzapine was not found to be significantly different for response and relapse rates; however, treatment with olanzapine was found to have significantly greater sustained remission rates than treatment with other antipsychotics. In the inpatient setting, where patients tend to be more severe and difficult to manage, olanzapine treatment may lead to higher sustained remission rates than other antipsychotics.
{"title":"Remission, response, and relapse rates in patients with acute schizophrenia treated with olanzapine monotherapy or other atypical antipsychotic monotherapy: 12-month prospective observational study","authors":"Michihiro Takahashi, N. Nakahara, S. Fujikoshi, M. Iyo","doi":"10.2147/POR.S64973","DOIUrl":"https://doi.org/10.2147/POR.S64973","url":null,"abstract":"Purpose To compare the rates of antipsychotic response, remission, and relapse in patients with schizophrenia treated with olanzapine or other antipsychotics in usual clinical care in Japan. Patients and methods This analysis of a 12-month, prospective, noninterventional study examined outcomes for 1,089 inpatients and outpatients with schizophrenia who initiated antipsychotic monotherapy. All treatment decisions, including medication choice, were left to the discretion of the treating physician. The rates of treatment response, relapse, and 6-month sustained remission were compared between olanzapine monotherapy (OLZ) and other anti-psychotic monotherapy (OAN), and between OLZ and other atypical antipsychotic monotherapy (OAT). Visit-wise comparisons of treatment response and remission were examined using repeated-measures logistic regressions. Propensity scores were used to control for potential baseline differences between groups. Results Response rates were higher for OLZ patients and relapse rates were consistently lower for OLZ patients, however the differences were not statistically significant. Rates of 6-month sustained remission were significantly higher for OLZ than OAN patients (P=0.032) and for OLZ than OAT patients (P=0.041). An exploratory analysis of OLZ and OAN comparison found outpatients treated with OLZ or OAN had similar sustained remission rates (OLZ: 22.2%, OAN: 22.8%), while inpatients treated with OLZ had significantly higher sustained remission rates than inpatients treated with OAN (OLZ: 17.1%, OAN: 6.6%, odds ratio [95% confidence interval] =3.54 [2.00–6.25]). Conclusion In usual care in Japan, treating the acute symptoms of schizophrenia with olanzapine was not found to be significantly different for response and relapse rates; however, treatment with olanzapine was found to have significantly greater sustained remission rates than treatment with other antipsychotics. In the inpatient setting, where patients tend to be more severe and difficult to manage, olanzapine treatment may lead to higher sustained remission rates than other antipsychotics.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"6 1","pages":"39 - 46"},"PeriodicalIF":8.9,"publicationDate":"2015-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S64973","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68457455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
: Current guidelines typically adopt a mechanistic approach to therapeutic management rather than a more individualized approach, guided by analysis of a patient’s problems. The result is that many patients end up on high levels of medications, possibly over-treated, yet uncontrolled. Guidelines currently recommend solutions based on the mean outcomes from registration trials. As such, they are probably applicable to only around 5% of the respiratory population that lies either side of that mean and not the majority of patients, eg, those with comorbidities and lifestyle complications. While the guidelines’ approach puts evidence at the center of their decision making, an evidence-based approach that will benefit the patient must put the patient at the center and adapt the available evidence to their specific needs. Examination of databases goes some way to seeing what happens in real-life and (to some degree) reflects this more patient-centric approach to evaluation of the evidence. By considering the interaction Abstract: In recent years we have developed different epidemiological studies with data obtained from the Information System for Development in Research in Primary Care, a population database that contains information of 5.8 million inhabitants (80% of Catalonia’s population). In one of them newly diagnosed COPD patients in the years 2007–2012 were identified through a diagnostic algorithm, and patients with a diagnostic spirometry were included and classified based on GOLD severity stages. Information about the initial treatment patterns was collected. No information regarding Modified Medical Research Council Dyspnea Scale (mMRC) or the COPD assessment test (CAT) was available but previous diagnosis of asthma and exacerbations during the previous year were collected. We identified 15,312 patients with newly diagnosed COPD. The frequency of patients with a previous diagnosis of asthma or frequent exacerbations was similar between groups (up to 6.6% of patients with previous asthma and 24.5% of frequent exacerbations). Regarding treatment, milder patients were more likely to receive short-acting bronchodilators in monotherapy (21% of patients in GOLD 1 versus 14.8% in GOLD 4) or no treatment after diagnosis (38.7% GOLD 1 versus 13.6% GOLD 4) while patients in GOLD 4 received triple therapy more frequently compared to GOLD 1 (36.6% versus 5.7%). Few patients were treated with double therapy (from 1.6% patients in GOLD 1 to 4% in GOLD 3). The percentage of patients treated with inhaled corticosteroid was higher in the severe groups (28.3%, 37.3%, 51.3%, 59.3% for GOLD 1 to 4 respectively). Other studies are ongoing on the prevalence of AAT determinations in primary care and the compliance with once daily and twice daily long-acting muscarinic antagonists in COPD in primary care. Background: The large-scale international implementing Helping Asthma in Real People (iHARP) project, which arose from the pilot project in Ireland in 2009, aims
{"title":"Meeting abstracts from the Respiratory Effectiveness Group 2015 Winter Summit – databases and registries around the world: maximizing the yield","authors":"A. Chisholm, Mylee Durack","doi":"10.2147/POR.S83049","DOIUrl":"https://doi.org/10.2147/POR.S83049","url":null,"abstract":": Current guidelines typically adopt a mechanistic approach to therapeutic management rather than a more individualized approach, guided by analysis of a patient’s problems. The result is that many patients end up on high levels of medications, possibly over-treated, yet uncontrolled. Guidelines currently recommend solutions based on the mean outcomes from registration trials. As such, they are probably applicable to only around 5% of the respiratory population that lies either side of that mean and not the majority of patients, eg, those with comorbidities and lifestyle complications. While the guidelines’ approach puts evidence at the center of their decision making, an evidence-based approach that will benefit the patient must put the patient at the center and adapt the available evidence to their specific needs. Examination of databases goes some way to seeing what happens in real-life and (to some degree) reflects this more patient-centric approach to evaluation of the evidence. By considering the interaction Abstract: In recent years we have developed different epidemiological studies with data obtained from the Information System for Development in Research in Primary Care, a population database that contains information of 5.8 million inhabitants (80% of Catalonia’s population). In one of them newly diagnosed COPD patients in the years 2007–2012 were identified through a diagnostic algorithm, and patients with a diagnostic spirometry were included and classified based on GOLD severity stages. Information about the initial treatment patterns was collected. No information regarding Modified Medical Research Council Dyspnea Scale (mMRC) or the COPD assessment test (CAT) was available but previous diagnosis of asthma and exacerbations during the previous year were collected. We identified 15,312 patients with newly diagnosed COPD. The frequency of patients with a previous diagnosis of asthma or frequent exacerbations was similar between groups (up to 6.6% of patients with previous asthma and 24.5% of frequent exacerbations). Regarding treatment, milder patients were more likely to receive short-acting bronchodilators in monotherapy (21% of patients in GOLD 1 versus 14.8% in GOLD 4) or no treatment after diagnosis (38.7% GOLD 1 versus 13.6% GOLD 4) while patients in GOLD 4 received triple therapy more frequently compared to GOLD 1 (36.6% versus 5.7%). Few patients were treated with double therapy (from 1.6% patients in GOLD 1 to 4% in GOLD 3). The percentage of patients treated with inhaled corticosteroid was higher in the severe groups (28.3%, 37.3%, 51.3%, 59.3% for GOLD 1 to 4 respectively). Other studies are ongoing on the prevalence of AAT determinations in primary care and the compliance with once daily and twice daily long-acting muscarinic antagonists in COPD in primary care. Background: The large-scale international implementing Helping Asthma in Real People (iHARP) project, which arose from the pilot project in Ireland in 2009, aims ","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"6 1","pages":"13 - 38"},"PeriodicalIF":8.9,"publicationDate":"2015-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S83049","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68457083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
C. Bushe, B. Wilson, F. Televantou, M. Belger, L. Watson
Background Adult attention deficit hyperactivity disorder (ADHD) has been largely ignored in psychiatric and general practice guidance until recently. Adult ADHD has a high social and medical burden, but health care is not well described in the UK. The main study objective was to evaluate a primary care adult ADHD population in terms of prescribing and health care contact rates. Methods This was a retrospective observational study using data from the Clinical Practice Research Database from January 1, 2002 to July 31, 2011. Adult patients with an incident ADHD diagnosis or ADHD medication were identified as having been free of ADHD medication or diagnoses in the previous 2 years. Patients were followed for 12–24 months after diagnosis. Results Of the 663 patients with ADHD in the cohort, 54.1% were prescribed ADHD medication during the observation period. During the first 6 months, 34.2% of patients initiated methylphenidates and 14.0% atomoxetine. In total, 36.3% patients were referred to secondary care psychiatry during observation, with the remaining population (63.7%) never having a referral. Most of the referrals were before diagnosis in primary care. At the end of the observation period, 16.2% of patients were on antipsychotics, 17.3% hypnotics, and 34.8% antidepressants or anxiolytics; however, some patients appeared to be prescribed antipsychotic or antidepressant medications even if they did not have an observable diagnosis in their records. Health care contact rates (general practitioner or hospital) increased by 39.2% post-diagnosis (incidence rate ratio: 1.39; 95% confidence interval: 1.32, 1.47), which may be related to the need for medication monitoring and titration. Conclusion This study has shown in primary care that there is relatively low use of ADHD medication, low referrals into secondary care, high rates of usage of psychiatric non-ADHD medications for different indications, and an increasing burden in terms of health care contacts in adult ADHD patients post-diagnosis.
{"title":"Understanding the treatment of attention deficit hyperactivity disorder in newly diagnosed adult patients in general practice: a UK database study","authors":"C. Bushe, B. Wilson, F. Televantou, M. Belger, L. Watson","doi":"10.2147/POR.S74161","DOIUrl":"https://doi.org/10.2147/POR.S74161","url":null,"abstract":"Background Adult attention deficit hyperactivity disorder (ADHD) has been largely ignored in psychiatric and general practice guidance until recently. Adult ADHD has a high social and medical burden, but health care is not well described in the UK. The main study objective was to evaluate a primary care adult ADHD population in terms of prescribing and health care contact rates. Methods This was a retrospective observational study using data from the Clinical Practice Research Database from January 1, 2002 to July 31, 2011. Adult patients with an incident ADHD diagnosis or ADHD medication were identified as having been free of ADHD medication or diagnoses in the previous 2 years. Patients were followed for 12–24 months after diagnosis. Results Of the 663 patients with ADHD in the cohort, 54.1% were prescribed ADHD medication during the observation period. During the first 6 months, 34.2% of patients initiated methylphenidates and 14.0% atomoxetine. In total, 36.3% patients were referred to secondary care psychiatry during observation, with the remaining population (63.7%) never having a referral. Most of the referrals were before diagnosis in primary care. At the end of the observation period, 16.2% of patients were on antipsychotics, 17.3% hypnotics, and 34.8% antidepressants or anxiolytics; however, some patients appeared to be prescribed antipsychotic or antidepressant medications even if they did not have an observable diagnosis in their records. Health care contact rates (general practitioner or hospital) increased by 39.2% post-diagnosis (incidence rate ratio: 1.39; 95% confidence interval: 1.32, 1.47), which may be related to the need for medication monitoring and titration. Conclusion This study has shown in primary care that there is relatively low use of ADHD medication, low referrals into secondary care, high rates of usage of psychiatric non-ADHD medications for different indications, and an increasing burden in terms of health care contacts in adult ADHD patients post-diagnosis.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"6 1","pages":"1 - 12"},"PeriodicalIF":8.9,"publicationDate":"2015-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S74161","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68457069","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
E. Verdun di Cantogno, M. Tomlinson, Laure Manuel, K. Thakur
Purpose This international survey recorded the opinions of multiple sclerosis (MS) nurses about their role in treatment decision making and about the importance of different attributes of autoinjectors used to deliver first-line parenteral therapy. Methods The survey involved 52 MS nurses in different practice settings in France, Germany, Italy, the UK, and the USA. Nurses described their role in patient education and in treatment decision making. They also rated the importance of nine prespecified attributes of autoinjectors and stated their preference, both overall and by attribute, for one of two autoinjectors used to deliver interferon β-1b (ExtaviPro® 30G and Betacomfort®). Nurses’ preferences were compared with those previously collected from patients using an identical questionnaire. Results There were pronounced differences between practice settings and between countries in the opinions of MS nurses about their influence on treatment decision making. Nurses considered themselves instrumental in helping patients decide between treatment options offered by neurologists. Of the nine autoinjector attributes, nurses rated “reliable to use” as most important, followed by attributes associated with convenience (“easy to operate,” “ergonomic shape,” “reach” [of injection sites], and “one-handed injection”). Nurses’ and patients’ rankings of attributes were closely aligned. For the nine attributes, 74%–98% of nurses preferred ExtaviPro® 30G to Betacomfort®, 94% preferring ExtaviPro® 30G overall. Nurses showed a greater preference than patients for ExtaviPro® 30G with respect to “easy to operate” (92% vs 78%), “intuitive to use” (98% vs 78%), and “attractive design” (98% vs 83%; P<0.05, all), but preference rates were otherwise similar across the two groups. The most common reasons in both groups for preferring ExtaviPro® 30G to Betacomfort® were “easy to use” and “ergonomic shape.” Conclusion MS nurses play a key role in patient guidance and education. Their preferences for ExtaviPro® 30G likely reflect their understanding of the challenges patients face when self-administering treatment.
{"title":"Autoinjector preference in multiple sclerosis and the role of nurses in treatment decisions: results from an international survey in Europe and the USA","authors":"E. Verdun di Cantogno, M. Tomlinson, Laure Manuel, K. Thakur","doi":"10.2147/POR.S72012","DOIUrl":"https://doi.org/10.2147/POR.S72012","url":null,"abstract":"Purpose This international survey recorded the opinions of multiple sclerosis (MS) nurses about their role in treatment decision making and about the importance of different attributes of autoinjectors used to deliver first-line parenteral therapy. Methods The survey involved 52 MS nurses in different practice settings in France, Germany, Italy, the UK, and the USA. Nurses described their role in patient education and in treatment decision making. They also rated the importance of nine prespecified attributes of autoinjectors and stated their preference, both overall and by attribute, for one of two autoinjectors used to deliver interferon β-1b (ExtaviPro® 30G and Betacomfort®). Nurses’ preferences were compared with those previously collected from patients using an identical questionnaire. Results There were pronounced differences between practice settings and between countries in the opinions of MS nurses about their influence on treatment decision making. Nurses considered themselves instrumental in helping patients decide between treatment options offered by neurologists. Of the nine autoinjector attributes, nurses rated “reliable to use” as most important, followed by attributes associated with convenience (“easy to operate,” “ergonomic shape,” “reach” [of injection sites], and “one-handed injection”). Nurses’ and patients’ rankings of attributes were closely aligned. For the nine attributes, 74%–98% of nurses preferred ExtaviPro® 30G to Betacomfort®, 94% preferring ExtaviPro® 30G overall. Nurses showed a greater preference than patients for ExtaviPro® 30G with respect to “easy to operate” (92% vs 78%), “intuitive to use” (98% vs 78%), and “attractive design” (98% vs 83%; P<0.05, all), but preference rates were otherwise similar across the two groups. The most common reasons in both groups for preferring ExtaviPro® 30G to Betacomfort® were “easy to use” and “ergonomic shape.” Conclusion MS nurses play a key role in patient guidance and education. Their preferences for ExtaviPro® 30G likely reflect their understanding of the challenges patients face when self-administering treatment.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"5 1","pages":"53 - 64"},"PeriodicalIF":8.9,"publicationDate":"2014-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S72012","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68457065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Often within oral health, clinical outcome measures dominate trial design rather than behavioral outcome measures, and often there is a reliance on proxy self-reporting of children’s behavior with no corroboration through triangulation of measures. The complexity of the interventions involved in oral health intervention is often overlooked in trial design, and more flexible pragmatic designs that take account of the research context may be more appropriate. Some of the limitations in oral health behavioral intervention studies (trials) in primary school age children were reported in a recently published Cochrane review. This paper aims to critically discuss the findings of a recent Cochrane review in terms of the methodological implications that arise for future design, development, measurement, and reporting of oral health trials in primary school age children. Key components of the UK Medical Research Council’s framework for the design and evaluation of complex interventions are discussed in relation to using taxonomies of behavior change. This paper is not designed to be a definitive guide but aims to bring learning from other areas of public health and health promotion into dental public health. Ultimately, the aim is to aid the design of more successful interventions that produce long-term behavioral changes in children in relation to toothbrushing and nighttime sugar snacking.
{"title":"Challenges in designing, conducting, and reporting oral health behavioral intervention studies in primary school age children: methodological issues","authors":"A. M. Cooper, M. Coffey, L. Dugdill","doi":"10.2147/POR.S52287","DOIUrl":"https://doi.org/10.2147/POR.S52287","url":null,"abstract":"Often within oral health, clinical outcome measures dominate trial design rather than behavioral outcome measures, and often there is a reliance on proxy self-reporting of children’s behavior with no corroboration through triangulation of measures. The complexity of the interventions involved in oral health intervention is often overlooked in trial design, and more flexible pragmatic designs that take account of the research context may be more appropriate. Some of the limitations in oral health behavioral intervention studies (trials) in primary school age children were reported in a recently published Cochrane review. This paper aims to critically discuss the findings of a recent Cochrane review in terms of the methodological implications that arise for future design, development, measurement, and reporting of oral health trials in primary school age children. Key components of the UK Medical Research Council’s framework for the design and evaluation of complex interventions are discussed in relation to using taxonomies of behavior change. This paper is not designed to be a definitive guide but aims to bring learning from other areas of public health and health promotion into dental public health. Ultimately, the aim is to aid the design of more successful interventions that produce long-term behavioral changes in children in relation to toothbrushing and nighttime sugar snacking.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"5 1","pages":"43 - 51"},"PeriodicalIF":8.9,"publicationDate":"2014-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S52287","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68456658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
E. Drevenhorn, A. Bengtson, P. Nyberg, K. Kjellgren
Background There is a well-known problem in hypertension care with patients’ adherence to treatment. Patients who score high in answering the instrument Satisfaction with Information about Medicine Scale are reported to have greater adherence to their medication. Aim To explore how hypertensive patients’ satisfaction with information about their medicines was affected by nurses’ education in Motivational Interviewing. Material and methods The Stages of Change model and Motivational Interviewing was the theoretical base for consultation training for nurses. Nineteen nurses attended 3 days of video-recorded consultation training with simulated patients. They were updated in hypertensive medication and were trained in motivating patients to improve their self-management as well as adherence to lifestyle changes and medication. The satisfaction with information instrument identifies patients’ satisfaction with information about the action and usage of medication as well as potential problems with it. The instrument was used to assess how well the needs of individual patients for medicine information were met at baseline and 2 years after the training. The 19 trained nurses in the intervention group worked with 137 patients, and a control group of 16 nurses, who gave normal care, worked with 51 patients. Results There was a difference between the intervention and control group in total score (P=0.028) 2 years after the intervention. Patients in the intervention group perceived higher satisfaction with the action and usage of their medication (P=0.001) and a lower degree of potential problems with their medication (P=0.001). Patients in the control group also perceived a lower degree of potential problems with their medication (P=0.028). Conclusion We suggest that consultation training for nurses with the aim of motivating patients to be more self-directed in their self-care improves satisfaction with information about medication.
{"title":"Effects on hypertensive patients’ satisfaction with information about their medication after nurses’ consultation training","authors":"E. Drevenhorn, A. Bengtson, P. Nyberg, K. Kjellgren","doi":"10.2147/POR.S58352","DOIUrl":"https://doi.org/10.2147/POR.S58352","url":null,"abstract":"Background There is a well-known problem in hypertension care with patients’ adherence to treatment. Patients who score high in answering the instrument Satisfaction with Information about Medicine Scale are reported to have greater adherence to their medication. Aim To explore how hypertensive patients’ satisfaction with information about their medicines was affected by nurses’ education in Motivational Interviewing. Material and methods The Stages of Change model and Motivational Interviewing was the theoretical base for consultation training for nurses. Nineteen nurses attended 3 days of video-recorded consultation training with simulated patients. They were updated in hypertensive medication and were trained in motivating patients to improve their self-management as well as adherence to lifestyle changes and medication. The satisfaction with information instrument identifies patients’ satisfaction with information about the action and usage of medication as well as potential problems with it. The instrument was used to assess how well the needs of individual patients for medicine information were met at baseline and 2 years after the training. The 19 trained nurses in the intervention group worked with 137 patients, and a control group of 16 nurses, who gave normal care, worked with 51 patients. Results There was a difference between the intervention and control group in total score (P=0.028) 2 years after the intervention. Patients in the intervention group perceived higher satisfaction with the action and usage of their medication (P=0.001) and a lower degree of potential problems with their medication (P=0.001). Patients in the control group also perceived a lower degree of potential problems with their medication (P=0.028). Conclusion We suggest that consultation training for nurses with the aim of motivating patients to be more self-directed in their self-care improves satisfaction with information about medication.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"5 1","pages":"35 - 41"},"PeriodicalIF":8.9,"publicationDate":"2014-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S58352","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68457318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose To quantitatively address the burden of attention-deficit/hyperactivity disorder (ADHD) in Europe (Germany, the UK, Sweden, Denmark, and the Netherlands), to describe adult experience leading to diagnosis and treatment of ADHD, and to compare those findings with results from the US. Survey respondents and methods Data were collected from an international web-based survey of adults from Europe and the US. Sociodemographics, comorbidities, work productivity/activity impairments, and health care utilization of adults reporting an ADHD diagnosis (n=431) and a similar number of adults without ADHD (n=449) were compared. Respondents’ experiences with the diagnosis and treatment of ADHD and the perceived effects of the condition on psychosocial functioning were assessed. In addition, multivariate regression analyses were performed to compare the burden of ADHD between the two regions. Results Adults with ADHD in both regions were generally less likely to be married, employed, or rate their health as good/very good/excellent and were more likely to smoke, have experienced alcoholism, have other mental health conditions, have work productivity/activity impairments, and use health care resources. Although the specialties of health care professionals consulted prior to diagnosis were similar between the two regions, there was a notable difference in the length of time it took to receive a first ADHD diagnosis. Only 55% of European respondents received a diagnosis within 6 months of their first physician consultation regarding their ADHD symptoms, compared to 90% in the US. The results of regression analyses confirmed a greater impact of ADHD on psychosocial functioning, work productivity impairments, and the total number of provider visits in Europe. Conclusion The results revealed a significant impact of ADHD on adults over a range of outcomes, including social, family, and work relationships, health-related work productivity impairment, and health care resource use, with a generally greater burden of illness among European study participants than those from the US.
{"title":"Diagnosis, treatment, and burden of illness among adults with attention-deficit/hyperactivity disorder in Europe","authors":"S. Able, V. Haynes, Jihyung Hong","doi":"10.2147/POR.S64348","DOIUrl":"https://doi.org/10.2147/POR.S64348","url":null,"abstract":"Purpose To quantitatively address the burden of attention-deficit/hyperactivity disorder (ADHD) in Europe (Germany, the UK, Sweden, Denmark, and the Netherlands), to describe adult experience leading to diagnosis and treatment of ADHD, and to compare those findings with results from the US. Survey respondents and methods Data were collected from an international web-based survey of adults from Europe and the US. Sociodemographics, comorbidities, work productivity/activity impairments, and health care utilization of adults reporting an ADHD diagnosis (n=431) and a similar number of adults without ADHD (n=449) were compared. Respondents’ experiences with the diagnosis and treatment of ADHD and the perceived effects of the condition on psychosocial functioning were assessed. In addition, multivariate regression analyses were performed to compare the burden of ADHD between the two regions. Results Adults with ADHD in both regions were generally less likely to be married, employed, or rate their health as good/very good/excellent and were more likely to smoke, have experienced alcoholism, have other mental health conditions, have work productivity/activity impairments, and use health care resources. Although the specialties of health care professionals consulted prior to diagnosis were similar between the two regions, there was a notable difference in the length of time it took to receive a first ADHD diagnosis. Only 55% of European respondents received a diagnosis within 6 months of their first physician consultation regarding their ADHD symptoms, compared to 90% in the US. The results of regression analyses confirmed a greater impact of ADHD on psychosocial functioning, work productivity impairments, and the total number of provider visits in Europe. Conclusion The results revealed a significant impact of ADHD on adults over a range of outcomes, including social, family, and work relationships, health-related work productivity impairment, and health care resource use, with a generally greater burden of illness among European study participants than those from the US.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"5 1","pages":"21 - 33"},"PeriodicalIF":8.9,"publicationDate":"2014-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S64348","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68457387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}