A treatment strategy with nifedipine versus labetalol for women with pregnancy hypertension: study protocol for a randomised controlled trial (Giant PANDA).

BACKGROUND: Approximately one in ten women have high blood pressure during pregnancy. Hypertension is associated with adverse maternal and perinatal outcomes, and as treatment improves maternal outcomes, antihypertensive treatment is recommended. Previous trials have been unable to provide a definitive answer on which antihypertensive treatment is associated with optimal maternal and neonatal outcomes and the need for robust evidence evaluating maternal and infant benefits and risks remains an important, unanswered question for research and clinical communities. METHODS: The Giant PANDA study is a pragmatic, open-label, multicentre, randomised controlled trial of a treatment initiation strategy with nifedipine (calcium channel blocker), versus labetalol (mixed alpha/beta blocker) in 2300 women with pregnancy hypertension. The primary objective is to evaluate if treatment with nifedipine compared to labetalol in women with pregnancy hypertension reduces severe maternal hypertension without increasing fetal or neonatal death or neonatal unit admission. Subgroup analyses will be undertaken by hypertension type (chronic, gestational, pre-eclampsia), diabetes (yes, no), singleton (yes, no), self-reported ethnicity (Black, all other), and gestational age at randomisation categories (11 + 0 to 19 + 6, 20 + 0 to 27 + 6, 28 + 0 to 34 + 6 weeks). A cost-effectiveness analysis using an NHS perspective will be undertaken using a cost-consequence analysis up to postnatal hospital discharge and an extrapolation exercise with a lifetime horizon conditional on the results of the cost-consequence analysis. DISCUSSION: This trial aims to address the uncertainty of which antihypertensive treatment is associated with optimal maternal and neonatal outcomes. The trial results are intended to provide definitive evidence to inform guidelines and linked, shared decision-making tools, thus influencing clinical practice. TRIAL REGISTRATION: EudraCT number: 2020-003410-12, ISRCTN: 12,792,616 registered on 18 November 2020.

Effect of protein and glucogenic precursor supplementation on forage digestibility, serum metabolites, energy utilization, and rumen parameters in sheep.

Supplementation of glucogenic precursors in roughage diets may increase production responses due to improved efficiencies of nutrient utilization. Therefore, the objective of this study was to determine the effect of source of supplemental glucogenic potential (GP) on forage digestibility, serum metabolites, energy utilization, and rumen parameters of growing wethers consuming a roughage diet (8.8% crude protein, 71.4% ash-free neutral detergent fiber). Crossbred wethers (49.1 ± 4.7 kg initial BW; n = 16) were utilized in a 4 × 4 replicated Latin Square design with four periods of 21 d. Supplements were designed to supplement increasing amount of GP: 1) no supplementation (CON; 0 g), 2) 40 g of calcium propionate (CAP; 30 g of GP), 3) 70 g of blood meal + 100 g of feather meal (BF; 40 g of GP), or 4) combination of CAP and BF (COMBO; 70 g of GP). Total fecal and urine collection was conducted from days 13-17 to calculate digestibility estimates and urinary losses. An acetate tolerance test was administered on day 17 to determine the effect of GP on acetate clearance. Blood samples were collected on day 19 and were analyzed for serum concentrations of glucose, urea N (SUN), non-esterified fatty acids, and amino acids. Rumen fluid was collected on day 21 to determine supplementation effects on ruminal volatile fatty acid (VFA) and ammonia concentrations. Wethers receiving BF and COMBO supplementation had greatest (P ≤ 0.01) DM and OM total tract digestibility. Supplementation did not affect (P ≥ 0.37) NDF digestibility or digestible energy. Urinary nitrogen excretion was greatest (P = 0.02) for BF and COMBO. Circulating serum essential amino acid concentration was increased (P < 0.01) in BF and COMBO compared to CAP and CON. In addition, BF and COMBO had increased (P < 0.01) SUN concentrations compared to CAP and CON. Acetate half-life was not affected (P = 0.39) by supplementation strategy. However, area under the curve (AUC) for acetate was decreased (P = 0.04) with supplementation of BF and COMBO compared to CON-fed wethers. Ruminal propionate concentration was increased (P ≤ 0.01) for wethers fed CAP and COMBO supplementation, which resulted in decreased (P ≤ 0.01) A:P ratio. Overall, these results indicate that the increased propionate supply by providing propionate salts did not result in a protein sparing impact or increased N retention.

Implementation of national antenatal hypertension guidelines: a multicentre multiple methods study.

OBJECTIVE: To evaluate the implementation of National Institute for Health and Care Excellence antenatal hypertension guidelines, to identify strategies to reduce incidences of severe hypertension and associated maternal and perinatal morbidity and mortality in pregnant women with chronic hypertension. METHODS: We used a multiple method multisite approach to establish implementation of guidelines and the associated barriers and facilitators. We used a national survey of healthcare professionals (n=97), case notes review (n=55) and structured observations (n=42) to assess implementation. The barriers and facilitators to implementation were identified from semistructured qualitative interviews with healthcare professionals (n=13) and pregnant women (n=18) using inductive thematic analysis. The findings were integrated and evaluated using the Consolidated Framework for Implementation Research. SETTING AND PARTICIPANTS: Pregnant women with chronic hypertension and their principal carers (obstetricians, midwives and physicians), at three National Health Service hospital trusts with different models of care. RESULTS: We found severe hypertension to be prevalent (46% of case notes reviewed) and target blood pressure practices to be suboptimal (56% of women had an antenatal blood pressure target documented). Women were infrequently given information (52%) or offered choice (19%) regarding antihypertensives. Women (14/18) reported internal conflict in taking antihypertensives and non-adherence was prevalent (8/18). Women who were concordant with treatment recommendations described having mutual trust with professionals mediated through appropriate information, side effect management and involvement in decision making. Professionals reported needing updates and tools for target blood pressure setting and shared decision making underpinned by antihypertensive safety and effectiveness research. CONCLUSIONS: Women's non-adherence to antihypertensives is higher than anticipated. Suboptimal information provision around treatment, choice of antihypertensives and target setting practices by healthcare professionals may be contributory. Understanding the reasons for non-adherence will inform education and decision-making strategies needed to address both clinician and women's behaviour. Further research into the effectiveness and long-term safety of common antihypertensives is also required.

A randomised controlled trial of long-chain omega-3 polyunsaturated fatty acids in the management of rotator cuff related shoulder pain.

STUDY DESIGN: Multicentre, double-blind, placebo-controlled randomised clinical trial. OBJECTIVES: To compare the effectiveness of long chain omega-3 polyunsaturated fatty acids (PUFAs) as part of the management for people diagnosed with rotator cuff related shoulder pain (RCRSP). SUMMARY OF BACKGROUND: Although there is no robust evidence to support their use, omega-3 PUFAs have been recommended for those with tendinopathy due to their potential to moderate inflammation. METHODS: Participants with RCRSP (n=73) were randomised to take either nine MaxEPA capsules providing 1.53 g eicosapentaenoic acid, 1.04 g docosahexaenoic acid or nine matching placebo capsules containing oleic acid per day for 8 weeks. In addition, participants attended an exercise/education programme for 8 weeks. Participants were assessed at prerandomisation, 8 weeks (primary outcome point), 3 months, 6 months and 12 months (secondary outcome point). Primary outcome was the Oxford Shoulder Score (OSS). Secondary outcomes included the Shoulder Pain and Disability Index (SPADI), Patient Specific Functional Score, Euro Qol 5D-3L, Short Form 36, global rating of change and impairment measurements. Analysis was by intention to treat. RESULTS: Difference in the change in the OSS between the two groups at 2 months was -0.1 (95% CI -2.6 to 2.5, p=0.95). The change in SPADI scores was -8.3 (95% CI -15.6 to -0.94, p=0.03, analysed by analysis of covariance adjusted for baseline) at 3 months. CONCLUSION:  Omega-3 PUFA supplementation may have a modest effect on disability and pain outcomes in RCRSP.

Evaluating the Effectiveness of a Dialectical Behaviour Therapy (DBT) Informed Programme in a Community Perinatal Team.

BACKGROUND: Adapted DBT programmes have been well documented but little has been published on such programmes in the perinatal period. AIM: To assess the effectiveness of a stand-alone DBT skills group for perinatal women with emotion dysregulation. METHOD: A stand-alone DBT-informed skills training group was offered to 21 women with emotional dysregulation under the care of a perinatal community mental health team; 14 completed the programme. Staff received support via a consultation group. Modules included mindfulness, emotional regulation, distress tolerance and interpersonal effectiveness adapted to the specific demands of parenting infants. Outcome measures were collected at three time points: assessment, start of the group and at the end. RESULTS: Statistical analysis showed significant reduction in CORE scores over the intervention period (t (13) = 5.32, p < .001; Cohen's d = 0.83), with similar effects on the Mental Health Confidence Scale (t (13) = ‒8.03, p < .001, Cohen's d = 0.83) and Living with Emotions Scale (t (13) = ‒9.42, p < .001, Cohen's d = 0.93). There were no significant changes on these three measures from assessment to start of the group. CONCLUSIONS: In this uncontrolled study, the intervention period was associated with reduced distress, increased confidence and ability to regulate emotion. Recommendations for continuing this model of service delivery are made. Further research is needed.

Care and treatment of hepatitis C among Aboriginal people in New South Wales, Australia: implications for the implementation of new treatments.

INTRODUCTION: Despite Aboriginal Australians being over-represented in populations of people living with hepatitis C (HCV), there is a dearth of research to guide policy and programme development in the area of care and treatment, particularly relating to new HCV treatments. METHOD: In-depth interviews were conducted with 39 people identifying as Aboriginal Australians and living with HCV in New South Wales. RESULTS: Participants' experiences were characterised by a lack of detailed or appropriate information provided at diagnosis, high levels of stigma associated with HCV and low overall knowledge of HCV as reported for themselves and their communities. Despite poor diagnosis experiences, participants had undertaken changes to their lifestyle, especially in relation to alcohol use, in order to promote liver health. Concerns about treatment side effects and efficacy impacted participants' decisions to undertake treatment. Eleven participants had undertaken HCV treatment in a variety of care models with a peer worker and in prison. CONCLUSIONS: The similarities between concerns and experiences of Aboriginal people and other populations living with HCV do not suggest that services and strategies to engage these populations should also be the same. These results suggest that further engagement of the primary care sector in HCV care is important as well as increasing Aboriginal community knowledge of HCV. A variety of service models should be available to meet individuals' preferences, including those offered within Aboriginal community controlled health services emphasising holistic notions of health, and supported by information and communication programmes using principles of health literacy relevant to Aboriginal people.