Randomized database studies: a combination of the strengths of observational studies and randomized clinical trials?

Before a drug is allowed into clinical practice, randomized clinical trial (RCT) have been conducted in order to demonstrate effi cacy and safety. The RCT method uses random treatment allocation to achieve comparable study groups and is further characterized by strict patient inclusion criteria, and strict follow-up schemes of the study groups.2,3 Once a drug enters the market, the drug is prescribed to a large number of heterogeneous patients who have concomitant diseases and drug use. As a result, unknown side effects may emerge (e.g., rare side effects, side effects due to interactions or comorbidity). In addition, the effectiveness of the drug in clinical practice is not the same as the effi cacy of the drug in clinical studies, mostly because usage patterns can be quite different. Postmarketing surveillance is the fi eld that studies the benefi cial and negative effects of drugs after they have been marketed. In post-marketing studies, both experimental and observational methods can be applied to study drug safety and effectiveness. Both methods have advantages and disadvantages. We will fi rst briefl y discuss these methods. Experimental MethodsPragmatic or naturalistic trials are suggested as a possible solution to the low generalisability of pre-marketing RCTs. In a pragmatic trial treatment is assigned randomly but patient inclusion is more liberal (less strict inclusion criteria) and the treatment modalities are not organized as strictly as in RCTs (corresponding with regular patient care).5 Therefore the results of pragmatic trials show effectiveness rather than effi cacy and better refl ect routine care practice. However, pragmatic trials often fail (or are not even considered as a possible alternative) because the implementation is time consuming and disrupts daily care processes or is ethically diffi cult.6,7Observational methodsObservational post-marketing studies typically are based on data that are collected for other purposes such as claims data or electronic medical records.The main objective of this thesis was to implement and test the randomized database study, which conceptually should bridge the gap between observational studies and randomzed clinical trials

Spironolactone and risk of upper gastrointestinal events: population based case-control study

OBJECTIVE: To confirm and quantify any association between spironolactone and upper gastrointestinal bleeding and ulcers. DESIGN: Population based case-control study. SETTING: A primary care information database in the Netherlands. PARTICIPANTS: All people on the database who were aged 18 or more between 1 January 1996 and 30 September 2003. Patients with a history of alcoholism or gastrointestinal cancer were excluded. Ten controls were matched to each case of gastroduodenal ulcer or upper gastrointestinal bleeding by age (year of birth), sex, and index date. MAIN OUTCOME MEASURES: The occurrence of an upper gastrointestinal event (bleeding or ulcers), adjusted for potential confounders with conditional logistic regression analysis. RESULTS: Within the source population of 306 645 patients, 523 cases of gastric or duodenal ulcer or upper gastrointestinal

Strategies for improving patient recruitment to focus groups in primary care: a case study reflective paper using an analytical framework

<p>Abstract</p> <p>Background</p> <p>Recruiting to primary care studies is complex. With the current drive to increase numbers of patients involved in primary care studies, we need to know more about successful recruitment approaches. There is limited evidence on recruitment to focus group studies, particularly when no natural grouping exists and where participants do not regularly meet. The aim of this paper is to reflect on recruitment to a focus group study comparing the methods used with existing evidence using a resource for research recruitment, PROSPeR (Planning Recruitment Options: Strategies for Primary Care).</p> <p>Methods</p> <p>The focus group formed part of modelling a complex intervention in primary care in the Resources for Effective Sleep Treatment (REST) study. Despite a considered approach at the design stage, there were a number of difficulties with recruitment. The recruitment strategy and subsequent revisions are detailed.</p> <p>Results</p> <p>The researchers' modifications to recruitment, justifications and evidence from the literature in support of them are presented. Contrary evidence is used to analyse why some aspects were unsuccessful and evidence is used to suggest improvements. Recruitment to focus group studies should be considered in two distinct phases; getting potential participants to contact the researcher, and converting those contacts into attendance. The difficulty of recruitment in primary care is underemphasised in the literature especially where people do not regularly come together, typified by this case study of patients with sleep problems.</p> <p>Conclusion</p> <p>We recommend training GPs and nurses to recruit patients during consultations. Multiple recruitment methods should be employed from the outset and the need to build topic related non-financial incentives into the group meeting should be considered. Recruitment should be monitored regularly with barriers addressed iteratively as a study progresses.</p

Perceived barriers and facilitators of structural reimbursement for remote patient monitoring, an exploratory qualitative study

Objective: Structural reimbursement can be an important factor for large-scale implementing and upscaling of remote patient monitoring (RPM). During the COVID-19 pandemic, the Dutch Healthcare Authority expanded regulations, creating novel opportunities to reimburse RPM. Despite these regulations, barriers to the reim-bursement of RPM remain. This study aimed to identify the barriers and facilitators of structural reimbursement of RPM in hospital care in the Netherlands and to propose actionable recommendations.Methods: This is an exploratory qualitative study with relevant stakeholders in the Dutch purchasing market: the Dutch Healthcare Authority, health insurers, and healthcare providers. Semi-structured interviews were held between October and December of 2020. All interviews were conducted using a digital medium, transcribed verbatim, and thematically analyzed.Results: Multiple perceived barriers were mentioned: wrong pocket problems (i.e. the entity that bears the costs of implementation does not receive the benefits), no uniform quality and outcome indicators, lack of willingness to redesign care pathways by providers, and difficulties implementing cross-sector models. Perceived facilitators included interdisciplinary cooperation and transparency, the use of alternative payment models, increase in the total number of patients per RPM project, and the optional reimbursement scheme. Conclusion: Our interviews found barriers and facilitators concerning structural reimbursement of RPM in hos-pital settings in the Netherlands. Our results emphasize that the successful integration of structural reimburse-ment requires: 1) understanding the improvement potential of RPM by creating business cases, 2) co-creation (redesigning care paths) from the outset of an RPM project, 3) and allocating financial risk by providers and insurers.Public Interest Summary: The COVID-19 pandemic has demonstrated the strong potential of consultation and monitoring patients at a distance. Remote patient monitoring -the use of information technologies for moni-toring patients at a distance -is seen as a potential solution to urgent challenges in the healthcare system. Nevertheless, embedding remote patient monitoring innovations into routine healthcare is often challenging, partly due to difficulties in reimbursing these initiatives. Barriers to reimbursing remote patient monitoring included organizational factors, no uniform quality and outcome indicators, and difficulties using different payment models. Perceived facilitators included an increase in the total number of patients per project, better interdisciplinary cooperation and transparency, and help from the Dutch Healthcare Authority. Introducing these insights into healthcare policy dialogues could support reimbursement of remote patient monitoring and stim-ulate the collaboration of healthcare stakeholders responsible for implementing and scaling up remote patient monitoring projects.Prevention, Population and Disease management (PrePoD)Public Health and primary car

Perceived barriers and facilitators of structural reimbursement for remote patient monitoring, an exploratory qualitative study

Objective: Structural reimbursement can be an important factor for large-scale implementing and upscaling of remote patient monitoring (RPM). During the COVID-19 pandemic, the Dutch Healthcare Authority expanded regulations, creating novel opportunities to reimburse RPM. Despite these regulations, barriers to the reim-bursement of RPM remain. This study aimed to identify the barriers and facilitators of structural reimbursement of RPM in hospital care in the Netherlands and to propose actionable recommendations.Methods: This is an exploratory qualitative study with relevant stakeholders in the Dutch purchasing market: the Dutch Healthcare Authority, health insurers, and healthcare providers. Semi-structured interviews were held between October and December of 2020. All interviews were conducted using a digital medium, transcribed verbatim, and thematically analyzed.Results: Multiple perceived barriers were mentioned: wrong pocket problems (i.e. the entity that bears the costs of implementation does not receive the benefits), no uniform quality and outcome indicators, lack of willingness to redesign care pathways by providers, and difficulties implementing cross-sector models. Perceived facilitators included interdisciplinary cooperation and transparency, the use of alternative payment models, increase in the total number of patients per RPM project, and the optional reimbursement scheme. Conclusion: Our interviews found barriers and facilitators concerning structural reimbursement of RPM in hos-pital settings in the Netherlands. Our results emphasize that the successful integration of structural reimburse-ment requires: 1) understanding the improvement potential of RPM by creating business cases, 2) co-creation (redesigning care paths) from the outset of an RPM project, 3) and allocating financial risk by providers and insurers.Public Interest Summary: The COVID-19 pandemic has demonstrated the strong potential of consultation and monitoring patients at a distance. Remote patient monitoring -the use of information technologies for moni-toring patients at a distance -is seen as a potential solution to urgent challenges in the healthcare system. Nevertheless, embedding remote patient monitoring innovations into routine healthcare is often challenging, partly due to difficulties in reimbursing these initiatives. Barriers to reimbursing remote patient monitoring included organizational factors, no uniform quality and outcome indicators, and difficulties using different payment models. Perceived facilitators included an increase in the total number of patients per project, better interdisciplinary cooperation and transparency, and help from the Dutch Healthcare Authority. Introducing these insights into healthcare policy dialogues could support reimbursement of remote patient monitoring and stim-ulate the collaboration of healthcare stakeholders responsible for implementing and scaling up remote patient monitoring projects