Are pregnant women satisfied with perinatal standards of care during COVID-19 pandemic?

AbstractCOVID-19 restrictive measures severely impacted maternity services worldwide, but little is known about the differences in women’s concerns, perception of the modifications of maternity services and childbirth programs at different times during the pandemic. Here we report data from the first COVID-19 wave in Italy, during the 2020 national lockdown (March-April) and soon after lockdown release (May).1307 pregnant women answered the survey during national lockdown (phase 1) or after restrictive measures were released (phase 2). Women reported a significantly higher COVID-19 concern during phase 1 than during phase 2 (2.34 SD 0.5 vs 2.12 SD 0.5 on a Likert scale 0-3; p<0.001). Several domains of perinatal care were affected during COVID-19 lockdown: while antenatal visits, the use of technology to keep in touch with healthcare professionals, and closeness of caregivers were generally more appreciated (especially during phase 2), women reported the greatest difficulties in receiving clear information on hospitalization, birth plan and partner’s presence at birth.Italian pregnant women’s worries about the effects of the pandemic on health and their perception of quality in the organization of maternity services improved during lockdown, but they continued to represent a challenge in May, especially regarding organizational aspects of hospitalization and childbirth.

Download Full-text

Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

Gates Open Research ◽

10.12688/gatesopenres.12867.2 ◽

2019 ◽

Vol 2 ◽

pp. 56 ◽

Cited By ~ 1

Author(s):

Mark M. Kabue ◽

Lindsay Grenier ◽

Stephanie Suhowatsky ◽

Jaiyeola Oyetunji ◽

Emmanuel Ugwa ◽

...

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Data Collection ◽

Pregnant Women ◽

Controlled Trial ◽

Phase 1 ◽

First Year ◽

Phase 2 ◽

Randomized Controlled ◽

Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

Download Full-text

“Actua” project: secondary prevention in patients at high-cardiovascular risk

European Heart Journal ◽

10.1093/eurheartj/ehab724.2550 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

A Prieto Lobato ◽

M J Corbi Pascual ◽

M Redondo Prieto ◽

M Cubells Pastor ◽

A Muros Ortega ◽

...

Keyword(s):

Cardiovascular Risk ◽

Secondary Prevention ◽

Phase 1 ◽

Standards Of Care ◽

Consensus Method ◽

High Dispersion ◽

Phase 2 ◽

High Cardiovascular Risk ◽

Private Company ◽

Artery Disease

Abstract Introduction It is acknowledged that secondary prevention for patients at high cardiovascular risk is suboptimal. Data from EUROASPIRE V registry showed that less than 50% of cardiovascular risks factors were controlled in this population. Purpose “Actua” study was designed to identify potential gaps regarding secondary prevention for patients at very-high cardiovascular risk. The main objective was to assess differences between scientific evidence and clinical practice through an agreement/disagreement analysis of a questionnaire with statements based on clinical guidelines and expert recommendations. Methods A qualitative analysis based on Delphi methodology was conducted. The study was divided into 2 phases. In phase 1, doctors were asked to show agreement or disagreement with the statements presented by the scientific committee through a Likert 5-points-scale. Consensus was stablished according to consensus method of Tastle. Results were expressed as a percentage (%CNS) which shows power of agreement or disagreement consensus. CNS>70% were considered as consensus. In phase 2, same doctors were asked again about the statements with no consensus or high dispersion in previous phase, after disclosing results in phase 1. In addition, a third questionnaire was conducted to asses socio-demographic data of the sample. Results 246 and 265 questionnaires were conducted in phase 1 and 2 respectively. 90% of respondents in phase 1 and 94,3% in phase 2 answered all the questions. Statements which showed consensus among participants are represented in table 1. As reported, there was consensus in goals for blood pressure (<130/80mmHg), cLDL (<70mg/dl), chronic use of acetylsalicylic acid in secondary prevention for coronary artery disease, stroke and peripheral artery disease. Doctors also agreed with the fact that 40mg atorvastatin can achieve 50% cLDL reduction levels from baseline. Scarce resources in secondary prevention were reported as main reason for medical attendants not following the best standards of care. Besides, most respondents agreed with the statement that a simpler treatment regime could improve therapeutical adherence in most patients. In phase 2, consensus was achieved in the statements showed in table 2. Conclusion Doctors admitted that complex recommendations and lack of following-up were the main causes of low adherence to treatment among patients at high cardiovascular risk. Limitations The study was conducted following recommendations from 2016 ESC/EAS guidelines for the management of dyslipaemias. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Grupo Ferrer Internacional, S.A. Table 1. Questions phase 1 Table 2. Questions phase 2

Download Full-text

A phase Ib/II, open-label study of tivozanib in combination with durvalumab in subjects with untreated advanced hepatocellular carcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e16599 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e16599-e16599

Author(s):

Renuka V. Iyer ◽

Daneng Li ◽

Farshid Dayyani ◽

Michael N. Needle ◽

Thomas Adam Abrams

Keyword(s):

Patient Outcomes ◽

Phase 1 ◽

Single Agent ◽

Objective Response ◽

Standards Of Care ◽

Advanced Hepatocellular Carcinoma ◽

Phase 2 ◽

Safety And Efficacy ◽

Advanced Hcc ◽

Grade 3

e16599 Background: VEGFR TKIs and checkpoint inhibitors are current standards of care in HCC as single agents, however treatment options are limited, and significant unmet need remains. A recent ph3 study combining bevacizumab (VEGF-A Mab) with a PDL1 inhibitor have shown promising improvements in OS demonstrating that a combination of VEGF and PDL1 inhibition can improve patient outcomes over single agent treatment. Tivozanib (T, a potent and selective VEGFR 1, 2 & 3 TKI) and durvlaumab (D, a PD-L1 antibody) have both demonstrated single agent activity in HCC and have been combined safely with other therapies to enhance patient outcomes in other tumor types. It is hypothesized that more complete inhibition of the VEGF pathway by tivozanib compared to bevacizumab combined with PDL1 inhibition may further enhance patient outcomes. The ph1 portion of this study combines T with D to establish the recommended phase 2 dose (RP2D) and provide preliminary safety and efficacy data. Methods: Major eligibility criteria are adults with documented advanced HCC, Child-Pugh Class A, ECOG 0 or 1, creatinine clearance > 40 ml/min. Major exclusion criteria are co-infection with HBV and either HDV or HCV and significant organ dysfunction. Six patients with untreated advanced HCC will be treated with the combination of T 1 mg orally for 21 days followed by 7 days off treatment and D 1500 mg intravenously every 28 days. A DLT is generally defined as the occurrence of any Grade ≥3 immune or non-immune AE in Cycle 1 that is at least possibly related to the investigational regimen other than any grade of vitiligo or alopecia or Grade 3 controllable hypertension. If two or more patients have a DLT then the dose of tivozanib will be reduced to 1 mg every other day without interruption for the second cohort. In the Phase 2 portion of the study an additional 30 patients will be treated at the RP2D. The primary objective is to establish the RP2D and the safety and tolerability for this combination in patients with advanced HCC. Secondary objectives are to assess the objective response rate, progression free survival, and overall survival in this population. Patients will be treated until progression of disease, unacceptable side effects, or death. Outcome measures will be adverse events per CTCAE v.5 and cross-sectional imaging performed every 8 weeks. Results: Phase 1 safety and efficacy findings for this novel combination will be reported at the meeting. Conclusions: Phase 1 safety and efficacy findings for this novel combination will be reported at the meeting. Clinical trial information: NCT03970616 .

Download Full-text

Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

Gates Open Research ◽

10.12688/gatesopenres.12867.1 ◽

2018 ◽

Vol 2 ◽

pp. 56 ◽

Cited By ~ 5

Author(s):

Mark M. Kabue ◽

Lindsay Grenier ◽

Stephanie Suhowatsky ◽

Jaiyeola Oyetunji ◽

Emmanuel Ugwa ◽

...

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Data Collection ◽

Pregnant Women ◽

Controlled Trial ◽

Phase 1 ◽

First Year ◽

Phase 2 ◽

Randomized Controlled ◽

Cluster Randomized

Download Full-text

Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): a feasibility study and pilot randomised trial

Health Technology Assessment ◽

10.3310/hta20330 ◽

2016 ◽

Vol 20 (33) ◽

pp. 1-236 ◽

Cited By ~ 18

Author(s):

Nadine E Foster ◽

Annette Bishop ◽

Bernadette Bartlam ◽

Reuben Ogollah ◽

Panos Barlas ◽

...

Keyword(s):

Back Pain ◽

Pregnant Women ◽

Phase 1 ◽

Health Technology ◽

Self Management ◽

Phase 2 ◽

Patient Reported ◽

Pilot Rct

BackgroundMany pregnant women experience low back pain. Acupuncture appears to be a safe, promising intervention but evidence is needed about its clinical effectiveness and cost-effectiveness.ObjectivesTo assess the feasibility of a future large randomised controlled trial (RCT) testing the additional benefit of adding acupuncture to standard care (SC) for pregnancy-related back pain.DesignPhase 1: a questionnaire survey described current care for pregnancy-related back pain. Focus groups and interviews with midwives, physiotherapists and pregnant women explored acceptability and feasibility of acupuncture and the proposed RCT. Phase 2: a single-centre pilot RCT. Participants were identified using six methods and randomised to SC, SC plus true acupuncture or SC plus non-penetrating acupuncture.ParticipantsPhase 1: 1093 physiotherapists were surveyed and 15 midwives, 21 physiotherapists and 17 pregnant women participated in five focus groups and 20 individual interviews. Phase 2: 125 women with pregnancy-related back pain participated.InterventionsSC: a self-management booklet and onward referral for one-to-one physiotherapy (two to four sessions) for those who needed it. SC plus true acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising true (penetrating) acupuncture, advice and exercise. SC plus non-penetrating acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising non-penetrating acupuncture, advice and exercise.Main outcome measuresPilot RCT outcomes included recruitment rates, treatment fidelity, follow-up rate, patient-reported pain and function, quality of life and health-care resource use. Birth and neonatal outcomes were also assessed. Staff overseeing outcome data collection were blind to treatment allocation.ResultsPhase 1: 629 (57.5%) physiotherapists responded to the survey, 499 were experienced in treating pregnancy-related back pain and reported 16 advice and 18 treatment options. Typical treatment comprised two to four individual sessions of advice and exercise over 6 weeks. Acupuncture was reported by 24%. Interviews highlighted the impact of back pain and paucity of effective interventions. Women and midwives strongly supported a RCT and expressed few concerns. Physiotherapists’ concerns about acupuncture in pregnancy informed a training programme prior to the pilot RCT. Phase 2: We recruited 125 of 280 potentially eligible women (45%) in 6 months and randomised 41 to SC and 42 each to the SC plus true acupuncture and SC plus non-penetrating acupuncture arms. Analysis was conducted with 124 participants (41, 42 and 41, respectively) as one participant was randomised in error. Three of six recruitment methods were the most successful. In total, 10% of women (n = 4) randomised to SC alone accessed one-to-one physiotherapy and received an average of two treatments. The average number of treatments was six for both SC plus true acupuncture and SC plus non-penetrating acupuncture. Treatments were in line with protocols. Eight-week follow-up was 74%. Patient-reported outcomes (pain, function and quality of life) favoured the addition of acupuncture. There was no evidence of serious adverse events on mothers or birth and neonatal outcomes. The Pelvic Girdle Questionnaire was found to be an appropriate outcome measure for a future trial.ConclusionsA future main RCT is feasible and would be welcomed by women and clinicians. Longer-term follow-up and further follow-up efforts are recommended for a main trial.Trial registrationCurrent Controlled Trials ISRCTN49955124.FundingThis project was funded by the National Institute of Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 33. See the NIHR Journals Library website for further project information.

Download Full-text

Rationalization and internalization

Swiss Journal of Psychology ◽

10.1024//1421-0185.60.4.215 ◽

2001 ◽

Vol 60 (4) ◽

pp. 215-230 ◽

Cited By ~ 6

Author(s):

Jean-Léon Beauvois

Keyword(s):

Phase 1 ◽

Facilitatory Effect ◽

Phase 2 ◽

Causal Explanations ◽

Reduction Effect ◽

Dissonance Reduction

After having been told they were free to accept or refuse, pupils aged 6–7 and 10–11 (tested individually) were led to agree to taste a soup that looked disgusting (phase 1: initial counter-motivational obligation). Before tasting the soup, they had to state what they thought about it. A week later, they were asked whether they wanted to try out some new needles that had supposedly been invented to make vaccinations less painful. Agreement or refusal to try was noted, along with the size of the needle chosen in case of agreement (phase 2: act generalization). The main findings included (1) a strong dissonance reduction effect in phase 1, especially for the younger children (rationalization), (2) a generalization effect in phase 2 (foot-in-the-door effect), and (3) a facilitatory effect on generalization of internal causal explanations about the initial agreement. The results are discussed in relation to the distinction between rationalization and internalization.

Download Full-text

PENERAPAN MODEL QUANTUM LEARNING UNTUK MENINGKATKAN HASIL BELAJAR AUTOCAD SISWA KELAS X TEKNIK PEMESINAN SMK NEGERI 1 STABAT

Jurnal Teknologi Pendidikan (JTP) ◽

10.24114/jtp.v5i1.509 ◽

2013 ◽

Vol 5 (1) ◽

Author(s):

Abdul Hasan Saragih

Keyword(s):

Positive Response ◽

Phase 1 ◽

First Grade ◽

Learning Model ◽

Second Phase ◽

Phase 2 ◽

Phase 3 ◽

The Third ◽

Third Phase ◽

Quantum Learning

This classroom research was conducted on the autocad instructions to the first grade of mechinary class of SMK Negeri 1 Stabat aiming at : (1) improving the student’ archievementon autocad instructional to the student of mechinary architecture class of SMK Negeri 1 Stabat, (2) applying Quantum Learning Model to the students of mechinary class of SMK Negeri 1 Stabat, arising the positive response to autocad subject by applying Quantum Learning Model of the students of mechinary class of SMK Negeri 1 Stabat. The result shows that (1) by applying quantum learning model, the students’ achievement improves significantly. The improvement ofthe achievement of the 34 students is very satisfactory; on the first phase, 27 students passed (70.59%), 10 students failed (29.41%). On the second phase 27 students (79.41%) passed and 7 students (20.59%) failed. On the third phase 30 students (88.24%) passed and 4 students (11.76%) failed. The application of quantum learning model in SMK Negeri 1 Stabat proved satisfying. This was visible from the activeness of the students from phase 1 to 3. The activeness average of the students was 74.31% on phase 1,81.35% on phase 2, and 83.63% on phase 3. (3) The application of the quantum learning model on teaching autocad was very positively welcome by the students of mechinary class of SMK Negeri 1 Stabat. On phase 1 the improvement was 81.53% . It improved to 86.15% on phase 3. Therefore, The improvement ofstudent’ response can be categorized good.

Download Full-text

In situ deteriorating patient simulation in general practice

British Journal of General Practice ◽

10.3399/bjgp20x711425 ◽

2020 ◽

Vol 70 (suppl 1) ◽

pp. bjgp20X711425

Author(s):

Joanna Lawrence ◽

Petronelle Eastwick-Field ◽

Anne Maloney ◽

Helen Higham

Keyword(s):

Life Support ◽

Early Recognition ◽

Phase 1 ◽

Patient Simulation ◽

Medical Emergency ◽

Phase 2 ◽

Action Plans ◽

Integrated Simulation ◽

Deteriorating Patient

BackgroundGP practices have limited access to medical emergency training and basic life support is often taught out of context as a skills-based event.AimTo develop and evaluate a whole team integrated simulation-based education, to enhance learning, change behaviours and provide safer care.MethodPhase 1: 10 practices piloted a 3-hour programme delivering 40 minutes BLS and AED skills and 2-hour deteriorating patient simulation. Three scenarios where developed: adult chest pain, child anaphylaxis and baby bronchiolitis. An adult simulation patient and relative were used and a child and baby manikin. Two facilitators trained in coaching and debriefing used the 3D debriefing model. Phase 2: 12 new practices undertook identical training derived from Phase 1, with pre- and post-course questionnaires. Teams were scored on: team working, communication, early recognition and systematic approach. The team developed action plans derived from their learning to inform future response. Ten of the 12 practices from Phase 2 received an emergency drill within 6 months of the original session. Three to four members of the whole team integrated training, attended the drill, but were unaware of the nature of the scenario before. Scoring was repeated and action plans were revisited to determine behaviour changes.ResultsEvery emergency drill demonstrated improved scoring in skills and behaviour.ConclusionA combination of: in situ GP simulation, appropriately qualified facilitators in simulation and debriefing, and action plans developed by the whole team suggests safer care for patients experiencing a medical emergency.

Download Full-text

Clinical Drug Development for the Treatment of Pulmonary Arterial Hypertension: Collaboration With the Pharmaceutical Industry and Regulatory Agencies

Advances in Pulmonary Hypertension ◽

10.21693/1933-088x-9.4.214 ◽

2010 ◽

Vol 9 (4) ◽

pp. 214-219

Author(s):

Robyn J. Barst

Keyword(s):

Clinical Trials ◽

Pulmonary Arterial Hypertension ◽

Drug Development ◽

Phase 1 ◽

Preclinical Studies ◽

Phase 2 ◽

Phase 3 ◽

Preclinical Testing ◽

New Drug ◽

Pulmonary Arterial

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?

Download Full-text