bluuebunny/crossref_metadata_2025_split huggingface dataset:
Protocol for a quasi-experimental study of the effectiveness and cost-effectiveness of mother and baby units compared with general psychiatric inpatient wards and crisis resolution team services (The ESMI study) in the provision of care for women in the postpartum period
Authors: Trevillion Kylee , Shallcross Rebekah , Ryan Elizabeth , Heslin Margaret , Pickles Andrew , Byford Sarah , Jones Ian , Johnson Sonia , Pawlby Susan , Stanley Nicky , Rose Diana , Seneviratne Gertrude , Wieck Angelika , Jennings Stacey , Potts Laura , Abel Kathryn M , Howard Louise M 
Published: March 2019

IntroductionResearch into what constitutes the best and most effective care for women with an acute severe postpartum mental disorder is lacking. The effectiveness and cost-effectiveness of psychiatric mother and baby units (MBUs) has not been investigated systematically and there has been no direct comparison of the outcomes of mothers and infants admitted to these units, compared with those accessing generic acute psychiatric wards or crisis resolution teams (CRTs). Our primary hypothesis is that women with an acute psychiatric disorder, in the first year after giving birth, admitted to MBUs are significantly less likely to be readmitted to acute care (an MBU, CRTs or generic acute ward) in the year following discharge than women admitted to generic acute wards or cared for by CRTs.Methods and analysisQuasi-experimental study of women accessing different types of acute psychiatric services in the first year after childbirth. Analysis of the primary outcome will be compared across the three service types, at 1-year postdischarge. Cost-effectiveness will be compared across the three service types, at 1-month and 1-year postdischarge; explored in terms of quality-adjusted life years. Secondary outcomes include unmet needs, service satisfaction, maternal adjustment, quality of mother–infant interaction. Outcomes will be analysed using propensity scoring to account for systematic differences between MBU and non-MBU participants. Analyses will take place separately within strata, defined by the propensity score, and estimates pooled to produce an average treatment effect with weights to account for cohort attrition.Ethics and disseminationThe study has National Health Service (NHS) Ethics Approval and NHS Trust Research and Development approvals. The study has produced protocols on safeguarding maternal/child welfare. With input from our lived experience group, we have developed a dissemination strategy for academics/policy-makers/public.
A qualitative study of cancer care professionals’ experiences of working with migrant patients from diverse cultural backgrounds
Authors: Broom Alex , Parker Rhiannon Bree , Kirby Emma , Kokanović Renata , Woodland Lisa , Lwin Zarnie , Koh Eng-Siew 
Published: March 2019

ObjectivesTo improve the experiences of people from diverse cultural backgrounds, there has been an increased emphasis on strengthening cultural awareness and competence in healthcare contexts. The aim of this focus-group based study was to explore how professionals in cancer care experience their encounters with migrant cancer patients with a focus on how they work with cultural diversity in their everyday practice, and the personal, interpersonal and institutional dimensions therein.DesignThis paper draws on qualitative data from eight focus groups held in three local health districts in major metropolitan areas of Australia. Participants were health professionals (n=57) working with migrants in cancer care, including multicultural community workers, allied health workers, doctors and nurses. Focus group discussions were audio recorded and transcribed in full. Data were analysed using the framework approach and supported by NVivo V.11 qualitative data analysis software.ResultsFour findings were derived from the analysis: (1) culture as merely one aspect of complex personhood; (2) managing culture at the intersection of institutional, professional and personal values; (3) balancing professional values with patient values and beliefs, and building trust and respect; and (4) the importance of time and everyday relations for generating understanding and intimacy, and for achieving culturally competent care.ConclusionsThe findings reveal: how culture is often misconstrued as manageable in isolation; the importance of a renewed emphasis on culture as interpersonalandinstitutional in character; and the importance of prioritising the development of quality relationships requiring additional time and resource investments in migrant patients for enacting effective intercultural care.
Typical use effectiveness of Natural Cycles: postmarket surveillance study investigating the impact of previous contraceptive choice on the risk of unintended pregnancy
Authors: Bull Jonathan , Rowland Simon , Lundberg Olof , Berglund-Scherwitzl Elina , Gemzell-Danielsson Kristina , Trussell James , Scherwitzl Raoul 
Published: March 2019

ObjectiveTo investigate the association between contraceptive effectiveness of Natural Cycles and users’ previous choice of contraceptive, and to evaluate the impact of shifting from other methods to Natural Cycles on the risk of unintended pregnancy.SettingNatural Cycles mobile application.Participants16 331 Natural Cycles users in Sweden for the prevention of pregnancy.Outcome measuresRisk of unintended pregnancy.Study designReal world evidence was collected from Natural Cycles users regarding contraceptive use prior to using Natural Cycles and sexual activity while using Natural Cycles. We calculated the typical use 1-year Pearl Index (PI) and 13-cycle failure rate of Natural Cycles for each cohort. The PI was compared with the population PI of their stated previous methods.ResultsFor women who had used condoms before, the PI of Natural Cycles was the lowest at 3.5±0.5. For women who had used the pill before, the PI of Natural Cycles was the highest at 8.1±0.6. The frequency of unprotected sex on fertile days partially explained some of the observed variation in PI between cohorts. 89% of users switched to Natural Cycles from methods with higher or similar reported PIs.ConclusionThe effectiveness of Natural Cycles is influenced by previous contraceptive choice and this should be considered when evaluating the suitability of the method for the individual. We estimate that Natural Cycles usage can reduce the overall likelihood of having an unintended pregnancy by shifting usage from less effective methods.
Multicentre, prospective, randomised, controlled, blinded-endpoint study to evaluate the efficacy and safety of pterygopalatine ganglion pulsed radiofrequency treatment for cluster headache: study protocol
Authors: Li Jin , Ren Hao , Wang Baoguo , Wu Dasheng , Luo Fang 
Published: March 2019

IntroductionSingle-centre reports on small groups of patients have shown that pterygopalatine ganglion pulsed radiofrequency treatment in patients with refractory cluster headache (CH) can quickly relieve pain without significant side effects. However, a randomised controlled trial is still necessary to evaluate whether pterygopalatine ganglion pulsed radiofrequency (PRF) treatment is a viable treatment option for patients with CH who are not responding to drug treatment.Methods and analysisThis investigation is a multicentre, prospective, randomised, controlled, blinded-endpoint study. We will enrol 80 patients with CH who are not responding to medication. The enrolled patients will be randomly divided into two groups: the nerve block (NB) group and the PRF group. All patients will undergo CT-guided pterygopalatine ganglion puncture. A mixture containing steroids and local anaesthetics will be slowly injected into the patients in the NB group. The patients in the PRF group will be treated with PRF at 42°C for 360 s. After treatment, the duration of cluster periods; degree of pain during headache attacks; frequency of headache attacks; duration of each headache attack; dose of auxiliary analgesic drugs; duration of remission; degree of patient satisfaction; effectiveness rates at 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after the procedure; and intraoperative and postoperative adverse events will be compared between the two groups.Ethics and disseminationThis study was approved by the institutional ethics committee of the Beijing Tiantan Hospital (approval number: KY 2018-027-02). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings.Trial registration numberNCT03567590; Pre-results.
Modified Delphi survey for the evidence summarisation of patient decision aids: Study protocol
Authors: Durand Marie-Anne , Dannenberg Michelle D , Saunders Catherine H , Giguere Anik M C , Alper Brian S , Hoffmann Tammy , Perestelo-Pérez Lily , Campbell Stephen T , Elwyn Glyn 
Published: March 2019

IntroductionInformation included in a patient decision aid (PDA) can significantly influence patients’ decisions and is, therefore, expected to be evidence-based and rigorously selected and summarised. PDA developers have not yet agreed on a standardised process for the selection and summarisation of the supporting evidence. We intend to generate consensus on a process (and related steps and criteria) for selecting and summarising evidence for PDAs using a modified Delphi survey.Methods and analysisWe will develop an evidence summarisation process specific to PDA development by using a consensus-based Delphi approach, surveying international experts and stakeholders with two to three rounds. To increase generalisability and acceptability, we will distribute the survey to the following stakeholder groups: PDA developers, researchers with expertise in shared decision making, PDA development and evidence summarisation, members of the International Patient Decision Aids Standards (IPDAS) collaboration, policy makers with expertise in PDA certification and patient stakeholder groups. For each criterion, if at least 80% of survey participants rank the criterion as most important/least important, we will consider that consensus has been achieved.Ethics and disseminationIt is critical for PDAs to have accurate and trustworthy evidence-based information about the risks and benefits of health treatments and tests, as these decision aids help patients make important choices. We want to generate consensus on an approach for selecting and summarising the evidence included in PDAs, which can be widely implemented by PDA developers. Dartmouth College’s Committee for the Protection of Human Subjects approved this protocol. We will publish our results in a peer reviewed journal.
INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol
Authors: Collings Richard , Freeman Jennifer A , Latour Jos , Vickery Patricia Jane , Glasser Sam , Lepesis Vasileios , Enki Doyo , Paton Joanne 
Published: March 2019

IntroductionFoot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.AimThis study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.Methods and analysisThis study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.Ethics and disseminationThe study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.Trials registration numberISRCTN16011830; Pre-results.
Encounter rates and group sizes of diurnal primate species of Mole National Park, Ghana
Authors: Wiafe Edward Debrah 
Published: March 2019

Primate species are not widely explored in Ghana’s savannah ecosystems. We report data on encounter rates and group sizes of primates at the Mole National Park in Ghana. Forty transects, each of 5km length, were randomly laid in the park for the study. Four species of primates were visually recorded during field surveys: Olive Baboon Papio anubis, Patas Monkey Erythrocebus patas, Green Monkey Chlorocebus sabaeus and Colobus vellerosus. The status of C. vellerosus is Critically Endangered, the status of the other species is Least Concern according to the IUCN Red List. Encounter rates (groups/km) were 0.98, 0.65 and 0.45 for Olive Baboons, Patas Monkeys and Green Monkeys respectively. The mean group sizes were: Olive Baboon 10.8 (SE=1.1, range=1-38), Patas Monkey 12.2 (SE=3.3, range=1-35), and Green Monkey 10.0 (SE=1.9, range=1-25). Only one group of White-thighed Colobus with a group size of six was encountered. Encounter rates and group sizes of the same species varied in different parts of the park, and factors such as resource distribution and security against secret hunting may have influenced this variation. Authors recommend further studies to facilitate better understanding of these primates.
Usefulness of Blood Pressure Variability Indices Derived From 24‐Hour Ambulatory Blood Pressure Monitoring in Detecting Autonomic Failure
Authors: Lodhi Hamza A. , Peri‐Okonny Poghni A. , Schesing Kevin , Phelps Kamal , Ngo Christian , Evans Hillary , Arbique Debbie , Price Angela L. , Vernino Steven , Phillips Lauren , Mitchell Jere H. , Smith Scott A. , Yano Yuichiro , Das Sandeep R. , Wang Tao , Vongpatanasin Wanpen 
Published: March 2019

Background

Increased blood pressure (
BP
) variability and nondipping status seen on 24‐hour ambulatory
BP
monitoring are often observed in autonomic failure (
ATF
).

Methods and Results

We assessed
BP
variability and nocturnal
BP
dipping in 273 patients undergoing ambulatory
BP
monitoring at Southwestern Medical Center between 2010 and 2017.
SD
, average real variability, and variation independent of mean were calculated from ambulatory
BP
monitoring. Patients were divided into a discovery cohort (n=201) and a validation cohort (n=72).
ATF
was confirmed by formal autonomic function test. In the discovery cohort, 24‐hour and nighttime average real variability,
SD
, and variation independent of mean did not differ significantly between
ATF
(n=25) and controls (n=176, all
P
>0.05). However, daytime SD, daytime coefficient of variation, and daytime variation independent of mean of systolic
BP
(
SBP
) were all significantly higher in patients with
ATF
than in controls in both discovery and validation cohorts. Nocturnal
BP
dipping was more blunted in
ATF
patients than controls in both cohorts (both
P
<0.01). Using the threshold of 16 mm Hg, daytime SD
SBP
yielded a sensitivity of 77% and specificity of 82% in detecting
ATF
in the validation cohort, whereas nondipping status had a sensitivity of 80% and specificity of 44%. The area under the receiver operator characteristic of daytime
SD SBP
was greater than the area under the receiver operator characteristic of nocturnal
SBP
dipping (0.79 [0.66‐0.91] versus 0.73 [0.58‐0.87], respectively).

Conclusions

Daytime
SD
of
SBP
is a better screening tool than nondipping status in detecting autonomic dysfunction.
Toll‐Like Receptor 9 Plays a Pivotal Role in Angiotensin II–Induced Atherosclerosis
Authors: Fukuda Daiju , Nishimoto Sachiko , Aini Kunduziayi , Tanaka Atsushi , Nishiguchi Tsuyoshi , Kim‐Kaneyama Joo‐ri , Lei Xiao‐Feng , Masuda Kiyoshi , Naruto Takuya , Tanaka Kimie , Higashikuni Yasutomi , Hirata Yoichiro , Yagi Shusuke , Kusunose Kenya , Yamada Hirotsugu , Soeki Takeshi , Imoto Issei , Akasaka Takashi , Shimabukuro Michio , Sata Masataka 
Published: March 2019

Background

Toll‐like receptor (
TLR
) 9 recognizes bacterial
DNA
, activating innate immunity, whereas it also provokes inflammation in response to fragmented
DNA
released from mammalian cells. We investigated whether
TLR
9 contributes to the development of vascular inflammation and atherogenesis using apolipoprotein E–deficient (
Apoe

−/−

) mice.

Methods and Results

Tlr9
‐deficient
Apoe

−/−

(
Tlr9

−/−

Apoe

−/−

) mice and
Apoe

−/−

mice on a Western‐type diet received subcutaneous angiotensin
II
infusion (1000 ng/kg per minute) for 28 days. Angiotensin
II
increased the plasma level of double‐stranded DNA, an endogenous ligand of
TLR
9, in these mice. Genetic deletion or pharmacologic blockade of
TLR
9 in angiotensin II–infused
Apoe

−/−

mice attenuated atherogenesis in the aortic arch (
P
<0.05), reduced the accumulation of lipid and macrophages in atherosclerotic plaques, and decreased
RNA
expression of inflammatory molecules in the aorta with no alteration of metabolic parameters. On the other hand, restoration of
TLR
9 in bone marrow in
Tlr9

−/−

Apoe

−/−

mice promoted atherogenesis in the aortic arch (
P
<0.05). A
TLR
9 agonist markedly promoted proinflammatory activation of
Apoe

−/−

macrophages, partially through p38 mitogen‐activated protein kinase signaling. In addition, genomic
DNA
extracted from macrophages promoted inflammatory molecule expression more effectively in
Apoe

−/−

macrophages than in
Tlr9

−/−

Apoe

−/−

macrophages. Furthermore, in humans, circulating double‐stranded
DNA
in the coronary artery positively correlated with inflammatory features of coronary plaques determined by optical coherence tomography in patients with acute myocardial infarction (
P
<0.05).

Conclusions

TLR
9 plays a pivotal role in the development of vascular inflammation and atherogenesis through proinflammatory activation of macrophages.
TLR
9 may serve as a potential therapeutic target for atherosclerosis.
Global Brain Perfusion and the Risk of Transient Ischemic Attack and Ischemic Stroke: The Rotterdam Study
Authors: Fani Lana , Bos Daniel , Mutlu Unal , Portegies Marileen L.P. , Zonneveld Hazel I. , Koudstaal Peter J. , Vernooij Meike W. , Ikram M. Arfan , Ikram M. Kamran 
Published: March 2019

Background

The role of subtle disturbances of brain perfusion in the risk of transient ischemic attack (
TIA)
or ischemic stroke remains unknown. We examined the association between global brain perfusion and risk of
TIA
and ischemic stroke in the general population.

Methods and Results

Between 2005 and 2015, 5289 stroke‐free participants (mean age, 64.3 years; 55.6% women) from the Rotterdam Study underwent phase‐contrast brain magnetic resonance imaging at baseline to assess global brain perfusion. These participants were followed for incident
TIA
or ischemic stroke until January 1, 2016. We investigated associations between global brain perfusion (mL of blood flow/100 mL of brain/min) and risk of
TIA
and ischemic stroke using Cox regression models with adjustment for age, sex, and cardiovascular risk factors. Additionally, we investigated whether associations were modified by retinal vessel calibers, small and large vessel disease, blood pressure, and heart rate. During a median follow‐up of 7.2 years (36 103 person‐years), 137 participants suffered a
TIA
and another 108 an ischemic stroke. We found that lower global brain perfusion was associated with a higher risk of
TIA
, but not with the risk of ischemic stroke (adjusted hazard ratio, 95% CI, per standard deviation decrease of global brain perfusion: 1.29, 1.07–1.55 for
TIA
and adjusted hazard ratio of 1.06, 0.87–1.30 for ischemic stroke). Across strata of wider arteriolar retinal calibers, lower brain perfusion was more prominently associated with
TIA
, but not with ischemic stroke.

Conclusions

In a community‐dwelling population, impaired global brain perfusion increased the risk of
TIA
, but not of ischemic stroke.
Adherence to Guidelines for Screening Polysomnography in Children with Down Syndrome
Authors: Knollman Philip D. , Heubi Christine H. , Meinzen‐Derr Jareen , Smith David F. , Shott Sally R. , Wiley Susan , Ishman Stacey L. 
Published: March 2019

ObjectivesTo compare the percentage and mean age of children with Down syndrome (DS) who underwent polysomnography (PSG) to evaluate for obstructive sleep apnea (OSA) before and after the introduction of the American Academy of Pediatrics guidelines recommending universal screening by age 4 years.Study DesignRetrospective cohort study.SettingSingle tertiary pediatric hospital.MethodsThis study is a review of patients with DS seen in a subspecialty clinic. Children born preguidelines (2000‐2006) were compared with children born postguidelines (2007‐2012) regarding percentage receiving PSG, age at first PSG, and rate of OSA.ResultsWe included 766 children with DS; 306 (40%) were born preguidelines. Overall, 61% (n = 467) underwent PSG, with a mean ± SD age of 4.2 ± 2.9 years at first PSG; 341 (44.5%) underwent first PSG by age 4 years. The rate of OSA (obstructive index ≥1 event/hour) among children undergoing first PSG was 78.2%. No difference was seen in the percentage receiving PSG preguidelines (63.4%) versus postguidelines (59.4%, P =. 26). The mean age at the time of first PSG was 5.3 ± 3.5 years preguidelines versus 3.4 ± 2.0 years postguidelines (P <. 0001). Children in the postguidelines cohort were more likely to undergo first PSG during the ages of 1 through 4 years (67.4% vs 52.1%, P <. 0001). There was no difference in rates of OSA between the pre‐ and postguidelines cohorts (79.8% vs 75.9%, P =. 32).ConclusionsNearly two‐thirds of children with DS (61%) underwent PSG overall, with a significant shift toward completion of PSG at an earlier age after the introduction of the American Academy of Pediatrics guidelines for universal screening for OSA.