Do clinical trials improve quality of care? A comparison of clinical processes and outcomes in patients in a clinical trial and similar patients outside a trial where both groups are managed according to a strict protocol

BackgroundParticipants in clinical trials as well as researchers conducting them, establish a close link between clinical trial and quality care. However, what understanding do they have of the concept of quality of care? This study aimed to answer this question by presenting the criteria which define for them quality care in the context of clinical research.MethodsThe data were collected from the participants involved in these clinical trials as well as from the health workers (research teams and other health workers) using a qualitative approach with 70 in-depth interviews. Direct observations of the participants partaking in care activities were also made in both health districts. The data were recorded, transcribed and then analysed on the thematic content basis.ResultsFor the health workers interviewed, the clinical trials are conducted in optimal conditions which highly contribute to ensure a good quality of care. To them, quality of care in the process of the trial implementation is evident from some availability of qualified human resources, quality medico-technical equipment, as well as good clinical practice strictly adhered to by the researchers.As for the participants, the quality of care in clinical trials meets specific criteria. To them, quality care delivered by the research team became tangible through laboratory tests before any treatment proposal, the promptness in taking care of any discomfort, as well as the regular and permanent follow-up of the patient until recovery of his health. Blood sampling for laboratory examinations was highly appreciated and mentioned by our respondents as the main indicator of the quality of care provided by the research teams.ConclusionThe quality of care according to the criteria the participants and the health workers assigned to it, is intrinsically linked to clinical trials.

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P4P Programs May Not Improve Quality of Care

Internal Medicine News ◽

10.1016/s1097-8690(08)70219-1 ◽

2008 ◽

Vol 41 (4) ◽

pp. 45

Author(s):

JEFF EVANS

Keyword(s):

Quality Of Care ◽

Improve Quality

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Disease Management Programs May Improve Quality of Care, But May Not Save Money

PsycEXTRA Dataset ◽

10.1037/e532452010-001 ◽

2007 ◽

Keyword(s):

Quality Of Care ◽

Disease Management ◽

Improve Quality ◽

Disease Management Programs

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Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽

10.1186/s13063-021-05113-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Zhuoran Kuang ◽

◽

Xiaoyan Li ◽

Jianxiong Cai ◽

Yaolong Chen ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Secondary Outcome ◽

Specific Information ◽

Clinical Trial Registry ◽

Data Set ◽

Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

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Improving nursing documentation for surgical patients in a referral hospital in Freetown, Sierra Leone: protocol for assessing feasibility of a pilot multifaceted quality improvement hybrid type project

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00768-5 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Nataliya Brima ◽

Nick Sevdalis ◽

K. Daoh ◽

B. Deen ◽

T. B. Kamara ◽

...

Keyword(s):

Quality Improvement ◽

Quality Of Care ◽

Sierra Leone ◽

Referral Hospital ◽

Audit And Feedback ◽

Health System Strengthening ◽

Theory Of Change ◽

Improve Quality ◽

Nursing Documentation

Abstract Background There is an urgent need to improve quality of care to reduce avoidable mortality and morbidity from surgical diseases in low- and middle-income countries. Currently, there is a lack of knowledge about how evidence-based health system strengthening interventions can be implemented effectively to improve quality of care in these settings. To address this gap, we have developed a multifaceted quality improvement intervention to improve nursing documentation in a low-income country hospital setting. The aim of this pilot project is to test the intervention within the surgical department of a national referral hospital in Freetown, Sierra Leone. Methods This project was co-developed and co-designed by in-country stakeholders and UK-based researchers, after a multiple-methodology assessment of needs (qualitative, quantitative), guided by a participatory ‘Theory of Change’ process. It has a mixed-method, quasi-experimental evaluation design underpinned by implementation and improvement science theoretical approaches. It consists of three distinct phases—(1) pre-implementation(project set up and review of hospital relevant policies and forms), (2) intervention implementation (awareness drive, training package, audit and feedback), and (3) evaluation of (a) the feasibility of delivering the intervention and capturing implementation and process outcomes, (b) the impact of implementation strategies on the adoption, integration, and uptake of the intervention using implementation outcomes, (c) the intervention’s effectiveness For improving nursing in this pilot setting. Discussion We seek to test whether it is possible to deliver and assess a set of theory-driven interventions to improve the quality of nursing documentation using quality improvement and implementation science methods and frameworks in a single facility in Sierra Leone. The results of this study will inform the design of a large-scale effectiveness-implementation study for improving nursing documentation practices for patients throughout hospitals in Sierra Leone. Trial registration Protocol version number 6, date: 24.12.2020, recruitment is planned to begin: January 2021, recruitment will be completed: December 2021.

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Physician beliefs about the impact of meaningful use of the EHR

Applied Clinical Informatics ◽

10.4338/aci-2014-05-ra-0050 ◽

2014 ◽

Vol 05 (03) ◽

pp. 789-801 ◽

Cited By ~ 13

Author(s):

D.Y. Ting ◽

M. Healey ◽

S.R. Lipsitz ◽

A.S. Karson ◽

J. S. Einbinder ◽

...

Keyword(s):

Quality Of Care ◽

Primary Care Physicians ◽

Meaningful Use ◽

The United States ◽

Improve Quality ◽

Cross Sectional ◽

Incentive Program ◽

Physician Beliefs ◽

The Impact

SummaryBackground: As adoption and use of electronic health records (EHRs) grows in the United States, there is a growing need in the field of applied clinical informatics to evaluate physician perceptions and beliefs about the impact of EHRs. The meaningful use of EHR incentive program provides a suitable context to examine physician beliefs about the impact of EHRs.Objective: Contribute to the sparse literature on physician beliefs about the impact of EHRs in areas such as quality of care, effectiveness of care, and delivery of care.Methods: A cross-sectional online survey of physicians at two academic medical centers (AMCs) in the northeast who were preparing to qualify for the meaningful use of EHR incentive program.Results: Of the 1,797 physicians at both AMCs who were preparing to qualify for the incentive program, 967 completed the survey for an overall response rate of 54%. Only 23% and 27% of physicians agreed or strongly agreed that meaningful use of the EHR will help them improve the care they personally deliver and improve quality of care respectively. Physician specialty was significantly associated with beliefs; e.g., 35% of primary care physicians agreed or strongly agreed that meaningful use will improve quality of care compared to 26% of medical specialists and 21% of surgical specialists (p=0.009). Satisfaction with outpatient EHR was also significantly related to all belief items.Conclusions: Only about a quarter of physicians in our study responded positively that meaningful use of the EHR will improve quality of care and the care they personally provide. These findings are similar to and extend findings from qualitative studies about negative perceptions that physicians hold about the impact of EHRs. Factors outside of the regulatory context, such as physician beliefs, need to be considered in the implementation of the meaningful use of the EHR incentive program.Citation: Emani S, Ting DY, Healey M, Lipsitz SR, Karson AS, Einbinder JS, Leinen L, Suric V, Bates DW. Physician beliefs about the impact of meaningful use of the EHR: A cross-sectional study. Appl Clin Inf 2014; 5: 789–801http://dx.doi.org/10.4338/ACI-2014-05-RA-0050

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