Early Advice Research Articles

Risk factors for perinatal cardiac complications in pregnancy with pulmonary hypertension.

To analyze the risk factors for complications in pregnancy associated with pulmonary hypertension (PH) and to develop a logistic regression model to predict cardiac outcomes. A retrospective analysis was performed on 249 women with PH, who were followed at the Beijing Anzhen Hospital, Affiliated to the Capital Medical University, from January 2012 to March 2015. All pregnancies were recorded. Overall, 214 cases of pulmonary arterial hypertension were identified. Univariate analysis and multivariate analysis were performed to determine the risk factors occurring during or after pregnancy in women with PH. Ultimately, six independent risk factors for cardiac events were determined. There were 70 cases of cardiac complications (28.1%) with PH, including 7 cases of maternal death (2.81%). Independent risk factors were rapid progression of symptoms [OR=3.044, 95%CI (1.042-8.895), P<0.05], brain natriuretic peptide (BNP) plasma levels ≥300pg/mL [OR=5.543, 95%CI (1.403-21.896), P<0.05], severe pulmonary hypertension (PAP≥80mmHg, 1mmHg=0.133kPa) [OR=6.769, 95%CI (2.748-16.677), P<0.05], World Health Organization functional class (WHO-FC) III-IV [OR=6.053, 95%CI (2.638-13.886), P<0.05], PH pre-pregnancy [OR=5.434, 95%CI (1.298-22.738), P<0.05], and delivery ≥28weeks gestation [OR=10.876, 95%CI (3.957-29.893), P<0.05]. Early advice on contraception for patients with PH, and the need for patients to undergo a comprehensive assessment of cardiac function pre-pregnancy are suggested from the results of the present study.

Stroke survivors' views and experiences on impact of visual impairment.

ObjectivesWe sought to determine stroke survivors’ views on impact of stroke‐related visual impairment to quality of life.Materials and MethodsStroke survivors with visual impairment, more than 1 year post stroke onset, were recruited. Semistructured biographical narrative interviews were audio‐recorded and transcribed verbatim. A thematic approach to analysis of the qualitative data was adopted. Transcripts were systematically coded using NVivo10 software.ResultsThirty‐five stroke survivors were interviewed across the UK: 16 females, 19 males; aged 20–75 years at stroke onset. Five qualitative themes emerged: “Formal care,” “Symptoms and self,” “Adaptations,” “Daily life,” and “Information.” Where visual problems existed, they were often not immediately recognized as part of the stroke syndrome and attributed to other causes such as migraine. Many participants did not receive early vision assessment or treatment for their visual problems. Visual problems included visual field loss, double vision, and perceptual problems. Impact of visual problems included loss in confidence, being a burden to others, increased collisions/accidents, and fear of falling. They made many self‐identified adaptations to compensate for visual problems: magnifiers, large print, increased lighting, use of white sticks. There was a consistent lack of support and provision of information about visual problems.ConclusionsPoststroke visual impairment causes considerable impact to daily life which could be substantially improved by simple measures including early formal visual assessment, management and advice on adaptive strategies and self‐management options. Improved education about poststroke visual impairment for the public and clinicians could aid earlier diagnosis of visual impairments.

Employment characteristics of a complex adult congenital heart disease cohort.

Due to advances in surgical techniques and subsequent management, there have been remarkable improvements in the survival of patients with congenital heart disease. In particular, larger numbers of patients with complex disease are now living into adulthood and are entering the workforce. To establish the types of employment complex adult congenital heart disease (ACHD) patients are engaged in, based on the largest cohort of patients with a single-ventricle circulation in the UK. Records of all patients with a univentricular (Fontan) circulation at the Queen Elizabeth Hospital were reviewed. Employment status was categorized according to the Standard Occupational Classification criteria (2010). A total of 210 patient records were reviewed. There was the same proportion of professionals in our cohort compared to the rest of the UK (20% versus 20%). There were greater proportions working in the caring, leisure and other service occupations (15% versus 9%), the elementary occupations (17% versus 11%), sales and customer service occupations (14% versus 8%) and administrative and secretarial occupations (12% versus 11%). The reverse trend was observed for associate professions and technical occupations (7% versus 14%), skilled trades (10% versus 11%), process, plant and machine operatives (3% versus 6%) and managers, directors and senior officials (2% versus 10%). The data show that ACHD patients with a single ventricle are engaged in a diverse range of occupations. It is essential that early education and employment advice are given to this cohort to maximize future employment potential.

Early Cultivation Advice

Early Cultivation Advice

Large armored bridging over fractured vertebra with intraspinal tumor mimicking bony mass caused by migrated fragments of burst cervical vertebra presenting with severe cervical myelopathy

Abstract Vertebral body may get displaced anterior or posteror with elements of rotation. However, burst cervical spine vertebral fracture may migrate anteriorly and posteriorly simultaneously. However anterior displaced fragment forming armor like mass is very rare. Similarly, the posteriorly propelled fragments migrating caudally and posterolaterally producing a large osseous mass inside spinal canal mimicking bony tumour causing severe cervical canal stenosis and presenting with marked myelopathy is extremely rare. To the best knowledge of authors, association of such traumatic dual pathology represents first of its kind in western literature, who was neglected early medical advice and presenting with marked compressive cervical myelopathy. She underwent successful surgical decompression with gradual recovery of spastic limb weakness and recovery of sensation. Authors also highlights the importance of early resuscitation and adequate maintainace of mean arterial pressure following acute spinal cord injury. Pertinent literature is briefly reviewed.

Young Women's Perceptions Regarding Communication with Healthcare Providers About Breast Cancer, Risk, and Prevention.

Women younger than 45 years old have lower rates of breast cancer, but higher risk of recurrence and mortality after a cancer diagnosis. African American women are at risk for early onset and increased mortality; Ashkenazi Jewish women are at risk for genetic mutations leading to breast and ovarian cancer. Although younger women are encouraged to talk to doctors about their family history, little is known about these discussions. In 2015, 167 women aged 18-44 years participated in 20 focus groups segmented by geographic location, age, race/ethnicity, and family history of breast and ovarian cancer. Transcript data were analyzed using NVivo 10 software. Although the majority of women talked to their doctor about breast and ovarian cancer, these conversations were brief and unsatisfying due to a lack of detail. Topics included family history, breast cancer screening, and breast self-examination. Some women with and without family history reported that healthcare providers offered screening and early detection advice based on their inquiries. However, few women took action or changed lifestyle behaviors with the intent to reduce risk as a result of the conversations. Conversations with young women revealed missed opportunities to: enhance patient-provider communication and increase knowledge about breast cancer screening and surveillance for higher risk patients. Physicians, allied health professionals, and the public health community can better assist women in getting accurate and timely information about breast and ovarian cancer, understanding their family history to determine risk, and increasing healthy behaviors.

Timing of food introduction and atopy prevention

The apparent increase in atopic disease, particularly food allergy, over the past 2 decades has resulted in reconsideration of prevention strategies aimed at the infant’s diet. Early advice to have atopy-prone infants delay ingestion of potential food allergens, such as egg, cow’s milk, and peanut, was rescinded, as new evidence emerged that did not support these approaches. More recently, randomized controlled trials have provided data to support an opposite strategy, promoting early ingestion of allergens as a means of food allergy prevention. Specifically, new guidelines suggest early ingestion of peanut as a means to prevent peanut allergy. Additional dietary approaches regarding breastfeeding, early introduction of other types of food allergens, formula feeding, dietary nutrients, and probiotics are also under scrutiny as potential preventative strategies. This review focuses on the timing of food introduction as a preventative strategy for food allergy and also discusses other aspects of the infant diet that may provide opportunities for prevention of atopic disease.

Early dynamic ultrasound for neonatal hip instability: implications for rural Australia

BackgroundNeonatal instability of the hip (NIH), where the femoral head can move away from the acetabulum, in the first weeks of life, is an important risk factor for developmental dysplasia of the hip (DDH). In rural areas in Australia, there is a recent trend to increased late diagnosis of DDH. Clinical screening of infant hips, a common practice in Australia, is experience dependent. Best practice early screening techniques are still debated with different techniques and timing used internationally. This systematic review examines early dynamic ultrasound (eDUS) screening for hip instability in the first 6 weeks after birth, and the early interventions informed by these findings and considers the findings for the context of rural Australia.MethodsThe Cochrane Library, Medline, CINAHL and PEDro were searched for original research or systematic reviews, and clinical studies 1998 to 2015 involving dynamic ultrasound. Critical Appraisal Skills Programme tools were used to appraise the studies.ResultNineteen studies were included. Early Dynamic Ultrasound (DUS) is consistently described as a reliable assessment of NIH. Early DUS is recommended for risk factors including geographical areas of high prevalence. Approaches to early intervention of hips with excessive movement are somewhat discipline-related and include: primary prevention (advice), secondary prevention (abduction supports), and conservative management (removable splints).ConclusionsIn the context of increased prevalence of DDH in rural Australia, contemporary evidence suggests that introduction of early DUS could provide rural infants with more effective screening than clinical examination alone. Targeted early advice about posturing and simple removable supports to abduct infant hips could prevent some cases of DDH in rural Australia.

Exploring infant deformational or positional plagiocephaly prevention and management by Maternal Child Health Nurses and Paediatric Physiotherapists

Objectives: To explore Maternal Child Health (MCH) nurses’ and Paediatric Physiotherapists’ (Physiotherapists) experience with infant deformational or positional plagiocephaly (plagiocephaly). Design: Cross-sectional online survey. Setting: Community health setting in Victoria, Australia. Subjects: MCH nurses and Paediatric Physiotherapists in Victoria were invited to participate. Main outcome measures: Survey results were collated and analysed descriptively. Results: Surveys were completed by 183/961(19%) MCH nurses and a sample of 16 Physiotherapists, from a cross section of metropolitan (62%), regional (18%) and rural/remote (24%) Victoria. All MCH nurses and Physiotherapists reported seeing infants with plagiocephaly in the previous 12 months. Responses indicated MCH nurses saw between 11-50 infants with plagiocephaly (n=110). These were first diagnosed by MCH nurses at one to three months. Infants first presented to Physiotherapists on average at four to six months. All MCH nurses and Physiotherapists implemented prevention strategies and both groups thought it was effective subject to parents’ implementing the advice. Strategies for prevention and management of plagiocephaly included early prone play (tummy-time) and counter positioning. Physiotherapists also included gross motor exercises, stretches if torticollis was present and, if appropriate, referral for helmet therapy. Referrals of infants with plagiocephaly by MCH nurses were made to Physiotherapists, General Practitioners, Chiropractors and Osteopaths. Conclusions: All MCH nurses and Physiotherapist respondents see infants with plagiocephaly, MCH nurses earlier than Physiotherapists. The effectiveness of plagiocephaly prevention advice can be called into question because of the high numbers of infants presenting and subsequent referrals to different health professionals. Recommendations from respondents included a review of past initiatives including extensive education for Maternal Child Health Nurses, Pamphlets in their Home visiting pack and video for demonstration at first time mothers group and the provision of clearer early prevention advice in the Government Key Ages and Stages (KAS) Framework for MCH nurses.

Translating Myocardial Remuscularization.

Myocardial remuscularization can be achieved by the implantation of cardiomyocyte-containing grafts. Critical steps toward clinical translation of the first generation cardiac remuscularization therapies include the choice of animal models with high predictive validity for therapeutic outcome in clinical trials. Clinically relevant remuscularization of the failing human heart remains unachieved to date. Proof-of-concept studies in small and large animal models provide compelling evidence as to the principle feasibility of myocardial remuscularization with human cardiomyocyte grafts.1,2 Clinical trials suggest myocardial protection and preservation by cell therapeutics.3,4 The mechanisms underlying the reported therapeutic effects remain under debate, but likely include the release of protective factors (growth factors, noncoding RNA) and modulation of the disease-related inflammatory response. Further studies are needed to define the paracrine milieu hypothesis and unleash its full therapeutic potential, aiming at delaying or preventing disease progression in patients with acute and subacute myocardial injury. The implantation of cardiomyocyte grafts follows a different strategy, namely remuscularization by integration of exogenously produced cardiomyocytes. Patients with chronically scarred myocardium presenting clinically with end-stage heart failure are the primary target. The suggested plug-and-play mechanism of direct cardiac remuscularization seems straight forward, but similar as for the paracrine milieu hypothesis there is a clear need for a better understanding of how, when, and where to integrate exogenous cardiomyocytes into the failing heart to achieve optimal results. Moreover, the path toward clinical application as off-the-shelf cardiomyocyte allograft therapeutics is less defined as for point-of-care autograft formulations and small chemical or biological compounds. A challenge to direct cardiac remuscularization was for many years the limited availability of bona fide cardiomyocytes. Cardiac biopsies can be used to harvest proliferative mesenchymal cells with progenitor cell properties, but without the capacity to spontaneously convert/transdifferentiate into terminally differentiated cardiomyocytes at a therapeutically relevant scale. Induced …

WHY PATIENTS SHOULD BE INVOLVED IN HEALTH TECHNOLOGY ASSESSMENT.

Some countries make considerable effort to involve patients and patient groups in their health technology assessment (HTA) processes; others are only just considering or are yet to consider patient involvement in HTA. This commentary offers four arguments why patient involvement should be prioritized by those HTA agencies that do not yet involve patients: (1) from a patients' rights perspective, (2) based on patient and community values, (3) centering on evidentiary contributions, and (4) from a methodological perspective. The first argument builds on the Alma-Ata Declaration, which holds that patients have a right and duty to have a say in the planning and delivery of their health care, individually and collectively. Where HTA is used to determine access to technologies and services, we argue that patients have a right to be heard. The second argues that decisions about treatments and services need to be aligned with the core values and morals of the patients whom the health system serves. The third argues that patients have unique knowledge and insights about living with a health condition and their needs for services and treatments regarding that condition, which can add to the knowledge base and value of the HTA process. The fourth argues that involvement of patients can facilitate methodological advancement of HTA, in areas such as early scientific advice and managed entry with evidence development. An HTA process that includes patient perspectives can, therefore, provide added value to patients, policy makers and healthcare professionals alike.

Social Media and Authoritarianism

An analysis of the purported potential of social media as a democracy catalyzer is performed, paying attention to its role during the Iranian Protests and the Arab Spring. Then, the different ways in which authoritarian regimes can tamper social are explored.Social media is not a democratization force and authoritarian regimes can exploit it to their advantage. Moreover, there is a trend towards authoritarianism with regards to social media in a number of countries including Western democracies.This paper dispels the idea that social media may be a democratization catalyzer and shows that, instead, social media is considered a problem by many countries including full democracies. I argue that the combination of war on terror, economic crisis, contentious politics and populism bodes badly for liberal democracies with social media regulation being an early advice of future democratic erosions.

Management of Premenstrual Syndrome: Green-top Guideline No. 48.

Management of Premenstrual Syndrome: Green-top Guideline No. 48.

Edith Wharton in Washington, 2–4 June 2016

Edith Wharton in Washington, 2–4 June 2016

PHP305 - G-BA Early Advice VS. EMA/HTA Parallel Advice from a German Perspective

PHP305 - G-BA Early Advice VS. EMA/HTA Parallel Advice from a German Perspective

PHP374 - Strategic Considerations to Engage in Early Advice with European Health Technology Assessment Bodies

PHP374 - Strategic Considerations to Engage in Early Advice with European Health Technology Assessment Bodies

PHP383 - Adaptive Reimbursement Model: How to Correlate The Price to The Level of Evidences During The Entire Drug Life Cycle

Accelerated processes are defined by Regulatory to grant authorization for therapies with high unmet medical needs often based on limited, or preliminary set of evidences. This high degree of uncertainty makes reimbursement decision a complex exercise and can lead to negative decisions: Delay of reimbursement, deferring access of innovative treatment to patients; Negative reimbursement while treatment may demonstrate its incremental benefits at a later stage, preventing patients’ access to innovative treatments; Positive reimbursement while treatment may not have any incremental benefits at a later stage, negatively impacting budget to detriment of effective treatment. Additional flexibility in reimbursement is needed where Italy, leveraging their existing infrastructure can pioneer adaptive reimbursement. Four Practical Recommendations were derived: Foster greater collaboration between Regulatory and decision makers (Adaptive Pathways and PRIME) to ensure HTA evidence standards are met; Run early HTA advice to collect feedback from decision makers; collect real-life evidences leveraging AIFA registry; Set simple, clear criteria when defining exit strategy; must consider cases with negative results to decide whether to continue reimbursement or withdraw treatment from the market; Pricing agreement must be financially sustainable for both parties; use Managed Entry Agreement with fair risk sharing. The need for adaptive reimbursement model is clearly recognized by decision makers and pharmaceutical companies. The most significant hurdle is to define the price agreement and prevent pharmaceutical companies to price at the high end of the market. Conversely, a lack of belief in the decision makers’ ability to increase pricing persists. Thanks to AIFA system, Italy shall pilot a concrete example of adaptive reimbursement model to create confidence in the approach.

Doctors’ recognition and management of melanoma patients’ risk: An Australian population-based study

BackgroundGuidelines recommend that health professionals identify and manage individuals at high risk of developing melanoma, but there is limited population-based evidence demonstrating real-world practices. ObjectiveA population-based, observational study was conducted in the state of New South Wales, Australia to determine doctors’ knowledge of melanoma patients’ risk and to identify factors associated with better identification and clinical management. MethodsData were analysed for 1889 patients with invasive, localised melanoma in the Melanoma Patterns of Care study. This study collected data on all melanoma diagnoses notified to the state’s cancer registry during a 12-month period from 2006 to 2007, as well as questionnaire data from the doctors involved in their care. ResultsThree-quarters (74%) of patients had doctors who were aware of their risk factor status with respect to personal and family history of melanoma and the presence of many moles. Doctors working in general practice, skin cancer clinics and dermatology settings had better knowledge of patients’ risk factors than plastic surgeons. Doctors were 15% more likely to know the family history of younger melanoma patients (<40years) than of those ≥80 years (95% confidence interval 4–26%). Early detection-related follow-up advice was more likely to be given to younger patients, by doctors aware of their patients’ risk status, by doctors practising in plastic surgery, dermatology and skin cancer clinic settings, and by female doctors. ConclusionBoth patient-related and doctor-related factors were associated with doctors’ recognition and management of melanoma patients’ risk and could be the focus of strategies for improving care.

Does it matter whether physicians' recommendations are given early or late in the decision-making process? An experimental study among patients with schizophrenia.

ObjectivesPhysicians' recommendations are seen as an essential component in many models of medical decision-making, including shared decision-making. It is, however, unclear at what time in the decision-making process the recommendation is best given, not to adversely influence patient preferences. Within the present study we wanted to evaluate at what time in the decision-making process a doctor's recommendation is best given, not to adversely influence patient preferences.DesignWe performed an experimental study involving hypothetical decisions vignettes and compared the influence of 3 conditions (no advice, early advice, late advice) on patients' decision-making.SettingN=21 psychiatric hospitals in Germany.ParticipantsN=208 inpatients suffering from schizophrenia.Primary and secondary outcome measuresThe main outcome was the number of patients choosing the option in each experimental condition that had been less preferable to most patients during pretests. Additional outcome measures were patient satisfaction and reactance.ResultsPatients in the ‘late advice’ condition more often (n=49) accepted an advice that was against their preferences compared with the other conditions (n=36 for ‘early advice’, p=0.024).ConclusionsAlthough giving advice is an important part of every doctor's daily practice and is seen as an essential element of shared decision-making, hitherto there has been little empirical evidence relating to the influence of physicians' advice on patients' decision-making behaviour. With our study we could show that the point in time an advice is given by a physician does have an influence on patients' decisional behaviour even if the mechanism of this effect is not yet understood.

Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) trial: the protocol for a large pilot study

IntroductionAcute kidney injury (AKI) contributes to morbidity and mortality, and its care is often suboptimal and/or delayed. The Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) study is a...