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Book ; Online: Lean for the Long Term

Baker, Jr. William H / Rolfes, Kenneth

Sustainment is a Myth, Transformation is Reality

2015

Abstract: ... in 2012. Maintaining a customer-focused Lean strategy and continuous improvement culture can become ... business management system for the company.Lean for the Long Term allows readers to benefit ... from the operating experience and research of the authors who have been deeply involved in leading Lean transformations ...

Abstract	The average tenure of a departing CEO has declined from approximately 10 years in 2000 to 8.1 years in 2012. Maintaining a customer-focused Lean strategy and continuous improvement culture can become a challenge when management changes often, unless it has become an institutionalized company-branded business management system for the company.Lean for the Long Term allows readers to benefit from the operating experience and research of the authors who have been deeply involved in leading Lean transformations that last in today's ever-changing business landscape. It presents a Lean management sy
Language	English
Size	Online-Ressource (222 p)
Publisher	CRC Press
Publishing place	Hoboken
Document type	Book ; Online
Note	Description based upon print version of record
ISBN	9781482257168 ; 1482257165
Database	Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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Book: Lean for the long term

Baker, William H / Rolfes, Kenneth D

sustainment is a myth, transformation is reality

(A Productivity Press book)

2015

Abstract: ... in leading Lean Transformations and sustaining the gains in an ever-changing world. It explores the effects ... of cultural and business shifts on the fragile nature of a Lean culture. Using clear, simple language ... for a new leader, and Lean practitioners experiencing shifts beyond their control"-- ...

Author's details	William H. Baker, Jr.; Kenneth D. Rolfes
Series title	A Productivity Press book
Abstract	"This book uses the operating experience and research of the authors who have been deeply involved in leading Lean Transformations and sustaining the gains in an ever-changing world. It explores the effects of cultural and business shifts on the fragile nature of a Lean culture. Using clear, simple language, it offers guidance and advice to senior executives coming into a new job, board members when searching for a new leader, and Lean practitioners experiencing shifts beyond their control"--
Keywords	Cost control ; Industrial management ; Organizational change ; Organizational effectiveness ; Total quality management ; Lean Management ; Organisatorischer Wandel
Language	English
Size	XIV, 212 S., Ill., graph. Darst.
Publisher	CRC Press
Publishing place	Boca Raton, Fla. u.a.
Document type	Book
Note	Includes bibliographical references and index
ISBN	9781482257168 ; 1482257165
Database	ECONomics Information System

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Article: COVID-19 vaccine reactogenicity – A cohort event monitoring study in the Netherlands using patient reported outcomes

Rolfes, Leàn / Härmark, Linda / Kant, Agnes / van Balveren, Leontine / Hilgersom, Wil / van Hunsel, Florence

Vaccine. 2022 Feb. 11, v. 40, no. 7

2022

Abstract: To explore factors that are associated with reactogenicity in general and systemic after the first dose of COVID-19 vaccine in the Netherlands. A web-based prospective cohort design using patient reported outcomes (PROs). Any person who has been ... ...

Abstract	To explore factors that are associated with reactogenicity in general and systemic after the first dose of COVID-19 vaccine in the Netherlands. A web-based prospective cohort design using patient reported outcomes (PROs). Any person who has been vaccinated with any brand of COVID-19 vaccine in the Dutch COVID immunization programme. 22,184 participants. Of these, 13,959 (62.9%) experienced reactogenicity in general and 11,979 (54.0%) systemic reactogenicity within 7 days after vaccination. Factors that are associated with the occurrence of reactogenicity after COVID-19 vaccination. Compared to the Comirnaty® vaccine, the highest odds ratio (OR) for developing reactogenicity was for the Vaxzevria® vaccine (OR 5.18) followed by Spikevax® (OR 2.16), and Janssen (OR 1.65). Participants with a history of COVID-19 disease had a 3.10 increased odds for reactogenicity. Women had a 2.08 increased odds compared to men. Older participants experienced less reactogenicity. Compared to the age group < 50, the ORs for the age groups 50–60, 61–79, and ≥80 were 0.36, 0.15, and 0.10 respectively. The use of an antipyretic drug, or a drug for nervous system disorders gave an increased odds of 1.34 and 1.16 respectively. A body mass index of 25.0–29.9 and over 30 was negatively associated with reactogenicity (OR 0.87 and OR 0.72 respectively). Comorbidities that were associated with reactogenicity were cardiac disorders (OR 1.26), respiratory disorders (OR 1.31), psychiatric disorders (1.37), reproductive disorders (OR 1.54), and eye disorders (OR 1.55). The factors associated with systemic reactogenicity were mostly comparable, but there were differences for comorbidities, drug use, and the strength of the regression coefficient. This extensive study with over 22,000 vaccine recipients in the Netherlands demonstrated that, taken into account all factors in the model, the Comirnaty® vaccine gave the least and the Vaxzevria® vaccine the most reactogenicity in general and systemic after the first dose. Also a person with a history of COVID-19 disease, female sex and younger age had an increased odds for experiencing reactogenicity after vaccination.
Keywords	COVID-19 infection ; Internet ; body mass index ; comorbidity ; eyes ; females ; models ; odds ratio ; patients ; regression analysis ; vaccination ; vaccines ; Netherlands
Language	English
Dates of publication	2022-0211
Size	p. 970-976.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.01.013
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: An evaluation of postmarketing reports of hyperglycaemia associated with dolutegravir for treatment of HIV in Eswatini.

Duga, Alemayehu L / Magongo, Sibongile / Nhlabatsi, Siphesihle / Ladwar, Denis O / Härmark, Linda / Rolfes, Leàn

AIDS research and therapy

2022 Volume 19, Issue 1, Page(s) 54

Abstract: Background: Dolutegravir (DTG) is an Integrase Strand Transfer Inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV infection. It is available in a number of pharmaceutical preparations including the fixed- ...

Abstract	Background: Dolutegravir (DTG) is an Integrase Strand Transfer Inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV infection. It is available in a number of pharmaceutical preparations including the fixed-dose combination (TLD) containing tenofovir (300 mg) + lamivudine (300 mg) + dolutegravir (50 mg). In 2018, Eswatini adopted TLD as the preferred first-line HIV treatment regimen for adults and adolescents as per WHO recommendations. From March 2019 to March 2020, the National Pharmacovigilance Center (NPC) in Eswatini received 8 reports of hyperglycaemia associated with the use of DTG. This study was conducted to investigate if Eswatini NPC database included cases suggestive of causality between dolutegravir and hyperglycaemia. Method: A qualitative synthesis of information from the Eswatini national pharmacovigilance database from March 2019 to March 2020 was conducted to investigate a casual association between hyperglycaemia and dolutegravir. Results: All reports with dolutegravir containing regimen and suspected Adverse Event of hyperglycaemia in the period of March 2019 to March 2020 were included in the study. Seven of the reports were serious (resulted in hospitalization and one case concerned optic neuritis, leading to blindness). Two patients had a medical history of diabetes while the rest of the patients had never experienced hyperglycaemia before starting dolutegravir. For all the reports, the time to onset of hyperglycaemia ranges from 2-5 months after the initiation of DTG. None of the patients discontinued the use of DTG. All the patients were treated with oral hypoglycaemic medication. In severe cases, patients were treated with intravenous normal saline and ringer lactate as well as rapid-acting insulins. All patients are currently stable on oral hypoglycaemic drugs. Conclusion: Cases that support causality between dolutegravir containing regimen and hyperglycaemia were found. These cases were mainly serious. Based on these findings it is recommended that healthcare professionals (HCPs) actively screen all patients for risk factors of hyperglycaemia before DTG initiation. In addition, it is important that HCPs are aware of the possible association between DTG and hyperglycaemia.
MeSH term(s)	Adult ; Adolescent ; Humans ; HIV Infections/drug therapy ; Hyperglycemia/chemically induced ; Hyperglycemia/drug therapy ; Eswatini ; Heterocyclic Compounds, 3-Ring/adverse effects
Chemical Substances	dolutegravir (DKO1W9H7M1) ; Heterocyclic Compounds, 3-Ring
Language	English
Publishing date	2022-11-24
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2173450-1
ISSN	1742-6405 ; 1742-6405
ISSN (online)	1742-6405
ISSN	1742-6405
DOI	10.1186/s12981-022-00481-0
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Article ; Online: COVID-19 vaccine reactogenicity - A cohort event monitoring study in the Netherlands using patient reported outcomes.

Rolfes, Leàn / Härmark, Linda / Kant, Agnes / van Balveren, Leontine / Hilgersom, Wil / van Hunsel, Florence

Vaccine

2022 Volume 40, Issue 7, Page(s) 970–976

Abstract: Objectives: To explore factors that are associated with reactogenicity in general and systemic after the first dose of COVID-19 vaccine in the Netherlands.: Design: A web-based prospective cohort design using patient reported outcomes (PROs).: ... ...

Abstract	Objectives: To explore factors that are associated with reactogenicity in general and systemic after the first dose of COVID-19 vaccine in the Netherlands. Design: A web-based prospective cohort design using patient reported outcomes (PROs). Setting: Any person who has been vaccinated with any brand of COVID-19 vaccine in the Dutch COVID immunization programme. Participants: 22,184 participants. Of these, 13,959 (62.9%) experienced reactogenicity in general and 11,979 (54.0%) systemic reactogenicity within 7 days after vaccination. Main outcome measures: Factors that are associated with the occurrence of reactogenicity after COVID-19 vaccination. Results: Compared to the Comirnaty® vaccine, the highest odds ratio (OR) for developing reactogenicity was for the Vaxzevria® vaccine (OR 5.18) followed by Spikevax® (OR 2.16), and Janssen (OR 1.65). Participants with a history of COVID-19 disease had a 3.10 increased odds for reactogenicity. Women had a 2.08 increased odds compared to men. Older participants experienced less reactogenicity. Compared to the age group < 50, the ORs for the age groups 50-60, 61-79, and ≥80 were 0.36, 0.15, and 0.10 respectively. The use of an antipyretic drug, or a drug for nervous system disorders gave an increased odds of 1.34 and 1.16 respectively. A body mass index of 25.0-29.9 and over 30 was negatively associated with reactogenicity (OR 0.87 and OR 0.72 respectively). Comorbidities that were associated with reactogenicity were cardiac disorders (OR 1.26), respiratory disorders (OR 1.31), psychiatric disorders (1.37), reproductive disorders (OR 1.54), and eye disorders (OR 1.55). The factors associated with systemic reactogenicity were mostly comparable, but there were differences for comorbidities, drug use, and the strength of the regression coefficient. Conclusions: This extensive study with over 22,000 vaccine recipients in the Netherlands demonstrated that, taken into account all factors in the model, the Comirnaty® vaccine gave the least and the Vaxzevria® vaccine the most reactogenicity in general and systemic after the first dose. Also a person with a history of COVID-19 disease, female sex and younger age had an increased odds for experiencing reactogenicity after vaccination.
MeSH term(s)	COVID-19 ; COVID-19 Vaccines ; Female ; Humans ; Male ; Netherlands ; Patient Reported Outcome Measures ; Prospective Studies ; SARS-CoV-2
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2022-01-17
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.01.013
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Article ; Online: Spontaneously reported adverse events following COVID-19 basic and booster immunizations in the Netherlands.

van der Boor, Saskia C / Schmitz-de Vries, Else T J / Smits, Dennis / Scholl, Joep H G / Rolfes, Leàn / van Hunsel, Florence

Vaccine

2023 Volume 41, Issue 29, Page(s) 4319–4326

Abstract: Introduction: The rapid roll-out of novel COVID-19 vaccines made near real-time post-marketing safety surveillance essential to identify rare and long-term adverse events following immunization (AEFIs). In light of the ongoing booster vaccination ... ...

Abstract	Introduction: The rapid roll-out of novel COVID-19 vaccines made near real-time post-marketing safety surveillance essential to identify rare and long-term adverse events following immunization (AEFIs). In light of the ongoing booster vaccination campaigns, it is key to monitor changes in observed safety patterns post-vaccination. The effect of sequential COVID-19 vaccinations, as well as heterologous vaccination sequences, on the observed post-vaccination safety pattern, remains largely unknown. Methods: The primary objective of this study was to describe the profile of spontaneously reported AEFIs following COVID-19 vaccination in the Netherlands, including the primary and booster series. Reports from consumers and healthcare professionals were collected via a COVID-19 vaccine-tailored online reporting form by the National Pharmacovigilance Centre Lareb (Lareb) between 6 January 2021 and 31 August 2022. The data were used to describe the most frequently reported AEFIs per vaccination moment, the consumer experienced burden per AEFI, and differences in AEFIs reported for homologous and heterologous vaccination sequences. Results: Lareb received 227,884 spontaneous reports over a period of twenty months. Overall, a high degree of similarity in local and systemic AEFIs per vaccination moment was observed, with no apparent change in the number of reports of serious adverse events after multiple COVID-19 vaccinations. No differences in the pattern of reported AEFIs per vaccination sequence was observed. Conclusion: Spontaneous reported AEFIs demonstrated a similar reporting pattern for homologous and heterologous primary and booster series of COVID-19 vaccination in the Netherlands.
MeSH term(s)	Humans ; COVID-19 Vaccines/adverse effects ; Adverse Drug Reaction Reporting Systems ; Netherlands/epidemiology ; Immunization, Secondary/adverse effects ; COVID-19/prevention & control ; Vaccination/adverse effects
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2023-05-24
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.05.053
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Article ; Online: Interaction of OTC drug noscapine and acenocoumarol and phenprocoumon.

Lokhorst, Bianca / Rolfes, Leàn / Jessurun, Naomi T

British journal of clinical pharmacology

2019 Volume 85, Issue 5, Page(s) 1041–1043

MeSH term(s)	Acenocoumarol/pharmacology ; Acenocoumarol/therapeutic use ; Adult ; Aged ; Aged, 80 and over ; Anticoagulants/pharmacology ; Anticoagulants/therapeutic use ; Antitussive Agents/pharmacology ; Antitussive Agents/therapeutic use ; Cough/drug therapy ; Drug Interactions ; Female ; Hemorrhage/blood ; Hemorrhage/chemically induced ; Humans ; International Normalized Ratio ; Male ; Middle Aged ; Netherlands ; Nonprescription Drugs/pharmacology ; Nonprescription Drugs/therapeutic use ; Noscapine/pharmacology ; Noscapine/therapeutic use ; Phenprocoumon/pharmacology ; Phenprocoumon/therapeutic use ; Thromboembolism/prevention & control
Chemical Substances	Anticoagulants ; Antitussive Agents ; Nonprescription Drugs ; Noscapine (8V32U4AOQU) ; Acenocoumarol (I6WP63U32H) ; Phenprocoumon (Q08SIO485D)
Language	English
Publishing date	2019-02-26
Publishing country	England
Document type	Letter
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.13887
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Article ; Online: Fifteen years of patient reporting -what have we learned and where are we heading to?

van Hunsel, Florence / Härmark, Linda / Rolfes, Leàn

Expert opinion on drug safety

2019 Volume 18, Issue 6, Page(s) 477–484

Abstract: Introduction: In April 2003, the Netherlands Pharmacovigilance Centre Lareb successfully implemented patient reporting to their spontaneous reporting system. The number of reports by patients rapidly grew, prompting the need to evaluate the value of the ...

Abstract	Introduction: In April 2003, the Netherlands Pharmacovigilance Centre Lareb successfully implemented patient reporting to their spontaneous reporting system. The number of reports by patients rapidly grew, prompting the need to evaluate the value of the patient reporting scheme and to compare experiences with other countries. The aim of this article is to summarize our 15-year experience of working with direct patient reporting in pharmacovigilance and to discuss necessary steps in order to optimize the use of patient reports in the future. Areas covered: This article is based on Lareb studies on patient reporting from 2004 onwards and covers the evolution of the Dutch patient reporting system, the value of patient participation in pharmacovigilance, the impact of patient reporting on the spontaneous reporting system and future steps to strengthen patient reporting. Expert opinion: After 15 years of experience with patient reporting we conclude that patients can add value to pharmacovigilance. We recognize that there is a big leap between allowing patients to report and actual patient involvement in pharmacovigilance. It is our belief that increased patient involvement in pharmacovigilance is a way to improve pharmacovigilance, enhancing the general public's trust in medicines.
MeSH term(s)	Adverse Drug Reaction Reporting Systems/trends ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Humans ; Netherlands ; Pharmacovigilance ; Self Report
Language	English
Publishing date	2019-05-16
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2088728-0
ISSN	1744-764X ; 1474-0338
ISSN (online)	1744-764X
ISSN	1474-0338
DOI	10.1080/14740338.2019.1613373
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Article ; Online: Surveillance of Drug Safety During Pregnancy: Insight in Current International Activities, Future Intentions and Need for Support of National Pharmacovigilance Centres.

Kant, Agnes / de Vries, Loes / Rolfes, Leàn

Drug safety

2018 Volume 42, Issue 1, Page(s) 35–43

Abstract: Introduction: Surveillance of drug safety during pregnancy is a special interest of pharmacovigilance (PV). The role that national PV centres take in this field is, however, unclear.: Aim: The aim of this study was to provide insight into current ... ...

Abstract	Introduction: Surveillance of drug safety during pregnancy is a special interest of pharmacovigilance (PV). The role that national PV centres take in this field is, however, unclear. Aim: The aim of this study was to provide insight into current activities, future intentions and need for support of national PV centres in the field of drug safety during pregnancy. Method: A web-based questionnaire was used to ask PV centres about their current activities concerning the surveillance of drug safety during pregnancy, their intentions to implement or improve activities and need for support. For these three main topics, questions were posed about spontaneous adverse drug reaction (ADR) reporting, additional activities to obtain information, signal detection and informing healthcare professionals and the public. Results: The questionnaire was sent to PV centres of 172 countries. Response was 40%. In general, the PV centres received limited numbers of reports of ADRs in the (unborn) child, related to drug exposure during pregnancy. Signal detection in pregnancy cases is carried out by 8 out of 58 PV centres (13.5%). Most PV centres mention they have intentions to implement or improve activities, mainly for spontaneous reporting (69.4%) and methods for signal detection (67.2%). Support was needed for all topics of the questionnaire. Conclusion: Current activities of national PV centres concerning drug safety during pregnancy are limited. The majority of PV centres are, however, willing to improve or implement activities. Programmes should be set up in order to support and stimulate PV centres with these activities. The aim of all these activities is to increase knowledge about the safety of drugs during pregnancy.
MeSH term(s)	Adverse Drug Reaction Reporting Systems/standards ; Adverse Drug Reaction Reporting Systems/trends ; Drug-Related Side Effects and Adverse Reactions/diagnosis ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Female ; Forecasting ; Humans ; Internationality ; Pharmacovigilance ; Pregnancy ; Pregnancy Complications/chemically induced ; Pregnancy Complications/epidemiology ; Pregnancy Complications/prevention & control ; Retrospective Studies ; Surveys and Questionnaires/standards
Language	English
Publishing date	2018-10-03
Publishing country	New Zealand
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	1018059-x
ISSN	1179-1942 ; 0114-5916
ISSN (online)	1179-1942
ISSN	0114-5916
DOI	10.1007/s40264-018-0729-0
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Article: Electronic Health Record-Triggered Research Infrastructure Combining Real-world Electronic Health Record Data and Patient-Reported Outcomes to Detect Benefits, Risks, and Impact of Medication: Development Study.

Hek, Karin / Rolfes, Leàn / van Puijenbroek, Eugène P / Flinterman, Linda E / Vorstenbosch, Saskia / van Dijk, Liset / Verheij, Robert A

JMIR medical informatics

2022 Volume 10, Issue 3, Page(s) e33250

Abstract: Background: Real-world data from electronic health records (EHRs) represent a wealth of information for studying the benefits and risks of medical treatment. However, they are limited in scope and should be complemented by information from the patient ... ...

Abstract	Background: Real-world data from electronic health records (EHRs) represent a wealth of information for studying the benefits and risks of medical treatment. However, they are limited in scope and should be complemented by information from the patient perspective. Objective: The aim of this study is to develop an innovative research infrastructure that combines information from EHRs with patient experiences reported in questionnaires to monitor the risks and benefits of medical treatment. Methods: We focused on the treatment of overactive bladder (OAB) in general practice as a use case. To develop the Benefit, Risk, and Impact of Medication Monitor (BRIMM) infrastructure, we first performed a requirement analysis. BRIMM's starting point is routinely recorded general practice EHR data that are sent to the Dutch Nivel Primary Care Database weekly. Patients with OAB were flagged weekly on the basis of diagnoses and prescriptions. They were invited subsequently for participation by their general practitioner (GP), via a trusted third party. Patients received a series of questionnaires on disease status, pharmacological and nonpharmacological treatments, adverse drug reactions, drug adherence, and quality of life. The questionnaires and a dedicated feedback portal were developed in collaboration with a patient association for pelvic-related diseases, Bekkenbodem4All. Participating patients and GPs received feedback. An expert meeting was organized to assess the strengths, weaknesses, opportunities, and threats of the new research infrastructure. Results: The BRIMM infrastructure was developed and implemented. In the Nivel Primary Care Database, 2933 patients with OAB from 27 general practices were flagged. GPs selected 1636 (55.78%) patients who were eligible for the study, of whom 295 (18.0% of eligible patients) completed the first questionnaire. A total of 288 (97.6%) patients consented to the linkage of their questionnaire data with their EHR data. According to experts, the strengths of the infrastructure were the linkage of patient-reported outcomes with EHR data, comparison of pharmacological and nonpharmacological treatments, flexibility of the infrastructure, and low registration burden for GPs. Methodological weaknesses, such as susceptibility to bias, patient selection, and low participation rates among GPs and patients, were seen as weaknesses and threats. Opportunities represent usefulness for policy makers and health professionals, conditional approval of medication, data linkage to other data sources, and feedback to patients. Conclusions: The BRIMM research infrastructure has the potential to assess the benefits and safety of (medical) treatment in real-life situations using a unique combination of EHRs and patient-reported outcomes. As patient involvement is an important aspect of the treatment process, generating knowledge from clinical and patient perspectives is valuable for health care providers, patients, and policy makers. The developed methodology can easily be applied to other treatments and health problems.
Language	English
Publishing date	2022-03-16
Publishing country	Canada
Document type	Journal Article
ZDB-ID	2798261-0
ISSN	2291-9694
ISSN	2291-9694
DOI	10.2196/33250
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