scholarly journals PO 8264 QUALITY CARE CRITERIA IN A CLINICAL TRIAL CONTEXT: PATIENT AND DAFRA AND NANORO CMA HEALTH WORKER PERCEPTIONS IN BURKINA FASO

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A24.3-A25
Author(s):  
Barry Nourou ◽  
Léa Pare Toe ◽  
Patrice Toe

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.

2019 ◽  
Vol 9 (1) ◽  
pp. 17-26
Author(s):  
Essa Tawfiq ◽  
Sayed Ali Shah Alawi ◽  
Kayhan Natiq

Background: Training courses in integrated management of childhood illness (IMCI) have been conducted for health workers for nearly one and half decades in Afghanistan. The objective of the training courses is to improve quality of care in terms of health workers communication skills and clinical performance when they provide health services for under-5 children in public healthcare facilities. This paper presents our findings on the effects of IMCI training courses on quality of care in public primary healthcare facilities in Afghanistan. Methods: We used a cross-sectional post-intervention design with regression-adjusted difference-in-differences (DiD) analysis, and included 2 groups of health workers (treatment and control). The treatment group were those who have received training in IMCI recently (in the last 12 months), and the control group were those who have never received training in IMCI. The assessment method was direct observation of health workers during patient-provider interaction. We used data, collected over a period of 3 years (2015–2017) from primary healthcare facilities, and investigated training effects on quality of care. The outcome variables were 4 indices of quality care related to history taking, information sharing, counseling/medical advice, and physical examination. Each index was formed as a composite score, composed of several inter-related tasks of quality of care carried out by health workers during patient-provider interaction for under-5 children. Results: Data were collected from 733 primary healthcare facilities with 5818 patients. Quality of care was assessed at the level of patient-provider interaction. Findings from the regression-adjusted DiD multivariate analysis showed significant effects of IMCI training on 2 indices of quality care in 2016, and on 4 indices of quality care in 2017. In 2016 two indices of quality care showed improvement. There was an increase of 8.1% in counseling/medical advice index, and 8.7% in physical examination index. In 2017, there was an increase of 5.7% in history taking index, 8.0% in information sharing index, 10.9% in counseling/medical advice index, and 17.2% in physical examination index. Conclusion: Conducting regular IMCI training courses for health workers can improve quality of care for under-5 children in primary healthcare facilities in Afghanistan. Findings from our study have the potential to influence policy and strategic decisions on IMCI programs in developing countries.


Author(s):  
Rachel Wood ◽  
Vanessa Viljoen ◽  
Lisa Van Der Merwe ◽  
Robert Mash

Introduction: In Malawi, non-communicable diseases (NCDs) are thought to cause 28% of deaths in adults. The aim of this study was to establish the extent of primary care morbidity related to NCDs, as well as to audit the quality of care, in the primary care setting of Dedza District, central Malawi.Methods: This study was a baseline audit using clinic registers and a questionnaire survey of senior health workers at 5 clinics, focusing on care for hypertension, diabetes, asthma and epilepsy.Results: A total of 82 581 consultations were recorded, of which 2489 (3.0%) were for the selected NCDs. Only 5 out of 32 structural criteria were met at all 5 clinics and 9 out of 29process criteria were never performed at any clinic. The only process criteria performed at all five clinics was measurement of blood pressure. The staff’s knowledge on NCDs was basic and the main barriers to providing quality care were lack of medication and essential equipment, inadequate knowledge and guidelines, fee-for-service at two clinics, geographic inaccessibility and lack of confidence in the primary health care system by patients.Conclusion: Primary care morbidity from NCDs is currently low, although other studies suggest a significant burden of disease. This most likely represents a lack of utilisation, recognition, diagnosis and ability to manage patients with NCDs. Quality of care is poor due to a lack of essential resources, guidelines, and training.


2019 ◽  
Author(s):  
Adelaide M Lusambili ◽  
Violet Naanyu ◽  
Terrance J. Wade ◽  
Lindsay Mossman ◽  
Michaela Mantel ◽  
...  

ABSTRACTBackgroundUnder the Free Maternity Policy (FMP), Kenya has witnessed an increase health facility deliveries rather than home deliveries with Traditional Birth Attendants (TBA) resulting in improved maternal and neonatal outcomes. Despite these gains, maternal and infant mortality and morbidity rates in Kenya remain unacceptably high indicating that more work needs to be done.AimUsing data from the Access to Quality Care through Extending and Strengthening Health Systems (AQCESS) project’s qualitative gender assessment, this paper examines and describes women’s experience of disrespectful care during pregnancy, labour and delivery. The goal is to promote improved understanding of actual care conditions in order to develop interventions that can lift the standard of care, increase maternity facility use, and improve health outcomes for both women and newborns.MethodologyWe conducted sixteen focus group discussions (FGDs) with female adolescents, women, men and community health committee members. Twenty four key informants interviews (KII) including religious leaders, local government representatives, Ministry of Health (MOH) and local women’s organizations were conducted. Data were captured through audio recordings and reflective field notes.Research siteKisii and Kilifi Counties in Kenya.FindingsFindings show Nursing and medical care was sometimes disrespectful, humiliatings, uncompassionate, and neglectful. In both sites, male health workers were the most preferred by women as they were friendly and sensitive. Young women were more likely to be abused and women with disabled children were stigmatized.ConclusionsKenya needs to enforce the implementation of the quality of care guidelines for pregnancy and delivery, including respectful maternity care of pregnant women. To make sure these procedures are enforced, measurable benchmarks for maternity care need to be established, and hospitals need to be regularly monitored to make sure they are achieved. Quality of care and compassionate and caring staff may lead to successful and sustainable use of facility care.


2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  

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.


Author(s):  
Kari White ◽  
Subasri Narasimhan ◽  
Sophie A. Hartwig ◽  
Erin Carroll ◽  
Alexandra McBrayer ◽  
...  

Abstract Introduction Thirty-seven states require minors seeking abortion to involve a parent, either through notification or consent. Little research has examined how implementation of these laws affect service delivery and quality of care for those who involve a parent. Methods Between May 2018 and September 2019, in-depth interviews were conducted with 34 staff members involved in scheduling, counseling, and administration at abortion facilities in three Southeastern states. Interviews explored procedures for documenting parental involvement, minors’ and parents’ reactions to requirements, and challenges with implementation and compliance. Both inductive and deductive codes, informed by the Institute of Medicine’s healthcare quality framework, were used in the thematic analysis. Results Parental involvement laws adversely affected four quality care domains: efficiency, patient-centeredness, timeliness, and equity. Administrative inefficiencies stemmed from the extensive documentation needed to prove an adult’s relationship to a minor, increasing the time and effort needed to comply with state reporting requirements. If parents were not supportive of their minor’s decision, participants felt they had a duty to intervene to ensure the minor’s decision and needs remained centered. Staff further noted that delays to timely care accumulated as minors navigated parental involvement and other state mandates, pushing some beyond gestational age limits. Lower income families and those with complex familial arrangements had greater difficulty meeting state requirements. Conclusions Parental involvement mandates undermine health service delivery and quality for minors seeking abortion services in the Southeast. Policy Implications Removing parental involvement requirements would protect minors’ reproductive autonomy and support the provision of equitable, patient-centered healthcare.


2021 ◽  
Vol 33 (2) ◽  
Author(s):  
Yubraj Acharya ◽  
Nigel James ◽  
Rita Thapa ◽  
Saman Naz ◽  
Rishav Shrestha ◽  
...  

Abstract Background Nepal has made significant strides in maternal and neonatal mortality over the last three decades. However, poor quality of care can threaten the gains, as maternal and newborn services are particularly sensitive to quality of care. Our study aimed to understand current gaps in the process and the outcome dimensions of the quality of antenatal care (ANC), particularly at the sub-national level. We assessed these dimensions of the quality of ANC in 17 primary, public hospitals across Nepal. We also assessed the variation in the ANC process across the patients’ socio-economic gradient. Methods We used a convergent mixed methods approach, whereby we triangulated qualitative and quantitative data. In the quantitative component, we observed interactions between providers (17 hospitals from all 7 provinces) and 198 women seeking ANC and recorded the tasks the providers performed, using the Service Provision Assessments protocol available from the Demographic and Health Survey program. The main outcome variable was the number of tasks performed by the provider during an ANC consultation. The tasks ranged from identifying potential signs of danger to providing counseling. We analyzed the resulting data descriptively and assessed the relationship between the number of tasks performed and users’ characteristics. In the qualitative component, we synthesized users’ and providers’ narratives on perceptions of the overall quality of care obtained through focus group discussions and in-depth interviews. Results Out of the 59 tasks recommended by the World Health Organization, providers performed only 22 tasks (37.3%) on average. The number of tasks performed varied significantly across provinces, with users in province 3 receiving significantly higher quality care than those in other provinces. Educated women were treated better than those with no education. Users and providers agreed that the overall quality of care was inadequate, although providers mentioned that the current quality was the best they could provide given the constraints they faced. Conclusion The quality of ANC in Nepal’s primary hospitals is poor and inequitable across education and geographic gradients. While current efforts, such as the provision of 24/7 birthing centers, can mitigate gaps in service availability, additional equipment, infrastructure and human resources will be needed to improve quality. Providers also need additional training focused on treating patients from different backgrounds equally. Our study also points to the need for additional research, both to document the quality of care more objectively and to establish key determinants of quality to inform policy.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kate Doyle ◽  
Shamsi Kazimbaya ◽  
Ruti Levtov ◽  
Joya Banerjee ◽  
Myra Betron ◽  
...  

Abstract Background Rwanda has made great progress in improving reproductive, maternal, and newborn health (RMNH) care; however, barriers to ensuring timely and full RMNH service utilization persist, including women’s limited decision-making power and poor-quality care. This study sought to better understand whether and how gender and power dynamics between providers and clients affect their perceptions and experiences of quality care during antenatal care, labor and childbirth. Methods This mixed methods study included a self-administered survey with 151 RMNH providers with questions on attitudes about gender roles, RMNH care, provider-client relations, labor and childbirth, which took place between January to February 2018. Two separate factor analyses were conducted on provider responses to create a Gender Attitudes Scale and an RMNH Quality of Care Scale. Three focus group discussions (FGDs) conducted in February 2019 with RMNH providers, female and male clients, explored attitudes about gender norms, provision and quality of RMNH care, provider-client interactions and power dynamics, and men’s involvement. Data were analyzed thematically. Results Inequitable gender norms and attitudes – among both RMNH care providers and clients – impact the quality of RMNH care. The qualitative results illustrate how gender norms and attitudes influence the provision of care and provider-client interactions, in addition to the impact of men’s involvement on the quality of care. Complementing this finding, the survey found a relationship between health providers’ gender attitudes and their attitudes towards quality RMNH care: gender equitable attitudes were associated with greater support for respectful, quality RMNH care. Conclusions Our findings suggest that gender attitudes and power dynamics between providers and their clients, and between female clients and their partners, can negatively impact the utilization and provision of quality RMNH care. There is a need for capacity building efforts to challenge health providers’ inequitable gender attitudes and practices and equip them to be aware of gender and power dynamics between themselves and their clients. These efforts can be made alongside community interventions to transform harmful gender norms, including those that increase women’s agency and autonomy over their bodies and their health care, promote uptake of health services, and improve couple power dynamics.


2010 ◽  
Vol 19 (5) ◽  
pp. e52-e61 ◽  
Author(s):  
Liva Jacoby ◽  
James Jaccard

BackgroundFamilies’ experiences in the hospital influence their decisions about donating organs of brain-dead relatives. Meeting families’ support needs during this traumatic time is an obligation and a challenge for critical care staff.Objectives(1) To elicit family members’ accounts of various types of support received and perceived quality of care for themselves and their loved ones when they made the donation decision, and (2) to examine the relationship between these factors and the families’ donation decision.MethodsRetrospective telephone interviews of 199 families from different regions of the country were completed. Aside from demographic data, the survey addressed perceptions of informational, emotional, and instrumental support and quality of care.ResultsOne hundred fifty-four study participants consented to donation; 45 declined. White next of kin were significantly more likely than African Americans to consent. Specific elements of reported support were significantly associated with consent to donate. Donor and nondonor families had differing perceptions of quality care for themselves and their loved ones. Receiving understandable information about organ donation was the strongest predictor of consent.ConclusionsSpecific supportive behaviors by staff as recounted by family members of potential donors were significantly associated with consent to donation. These behaviors lend themselves to creative training and educational programs for staff. Such interventions are essential not only for next of kin of brain-dead patients, but also for staff and ultimately for the public as a whole.


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