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Trials Nov 2012In Germany, clinical trials and comparative effectiveness studies in primary care are still very rare, while their usefulness has been recognised in many other... (Review)
Review
BACKGROUND
In Germany, clinical trials and comparative effectiveness studies in primary care are still very rare, while their usefulness has been recognised in many other countries. A network of researchers from German academic general practice has explored the reasons for this discrepancy.
METHODS
Based on a comprehensive literature review and expert group discussions, problem analyses as well as structural and procedural prerequisites for a better implementation of clinical trials in German primary care are presented.
RESULTS
In Germany, basic biomedical science and technology is more reputed than clinical or health services research. Clinical trials are funded by industry or a single national programme, which is highly competitive, specialist-dominated, exclusive of pilot studies, and usually favours innovation rather than comparative effectiveness studies. Academic general practice is still not fully implemented, and existing departments are small. Most general practitioners (GPs) work in a market-based, competitive setting of small private practices, with a high case load. They have no protected time or funding for research, and mostly no research training or experience. Good Clinical Practice (GCP) training is compulsory for participation in clinical trials. The group defined three work packages to be addressed regarding clinical trials in German general practice: (1) problem analysis, and definition of (2) structural prerequisites and (3) procedural prerequisites. Structural prerequisites comprise specific support facilities for general practice-based research networks that could provide practices with a point of contact. Procedural prerequisites consist, for example, of a summary of specific relevant key measures, for example on a web platform. The platform should contain standard operating procedures (SOPs), templates, checklists and other supporting materials for researchers.
CONCLUSION
All in all, our problem analyses revealed that a substantial number of barriers contribute to the low implementation of clinical research in German general practice. Some issues are deeply rooted in Germany's market-based healthcare and academic systems and traditions. However, new developments may facilitate change: recent developments in the German research landscape are encouraging.
Topics: Clinical Trials as Topic; Comparative Effectiveness Research; General Practice; Germany; Health Care Costs; Humans; Models, Organizational; Primary Health Care; Research Design; Research Support as Topic; Time Factors; Workload
PubMed: 23136890
DOI: 10.1186/1745-6215-13-205 -
Achieving palliative care research efficiency through defining and benchmarking performance metrics.Current Opinion in Supportive and... Dec 2012Research efficiency is gaining increasing attention in the research enterprise, including palliative care research. The importance of generating meaningful findings and... (Review)
Review
PURPOSE OF REVIEW
Research efficiency is gaining increasing attention in the research enterprise, including palliative care research. The importance of generating meaningful findings and translating these scientific advances to improved patient care creates urgency in the field to address well documented system inefficiencies. The Palliative Care Research Cooperative Group (PCRC) provides useful examples for ensuring research efficiency in palliative care.
RECENT FINDINGS
Literature on maximizing research efficiency focuses on the importance of clearly delineated process maps, working instructions, and standard operating procedures in creating synchronicity in expectations across research sites. Examples from the PCRC support these objectives and suggest that early creation and employment of performance metrics aligned with these processes are essential to generate clear expectations and identify benchmarks. These benchmarks are critical in effective monitoring and ultimately the generation of high-quality findings that are translatable to clinical populations. Prioritization of measurable goals and tasks to ensure that activities align with programmatic aims is critical.
SUMMARY
Examples from the PCRC affirm and expand the existing literature on research efficiency, providing a palliative care focus. Operating procedures, performance metrics, prioritization, and monitoring for success should all be informed by and inform the process map to achieve maximum research efficiency.
Topics: Benchmarking; Efficiency, Organizational; Humans; Multicenter Studies as Topic; Organizational Objectives; Palliative Care; Planning Techniques; Process Assessment, Health Care; Research; Research Design; Translational Research, Biomedical
PubMed: 23080309
DOI: 10.1097/SPC.0b013e32835a7cb4 -
GMS Journal For Medical Education 2019
Topics: Education, Medical, Undergraduate; Evidence-Based Practice; Humans; Patient Selection; Schools, Medical; Waiting Lists
PubMed: 30828610
DOI: 10.3205/zma001218 -
BMJ Open May 2024Waste in medical research is a relatively well-known issue. However, only a few initiatives exist to address this issue. Lean Management methods (Lean) were developed in... (Review)
Review
INTRODUCTION
Waste in medical research is a relatively well-known issue. However, only a few initiatives exist to address this issue. Lean Management methods (Lean) were developed in industrial manufacturing and later applied within healthcare improvement. Overall, the results from studies of the application of Lean to healthcare appear to be positive in terms of greater efficiency regarding treatment outcomes and patient care. Nevertheless, the application of Lean to improve research processes is not well studied and, given that research alongside clinical practice and experiential knowledge provides the foundation for the treatment and care of patients, it is paramount to identify approaches and review the degree to which they increase efficiency within research procedures. Therefore, this review will scope the landscape of studies that investigated Lean and how to implement Lean in research processes, particularly regarding healthcare research.
METHODS AND ANALYSIS
Our approach follows the methodological framework of Arksey and O'Malley for conducting scoping reviews (PRISMA-ScR). The search strategy for this scoping review was developed using the PCC model. We will identify the relevant literature by searching four search databases: Scopus, Web of Science, Academic Search Premier and Business Source Complete. Next, we will use citation pearl growing to identify all relevant published literature. The data charting process will follow the PRISMA-ScR checklist and will be organised using NVivo. We will generate qualitative and quantitative assessments of the extracted data by using NVivo, RStudio and Excel. We will follow the PRISMA-ScR guideline when reporting the results.
ETHICS AND DISSEMINATION
The review will comprise existing published studies and no primary data will be collected. Our findings will be shared through open access peer-reviewed journals, national and international conferences and emails to all relevant collaborative relationships. We plan to disseminate our findings via academic social media platforms, newspaper articles and blogposts.
Topics: Humans; Research Design; Total Quality Management; Health Services Research; Quality Improvement; Efficiency, Organizational
PubMed: 38749681
DOI: 10.1136/bmjopen-2023-074207 -
Health Services Research Jun 2009To review and characterize existing health care efficiency measures in order to facilitate a common understanding about the adequacy of these methods. (Review)
Review
OBJECTIVE
To review and characterize existing health care efficiency measures in order to facilitate a common understanding about the adequacy of these methods.
DATA SOURCES
Review of the MedLine and EconLit databases for articles published from 1990 to 2008, as well as search of the "gray" literature for additional measures developed by private organizations.
STUDY DESIGN
We performed a systematic review for existing efficiency measures. We classified the efficiency measures by perspective, outputs, inputs, methods used, and reporting of scientific soundness.
PRINCIPAL FINDINGS
We identified 265 measures in the peer-reviewed literature and eight measures in the gray literature, with little overlap between the two sets of measures. Almost all of the measures did not explicitly consider the quality of care. Thus, if quality varies substantially across groups, which is likely in some cases, the measures reflect only the costs of care, not efficiency. Evidence on the measures' scientific soundness was mostly lacking: evidence on reliability or validity was reported for six measures (2.3 percent) and sensitivity analyses were reported for 67 measures (25.3 percent).
CONCLUSIONS
Efficiency measures have been subjected to few rigorous evaluations of reliability and validity, and methods of accounting for quality of care in efficiency measurement are not well developed at this time. Use of these measures without greater understanding of these issues is likely to engender resistance from providers and could lead to unintended consequences.
Topics: Community Health Planning; Cost-Benefit Analysis; Data Collection; Data Interpretation, Statistical; Efficiency, Organizational; Episode of Care; Health Services Research; Humans; Length of Stay; Models, Statistical; Outcome and Process Assessment, Health Care; Patient Discharge; Quality Indicators, Health Care; Quality of Health Care; Relative Value Scales; Reproducibility of Results; Research Design; Risk Adjustment; United States
PubMed: 19187184
DOI: 10.1111/j.1475-6773.2008.00942.x -
Archivio Italiano Di Urologia,... Oct 2017To evaluate the feasibility of performing laparoscopic radical prostatectomy (LRP) as a day case procedure while maintaining patient satisfaction and safety. Herein we...
BACKGROUND
To evaluate the feasibility of performing laparoscopic radical prostatectomy (LRP) as a day case procedure while maintaining patient satisfaction and safety. Herein we report our experience, selection criteria, and discharge criteria for day case LRP.
METHODS
We performed a prospective study with 32 patients undergoing extraperitoneal LRP. These patients were counselled before the procedure that they would go home the same evening of the procedure. Pain scores and quality of life data were recorded day 1 postoperatively via a telephone consultation. The patients underwent routine blood tests on day 2 and an outpatient review on day 7 and regularly thereafter via an assigned key worker. Socio-demographic data, comorbidities, and outcomes were collected for analysis.
RESULTS
All patients were successfully discharged the same day of surgery. Mean patient age was 62 years with a mean body mass index of 25. Mean operative time was 147 minutes, and estimated blood loss was 101 ml. Three patients were treated for post operative urinary tract infections; two patients developed infected lymphoceles which required percutaneous drainage and one patient required re-catheterisation due to a burst catheter balloon. Of these six complications four patients required re-admission. Post-operative pain, nausea and vomiting were low whilst patient satisfaction scores were unanimously high in all patients surveyed.
CONCLUSIONS
The early experience with extraperitoneal LRP as a same day surgery is promising although patients who are at high risk of lymphocele should be excluded. Preoperative patient counselling and selection is paramount. Patient satisfaction is not adversely affected by the shortened stay. Surgeon experience, a well-motivated patient, meticulous attention to detail through an integrated pathway, a multidisciplinary team and adequate postoperative assessment are essential.
Topics: Ambulatory Surgical Procedures; Blood Loss, Surgical; Humans; Laparoscopy; Male; Middle Aged; Operative Time; Pain, Postoperative; Patient Care Team; Patient Readmission; Patient Satisfaction; Patient Selection; Postoperative Complications; Prospective Studies; Prostatectomy; Prostatic Neoplasms; Quality of Life
PubMed: 28969402
DOI: 10.4081/aiua.2017.3.182 -
Implementation Science : IS Jul 2020Cross-system interventions can help integrate services across different service delivery systems but require organizations to establish strong collaborative...
BACKGROUND
Cross-system interventions can help integrate services across different service delivery systems but require organizations to establish strong collaborative relationships for implementation. Contingency theory suggests that the effectiveness of different collaborative strategies (i.e. specific ways organizations align operations and services) varies by context. This paper describes a study of different strategies for fostering collaboration between child welfare and substance abuse treatment agencies and the conditions under which they are effective for implementation. We also describe the development and piloting of the Collaborating Across Systems for Program Implementation (CASPI) tool-a decision-making guide intended to help researchers and organizational leaders identify and use appropriate collaborative strategies for their context.
METHODS/DESIGN
This multisite longitudinal, mixed methods study, leverages a naturally occurring implementation initiative -- in up to 17 Ohio counties -- to implement Ohio START (Sobriety Treatment and Reducing Trauma). START is a child welfare model that requires strong collaboration with local substance use treatment organizations to promote integrated services. During the first two years, we will identify collaborative strategies associated with improved START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features. We will conduct a convergent mixed methods study drawing on worker surveys, agency documents, administrative data, formal partner agreements, and group interviews. Data will be integrated and analyzed using Qualitative Comparative Analysis (QCA). To develop the CASPI, an expert panel comprised of implementation experts, and community stakeholders will convene to synthesize our findings and develop contents (including a decision tree). During the final year of the study, we will assess the acceptability, appropriateness, and feasibility of the CASPI in a randomized vignette experiment, and a pilot-test with 3 child welfare agencies that have not yet implemented START.
DISCUSSION
Our results will lay the groundwork for a larger controlled trial that will test the CASPI's effectiveness for supporting effective and efficient implementation of cross-system interventions like START. The CASPI is expected to help leaders and researchers select and use collaboration strategies tailored to their context and be applicable in a wide range of settings including rural communities. Our work also advances system-level implementation strategies.
TRIAL REGISTRATION
NCT03931005 , Registered April 29, 2019.
Topics: Child Protective Services; Cooperative Behavior; Humans; Implementation Science; Interinstitutional Relations; Ohio; Research Design; Substance Abuse Treatment Centers
PubMed: 32677987
DOI: 10.1186/s13012-020-01016-9 -
PLoS Computational Biology Oct 2019
Topics: Humans; Organization and Administration; Research; Research Design
PubMed: 31622329
DOI: 10.1371/journal.pcbi.1007395 -
Implementation Science : IS Mar 2012The introduction of evidence-based programs and practices into healthcare settings has been the subject of an increasing amount of research in recent years. While a... (Review)
Review
BACKGROUND
The introduction of evidence-based programs and practices into healthcare settings has been the subject of an increasing amount of research in recent years. While a number of studies have examined initial implementation efforts, less research has been conducted to determine what happens beyond that point. There is increasing recognition that the extent to which new programs are sustained is influenced by many different factors and that more needs to be known about just what these factors are and how they interact. To understand the current state of the research literature on sustainability, our team took stock of what is currently known in this area and identified areas in which further research would be particularly helpful. This paper reviews the methods that have been used, the types of outcomes that have been measured and reported, findings from studies that reported long-term implementation outcomes, and factors that have been identified as potential influences on the sustained use of new practices, programs, or interventions. We conclude with recommendations and considerations for future research.
METHODS
Two coders identified 125 studies on sustainability that met eligibility criteria. An initial coding scheme was developed based on constructs identified in previous literature on implementation. Additional codes were generated deductively. Related constructs among factors were identified by consensus and collapsed under the general categories. Studies that described the extent to which programs or innovations were sustained were also categorized and summarized.
RESULTS
Although "sustainability" was the term most commonly used in the literature to refer to what happened after initial implementation, not all the studies that were reviewed actually presented working definitions of the term. Most study designs were retrospective and naturalistic. Approximately half of the studies relied on self-reports to assess sustainability or elements that influence sustainability. Approximately half employed quantitative methodologies, and the remainder employed qualitative or mixed methodologies. Few studies that investigated sustainability outcomes employed rigorous methods of evaluation (e.g., objective evaluation, judgement of implementation quality or fidelity). Among those that did, a small number reported full sustainment or high fidelity. Very little research has examined the extent, nature, or impact of adaptations to the interventions or programs once implemented. Influences on sustainability included organizational context, capacity, processes, and factors related to the new program or practice themselves.
CONCLUSIONS
Clearer definitions and research that is guided by the conceptual literature on sustainability are critical to the development of the research in the area. Further efforts to characterize the phenomenon and the factors that influence it will enhance the quality of future research. Careful consideration must also be given to interactions among influences at multiple levels, as well as issues such as fidelity, modification, and changes in implementation over time. While prospective and experimental designs are needed, there is also an important role for qualitative research in efforts to understand the phenomenon, refine hypotheses, and develop strategies to promote sustainment.
Topics: Delivery of Health Care; Evidence-Based Practice; Health Planning Guidelines; Humans; Organizational Innovation; Program Evaluation; Research Design
PubMed: 22417162
DOI: 10.1186/1748-5908-7-17 -
American Family Physician Mar 2008Hospice is available for any patient who is terminally ill and chooses a palliative care approach. Because of the close relationship that primary care physicians often... (Review)
Review
Hospice is available for any patient who is terminally ill and chooses a palliative care approach. Because of the close relationship that primary care physicians often have with their patients, they are in a unique position to provide end-of-life care, which includes recognizing the need for and recommending hospice care when appropriate. The hospice benefit covers all expenses related to the terminal illness, including medication, nursing care, and equipment. Hospice should be considered when a patient has New York Heart Association class IV heart failure, severe dementia, activity-limiting lung disease, or metastatic cancer. Timely referrals are beneficial to both patient and hospice because of the cost related to initiating services and the time required to form a therapeutic relationship. Once the decision to refer to hospice is made, the family physician typically continues to be the patient's primary attending physician. The attending physician is expected to remain in charge of the patient's care, write orders, see the patient for office visits, and complete and sign the death certificate. Hospice, in turn, is a valuable physician resource when it comes to medication dosages, symptom management, and communication with patients and their families.
Topics: Hospice Care; Humans; Patient Selection; Physician's Role; Physicians, Family; Referral and Consultation
PubMed: 18386596
DOI: No ID Found