Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial.

Cesarean section rates worldwide are rising, driven by medically unnecessary cesarean use. The new World Health Organization Labour Care Guide (LCG) aims to improve the quality of care for women during labor and childbirth. Using the LCG might reduce overuse of cesarean; however, its effects have not been evaluated in randomized trials. We conducted a stepped-wedge, cluster-randomized pilot trial in four hospitals in India to evaluate the implementation of an LCG strategy intervention, compared with routine care. We performed this trial to pilot the intervention and obtain preliminary effectiveness data, informing future research. Eligible clusters were four hospitals with >4,000 births annually and cesarean rates ≥30%. Eligible women were those giving birth at ≥20 weeks' gestation. One hospital transitioned to intervention every 2 months, according to a random sequence. The primary outcome was the cesarean rate among women in Robson Group 1 (that is, those who were nulliparous and gave birth to a singleton, term pregnancy in cephalic presentation and in spontaneous labor). A total of 26,331 participants gave birth. A 5.5% crude absolute reduction in the primary outcome was observed (45.2% versus 39.7%; relative risk 0.85, 95% confidence interval 0.54-1.33). Maternal process-of-care outcomes were not significantly different, though labor augmentation with oxytocin was 18.0% lower with the LCG strategy. No differences were observed for other health outcomes or women's birth experiences. These findings can guide future definitive effectiveness trials, particularly in settings where urgent reversal of rising cesarean section rates is needed. Clinical Trials Registry India number: CTRI/2021/01/030695 .

Intrapartum care measures and indicators for monitoring the implementation of WHO recommendations for a positive childbirth experience: a scoping review.

OBJECTIVE: We aimed to identify all available studies describing measures or indicators used to monitor 41 intrapartum care practices described in the 2018 WHO intrapartum care recommendations, with a view to informing development of standardised measurement of implementing these recommendations. DESIGN: Systematic scoping review. METHODS: We conducted a scoping review to identify studies reporting measures of intrapartum care published between 1 January 2000 and 28 June 2021. Primary and secondary outcome measures included study characteristics (publication year, journal, country and World Bank classification) and intrapartum care measure characteristics (definition, numerator, denominator, measurement level and measurement approach). We searched MEDLINE, EMBASE, CINAHL, Cochrane Library, the Maternity and Infant Care Database, Global Index Medicus and grey literature using structured search terms related to included recommendations, focusing on respectful and supportive care, and clinical practices performed throughout labour and birth. The measures identified were classified by the WHO recommendation and their characteristics reported. RESULTS: We identified 150 studies which described 1331 intrapartum care measures. These measures corresponded to 35 of the 41 included WHO recommendations, and represented all domains of the WHO recommendations (care throughout labour and birth, first stage of labour, second stage of labour, third stage of labour). A total of 40.1% (534 of 1331 measures) of measures were related to respectful maternity care. Most studies used a questionnaire or survey measurement approach (522 of 1331 measures, 39.2%). CONCLUSION: This scoping review presents a database of existing intrapartum care measures used to monitor the quality of intrapartum care globally. There is no clear consensus on a core set of measures for evaluating the practice of the WHO's intrapartum care recommendations. This review provides a foundation to support the development of a core set of internationally standardised intrapartum care measures for the WHO intrapartum care recommendations, highlighting key areas requiring consensus and validation, and measure development.

Implementing the WHO Labour Care Guide to reduce the use of Caesarean section in four hospitals in India: protocol and statistical analysis plan for a pragmatic, stepped-wedge, cluster-randomized pilot trial.

BACKGROUND: The World Health Organization (WHO) Labour Care Guide (LCG) is a paper-based labour monitoring tool designed to facilitate the implementation of WHO's latest guidelines for effective, respectful care during labour and childbirth. Implementing the LCG into routine intrapartum care requires a strategy that improves healthcare provider practices during labour and childbirth. Such a strategy might optimize the use of Caesarean section (CS), along with potential benefits on the use of other obstetric interventions, maternal and perinatal health outcomes, and women's experience of care. However, the effects of a strategy to implement the LCG have not been evaluated in a randomised trial. This study aims to: (1) develop and optimise a strategy for implementing the LCG (formative phase); and (2) To evaluate the implementation of the LCG strategy compared with usual care (trial phase). METHODS: In the formative phase, we will co-design the LCG strategy with key stakeholders informed by facility assessments and provider surveys, which will be field tested in one hospital. The LCG strategy includes a LCG training program, ongoing supportive supervision from senior clinical staff, and audit and feedback using the Robson Classification. We will then conduct a stepped-wedge, cluster-randomized pilot trial in four public hospitals in India, to evaluate the effect of the LCG strategy intervention compared to usual care (simplified WHO partograph). The primary outcome is the CS rate in nulliparous women with singleton, term, cephalic pregnancies in spontaneous labour (Robson Group 1). Secondary outcomes include clinical and process of care outcomes, as well as women's experience of care outcomes. We will also conduct a process evaluation during the trial, using standardized facility assessments, in-depth interviews and surveys with providers, audits of completed LCGs, labour ward observations and document reviews. An economic evaluation will consider implementation costs and cost-effectiveness. DISCUSSION: Findings of this trial will guide clinicians, administrators and policymakers on how to effectively implement the LCG, and what (if any) effects the LCG strategy has on process of care, health and experience outcomes. The trial findings will inform the rollout of LCG internationally. TRIAL REGISTRATION: CTRI/2021/01/030695 (Protocol version 1.4, 25 April 2022).

The new WHO Labour Care Guide (LCG) is an innovative partograph that emphasises women-centred, evidence-based care during labour and childbirth. Together with clinicians working at four hospitals in India, we will develop and test a strategy to implement the LCG into routine care in labour wards of these hospitals. We will use a randomised trial design where this LCG strategy is introduced sequentially in each of the four hospitals, in a random order. We will collect data on all women giving birth and their newborns during this period and analyse whether the LCG strategy has any effects on the use of Caesarean section, women's and newborn's health outcomes, and women's experiences during labour and childbirth. While the trial is being conducted, we will also collect qualitative and quantitative data from doctors, nurses and midwives working in these hospitals, to understand their perspectives and experiences of using the LCG in their day-to-day work. In addition, we will collect economic data to understand how much the LCG strategy costs, and how much money it might save if it is effective. Through this study, our international collaboration will generate critical evidence and innovative tools to support implementation of the LCG in other countries.

Reframing evidence-based practice curricula to facilitate engagement in nursing students.

Evidence-based practice underscores a modern approach to nursing to ensure delivery of safe, up-to-date and person-centred care in the evolving clinical environment. While most entry-to-practice nursing courses incorporate elements of evidence-based research curricula, nursing students commonly struggle to see the relevance of research in their training. This study sought to understand nursing students' satisfaction and perspectives on research after an undergraduate research subject was redesigned to make overt the connection between research and professional nursing practice. Satisfaction significantly improved on routinely collected satisfaction surveys over a one-year period (mean increase 0.57, 95% CI 0.40-0.77, P < 0.001; medium effect size, 0.64). Open-ended questions elicited five themes: change to preconceived ideas of research to something accessible and useful; clear link between research and clinical and professional nursing practice; comments on subject format and scaffolded learning; increased skills in effective searching and extracting evidence; and improvements for the future. Student satisfaction increased when the connection between research learning and professional practice was made overt in a core research subject. This approach, along with scaffolded activities to increase confidence, had a marked positive impact on student's attitude and understanding of the utility of evidence-based practice and confidence in scrutinising practice in the clinical environment.

Therapies for human prion diseases.

The pathological foundation of human prion diseases is a result of the conversion of the physiological form of prion protein (PrP(c)) to the pathological protease resistance form PrP(res). Most patients with prion disease have unknown reasons for this conversion and the subsequent development of a devastating neurodegenerative disorder. The conversion of PrP(c) to PrP(res), with resultant propagation and accumulation results in neuronal death and amyloidogenesis. However, with increasing understanding of neurodegenerative processes it appears that protein-misfolding and subsequent propagation of these rouge proteins, is a generic phenomenon shared with diseases caused by tau, α-synucleins and ß-amyloid proteins. Consequently, effective anti-prion agents may have wider implications. A number of therapeutic approaches include polyanionic, polycyclic drugs such as pentosan polysulfate (PPS), which prevent the conversion of PrP(c) to PrP(res) and might also sequester and down-regulate PrP(res). Polyanionic compounds might also help to clear PrP(res). Treatments aimed at the laminin receptor, which is an important accessory molecule in the conversion of PrP(c) to PrP(res) - neuroprotection, immunotherapy, siRNA and antisense approaches have provided some experimental promise.

A patient with Creutzfeldt-Jakob disease presenting with amyotrophy: a case report.

INTRODUCTION: Creutzfeldt-Jakob disease (CJD) is an ultimately fatal, neurodegenerative disease caused by misfolded prion protein aggregation and accumulation. The development of amyotrophic features has been described in CJD, though rarely as an early or prominent feature. Consequently, the significance of amyotrophy in prion disease etiology remains unclear. CASE PRESENTATION: Our patient, a healthy 70-year-old French/Algerian man, presented to our hospital following a work-related fall and was admitted with lower limb skeletal muscle atrophy and fasciculations; the fasciculations progressed to involve the trunk, upper limbs and face. Within days, he developed evidence of a progressive ascending neurological syndrome and subsequent brain involvement with supranuclear palsy of upgaze, catalepsy and death 36 days after symptom onset. Amyotrophy remained the principle feature of his disease. Dementia started to develop within 10 days of the onset of his amyotrophy. Prion disease was confirmed at postmortem. CONCLUSIONS: Our observations suggest an unusual form of prion disease with prominent early involvement of anterior horn cells, ascending prion propagation in the central nervous system and a grave prognosis.

The distress of voice-hearing: the use of simulation for awareness, understanding and communication skill development in undergraduate nursing education.

Role-play scenarios are frequently used with undergraduate nursing students enrolled in mental health nursing subjects to simulate the experience of voice-hearing. However, role-play has limitations and typically does not involve those who hear voices. This collaborative project between mental health consumers who hear voices and nursing academics aimed to develop and assess simulated voice-hearing as an alternative learning tool that could provide a deeper understanding of the impact of voice-hearing, whilst enabling students to consider the communication skills required when interacting with voice-hearers. Simulated sounds and voices recorded by consumers on mp3 players were given to eighty final year nursing students undertaking a mental health elective. Students participated in various activities whilst listening to the simulations. Seventy-six (95%) students completed a written evaluation following the simulation, which assessed the benefits of the simulation and its implications for clinical practice. An analysis of the students' responses by an external evaluator indicated that there were three major learning outcomes: developing an understanding of voice-hearing, increasing students' awareness of its impact on functioning, and consideration of the communication skills necessary to engage with consumers who hear voices.

Multi-component weight-loss interventions for people with cardiovascular disease and/or type 2 diabetes mellitus: a systematic review.

OBJECTIVES: To determine whether weight loss interventions, which combine dietary, exercise and behaviour change strategies, result in reduced weight, body mass index (BMI) and waist circumference in people with coronary heart disease (CHD), hypertension (HTN) and/or type 2 diabetes mellitus (T2DM). DESIGN: A systematic review of studies published 1997 to 2010. DATA SOURCES: The electronic databases MEDLINE, PsycINFO, COCHRANE, CINAHL and EMBASE. REVIEW METHODS: Studies were included if samples were: ≥ 18 years old, overweight or obese (BMI 26-39.99 kg/m(2)), and diagnosed with CHD, T2DM and/or HTN. Only randomised controlled trials (RCTs) or systematic reviews of RCTs reporting group-based interventions that combined dietary, exercise and behavioural change strategies and outcomes for weight, BMI and/or waist circumference up to 12 months were included. Two researchers extracted data and appraised quality, with a third making final decisions. RESULTS: Eight RCTs were included (total n = 1428). Participants' mean age was 60.4 years and 61% were female. Interventions varied by contact time, content and delivery. Mean weight loss ranged from -2 kg to -4 kg (SD 4 kg) at 3-4 months, -1.3 kg to -8.2 kg (SD 4 kg) at 5-6 months and -0.87 (SD 0.57 kg) to -6.9 kg (SD 4 kg) at 12 months. Of the few studies that measured waist circumference the mean reduction was -3.1 cm at three and 12 months. CONCLUSIONS: Weight loss interventions that combine exercise, diet and behaviour change strategies result in minor weight loss at 3-12 months in people with CHD, T2DM or HTN. Further research is required to determine the most effective and efficient methods.

The needs of patients with early onset dementia.

AIM: The burden of early-onset dementia (EOD) is often overshadowed by an ageing population. METHODS: A questionnaire comprising 12 items was completed by 18 patients with EOD (15 with Alzheimer's disease [AD] and 3 with frontotemporal dementia) and 39 caregivers (20 spouses, 8 children, 7 siblings, 2 carers, and 2 health professionals). The onset of patients' symptoms was prior to the age of 65 years. Caregivers had to be supporting someone who matched these criteria. RESULTS: Early recognition and referral was perceived as the principle area of improvement by both patients (94.4%) and carers (69.2%; P < .0002). Patients evaluated "diagnosis" as the area of most need (88.9%) compared with caregivers who rated "treatment" (69.2%) as their principle concern. CONCLUSION: The perceived concerns of patients with EOD differ from that of the caregivers. Continued consumer involvement is essential in ensuring a tailored approach to young people with dementia.

A randomised trial of a weight loss intervention for overweight and obese people diagnosed with coronary heart disease and/or type 2 diabetes.

BACKGROUND: Weight reduction limits disease progression in obese people with coronary heart disease (CHD) and/or type 2 diabetes mellitus (T2DM). PURPOSE: To test a 16-week group-based weight reduction intervention combining exercise, diet and behaviour change strategies aimed to increase self-efficacy (Healthy Eating and Exercise Lifestyle Program-HEELP) on weight, body mass index (BMI), waist circumference and exercise. METHODS: Participants with CHD and/or T2DM and BMI between 27 to 39 kg/m(2) were randomised to HEELP (n=83) or usual care (n=65). RESULTS: Participants were aged a mean 63.47 years (SD 8.9), male (58 %) and Caucasian (79 %). HEELP participants lost significantly more weight, BMI and waist circumference and exercised more days/week for a longer duration/week than usual care. Clinically significant weight loss (≥5 %) was more common in HEELP than usual care. CONCLUSION: The HEELP resulted in weight loss and improved exercise behaviour in obese people with CHD and T2DM.

Weight management issues and strategies for people with high cardiovascular risk undertaking an Australian weight loss program: a focus group study.

Obesity is particularly hazardous for people with multiple cardiovascular risk factors and existing cardiovascular disease, although few studies investigate experiences and perceptions of weight loss in this population. This study provides an understanding of participants' knowledge, attitudes, and experiences of managing multiple risk factors and/or existing cardiovascular disease of participants who were undertaking a weight loss program. Thirty-five participants were recruited from the first 50 completing a multicomponent group-based weight loss intervention designed to follow cardiovascular disease and diabetes disease management programs. Four focus group interviews were conducted using a semistructured interview schedule. Data were analyzed using an inductive approach, and themes developed. Participants found the process of weight loss to be complex, dynamic, and challenging, as the conflicting needs of existing health conditions, social support, ambivalence, and time limitations required careful balance. In response, participants determinedly developed and tested strategies based on simplified principles, establishing routines for new health habits and portion control, and going back to basics in food selection. Therefore, weight loss programs for this population need to be specifically tailored to support patients' efforts and strategies.

Participants' perspectives of a multi-component, group-based weight loss programme supplement for cardiac rehabilitation: a qualitative study.

Addressing overweight and obesity in people with cardiovascular risk factors is an important aspect of cardiac rehabilitation, but minimal implementation of targeted strategies has occurred. The aim of this study was to describe participants' perspectives of a multi-component, group-based weight loss supplement to cardiac rehabilitation programmes. Four focus groups of participants completing the intervention (n = 16) and maintenance phases (n = 19) of the Healthy Eating and Exercise Lifestyle Program (HEELP) were conducted. Interviews were transcribed and thematically analyzed using an inductive process. The overall theme of participants' responses was that HEELP helped them reprogramme their lifestyle behaviours to achieve weight loss. The programme was unique compared with other weight loss programmes because it was delivered and developed by familiar and expert health professionals who tailored the programme to participants' health status. Themes included the process of recognizing and deciding to make a commitment to managing their weight problem and feeling supported by the group and the staff to do this. Participants valued the group-based structure and the specific tools used in the programme. The programme content and structure provides a framework for the development of supplemental programmes for overweight and obese people at high cardiovascular risk.