Facial Plastic Surgery

Forehead and Orbital Rim Remodeling
Facial features remodeling surgery is performed to obtain feminization of the face that corresponds to the gender perceived by patients. This includes techniques and findings to remodel the forehead and orbital rim to change the expression of the eyes, correction of the frontonasal angle in relation to rhinoplasty, hairline feminization, and eyebrow lift to correct the position and aesthetic dissatisfaction or the effects of aging.

Gender-related Facial Analysis
There exist several known anthropometric differences between the male and female facial skeleton and soft tissues. In general, the female face is less robust, rounder or heart shaped, with a shorter forehead, no supraorbital bossing, a smaller nose, more pronounced zygomatic prominences, fuller lips, a smaller mandibular width, and a more tapered chin. A method for analyzing these differences is critical for offering facial gender confirming surgery to the gender dysphoric patients, both for preoperative planning, as well as for setting postoperative expectations.

Lip Lift
The male upper lip has a distinctly longer cutaneous height from the nasal base to the upper vermilion border than its female counterpart. The subnasal indirect lip lift using the bullhorn technique or its modifications allows for shortening of this height to feminize the lower face, creating a more aesthetically pleasing upper lip secondary to increased vermilion height and lip pout. Patient selection is critical, taking into account lip height, vermilion height, alar base width, skin type, upper incisal show, and maxillary height. Precise measurements, controlled excision of the planned resection, and meticulous reapproximation of skin provide an aesthetic result, while minimizing visible scarring.

Lower Jaw Recontouring in Facial Gender-Affirming Surgery
Facial gender-affirming surgery can have significant impact on patient quality of life for some gender-dysphoric patients. Lower jaw contouring can be used to harmonize the face during facial gender-affirming surgery through masculinization or feminization. During feminization, the mandibular angle and body and chin are reduced in width and size. During masculinization, augmentation of the mandibular angle and body and chin are completed with alloplastic implants, fat, or bone. Complications are minimal. Further research is needed on outcomes of these procedures.

Midfacial Bony Remodeling
Craniofacial procedures to the midface in conjunction with work to the upper face and skull, and if needed the lower jaw, are a permanent and effective way to achieve feminization of the face in transgender patients. Although the surgery is more complex than other procedures, it should be considered for select patients. Further improvement of cosmesis may be considered a separate surgical entity and is not limited in scope or time by having undergone midface osteotomies. When carefully planned, bony surgery to the midface is safe and results in long-term predictive results and a favorable appearance as the patient ages.”

Cheek Augmentation Techniques
The restoration of a youthful appearance to the midface can enhance its femininity. In this article, we discuss several strategies and techniques, both surgical and nonsurgical, for augmentation of the lateral and centro-lateral midface.

Preparing for Facial Feminization Surgery
Facial feminization surgery may be a part of a treatment plan for gender dysphoria. Initial mental health assessment must occur. Referrals for hormonal therapy may then be made if appropriate. No guidelines exist for timing of facial feminization surgery. Generally, recommendations are for individuals to undergo hormonal therapy and live in a gender-congruent role for at least 12 months before surgical intervention. Referral letters meeting World Professional Association of Transgender Health guidelines must be made regarding the treatment course and goals. Informed consent must be obtained; patient should understand how surgical alteration fits into their overall treatment goals.

Forthcoming Issues
New Trends and Technologies in Facial Plastic Surgery

Contents
J. Regan Thomas

Contributors
J. REGAN THOMAS, MD

Facial Gender Affirmation Surgery

Michael T. Somenek (Editor)

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/S1064-7406(19)30012-4
First page of article
FACIAL PLASTIC SURGERY CLINICS OF NORTH AMERICA

Copyright

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/S1064-7406(19)30013-6
First page of article
ELSEVIER

Contributors

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/S1064-7406(19)30014-8
First page of article
J. REGAN THOMAS, MD

Contents

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/S1064-7406(19)30015-X
First page of article
J. Regan Thomas

Forthcoming Issues

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/S1064-7406(19)30016-1
First page of article
New Trends and Technologies in Facial Plastic Surgery

Facial Gender Affirmation Surgery

J. Regan Thomas, MDEmail the author MD J. Regan Thomas
Facial Plastic and Reconstructive Surgery, Department of Otolaryngology, Head and Neck Surgery, Northwestern University School of Medicine, 675 North Saint Clair Street, Suite 15-200, Chicago, IL 60611, USA

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/j.fsc.2019.02.002 |

First page of article
A key component for those individuals who have elected to undergo procedures to address gender dysmorphia is facial modification surgery. Gender dysphoria may cause people to experience major stress and impairment on social and personal levels. For these individuals, gender role changing, including surgery, may permit their outside appearance to match what they feel internally. Gender dysmorphia, previously referred to as gender identity disorder, often is assisted through the skills and procedures provided by facial plastic surgery.© 2019 Published by Elsevier Inc.

Exploring Facial Gender Affirmation Surgery

Michael T. Somenek, MDEmail the author MD Michael T. Somenek
SomenekMD- Advanced Facial Plastic Surgery, 2440 M Street NW, Suite 507, Washington, DC 20037, USA

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/j.fsc.2019.02.001 | CROSSMARK_Color_horizontal.svg

First page of article
Gender dysphoria (formerly gender identity disorder) is defined by strong, persistent feelings of identification with the opposite gender and discomfort with one’s own assigned sex that results in significant distress or impairment. With the transgender population now exceeding 25 million globally, there has been an increasing need to provide gender affirming care. This increased awareness looks to address gender dysphoria in a comprehensive manner, which encompasses the spectrum from mental health, hormone replacement, and surgical intervention.© 2019 Published by Elsevier Inc.

Gender-related Facial Analysis

Chrisovalantis Lakhiani, MDa
, Michael T. Somenek, MDb,∗,'Correspondence information about the author MD Michael T. SomenekEmail the author MD Michael T. Somenek

Facial Plastic Surgery Clinics, Volume 27, Issue 2

Published online: March 02, 2019
DOI: https://doi.org/10.1016/j.fsc.2019.01.006 | CROSSMARK_Color_horizontal.svg

There exist several known anthropometric differences between the male and female facial skeleton and soft tissues. In general, the female face is less robust, rounder or heart shaped, with a shorter forehead, no supraorbital bossing, a smaller nose, more pronounced zygomatic prominences, fuller lips, a smaller mandibular width, and a more tapered chin. A method for analyzing these differences is critical for offering facial gender confirming surgery to the gender dysphoric patients, both for preoperative planning, as well as for setting postoperative expectations.

First page of article
There exist several known anthropometric differences between the male and female facial skeleton and soft tissues. In general, the female face is less robust, rounder or heart shaped, with a shorter forehead, no supraorbital bossing, a smaller nose, more pronounced zygomatic prominences, fuller lips, a smaller mandibular width, and a more tapered chin. A method for analyzing these differences is critical for offering facial gender confirming surgery to the gender dysphoric patients, both for preoperative planning, as well as for setting postoperative expectations.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Hormonal, Medical, and Nonsurgical Aspects of Gender Affirmation

Ronni Hayon, MDa,∗,'Correspondence information about the author MD Ronni HayonEmail the author MD Ronni Hayon
, Kristin Stevenson, MDb

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/j.fsc.2018.12.001 | CROSSMARK_Color_horizontal.svg

Although the acronym LGBTQ is often used as a catchall label for sexual and gender minorities, transgender people have unique and individual health needs and unfortunately experience significant health disparities. This article reviews essential terminology and concepts relevant to discussions of gender and gender identity, practical tips for changes that can be made on the clinical and institutional levels in order to create a welcoming and safe environment for transgender patients, as well as current recommendations for the provision of gender-affirming medical therapy.

First page of article
Although the acronym LGBTQ is often used as a catchall label for sexual and gender minorities, transgender people have unique and individual health needs and unfortunately experience significant health disparities. This article reviews essential terminology and concepts relevant to discussions of gender and gender identity, practical tips for changes that can be made on the clinical and institutional levels in order to create a welcoming and safe environment for transgender patients, as well as current recommendations for the provision of gender-affirming medical therapy.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Preparing for Facial Feminization Surgery

Timing

Troy A. Pittman, MDa,∗,'Correspondence information about the author MD Troy A. PittmanEmail the author MD Troy A. Pittman
, James M. Economides, MDb

Facial Plastic Surgery Clinics, Volume 27, Issue 2

Published online: March 02, 2019
DOI: https://doi.org/10.1016/j.fsc.2018.12.002 | CROSSMARK_Color_horizontal.svg

Facial feminization surgery may be a part of a treatment plan for gender dysphoria. Initial mental health assessment must occur. Referrals for hormonal therapy may then be made if appropriate. No guidelines exist for timing of facial feminization surgery. Generally, recommendations are for individuals to undergo hormonal therapy and live in a gender-congruent role for at least 12 months before surgical intervention. Referral letters meeting World Professional Association of Transgender Health guidelines must be made regarding the treatment course and goals. Informed consent must be obtained; patient should understand how surgical alteration fits into their overall treatment goals.

First page of article
Facial feminization surgery may be a part of a treatment plan for gender dysphoria. Initial mental health assessment must occur. Referrals for hormonal therapy may then be made if appropriate. No guidelines exist for timing of facial feminization surgery. Generally, recommendations are for individuals to undergo hormonal therapy and live in a gender-congruent role for at least 12 months before surgical intervention. Referral letters meeting World Professional Association of Transgender Health guidelines must be made regarding the treatment course and goals. Informed consent must be obtained; patient should understand how surgical alteration fits into their overall treatment goals.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Cheek Augmentation Techniques

David M. Whitehead, MD, MSa
, Loren S. Schechter, MD, FACSb,∗,'Correspondence information about the author MD, FACS Loren S. SchechterEmail the author MD, FACS Loren S. Schechter

Facial Plastic Surgery Clinics, Volume 27, Issue 2

Published online: March 02, 2019
DOI: https://doi.org/10.1016/j.fsc.2018.12.003 | CROSSMARK_Color_horizontal.svg

The restoration of a youthful appearance to the midface can enhance its femininity. In this article, we discuss several strategies and techniques, both surgical and nonsurgical, for augmentation of the lateral and centro-lateral midface.

First page of article
The restoration of a youthful appearance to the midface can enhance its femininity. In this article, we discuss several strategies and techniques, both surgical and nonsurgical, for augmentation of the lateral and centro-lateral midface.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Forehead and Orbital Rim Remodeling

Marcelo Di Maggio, MDEmail the author MD Marcelo Di Maggio
MDM Surgery Center, Sanatorio Finochietto Medical Center, Buenos Aires, Avenida Cordoba 2678, C1187AAN, Argentina

Facial Plastic Surgery Clinics, Volume 27, Issue 2

Published online: March 02, 2019
DOI: https://doi.org/10.1016/j.fsc.2019.01.007 | CROSSMARK_Color_horizontal.svg

Facial features remodeling surgery is performed to obtain feminization of the face that corresponds to the gender perceived by patients. This includes techniques and findings to remodel the forehead and orbital rim to change the expression of the eyes, correction of the frontonasal angle in relation to rhinoplasty, hairline feminization, and eyebrow lift to correct the position and aesthetic dissatisfaction or the effects of aging.

First page of article
Facial features remodeling surgery is performed to obtain feminization of the face that corresponds to the gender perceived by patients. This includes techniques and findings to remodel the forehead and orbital rim to change the expression of the eyes, correction of the frontonasal angle in relation to rhinoplasty, hairline feminization, and eyebrow lift to correct the position and aesthetic dissatisfaction or the effects of aging.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Midfacial Bony Remodeling

Kalle Conneryd Lundgren, MD, PhD∗,'Correspondence information about the author MD, PhD Kalle Conneryd LundgrenEmail the author MD, PhD Kalle Conneryd Lundgren
, Maarten J. Koudstaal, MD, DMD, PhD
Department of Craniofacial Diseases, Karolinska University Hospital, Stockholm 171 77, Sweden

Facial Plastic Surgery Clinics, Volume 27, Issue 2

Published online: March 02, 2019
DOI: https://doi.org/10.1016/j.fsc.2018.12.004 | CROSSMARK_Color_horizontal.svg

Craniofacial procedures to the midface in conjunction with work to the upper face and skull, and if needed the lower jaw, are a permanent and effective way to achieve feminization of the face in transgender patients. Although the surgery is more complex than other procedures, it should be considered for select patients. Further improvement of cosmesis may be considered a separate surgical entity and is not limited in scope or time by having undergone midface osteotomies. When carefully planned, bony surgery to the midface is safe and results in long-term predictive results and a favorable appearance as the patient ages.”

First page of article
Craniofacial procedures to the midface in conjunction with work to the upper face and skull, and if needed the lower jaw, are a permanent and effective way to achieve feminization of the face in transgender patients. Although the surgery is more complex than other procedures, it should be considered for select patients. Further improvement of cosmesis may be considered a separate surgical entity and is not limited in scope or time by having undergone midface osteotomies. When carefully planned, bony surgery to the midface is safe and results in long-term predictive results and a favorable appearance as the patient ages.”

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Hair Transplantation Techniques for the Transgender Patient

Anthony Bared, MD∗,'Correspondence information about the author MD Anthony BaredEmail the author MD Anthony Bared
, Jeffrey S. Epstein, MD
Private Practice, Foundation for Hair Restoration, 6280 Sunset Drive, Suite 504, Miami, FL, USA

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/j.fsc.2018.12.005 | CROSSMARK_Color_horizontal.svg

Hair transplantation can play a complementary role in the spectrum of gender transformation procedures sought by transgender patients undergoing gender transformation surgery. The authors’ clinic has seen an increase in the demand for hair restoration in transgender patients. Hairline lowering, eyebrow transplantation, and pubic hair transplantation can play roles for male-to-female transgender patients whereas beard hair transplantation and body hair transplantation can play integral roles for female-to-male patients seeking gender transformation surgery. This article delineates an experience in the role hair restoration plays for transgender patients and outlines a surgical approach for these hair restoration procedures.

First page of article
Hair transplantation can play a complementary role in the spectrum of gender transformation procedures sought by transgender patients undergoing gender transformation surgery. The authors’ clinic has seen an increase in the demand for hair restoration in transgender patients. Hairline lowering, eyebrow transplantation, and pubic hair transplantation can play roles for male-to-female transgender patients whereas beard hair transplantation and body hair transplantation can play integral roles for female-to-male patients seeking gender transformation surgery. This article delineates an experience in the role hair restoration plays for transgender patients and outlines a surgical approach for these hair restoration procedures.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Lower Jaw Recontouring in Facial Gender-Affirming Surgery

Shane D. Morrison, MD, MSa,∗,'Correspondence information about the author MD, MS Shane D. MorrisonEmail the author MD, MS Shane D. Morrison
, Thomas Satterwhite, MDb,1

Facial Plastic Surgery Clinics, Volume 27, Issue 2

Published online: March 02, 2019
DOI: https://doi.org/10.1016/j.fsc.2019.01.001 | CROSSMARK_Color_horizontal.svg

Facial gender-affirming surgery can have significant impact on patient quality of life for some gender-dysphoric patients. Lower jaw contouring can be used to harmonize the face during facial gender-affirming surgery through masculinization or feminization. During feminization, the mandibular angle and body and chin are reduced in width and size. During masculinization, augmentation of the mandibular angle and body and chin are completed with alloplastic implants, fat, or bone. Complications are minimal. Further research is needed on outcomes of these procedures.

First page of article
Facial gender-affirming surgery can have significant impact on patient quality of life for some gender-dysphoric patients. Lower jaw contouring can be used to harmonize the face during facial gender-affirming surgery through masculinization or feminization. During feminization, the mandibular angle and body and chin are reduced in width and size. During masculinization, augmentation of the mandibular angle and body and chin are completed with alloplastic implants, fat, or bone. Complications are minimal. Further research is needed on outcomes of these procedures.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Feminization of the Chin

Genioplasty Using Osteotomies

Jordan Deschamps-Braly, MD, FACSEmail the author MD, FACS Jordan Deschamps-Braly
Deschamps-Braly Clinic of Plastic & Craniofacial Surgery, 360 Post Street, Suite 901, San Francisco, CA 94108, USA

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/j.fsc.2019.01.002 | CROSSMARK_Color_horizontal.svg

Chin reshaping can provide a more identifiable female appearance for transitioning male to female patients undergoing facial feminization. The “sliding” genioplasty has the most potential for dramatically reshaping the chin, while also avoiding many of the issues that may occur with implants. A chin should be evaluated radiologically and by physical examination to determine what changes should be made to any particular chin. When performing osseous genioplasty, the mental nerve can be protected by performing any osteotomies at least 6 mm below the inferior border of the mental nerve canal.

First page of article
Chin reshaping can provide a more identifiable female appearance for transitioning male to female patients undergoing facial feminization. The “sliding” genioplasty has the most potential for dramatically reshaping the chin, while also avoiding many of the issues that may occur with implants. A chin should be evaluated radiologically and by physical examination to determine what changes should be made to any particular chin. When performing osseous genioplasty, the mental nerve can be protected by performing any osteotomies at least 6 mm below the inferior border of the mental nerve canal.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Gender-confirming Rhinoplasty

Jens Urs Berli, MDa,∗,'Correspondence information about the author MD Jens Urs BerliEmail the author MD Jens Urs Berli
, Myriam Loyo, MDb

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/j.fsc.2019.01.003 | CROSSMARK_Color_horizontal.svg

Most surgeons who are not routinely treating gender dysphoric patients are more likely to see an isolated rhinoplasty consultation rather than a request for full facial gender confirmation surgery (FGCS). Different from other aspects of FGCS, the surgical basis of rhinoplasty is almost the same as for the cisgender population. Despite technical overlap, the care for patients seeking rhinoplasty for the indication of gender dysphoria vastly differs from that for the cisgender population. This review includes comments on gender norms and outline considerations for the preoperative work-up and operative execution as well as a comprehensive literature review.

First page of article
Most surgeons who are not routinely treating gender dysphoric patients are more likely to see an isolated rhinoplasty consultation rather than a request for full facial gender confirmation surgery (FGCS). Different from other aspects of FGCS, the surgical basis of rhinoplasty is almost the same as for the cisgender population. Despite technical overlap, the care for patients seeking rhinoplasty for the indication of gender dysphoria vastly differs from that for the cisgender population. This review includes comments on gender norms and outline considerations for the preoperative work-up and operative execution as well as a comprehensive literature review.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Lip Lift

Ara A. Salibian, MD
, Rachel Bluebond-Langner, MD∗,'Correspondence information about the author MD Rachel Bluebond-LangnerEmail the author MD Rachel Bluebond-Langner
Hansjörg Wyss Department of Plastic Surgery, New York University Langone Health, 305 East 33rd Street, New York, NY 10016, USA

Facial Plastic Surgery Clinics, Volume 27, Issue 2

Published online: March 02, 2019
DOI: https://doi.org/10.1016/j.fsc.2019.01.004 | CROSSMARK_Color_horizontal.svg

The male upper lip has a distinctly longer cutaneous height from the nasal base to the upper vermilion border than its female counterpart. The subnasal indirect lip lift using the bullhorn technique or its modifications allows for shortening of this height to feminize the lower face, creating a more aesthetically pleasing upper lip secondary to increased vermilion height and lip pout. Patient selection is critical, taking into account lip height, vermilion height, alar base width, skin type, upper incisal show, and maxillary height. Precise measurements, controlled excision of the planned resection, and meticulous reapproximation of skin provide an aesthetic result, while minimizing visible scarring.

First page of article
The male upper lip has a distinctly longer cutaneous height from the nasal base to the upper vermilion border than its female counterpart. The subnasal indirect lip lift using the bullhorn technique or its modifications allows for shortening of this height to feminize the lower face, creating a more aesthetically pleasing upper lip secondary to increased vermilion height and lip pout. Patient selection is critical, taking into account lip height, vermilion height, alar base width, skin type, upper incisal show, and maxillary height. Precise measurements, controlled excision of the planned resection, and meticulous reapproximation of skin provide an aesthetic result, while minimizing visible scarring.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Chondrolaryngoplasty—Thyroid Cartilage Reduction

Angela Sturm, MDa,b
, Scott R. Chaiet, MD, MBAc,∗,'Correspondence information about the author MD, MBA Scott R. ChaietEmail the author MD, MBA Scott R. Chaiet

Facial Plastic Surgery Clinics, Volume 27, Issue 2

DOI: https://doi.org/10.1016/j.fsc.2019.01.005 | CROSSMARK_Color_horizontal.svg

Chondrolaryngoplasty, also known as tracheal shave, is a surgical procedure performed for a prominent Adam’s apple, usually in transfeminine patients with gender dysphoria to this marker of male sex. Although laryngeal anatomy is complex, knowledge of landmarks and techniques discussed in this article results in a safe procedure with rare complications and improvement in quality of life.

First page of article
Chondrolaryngoplasty, also known as tracheal shave, is a surgical procedure performed for a prominent Adam’s apple, usually in transfeminine patients with gender dysphoria to this marker of male sex. Although laryngeal anatomy is complex, knowledge of landmarks and techniques discussed in this article results in a safe procedure with rare complications and improvement in quality of life.

© 2019 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

Facial Plastic Surgery

Radiology and Imaging

A new beginning
Anirudh Kohli

Indian Journal of Radiology and Imaging 2019 29(1):1-1

Is next-generation radiologist ready for the challenges?
Chander Mohan

Indian Journal of Radiology and Imaging 2019 29(1):2-3

Presidential address
Hemant Patel

Indian Journal of Radiology and Imaging 2019 29(1):4-5

Corrosive injuries of the upper gastrointestinal tract: A pictorial review of the imaging features
Rohan Kamat, Pankaj Gupta, Yalaka Rami Reddy, Suman Kochhar, Birinder Nagi, Rakesh Kochhar

Indian Journal of Radiology and Imaging 2019 29(1):6-13

Corrosive ingestion is a common form of poisoning. Corrosive agents cause severe damage to the gastrointestinal (GI) tract. The most severe forms of injury can lead to mortality; however, the major concern with this type of injury is life-long morbidity. Upper GI endoscopy is the test of choice for assessing severity in the acute phase of the disease. The long-term management is based on the site, length, number, location, and tightness of the stricture. This information is best provided by the barium contrast studies. In this pictorial review, a spectrum of findings in patients with corrosive injuries of the esophagus and stomach is illustrated. The role of various imaging modalities including barium studies, endoscopic ultrasound, computed tomography, and magnetic resonance imaging is discussed.

”Honeycomb” pattern of gallbladder wall thickening – A forward step in early diagnosis of “Severe Dengue Fever”
Jitendra Parmar, Maulik Vora, Chander Mohan, Sandip Shah, Harsh Mahajan, Tapan Patel

Indian Journal of Radiology and Imaging 2019 29(1):14-18

Aims and Objectives: To study “Honeycomb” pattern of gallbladder wall thickening (GBWT) in dengue fever (DF) and to assess its clinical significance in early diagnosis of severe DF. Materials and Methods: A total 244 patients of DF were studied, 84 patients were classified as severe DF, 61 patients as DF with warning signs, and 99 patients as DF without warning signs. Abdominal ultrasound was performed for assessment of GBWT patterns, hepatomegaly, splenomegaly, pancreatic enlargement, ascites, pleural effusion, and other additional findings were recorded in severe DF cases. Statistical comparison between “Honeycomb” pattern of GBWT and clinically severe DF was done using Pearson correlation test. Results: Out of 244 patients, 145 patients were males and 99 patients were females, belonging to various age groups ranging from 1 to 81 years and 14.34% (35 patients) among them included in pediatric group. In total, 65.57% (160 patients) were non-severe DF cases and 34.42% (84 patients) were severe DF cases. A total of 84 patients of severe DF, 92.85% patients showed GBWT, and out of which, 71.42% patients had “Honeycomb” pattern, whereas a total of 160 patients of non-severe DF patients, 45% patients had GBWT and out of which, only 5.6% patients showed “Honeycomb” pattern.”Honeycomb” pattern of GBWT shows sensitivity of 71.4%, 94.37%, Positive predictive value of 86.95%, and Negative predictive value of 86.28% in severe DF. Conclusion:”Honeycomb” pattern of GBWT is significant finding in severe DF. Its sensitivity and specificity are high in severe DF with significant statistical correlation. It can aid in early diagnosis of severe DF.

Adhesive capsulitis: MRI correlation with clinical stages and proposal of MRI staging
Amarnath Chellathurai, Komalavalli Subbiah, Atchaya Elangovan, Sivakumar Kannappan

Indian Journal of Radiology and Imaging 2019 29(1):19-24

Objective: The purpose of this study was to correlate the magnetic resonance imaging (MRI) findings of adhesive capsulitis with clinical stages and thereby propose a MR staging system. Materials and Methods: This study consisted of 74 patients with clinically diagnosed adhesive capsulitis. The edema of the inferior glenohumeral ligament (IGHL), pericapsular edema, thickness of anterior band of IGHL, axillary pouch, thickness of coracohumeral ligament, and obliteration of fat in the subcoracoid triangle were evaluated by MRI. Results: Thickening of the anterior band of IGHL showed most significant correlation with the clinical stages. The distribution of edema of IGHL and pericapsular edema also showed significant correlation with the clinical stages of adhesive capsulitis. Pericapsular edema and IGHL edema was not observed in stage IV. Conclusion: MR is a useful tool for evaluation and prediction of clinical stage of adhesive capsulitis.

Role of apparent diffusion coefficient as a biomarker in the evaluation of cervical cancer
Sunita Dashottar, T Preeth Pany, Nishant Lohia

Indian Journal of Radiology and Imaging 2019 29(1):25-32

Background: Diffusion-weighted magnetic resonance imaging (DW-MRI) has evolved as a major diagnostic and prognostic tool in cervical cancer. The aim of our study was to compare the change in mean apparent diffusion coefficient (ADC) value before and after concurrent chemoradiation therapy (CCRT) in carcinoma cervix thereby establishing its role as a cancer biomarker. Materials and Methods: A hospital-based prospective study was conducted in 35 patients diagnosed with cervical cancer. All 35 patients underwent pelvic MRI before and after 6 months of CCRT. The study was done over a period of 12 months. Conventional axial and sagittal T2 imaging was followed by DW-MRI. In the axial DW/ADC images at “b-value” of 800 s/mm2, a circular region of interest was drawn covering more than 60% of the tumor volume to calculate the ADC values. Statistical Package for the Social Sciences (version 21.0) was used for statistical evaluation. Chi-square test, independent samples t-test, and analysis of variance were used to analyze the data. The results are depicted as frequencies (number), proportion (percentages), and mean ± standard deviation. Results: Pre-CCRT mean ADC value was 0.814 × 10−3 mm2/s. Post-CCRT mean ADC value was 1.294 × 10−3 mm2/s. Mean ADC value of patients having lymph node involvement and parametrial extension was significantly lower when compared with those without lymph node involvement and parametrial extension (P = 0.001). Nonresponders with residual lesion had lower ADC values than responders with no residual lesion. An interesting and unique observation was that pre-CCRT mean ADC value of responders was higher than nonresponders. Conclusion: An increase in mean ADC value of 0.480 × 10−3 mm2/s after CCRT was found to be statistically significant (P < 0.001) thereby proving its role as an imaging biomarker in cancer cervix.

Cardiac T2* magnetic resonance analysis of membranous interventricular septum in assessment of cardiac iron overload in pediatric thalassemia patients: A pilot study
Ishan Kumar, Priyanka Aggarwal, Vineeta Gupta, Ashish Verma, Suwen Kumar, Ram C Shukla

Indian Journal of Radiology and Imaging 2019 29(1):33-39

Background: Cardiac iron deposition in transfusion-dependent thalassemia patients is patchy in distribution. Purpose: The purpose of this study is to assess the correlation between T2* matrices of membranous interventricular septum (MIVS) and T2* values of muscular interventricular septum (IVS) on magnetic resonance imaging (MRI) and to evaluate the relationship of myocardial T2* at these two locations with MRI-estimated liver iron concentrations (LIC) and electrocardiographic (ECG) parameters. Material and Methods: MRI of heart and liver was performed in 16 consecutive pediatric patients of transfusion-dependent thalassemia major to calculate liver iron concentration and T2* time of membranous and muscular IVS. ECG parameters of these patients were charted and correlated with MRI parameters. Results: No significant correlation between T2* values of muscular IVS and MIVS was observed. Mean T2* of MIVS (9.8 ms) was significantly lower than that of muscular IVS (26.9 ms). T2* of MIVS correlated strongly with LIC where as a weak correlation was observed between T2* of IVS and LIC. Significantly higher mean QTc (corrected QT interval) value (439.86 ms) was seen in patients with T2* IVS <20 ms. Conclusion: Addition of T2* analysis of MIVS to the existing MRI protocol, consisting of muscular IVS analysis, may offer a more sensitive estimation of cardiac iron overload.

Safety and outcomes of pre-operative portal vein embolization using N-butyl cyanoacrylate (Glue) in hepatobiliary malignancies: A single center retrospective analysis
Amar Mukund, Aniket Mondal, Yashwant Patidar, Senthil Kumar

Indian Journal of Radiology and Imaging 2019 29(1):40-46

Aims and Objectives: To evaluate the outcome of preoperative portal vein embolization (PVE) using N-butyl cyanoacrylate (NBCA) for change in future liver remnant (FLR) volume, biochemical changes, and procedure-related complications. The factors affecting FLR hypertrophy and the rate of resection was also evaluated for this cohort. Materials and Methods: From 2012 to 2017, PVE utilizing NBCA mixed with lipiodol (1:4) was performed using percutaneous approach in 28 patients with hepatobiliary malignancies with low FLR. All patients underwent volumetric computed tomography (CT) assessment before and at 3–5 weeks after PVE and total liver volume (TLV), FLR volume, and FLR/TLV ratio, changes in portal vein diameter and factors affecting FLR were evaluated. Complications and the resectability rate were recorded and analyzed. Result: PVE was successful in all 28 patients. The mean FLR increased by 52% ± 32% after PVE (P < 0.0001). The FLR/TLV ratio was increased by 14.2% ± 2.8% (P < 0.001). Two major complications were encountered without any impact on surgery. There was no significant change seen in liver function test and complete blood counts after PVE. Eighteen patients (64.28%) underwent hepatic resection without any liver failure, and only three patients developed major complication after surgery. Remaining ten patients did not undergo surgery because of extrahepatic metastasis detected either on follow-up imaging or staging laparotomy. Patients with diabetes showed a lower rate of hypertrophy (P < 0.05). Conclusion: Preoperative PVE with NBCA is safe and effective for increasing FLR volume in patients of all age group and even in patients with an underlying liver parenchymal disease with hepatobiliary malignancy. Lesser hypertrophy was noted in patients with diabetes. A reasonable resectability was achieved despite having a high rejection in gall bladder cancer subgroup due to rapid disease progression.

Early experience of combination therapy of transarterial chemoembolization and radiofrequency ablation for hepatocellular carcinoma measuring 3–7 cm
Yashwant Patidar, Lalit Garg, Amar Mukund, Shiv Kumar Sarin

Indian Journal of Radiology and Imaging 2019 29(1):47-52

Background of the Article: Hepatocellular carcinoma (HCC) is one of the most common human malignancies worldwide. Radiofrequency ablation (RFA) is considered curative option in selected patients; efficacy is severely limited by lesion size and lesions bordering a large vessel. On the other hand, transarterial chemoembolization (TACE) is not limited by lesion size and arterial occlusion of the tumor feeding vessels leads to increase the volume of the ablative zone. Combination treatments using both intraarterial liver-directed therapy and percutaneous ablation seek to overcome the disadvantages of the individual treatments alone, theoretically improving response to therapy and survival. Material and Methods: This is a single-center retrospectively study in which patients who received TACE plus RFA for HCC were evaluated for technical success, local tumor progression rates, distant intra and extrahepatic recurrences and survival. Results: The study included 22 patients, 21 patients had a solitary HCC of size 3–7 cm and one patient had three target lesions. Technical success achieved after first session of combination treatment was 100% (24/24). At 1 and 3 months follow-up 100% patients (24 target lesions) had complete response and at 6 months; 21 (87.5%) had complete response, one (4.2%) had local tumor progression and two patients (8.3%) developed progressive disease. No major difference in complication was noted. The event-free survival as shown by Kaplan–Meier graph analysis at 6 and 12 months were 90.7% and 66.4% with mean time to event-free survival was 11.1 months. Conclusion: The combined use of TACE and RFA is a safe and effective option in the treatment of patients with single large or multinodular HCC when surgical resection is not feasible and this approach provides better results than RFA or TACE alone.

Radiology and Imaging

Heart

Preface to the first issue of Heart India 2019
Alok Kumar Singh

Heart India 2019 7(1):1-2

Aspirin for primary prevention: The changing paradigms!
Akshyaya Kumar Pradhan, Vikas Gupta, Pravesh Vishwakarma

Heart India 2019 7(1):3-7

Aspirin has been a widely used antiplatelet drug for management of cardiovascular disease for last five decades. Multiple studies have established its role in secondary prevention of cardiovascular diseases. For primary prevention, the situation is not so simple. Initial studies (though large and with long follow up) performed two decades ago suggested an impressive positive risk -benefit profile. But such benefits could not be replicated in subsequent studies performed in the new millennium. Recently, three back to back studies of aspirin in primary prevention in contemporary era failed to demonstrate any benefits or the benefits were counterbalanced by bleeding events. Hence, the role of aspirin for primary prevention of cardiovascular disease is under intense scrutiny.

Efficacy of heart failure reversal therapy program in post-menopausal females with reduced ejection fraction: An observational study
Rohit M Sane, Snehal A Kholapure, Rahul S Mandole

Heart India 2019 7(1):8-13

Background: Heart failure with reduced ejection fraction (HFrEF) has growing prevalence, especially in postmenopausal females. Heart failure reversal therapy (HFRT) is a combination of Panchakarma and allied therapies used by Ayurveda physicians for chronic heart failure patients. This observational study was done to evaluate HFRT in HFrEF-affected postmenopausal females. Materials and Methods: The study was conducted between January 2015 and December 2017 at a Madhavbaug Hospital in Khopoli, India. The data of HFrEF patients who were administered HFRT twice over 7 days in hospital were considered. VO2 max, distance covered on 6-min walk test (6MWT), weight, body mass index (BMI), abdominal girth, heart rate (HR), and blood pressure (BP) were compared to day 1 and 90 of HFRT. Results: Twenty females were enrolled with a mean age of 64.2 ± 4.38 years. There was a significant improvement in mean VO2 max (12.30 ± 2.12 vs. 13.45 ± 2.10, P < 0.05) and mean distance covered after 6MWT (319.5 ± 92.1 vs. 369.5 ± 91.39 m, P < 0.05) of patients on day 90, when compared to day 1 of HFRT. Mean weight (55.20 ± 7.23 vs. 51.48 ± 6.70 kg, P < 0.05), mean BMI (22.51 ± 3.10 vs. 21.45 ± 2.47 kg/m2, P < 0.05), and mean abdominal girth (86.05 ± 8.57 vs. 81 ± 8.65 cm, P < 0.05) were decreased at 90 days after HFRT therapy initiation. BP and HR were reduced but not significantly (P > 0.05). Conclusion: HFRT effectively increases the VO2 max, distance walked on 6MWT and decreases metabolic parameters in postmenopausal HFrEF patients.

Spontaneous coronary artery dissection in acute coronary syndromes: A single-center experience
Suresh Madhavan, Jayaprasad Narayanapillai

Heart India 2019 7(1):14-20

Aim: Incidence, diagnosis, and management of spontaneous coronary artery dissection (SCAD) in the Indian subcontinent are less well understood. The present study is to find the incidence and clinical features of SCAD in acute coronary syndrome (ACS) patients undergoing coronary angiography in acute coronary settings. Subjects and Methods: This is a prospective and retrospective analysis conducted on ACS patients who underwent emergency angiogram in the Department of Cardiology, Government Medical College, Kottayam, India, from February 19, 2008, to December 31, 2017. Those without SCAD were kept as control. Results: Out of 3708 patients studied, SCAD was seen in 5.9% patients with 78.8% females and was responsible for 31.4% and 6% of ACS in females aged <50 and >50 years, respectively. The mean age of presentation was 47.2 years. Age <50 years, female sex, emotional and physical stress, and fibromuscular dysplasia (FMD) were the risk factors identified. In-hospital and 6-month mortality rate was 3.1% and 6.3%. 31.9% of SCAD patients were diagnosed to have FMD on follow-up. Only 4.1% of patients belonged to peripartum period. Medical management is superior in hemodynamically stable SCAD patients compared to invasive strategies. Conclusions: SCAD is far more common than expected in this part of the world, and the awareness regarding the diagnosis, treatment, and follow-up has to be improved.

Does hypertension deteriorate the health-related quality of life (HRQoL)? A matched cross-sectional analytical study in an urban area of Puducherry, South India
Bijaya Nanda Naik, Srikanta Kanungo, T Mahalakshmy

Heart India 2019 7(1):21-25

Introduction: Hypertension is a chronic disease which necessitates daily medication intake and changes in the lifestyles. This may influence the quality of life. Aims and Objective: The aim of the study was to compare the health-related quality life of hypertensive individuals and age- and gender-matched nonhypertensive individuals in an urban area of Puducherry. Setting and Design: The cross-sectional analytical study was conducted as facility as well as community-based study. Methodology: The study involved 101 hypertensive patients attending the outpatient department of an Urban Health Training Center and 101 age- and gender-matched nonhypertensive individuals recruited from the community. The health-related quality of life (HRQoL) was measured using Short Form-12 (SF-12) questionnaire. The HRQoL was expressed in eight domains: physical functioning, physical role play, bodily pain, general health, vitality, emotional role play, social functioning, and mental health. The data were entered in Epidata software, and analysis with unpaired t-test was done using SPSS software for comparison of scores between the two groups. Results: The hypertensive individuals were found to have lower quality of life in both physical and mental domains compared to nonhypertensive individuals. The physical functioning, bodily pain, and general health domains of physical component recorded statistically significant difference. Conclusion: Hypertensive individuals have poor quality of life, especially in physical component domain in our study population. Hypertensive individuals merit a vulnerable population and need special focus by health-care providers in the context of achieving universal health coverage and sustainable goals.

Echocardiographic abnormalities in patients with cirrhosis and relation to disease severity
PG Anish, Narayanapillai Jayaprasad, Suresh Madhavan, Raju George

Heart India 2019 7(1):26-30

Context: Cirrhosis is the leading cause for hepatic transplantation worldwide. Heart is one of the most adversely affected organs in cirrhosis and it increases morbidity and mortality in these patients. Aims: The objective of this study is to identify the echocardiographic abnormalities in patients with cirrhosis and their relation to severity of cirrhosis. Subjects and Methods: An observational study was done on patients with cirrhosis (n = 55) and age- and sex-matched controls (n = 30). Detailed echocardiographic examination including 2D, M-mode, pulsed-wave Doppler, tissue Doppler, and 2D speckle-tracking imaging was performed. Severity of cirrhosis was defined by model for end-stage liver disease (MELD) score. Comparison of various echo parameters among cases and controls and among the two groups with MELD score >12 and <12 was made. Results: The major echocardiographic abnormalities noticed were left ventricular hypertrophy in 47.3%, diastolic dysfunction in 40%, pulmonary artery hypertension in 32.7%, and pericardial effusion in 3.6% of patients. Among the various echocardiographic parameters, mitral annular velocity, deceleration time, isovolumetric relaxation time (IVRT), Sm velocity, e' velocity, E/e' ratio, and average global longitudinal strain (GLS) were significantly different in cirrhosis patients compared to the control population. Mitral annular a velocity and IVRT were significantly more in cirrhotic patients with MELD score >12. Conclusions: Cirrhosis is associated with increased LV mass and cardiac output. Diastolic dysfunction was present in 40% of patients. Although systolic function by ejection fraction was normal in cirrhotic patients, GLS was less compared to controls.

Which strategy for bifurcation lesions? Provisional or two stent: A dilemma
Sumit Kumar

Heart India 2019 7(1):31-33

Bifurcation lesions are synonymous with unfavorable angiographic and clinical outcomes. We present a case of a bifurcated lesion in the left anterior descending artery diagonal. She was managed by implanting a single stent using the proximal optimizing technique (POT), side branch inflation, and final POT (POT-side-POT technique), without final kissing balloon.

Year in cardiology 2018
Alok Kumar Singh

Heart India 2019 7(1):34-40

Heart

Homoeopathy

Research implementation in Education and clinical practice
Raj K Manchanda

Indian Journal of Research in Homoeopathy 2019 13(1):1-3

Exploring the predictive value of specific symptom as prognostic factor: Assessment of group-confined likelihood ratio for symptom ‘Headache’ in 20 lesser-known drugs
Jaya Gupta, Suhana P Azis, Lex Rutten, Raj K Manchanda, Abhishek Pramanik, Partha Sarathi Chakraborty, Pramodji Singh, JP Singh, Mahesh Sah, G R. C. Reddy, Manas Sarangi, Abhijit Chakma, Sunil Ramteke, PK Pradhan, P Devi, Ojit Singh, AR Sahoo, KK Avinash, Navin Kumar Singh, Siva Prasad Goli

Indian Journal of Research in Homoeopathy 2019 13(1):4-11

Aim: Assessment of group-confined likelihood ratio (GCLR) for the symptom ‘Headache’ from among 20 lesser-known remedies clinically verified by the Central Council for Research in Homoeopathy during the period 2012–2018. Materials and Methods: Analysis of data of the clinical verification study, which was a multicentric, open-label, observational clinical study conducted at 13 study sites of the council. The 50 medicines that completed the drug proving programme of the council were clinically verified in ascending potencies of 6C, 30C and 200C. Of these, 20 lesser-known medicines allowed analysis of the prevalence and LR of the symptom ‘Headache'. These 20 medicines were ordered according to the prevalence of headache, and LR >1 gave an indication what medicines were more related to headache than others. Results: The symptom ‘Headache’ was recorded in a part of the population: 4582 patients where 20 lesser-known medicines were prescribed. Of these medicines, 8 have a GCLR >1, indicating that the symptom headache could indicate these medicines out of the assessed group of 20. Only 5 had statistically significant confidence interval: Allium sativum, Formicum acidum, Gymnema sylvestre, Avena sativa and Persea americana. Among these, two medicines, Allium sativum and Formicum acidum, have significantly higher GCLR. Conclusion: Of 20 lesser-known homeopathic medicines, two could be considered for the further evaluation of the relationship with headache. These findings should be confirmed in properly organised prognostic factor research in a larger population, not restricted to specific medicines, that enables proper comparison.

A survey regarding awareness and beliefs about Homoeopathy among general population during Magh Mela at Allahabad, Uttar Pradesh, India
Manas Ranjan Sarangi, Abhishek Pramanik, Jaya Gupta, Ramesh Prasad, Pramodji Singh, Mahesh Shah, Alok Kumar Upadhyay, Saurabh Jain, Ambreesh Pandey, Arvind Kumar, Goutam Rakshit, Anil Khurana, Raj K Manchanda

Indian Journal of Research in Homoeopathy 2019 13(1):12-21

Background and Objective: Homoeopathy is one of the various alternative systems of medicine prevalent in India. A survey was conducted during the month of January–February 2017 in a congregation at Sangam, Allahabad, to know about the awareness of general population about Homoeopathy. Methods: A cross-sectional survey was conducted on patients and people visiting the health check-up camp and exhibition stall set-up during Magh Mela at Sangam, Allahabad. A self-administered questionnaire was used during the survey, devised by the Central Council for Research in Homoeopathy. Results: Of 1144 total respondents, 68.1% had knowledge about Homoeopathy. About 46.6% of respondents believed that it has no side effects and 15.1% believed that it is cost-effective. The diseases for which most of the participants have taken homoeopathic treatment were fever, common cold, constipation and diarrhoea. Conclusion: General population has knowledge about Homoeopathy, but various misconceptions are also prevalent. Awareness campaigns are needed to make people more aware about Homoeopathy and its effectiveness in various disorders.

Homoeopathic drug proving of Mangolia grandiflora: A randomised double blind placebo-controlled trial
Goutam Rakshit, AK Vichitra, Rajpal Singh, Amulya Ratna Sahoo, Sujata Kumari Choudhury, Vinay Kumar Singh

Indian Journal of Research in Homoeopathy 2019 13(1):22-36

Objective: This study was carried out to elicit the pathogenetic response of the drug Magnolia grandiflora in homoeopathic potencies on apparently healthy human beings. Materials and Methods: Drug Magnolia grandiflora was proved by the Central Council for Research in Homoeopathy (CCRH) through a double-blind placebo-controlled method. The study was conducted at three centres. The drug was proved in two potencies (6C and 30C) on 48 apparently healthy volunteers who were selected after conducting pre-trial medical examinations by the medical specialists and routine laboratory investigations. In the first phase, volunteers were given 56 doses (4 doses per day for 14 days) of placebo. In the next two phases, 56 doses (4 doses per day for 14 days) of each potency or placebo were consumed. Out of 48 provers, 32 were given the actual drug and 16 were given placebo. The symptoms generated during the trial period were noted by the volunteers and elaborated by the proving masters. The data obtained from all the three centres were compiled at the Proving-Cum-Data Processing Cell at CCRH headquarters after decoding. Results: Out of the 32 provers who were on the actual drug trial, 21 manifested symptoms. The drug was able to produce symptoms in each potency in most of the parts of the body. Conclusion: New and proved pathogenetic responses elicited during the proving trial expand the scope of use of the drug Magnolia grandiflora and will benefit the research scholars and clinicians. These symptoms will carry more value when verified clinically.

Evaluation of qualitative phytochemical analysis of water extract of Achyranthes aspera and Achyranthes aspera 30
Usha Kushwaha

Indian Journal of Research in Homoeopathy 2019 13(1):37-40

Introduction: Plant sources are a valuable starting material for drug development. These plants are the potential therapeutic agents, which provide maximum benefits with minimum adverse effects. Objective: The objective of the study is to evaluate the qualitative phytochemical analysis of water extract of whole plant excluding root of Achyranthes aspera and 30 potency of the same drug. Methodology: The qualitative phytochemical analysis of water extract of whole plant excluding root of Achyranthes aspera and Achyranthes aspera 30 has been performed to confirm the presence of alkaloid, saponin, phenolic compound, carbohydrate and proteins. Physicochemical constants such as ash, extractive values and moisture content were also determined. Results: The physicochemical analysis showed that the parts of this plant contained total ash value of 9.59% in which the acid-insoluble ash is 2.27%. The extractive values percentage of water-soluble extract is 20.91%. The qualitative phytochemical analysis reveals the presence of carbohydrates, protein, alkaloids, saponins and phenolic compounds in water extract of Achyranthes aspera and Achyranthes aspera 30. The analysis also shows that various bioactive phytochemicals are retained with dilution while preparation of Homoeopathic medicines. Conclusion: Achyranthes aspera in homoeopathic potency 30 contains its bioactive phytochemicals even after being a high dilution (with alcohol) of the original plant.

Efficacy of predefined homoeopathic medicines in the treatment of warts: Study protocol of double blind randomised placebo controlled trial
Central Council for Research in Homoeopathy

Indian Journal of Research in Homoeopathy 2019 13(1):41-47

Background and Objectives: The literature cites a large number of homoeopathic medicines for the treatment of warts. Studies on warts are based on experiences of individual practitioners and do not give specific factors, which are responsible for making a successful prescription for the treatment of warts. The present study was designed as a multicentric randomised, double-blind, placebo-controlled trial to evaluate response to homoeopathic treatment for the disappearance or resolution of warts and to validate the symptoms of the pre-identified 09 drugs (Antimonium crudum, Calcarea carbonicum, Causticum, Dulcamara, Natrum muriaticum, Nitric acidicum, Ruta graveolens, Sulphur and Thuja occidentalis) on clinical outcome in warts. Materials and Methods: The study would be conducted at eight centres of the Central Council for Research in Homoeopathy, where patients requiring any of the predefined medicines for warts would be randomised to Homoeopathy or placebo group using a computer-generated randomisation chart. The selected medicine would be prescribed first in 6C potency and dosage and subsequent potency as per the requirement of the case. Outcome is based on the percentage of warts completely disappeared assessed fortnightly for 6 months. Discussion: The study intends to combine randomised controlled trial with validation of symptoms of the pre-identified drugs in warts. The symptoms of verum group in each case successfully treated would be compared with that in the control group. The study would aid in assessing treatment efficacy and identifying the symptomatology on the basis of which successful prescriptions have been made.

Resolution of lacrimal gland tumour by Homoeopathic medicines – A case report
Partha Pratim Pal

Indian Journal of Research in Homoeopathy 2019 13(1):48-54

Lacrimal glands are exclusive structures possessing both epithelial and lymphoid tissue and may produce a variable range of pathologies such as neoplastic, infective, infiltrative, inflammatory and structural. Treatment is either anti-inflammatory in the form of corticosteroids, radiotherapy or complete excision in the field of modern medicine. A female patient named IB, aged 35 years, came with bilateral firm swelling of the lacrimal gland. She started treatment under modern medicine doctors; however, when she was advised for biopsy, for histopathological examination, she preferred to go for Homoeopathy. The swelling was developing gradually for 2 months – painless, no fluctuation, no fixity to skin and underlying structures. After thorough case-taking followed by repertorisation, Calcarea carbonica 1M, two doses were prescribed. The patient reported after 2 months with zero Outcome in Relation to Impact on Daily Living instrument score. Further modification was done in repertorisation, and now Silicea 1M, two doses was prescribed. Treatment continued for 4 more months and no new medicine or further repetition was required. Documentation was done in the form of photographs of the patient from the same angle under similar light exposure in every follow-up.

Role of homoeopathic medicine in the treatment of infantile haemangioma
Md Ismail Shaikh

Indian Journal of Research in Homoeopathy 2019 13(1):55-61

Infantile haemangioma is a benign vascular tumour of childhood, characterised by endothelial cell proliferation. It usually develops shortly after birth and grows most rapidly over the first 6 months. However, it may keep growing for up to 12–18 months. After that, it undergoes regression or involution, and 50% of all infantile haemangiomas have completed involution by the age of 5 years, 70% by the age of 7 years and 90% by the age of 9–12 years. However, in a small percentage of patients in whom haemangioma is not disappearing completely, residual fatty tissue or superficial skin telangiectasias remains. These patients may require drug therapy (propranolol/timolol/steroids/vincristine), surgery and/or laser therapy often during childhood involving certain risks or side effects. However, homoeopathic medicine can quickly, safely and effectively diminish proliferative growth and hasten resolution without any side effects. Two children with infantile haemangioma were treated with homoeopathic medicines, selected on the basis of their totality of symptoms and repertorisation. Each child was followed up every 2–4 weeks’ interval, and photographs were taken to assess/compare the vascularity, height (thickness), pliability and pigmentation according to the Vancouver Scar Scale chart. In the 1st case, the score reduced from 9 to 1 in about 10 months of follow-up and showed 88.8% improvement. In the 2nd case, the score reduced from 9 to 0 in about 10 months of follow-up and showed 100% improvement. These case reports show that early treatment of infantile haemangioma with Homoeopathy medicine can diminish proliferative growth and hasten resolution as early as possible without any side effects.

Research Highlights (January–March 2019)
Meenakshi Bhatia

Indian Journal of Research in Homoeopathy 2019 13(1):62-65

Dr Paras Nath Varma
Daisy Katarmal

Indian Journal of Research in Homoeopathy 2019 13(1):66-67

Dr. P. N. Varma, the ‘Grandmaster’ of Homoeopathy, left for his heavenly abode on 5th November 2018. The entire homoeopathic fraternity pays tributes to the legendary homeopath. Dr. P.N. Varma has made unique contributions to the homoeopathic manufacturing industry and scientific homoeopathy.

Homoeopathy

Clinical Trials News


www.bloodjournal.org?w=16&cs=1876081726 Blood CLINICAL TRIALS AND OBSERVATIONS

Azacitidine maintenance after intensive chemotherapy improves DFS in older AML patients
The prevention of relapse is the major therapeutic challenge in older patients with acute myeloid leukemia (AML) who have obtained a complete remission (CR) on intensive chemotherapy. In this randomized phase 3 study (HOVON97) in older patients (≥60 years) with AML or myelodysplastic syndrome with refractory anemia with excess of blasts, in CR/CR with incomplete hematologic recovery (CRi) after at least 2 cycles of intensive chemotherapy, we assessed the value of azacitidine as postremission therapy…

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In The Lancet veröffentlichte Ergebnisse zeigen Nichtunterlegenheit von CT-P13 gegenüber Referenz-Infliximab bei chronisch-entzündlichen Darmerkrankungen
KOPENHAGEN, Dänemark–(BUSINESS WIRE)–Wie Celltrion Healthcare heute mitteilte, hat die Fachzeitschrift The Lancet die vollständigen Daten seiner randomisierten kontrollierten Studie (RCT) zu CT-P13 (Infliximab-Biosimilar) bei Morbus Crohn, die PLANETCD-Studie, veröffentlicht. Die Ergebnisse der Phase-III-Studie zeigen die Nichtunterlegenheit von CT-P13 gegenüber Referenz-Infliximab bei Biologika-naiven Patienten mit mittelschwerem bis schwerem Morbus Crohn.1 CT-P13 ist bereits für die Behandl

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Les données publiées dans The Lancet démontrent la non-infériorité du CT-P13 par rapport à l’infliximab de référence dans le traitement des maladies inflammatoires intestinales
COPENHAGUE, Danemark–(BUSINESS WIRE)–Celltrion Healthcare a annoncé aujourd’hui que The Lancet a publié l’intégralité des données de son essai contrôlé randomisé sur le CT-P13 (infliximab biosimilaire) dans le traitement de la maladie de Crohn (MC), intitulé PLANETCD. Les résultats de l’étude de Phase III ont démontré la non-infériorité du CT-P13 par rapport à l’infliximab de référence chez les patients atteints d’une forme modérée à sévère de MC et n’ayant jamais encore reçu d’agent biologiq

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Data Published in The Lancet Shows that CT-P13 is Non-inferior to Reference Infliximab in Inflammatory Bowel Disease
COPENHAGEN, Denmark–(BUSINESS WIRE)–Celltrion Healthcare announced today that The Lancet has published the full data-set from its randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease (CD), the PLANETCD Study. Results from the phase III study demonstrated the non-inferiority of CT-P13 to reference infliximab in biologic-naïve patients with moderate-to-severe CD.1 CT-P13 is already approved for the treatment of eight autoimmune diseases including CD, a form of

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Uit gegevens gepubliceerd in The Lancet blijkt dat CT-P13 niet inferieur is aan referentiegeneesmiddel infliximab bij inflammatoire darmaandoening
KOPENHAGEN, Denemarken–(BUSINESS WIRE)–Celltrion Healthcare heeft vandaag bekendgemaakt dat The Lancet de volledige dataset heeft gepubliceerd van haar gerandomiseerde gecontroleerde studie (RCT) van CT-P13 (biosimilar infliximab) bij de ziekte van Crohn (CD), de PLANETCD-studie. Resultaten van het fase III-onderzoek toonden de non-inferioriteit aan van CT-P13 ten opzichte van referentiegeneesmiddel infliximab bij patiënten die naïef waren voor biologicals met matige tot ernstige CD.1 CT-P13

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I dati pubblicati sulla rivista The Lancet dimostrano che CT-P13 non è inferiore all’infliximab di riferimento nel trattamento delle malattie infiammatorie intestinali
COPENAGHEN, Danimarca–(BUSINESS WIRE)–Celltrion Healthcare ha annunciato oggi che The Lancet ha pubblicato i dati completi del suo studio controllato e randomizzato (RCT) PLANETCD su CT-P13 (infliximab biosimilare) sulla malattia di Crohn (MC). I risultati di fase III dello studio hanno dimostrato la non inferiorità di CT-P13 rispetto all’infliximab di riferimento nei pazienti naïve al trattamento biologico con MC da moderata a severa.1 CT-P13 è già approvato per il trattamento di otto malatt

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Datos publicados en The Lancet demuestran que CT-P13 no es inferior al Infliximab de referencia para el tratamiento de la enfermedad inflamatoria intestinal.
COPENHAGUE, Dinamarca–(BUSINESS WIRE)–Celltrion Healthcare ha anunciado hoy que The Lancet ha publicado el primer conjunto completo de datos sobre su estudio controlado aleatorizado (RCT) de CT-P13 (biosimilar Infliximab) en la enfermedad de Crohn, el estudio PLANETCD. Los resultados del estudio de Fase III demostraron la no inferioridad de CT-P13 respecto al Infliximab de referencia en pacientes que reciben por primera vez tratamientos biológicos, con enfermedad de Crohn de moderada a grave.

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Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients
FOSTER CITY, Calif. and MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced Week 24 results of FINCH 3, an ongoing, randomized, double-blind, active-controlled Phase 3 study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis. FINCH 3 evaluated filgotinib in combination with methotrexate and as monotherapy in

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Gilead and Galapagos Announce Filgotinib Meets Primary and Key Secondary Endpoints in the Phase 3 FINCH 1 Rheumatoid Arthritis Study
FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced Week 24 results of FINCH 1, an ongoing, randomized, double-blind, placebo- and active-controlled Phase 3 study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis. FINCH 1 evaluated filgotinib versus adalimumab or placebo, on a stable…

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Gilead and Galapagos Report Updated Safety Information for Filgotinib in Rheumatoid Arthritis (RA)
FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today also announced interim safety information from four studies of the investigational compound filgotinib for the treatment of rheumatoid arthritis (RA). The data include 24 week results of the ongoing Phase 3 FINCH 1, 2, and 3 trials, and updated Week 156 safety data from the Phase 2b DARWIN 3 long term extension study in patie

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vTv Therapeutics to Present at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases
HIGH POINT, N.C.–(BUSINESS WIRE)–vTv Therapeutics to present at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases.

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Thu Mar 28, 2019 22:30


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Biolinq Expands Series A Financing With $4.75 Million Investment
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Thu Mar 28, 2019 13:00


Janssen souhaite élargir l’utilisation de la thérapie combinée au DARZALEX®▼ (daratumumab) pour les patients atteints d’un myélome multiple récemment diagnostiqué éligibles à une greffe
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Initial results from the EMPRISE real-world study of empagliflozin compared with DPP-4 inhibitors presented at ACC.19 and AMCP 2019
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Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer
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Clinical Trials News

Quality of Care

1.
Specialist nursing support for unpaid carers of people with dementia: a mixed-methods feasibility study.
Editors
Gridley K1, Aspinal F1, Parker G1, Weatherly H2, Faria R2, Longo F2, van den Berg B2.

Source
Southampton (UK): NIHR Journals Library; 2019 Mar.
Health Services and Delivery Research.

Author information
Excerpt
BACKGROUND:
Unpaid carers are the mainstay of support for people with dementia. Admiral Nursing (AN) is the only specialist nursing service that specifically focuses on supporting such carers, but evidence of its effectiveness, costs and relationships with other health and social care services is limited. This project aimed to address this gap and explore the feasibility of a full-scale formal evaluation.

OBJECTIVES:
To explore the relationships between characteristics of carers and people with dementia, service type and input and outcomes; to develop and test data collection methods for subsequent economic evaluation; to explore the effect of AN on outcomes and costs, compared with usual care; to explore the perceived system-wide impact of specialist support for carers of people with dementia, compared with usual care; and to implement new data collection methods in AN, which could also be used by other services, to facilitate evaluation.

DESIGN:
A mixed-methods study, using secondary analysis of an administrative data set, and primary (cross-sectional) quantitative and qualitative data collection.

SETTING:
Qualitative research with carers in four areas of England; a survey of carers in 32 local authority areas (16 with and 16 without AN); and qualitative interviews with professionals in four areas.

PARTICIPANTS:
Thirty-five carers of people with dementia and 20 professionals were interviewed qualitatively; 346 carers completed in-scope questionnaires (46% through AN services and 54% from matched non-AN areas).

INTERVENTIONS:
Specialist nursing support for carers of people with dementia (with AN as an exemplar) compared with usual care.

MAIN OUTCOME MEASURES:
The Adult Social Care Outcomes Toolkit for Carers; the EuroQol-5 Dimensions, five-level version; and the Caregiver Self-Efficacy for Managing Dementia Scale.

DATA SOURCES:
Dementia UK’s AN administrative data set.

RESULTS:
Admiral Nurses are successfully targeting the most complex cases. They work predominantly with older carers who have the main responsibility for the person with dementia, who are heavily involved in caring activity and who may be at risk. Three outcome areas that are important to carers of people with dementia and are potentially affected by receiving support are (1) carer self-efficacy, (2) carer quality of life (3) and carer mental and physical health. The carers in the survey receiving support from AN were older, were more heavily involved in caring and had poorer outcomes than carers not in receipt of such support. When these differences were controlled for, carers supported by AN had better outcomes, although the differences did not reach statistical significance. Health and social care costs were similar in both groups. The perceived system-wide impact of services, such as AN, is not well understood by professional stakeholders.

LIMITATIONS:
Challenges were experienced in identifying similar carers in areas with or without an AN service and in the cross-sectional nature of the work.

CONCLUSIONS:
Specialist nursing support to carers of people with dementia may enable them to continue providing care to the end or very close to the end of the dementia journey. The outcomes for such carers may be no different from, or even slightly better than, those of similar carers without this support, although the costs to health and social care services are the same in each case.

FUTURE WORK:
Future research could investigate the impact of specialist support for carers on admission to long-term care. There is also a need for more work to encourage routine use of the selected outcome measures in dementia service delivery.

FUNDING:
The National Institute for Health Research Health Services and Delivery Research programme.

Copyright © Queen’s Printer and Controller of HMSO 2019. This work was produced by Gridley et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Sections
Plain English summary
Scientific summary
Chapter 1. Introduction
Chapter 2. Study design and methods
Chapter 3. Analysis of the Admiral Nursing administrative data set
Chapter 4. The outcomes of carer support and development of the carer questionnaire (work package 2)
Chapter 5. Analysis of the survey of carers of people with dementia
Chapter 6. Exploratory analysis of the outcomes and the costs of Admiral Nursing compared with those of usual care
Chapter 7. Understanding the wider impact of specialist support for carers of people with dementia
Chapter 8. Discussion and conclusions
Acknowledgements
References
Appendix 1. Work packages 5 and 6: ensuring that the study findings inform future research and practice
Appendix 2. Support for the carers of people with dementia survey
Appendix 3. Tables and figures
Appendix 4. Analysis from Chapter 5
Appendix 5. Analysis from Chapter 6
List of abbreviations
PMID: 30916917
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Specialist nursing support for unpaid carers of people with dementia: a mixed-methods feasibility study
Free full text
Select item 30917286
2.
Ann Am Thorac Soc. 2019 Mar 27. doi: 10.1513/AnnalsATS.201812-847IP. [Epub ahead of print]
The Future of Critical Care Lies in Quality Improvement and Education.
Niven AS1, Herasevich S2, Pickering BW3, Gajic O2.
Author information
Abstract
N/A (Innovation and Provocation Section).

PMID: 30917286 DOI: 10.1513/AnnalsATS.201812-847IP
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Select item 30917161
3.
PLoS One. 2019 Mar 27;14(3):e0214049. doi: 10.1371/journal.pone.0214049. eCollection 2019.
Spatial and socio-economic correlates of effective contraception among women seeking post-abortion care in healthcare facilities in Kenya.
Mutua MM1,2, Achia TNO2,3, Manderson L2,4, Musenge E2.
Author information
Abstract
INTRODUCTION:
Information, counseling, availability of contraceptives, and their adoption by post-abortion care (PAC) patients are central to the quality of PAC in healthcare facilities. Effective contraceptive adoption by these patients reduces the risks of unintended pregnancy and repeat abortion.

METHODS:
This study uses data from the Incidence and Magnitude of Unsafe Abortion Study of 2012 to assess the level and determinants of highly effective contraception among patients treated with complications from an unsafe abortion in healthcare facilities in Kenya. Highly effective contraception was defined as any method adopted by a PAC patient that reduces pregnancy rate by over 99%.

RESULTS:
Generally, contraceptive counseling was high among all PAC patients (90%). However, only 54% of them received a modern family planning method-45% a short-acting method and 9% a long-acting and permanent method. Adoption of highly effective contraception was determined by patient’s previous exposure to unintended pregnancies, induced abortion and modern family planning (FP). Facility level factors associated with the uptake of highly effective contraceptives included: facility ownership, availability of evacuation procedure room, whether the facility had a specialized obstetric-gynecologist, a facility that also had maternity services and the number of FP methods available for PAC patients.

DISCUSSION AND CONCLUSION:
For better adoption of highly effective FP, counseling of PAC patients requires an understanding of the patient’s past experience with contraception and their future fertility intentions and desires in order to meet their reproductive needs more specifically. Family planning integration with PAC can increase contraceptive uptake and improve the reproductive health of post-abortion care patients.

PMID: 30917161 DOI: 10.1371/journal.pone.0214049
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Select item 30917097
4.
Health Technol Assess. 2019 Mar;23(13):1-226. doi: 10.3310/hta23130.
Three biomarker tests to help diagnose preterm labour: a systematic review and economic evaluation.
Varley-Campbell J1, Mújica-Mota R1, Coelho H1, Ocean N1, Barnish M1, Packman D1, Dodman S1, Cooper C1, Snowsill T1,2, Kay T3, Liversedge N3, Parr M4, Knight L3, Hyde C1, Shennan A5,6, Hoyle M1.
Author information
Abstract
BACKGROUND:
Preterm birth may result in short- and long-term health problems for the child. Accurate diagnoses of preterm births could prevent unnecessary (or ensure appropriate) admissions into hospitals or transfers to specialist units.

OBJECTIVES:
The purpose of this report is to assess the test accuracy, clinical effectiveness and cost-effectiveness of the diagnostic tests PartoSure™ (Parsagen Diagnostics Inc., Boston, MA, USA), Actim® Partus (Medix Biochemica, Espoo, Finland) and the Rapid Fetal Fibronectin (fFN)® 10Q Cassette Kit (Hologic, Inc., Marlborough, MA, USA) at thresholds ≠50 ng/ml [quantitative fFN (qfFN)] for women presenting with signs and symptoms of preterm labour relative to fFN at 50 ng/ml.

METHODS:
Systematic reviews of the published literature were conducted for diagnostic test accuracy (DTA) studies of PartoSure, Actim Partus and qfFN for predicting preterm birth, the clinical effectiveness following treatment decisions informed by test results and economic evaluations of the tests. A model-based economic evaluation was also conducted to extrapolate long-term outcomes from the results of the diagnostic tests. The model followed the structure of the model that informed the 2015 National Institute for Health and Care Excellence guidelines on preterm labour diagnosis and treatment, but with antenatal steroids use, as opposed to tocolysis, driving health outcomes.

RESULTS:
Twenty studies were identified evaluating DTA against the reference standard of delivery within 7 days and seven studies were identified evaluating DTA against the reference standard of delivery within 48 hours. Two studies assessed two of the index tests within the same population. One study demonstrated that depending on the threshold used, qfFN was more or less accurate than Actim Partus, whereas the other indicated little difference between PartoSure and Actim Partus. No study assessing qfFN and PartoSure in the same population was identified. The test accuracy results from the other included studies revealed a high level of uncertainty, primarily attributable to substantial methodological, clinical and statistical heterogeneity between studies. No study compared all three tests simultaneously. No clinical effectiveness studies evaluating any of the three biomarker tests were identified. One partial economic evaluation was identified for predicting preterm birth. It assessed the number needed to treat to prevent a respiratory distress syndrome case with a ‘treat-all’ strategy, relative to testing with qualitative fFN. Because of the lack of data, our de novo model involved the assumption that management of pregnant women fully adhered to the results of the tests. In the base-case analysis for a woman at 30 weeks’ gestation, Actim Partus had lower health-care costs and fewer quality-adjusted life-years (QALYs) than qfFN at 50 ng/ml, reducing costs at a rate of £56,030 per QALY lost compared with qfFN at 50 ng/ml. PartoSure is less costly than Actim Partus while being equally effective, but this is based on diagnostic accuracy data from a small study. Treatment with qfFN at 200 ng/ml and 500 ng/ml resulted in lower cost savings per QALY lost relative to fFN at 50 ng/ml than treatment with Actim Partus. In contrast, qfFN at 10 ng/ml increased QALYs, by 0.002, and had a cost per QALY gained of £140,267 relative to fFN at 50 ng/ml. Similar qualitative results were obtained for women presenting at different gestational ages.

CONCLUSION:
There is a high degree of uncertainty surrounding the test accuracy and cost-effectiveness results. We are aware of four ongoing UK trials, two of which plan to enrol > 1000 participants. The results of these trials may significantly alter the findings presented here.

STUDY REGISTRATION:
The study is registered as PROSPERO CRD42017072696.

FUNDING:
The National Institute for Health Research Health Technology Assessment programme.

PLAIN-LANGUAGE-SUMMARY:
Infants may suffer from health problems if they are born early. If a mother has symptoms of labour before her baby is due, a test could be used to predict if the symptoms are real or a false alarm. A test could help the doctor to decide whether the mother needs treatment or to move to a specialist hospital or if she could be sent home (if it is a false alarm). Our report compares three tests [PartoSure™ (Parsagen Diagnostics Inc., Boston, MA, USA), Actim® Partus (Medix Biochemica, Espoo, Finland) and the Fetal Fibronectin (fFN) Test (Hologic, Inc., Marlborough, MA, USA)] on how well they predict an early birth and how the costs and the long-term health outcomes of the child compare between and among tests. All the published literature reporting the accuracy of the three tests and their costs was reviewed. We developed a new cost-effectiveness model, which estimated the long-term health outcomes of the child based on the test results. Twenty of the studies reviewed looked at how good the tests were at predicting an early birth within the next 7 days, and six looked at predicting birth within 48 hours. The designs of the studies and the women taking part in the studies varied greatly. This meant that comparing the accuracy of the tests was very difficult and it would be unfair to decide which test was the best. Our model suggested no firm conclusions for the cost-effectiveness of fFN compared with Actim Partus. PartoSure appears to be less costly than Actim Partus and equally good at predicting preterm birth, but this is based on a study of very few patients. There were no data that allowed us to compare all three tests together. The accuracy of the results is uncertain, mainly because all the studies are very different. We are aware of four related UK trials that are currently ongoing that plan to include large numbers of women.

KEYWORDS:
ACTIM PARTUS; FETAL FIBRONECTIN; PAMG-1; PARTOSURE; PH(IGFBP-1); PHOSPHORYLATED INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN; PLACENTAL ALPHA MACROGLOBULIN-1; TEST ACCURACY

PMID: 30917097 DOI: 10.3310/hta23130
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Select item 30917079
5.
J Manag Care Spec Pharm. 2019 Apr;25(4):490-498. doi: 10.18553/jmcp.2019.25.4.490.
The Impact of Price Reductions After Loss of Exclusivity in a Cost-Effectiveness Analysis: Fingolimod Versus Interferon Beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis.
Hua LH1, Hersh CM1, Morten P2, Kusel J2, Lin F3, Cave J3, Varga S4, Herrera V3, Ko JJ3.
Author information
Abstract
BACKGROUND:
Cost-effectiveness analyses tend not to take into account the availability of lower-priced generics following loss of exclusivity (LOE) of branded products. By not considering these generics, which are typically adopted quickly, total costs are likely to be overestimated and may be unreflective of real-world payer conditions in the United States.

OBJECTIVE:
To assess the impact of including future price reductions following LOE on the cost-effectiveness of fingolimod versus intramuscularly administered interferon beta-1a (IM IFNβ-1a) as treatments for multiple sclerosis.

METHODS:
This model was adopted from a previously published Markov model and was conducted from a U.S. payer perspective over a 10-year time horizon. Patients with relapsing-remitting multiple sclerosis entered the model and received either fingolimod (an oral therapy) or IM IFNβ-1a (an injectable). These treatments reflect the interventions studied in the TRANSFORMS randomized clinical trial. Clinical, cost, and utility inputs were based on a recent cost-effectiveness review of therapies for multiple sclerosis. To model LOE, price reductions and the proportion of patients switching to generic versions following LOE were based on published estimates. Price reductions varied to reflect the difference in product types (oral vs. large molecule injectable). Assumptions were also made around the proportion of patients switching to generic versions over time following LOE and the projected date of LOE. Outcomes included per-patient total direct costs (medication, administration and monitoring, and disease-related costs including relapses), quality-adjusted life-years, and the incremental cost per quality-adjusted life-year.

RESULTS:
Assuming no price reductions following LOE, fingolimod was considered cost-effective versus IM IFNβ-1a ($118,434 per quality-adjusted life-year), despite having higher total direct costs over 10 years ($475,740 vs. $446,792). When including future price reductions following LOE, total direct costs were reduced with fingolimod and were lower than those accrued with IM IFNβ-1a over the model time horizon ($308,570 vs. $442,653). Cost-effectiveness results were sensitive to changes in both clinical parameters and medication costs. Scenario analyses demonstrated that an earlier date of LOE was associated with lower total costs.

CONCLUSIONS:
Health economic models may predict higher total costs when the price reductions following LOE are not considered. Here, oral fingolimod was seen to be cost-saving versus IM IFNβ-1a over the model time horizon when such price reductions were included. The cost implications of not accounting for future price changes may determine whether an intervention is considered cost-effective and as such may influence reimbursement decisions based on cost-effectiveness thresholds. Multiple product types (e.g., oral, injectable, and infused agents) have been approved for use as treatments for multiple sclerosis in the United States, and LOE is likely to have a different effect on each of these therapies.

DISCLOSURES:
This study was funded by Novartis Pharmaceuticals Corporation. Hua and Hersh report consulting fees from Novartis for work on this study. Hua also reports speaking, advisory board, and consulting fees from Biogen, Genzyme, Teva, EMD Serono, Genentech, TG Therapeutics, and Novartis for activities outside of this study. Hersh also reports speaking and consulting fees from Novartis, Biogen, Genzyme, Genentech, and EMD Serono for activities outside of this study, and research grants from PCORI and Biogen. At the time of this research, Morten and Kusel were paid employees of Costello Medical, which was contracted by Novartis to undertake some of this study’s work. Lin, Cave, Herrera, and Ko were paid employees of Novartis at the time of this research. Cave, Herrera, and Ko also report owning stock in Novartis Pharmaceuticals. Varga provided services to Novartis at the time of this research and has nothing further to disclose. This research was presented as a poster at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2017; March 27-30, 2017; Denver, CO.

PMID: 30917079 DOI: 10.18553/jmcp.2019.25.4.490
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6.
J Crohns Colitis. 2019 Mar 27. pii: jjz003. doi: 10.1093/ecco-jcc/jjz003. [Epub ahead of print]
The Evolution of Health Care Utilisation and Costs for Inflammatory Bowel Disease Over Ten Years.
Pillai N1, Dusheiko M1,2,3, Maillard MH4,5, Rogler G6, Brüngger B7, Bähler C7, Pittet VEH1; Swiss IBD Cohort Study Group.
Author information
Abstract
BACKGROUND AND AIMS:
Inflammatory bowel disease [IBD] places an economic strain on health systems due to expensive pharmaceutical therapy, risk of hospitalisation and surgery, and long-term monitoring. The evolving treatment guidelines advocate rapid scale-up to biologic agents in order to improve health outcomes and quality of life. This study evaluated changes in health care utilisation and expenditures for IBD in Switzerland over time.

METHODS:
We extracted clinical, patient, and resource consumption data from the Swiss IBD Cohort Study between 2006 and 2016. Average unit costs for IBD-related events were derived from Swiss claims data and pharmaceutical price lists. We used multivariate regression, controlling for patient-level characteristics, to estimate trends and determinants of direct and indirect costs and resource utilisation.

RESULTS:
We included 2365 adults diagnosed with Crohn’s disease [CD; N = 1353] and ulcerative colitis [UC; N = 1012]. From 2006-16, mean health care expenditures per patient per year were 9504 euros [70% drugs, 23% inpatient, 7% outpatient] for CD and 5704 euros [68% drugs, 22% inpatient, 10% outpatient] for UC. Health care costs increased by 7% [CD] and 10% [UC] per year, largely due to rising pharmaceutical expenditures driven by increased biologic agent use. Inpatient, outpatient, and indirect costs fluctuated and did not offset increased pharmaceutical costs. Disease characteristics were important predictors of costs.

CONCLUSIONS:
Increased expenditure for IBD was marked by a shift towards greater pharmaceutical management over the past decade. This study highlights the need to identify cost-effective treatment strategies in the face of increased uptake and expenditures associated with innovative treatments.

Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions.

KEYWORDS:
Crohn’s disease; IBD; health economics; ulcerative colitis

PMID: 30916775 DOI: 10.1093/ecco-jcc/jjz003
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Select item 30916758
7.
Age Ageing. 2019 Mar 22. pii: afz025. doi: 10.1093/ageing/afz025. [Epub ahead of print]
Can comprehensive geriatric assessment be delivered without the need for geriatricians? A formative evaluation in two perioperative surgical settings.
Kocman D1, Regen E1, Phelps K1, Martin G2, Parker S3, Gilbert T4, Conroy S1.
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Abstract
INTRODUCTION:
the aim of this study was to design an approach to improving care for frail older patients in hospital services where comprehensive geriatric assessment (CGA) was not part of the clinical tradition.

METHODS:
the intervention was based on the principles of CGA, using quality improvement methodology to embed care processes. Qualitative methods and coproduction were used to inform development of the intervention, which was directed towards the health care professionals involved in peri-operative/surgical cancer care pathways in two large UK teaching hospitals. A formative, qualitative evaluation was undertaken; data collection and analysis were guided by normalisation process theory.

RESULTS:
the clinicians involved agreed to use the toolkit, identifying potential benefits including improved surgical decision making and delivery of interventions pre-operatively. However, sites concluded that pre-operative assessment was not the best place for CGA, and at the end of the 12-month trial, implementation was still nascent. Efforts competed against the dominance of national time-limited targets, and concerns relating to patients’ immediate treatment and recovery. Some participants involved in the peri-operative pathway felt that CGA required ongoing specialist input from geriatricians, but it was not clear that this was sustainable.

CONCLUSIONS:
clinical toolkits designed to empower non-geriatric teams to deliver CGA were received with initial enthusiasm, but did not fully achieve their stated aims due to the need for an extended period of service development with geriatrician support, competing priorities, and divergent views about appropriate professional domains.

© The Author(s) 2019. Published by Oxford University Press on behalf of the British Geriatrics Society.

KEYWORDS:
acute care; comprehensive ; frailty; geriatric assessment; older people; qualitative research; quality improvement

PMID: 30916758 DOI: 10.1093/ageing/afz025
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Select item 30916666
8.
J Med Internet Res. 2019 Mar 27;21(3):e10831. doi: 10.2196/10831.
Online Health Information Seeking and eHealth Literacy Among Patients Attending a Primary Care Clinic in Hong Kong: A Cross-Sectional Survey.
Wong DK1, Cheung MK1.
Author information
Abstract
BACKGROUND:
Previous studies have suggested that patients’ online health information seeking affects their medical consultations and patient-doctor relationships. An up-to-date picture of patients’ online health information-seeking behaviors can inform and prepare frontline health care professionals to collaborate, facilitate, or empower their patients to access and manage health information found online.

OBJECTIVE:
This study explores the prevalence, patterns, and predictors of online health information-seeking behaviors among primary care patients in Hong Kong, and the relations between online health information seeking and electronic health (eHealth) literacy.

METHODS:
Patients attending a university primary care clinic in Hong Kong were asked to complete a questionnaire survey on their demographic backgrounds; health status; frequency and pattern of online health information seeking; contents, sources, and reasons for online health information seeking; and their eHealth literacy. eHealth literacy was measured by the validated eHealth Literacy Scale (eHEALS). Regression analyses explored various demographic and behavioral predictors to online health information seeking, and predictors to eHealth literacy.

RESULTS:
In all, 97.32% (1162/1194) respondents used the internet, of which 87.44% (1016/1162) had used the internet to find health information. Most respondents (65.97%, 665/1008) searched once monthly or more. Few (26.88%, 271/1008) asked their doctor about health information found online, but most doctors (56.1%, 152/271) showed little or no interest at all. The most sought topic was symptom (81.59%, 829/1016), the top reason was noticing new symptoms or change in health (70.08%, 712/1016), the most popular source was online encyclopedia (69.98%, 711/1016), and the top reason for choosing a source was convenience (55.41%, 563/1016). Poisson regression analysis identified high eHEALS score, fair or poor self-rated health, having a chronic medical condition, and using the internet several times a day as significant predictors of online health information seeking. Multiple regression analysis identified lower age, better self-rated health, more frequent internet use, more frequent online health information seeking, and more types of health information sought as significant predictors to higher eHealth literacy.

CONCLUSIONS:
Online health information seeking is prevalent among primary care patients in Hong Kong, but only a minority shared the information with doctors. Websites were chosen more for convenience than for accuracy or authoritativeness. Doctors should recognize patients’ online health information-seeking behavior, and facilitate and empower them to search for high-quality online health information.

©David Ka-Ki Wong, Man-Kuen Cheung. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 27.03.2019.

KEYWORDS:
Hong Kong; eHealth literacy; online health information seeking; primary care

PMID: 30916666 DOI: 10.2196/10831
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9.
JMIR Mhealth Uhealth. 2019 Mar 27;7(3):e12284. doi: 10.2196/12284.
Mobile Phone-Based Use of the Photoplethysmography Technique to Detect Atrial Fibrillation in Primary Care: Diagnostic Accuracy Study of the FibriCheck App.
Proesmans T#1, Mortelmans C#2, Van Haelst R2, Verbrugge F1, Vandervoort P1, Vaes B2.
Author information
Abstract
BACKGROUND:
Mobile phone apps using photoplethysmography (PPG) technology through their built-in camera are becoming an attractive alternative for atrial fibrillation (AF) screening because of their low cost, convenience, and broad accessibility. However, some important questions concerning their diagnostic accuracy remain to be answered.

OBJECTIVE:
This study tested the diagnostic accuracy of the FibriCheck AF algorithm for the detection of AF on the basis of mobile phone PPG and single-lead electrocardiography (ECG) signals.

METHODS:
A convenience sample of patients aged 65 years and above, with or without a known history of AF, was recruited from 17 primary care facilities. Patients with an active pacemaker rhythm were excluded. A PPG signal was obtained with the rear camera of an iPhone 5S. Simultaneously, a single‑lead ECG was registered using a dermal patch with a wireless connection to the same mobile phone. PPG and single-lead ECG signals were analyzed using the FibriCheck AF algorithm. At the same time, a 12‑lead ECG was obtained and interpreted offline by independent cardiologists to determine the presence of AF.

RESULTS:
A total of 45.7% (102/223) subjects were having AF. PPG signal quality was sufficient for analysis in 93% and single‑lead ECG quality was sufficient in 94% of the participants. After removing insufficient quality measurements, the sensitivity and specificity were 96% (95% CI 89%-99%) and 97% (95% CI 91%-99%) for the PPG signal versus 95% (95% CI 88%-98%) and 97% (95% CI 91%-99%) for the single‑lead ECG, respectively. False-positive results were mainly because of premature ectopic beats. PPG and single‑lead ECG techniques yielded adequate signal quality in 196 subjects and a similar diagnosis in 98.0% (192/196) subjects.

CONCLUSIONS:
The FibriCheck AF algorithm can accurately detect AF on the basis of mobile phone PPG and single-lead ECG signals in a primary care convenience sample.

©Tine Proesmans, Christophe Mortelmans, Ruth Van Haelst, Frederik Verbrugge, Pieter Vandervoort, Bert Vaes. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 27.03.2019.

KEYWORDS:
algorithm; atrial fibrillation; electrocardiography; mobile phone; photoplethysmography

PMID: 30916656 DOI: 10.2196/12284
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10.
J Urol. 2019 Mar 27:101097JU0000000000000250. doi: 10.1097/JU.0000000000000250. [Epub ahead of print]
Clustering of Patients with Interstitial Cystitis/Bladder Pain Syndrome and Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Lai HH1,2, Thu JHL1, Moh FV1, Paradis A1, Vetter J1.
Author information
Abstract
AIMS:
To use clustering analysis of patient symptoms to discover common patient subtypes in females and males with interstitial cystitis/bladder pain syndrome (IC/BPS) or chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

METHODS:
Clinical variables included in the k-means clustering included the severity of urologic pain (0-10 numeric rating scale, NRS), urinary urgency (0-10 NRS), frequency (0-10 NRS), non-urologic pain (0-10 NRS), and either a yes or no to each of the six UPOINT domains.

RESULTS:
211 UCPPS patients seeking care of their IC/BPS or CP/CPPS were included. K-means clustering algorithm identified 3 clusters of IC/BPS and CP/CPPS patients: (1) a mild pelvic symptom cluster in about 30% of patients; (2) a severe pelvic symptom cluster in about 40% of patients; and (3) a systemic symptom cluster in about 30% of patients. Patients in the systemic cluster were younger (by about 5-7 years), more likely to be female, had the most severe urinary symptoms (urgency, frequency, painful bladder filling), the most severe pelvic pain and non-pelvic pain. They were also more likely to have chronic overlapping pain conditions (COPCs), psychosocial issues (depression, anxiety, somatic symptoms), and poorer quality of life than the two other pelvic clusters. They were not less likely to have Hunner lesions inside the bladder.

CONCLUSIONS:
Symptom-based clustering has identified 3 clusters of IC/BPS and CP/CPPS patients. These patient subtypes have different pelvic and systemic presentation. Patients within the systemic cluster may benefit from interdisciplinary therapies. Future studies to elucidate the differences in pathophysiology among these clusters are needed.

KEYWORDS:
Hunner lesions; chronic prostatitis;urologic chronic pelvic pain syndrome; clinical subtypes; clustering; interstitial cystitis; phenotypes

PMID: 30916629 DOI: 10.1097/JU.0000000000000250
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Select item 30916615
11.
Palliat Med. 2019 Mar 27:269216319839635. doi: 10.1177/0269216319839635. [Epub ahead of print]
Appropriate frameworks for economic evaluation of end of life care: A qualitative investigation with stakeholders.
Kinghorn P1, Coast J2.
Author information
Abstract
BACKGROUND::
The use of quality-adjusted life years rests on the assertion that the objective of the health care system is to improve health.

AIM::
To elicit the views of expert stakeholders on the purpose and evaluation of supportive end of life care, and explore how different purposes of end of life care imply the need for different evaluative frameworks.

DESIGN::
Semi-structured qualitative interviews, analysed through an economic lens using a constant comparative approach.

PARTICIPANTS::
Twenty professionals working in or visiting the United Kingdom or Republic of Ireland, with clinical experience and/or working as academics in health-related disciplines.

RESULTS::
Four purposes of end of life care were identified from and are critiqued with the aid of the qualitative data: to improve health, to enable patients to die in their preferred place, to enable the patient to experience a good death, and to enable the patient to experience a good death, and those who are close to the patient to have an experience which is as free as possible from fear, stress and distress.

CONCLUSION::
Managing symptoms and reducing anxiety were considered to be core objectives of end of life care and fit with the wider health service objective of improving/maximising health. A single objective across the entire health system ensures consistency in the way that resource allocation is informed across that entire system. However, the purpose of care at the end of life is more complex, encompassing diverse and patient-centred objectives which we have interpreted as enabling the patient to experience a good death.

KEYWORDS:
Palliative care; a good death; economic evaluation; place of death; quality-adjusted life years; terminal care

PMID: 30916615 DOI: 10.1177/0269216319839635
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Select item 30916510
12.
Harefuah. 2019 Mar;158(3):196-199.
[TREATMENT OF IMMUNE THROMBOCYTOPENIC PURPURA IN ADULTS: UPDATE].
[Article in Hebrew]
Blickstein D1.
Author information
Abstract
Primary immune thrombocytopenic purpura (ITP) is an acquired immune-mediated disorder characterized by isolated thrombocytopenia (platelet count less than 100X109/L), caused by IgG autoantibodies which bind to platelets and megakaryocyte, T cell-mediated platelet destruction and impaired megakaryocytic function. Symptoms can manifest as petechiae, purpura, mucosal bleeding and rarely fatal intracranial hemorrhage, as well as reduced quality of life. A wide range of bleeding manifestations exists and it is impossible to tell who will bleed, when and where. The goal of treatment is to prevent severe/life-threatening bleeding. Treatment modalities target various aspects of ITP pathophysiology such as the inhibition of autoantibody production (decreased autoimmune process), modulation of T cell activity (with prolongation of platelets survival), and stimulation of platelet production. The American Society of Hematology and the International Society of Thrombosis and Hemostasis published guidelines on the treatment of ITP patients, where first line treatment focuses on inhibition of autoantibody production and platelet degradation, second-line treatments include immunosuppressive drugs and splenectomy, and third-line treatments aim to stimulate platelet production by megakaryocytes. New available strategies might change the order of treatment lines. As in other situations, treatment should be tailored according to the patient’s age, life style, comorbidities and compliance.

PMID: 30916510
Publication types
Select item 30916456
13.
Pediatr Blood Cancer. 2019 Mar 27:e27728. doi: 10.1002/pbc.27728. [Epub ahead of print]
Gender-specific differences in parental health-related quality of life in childhood cancer.
Rensen N1,2, Steur LM1, Schepers SA2,3, Merks JH2,4, Moll AC5, Kaspers GJ1,2, Grootenhuis MA2,3, van Litsenburg RR1,2.
Author information
Abstract
BACKGROUND:
Parents of children with cancer are at risk for impaired health-related quality of life (HRQoL). Most prior research has focused on the HRQoL of mothers. The aim of this study is to describe HRQoL in mothers and fathers, and determine the influence of sociodemographic, medical, and psychosocial factors.

PROCEDURE:
In a cross-sectional study, both parents completed questionnaires on sociodemographics, distress, and HRQoL. Parental HRQoL was compared to healthy population values. Differences between mothers and fathers were evaluated with multilevel analysis. Gender-specific HRQoL determinants were assessed via multiple linear regression analysis.

RESULTS:
Parents (202 mothers, 150 fathers; comprising 121 couples) of 231 children with different cancer diagnoses (mean time since diagnosis 3.3 ± 1.4 years, 90% posttreatment) participated. Compared to healthy women and men, mothers and fathers reported significantly impaired HRQoL on the following domains: cognitive functioning, sleep, daily activities, and vitality (Cohen’s d = 0.3-0.9). Additionally, maternal HRQoL was reduced on the domains gross motor functioning, pain, social functioning, sexuality, and depressive emotions. Mothers scored worse than fathers on six of 12 domains. Risk factors for adverse outcomes in both parents were higher distress, emotional and parenting problems, little social support, medication use, and active treatment of the child. Other determinants in mothers were non-Dutch background and unemployment, while lower HRQoL in fathers was predicted by their child’s diagnosis type, shorter time since diagnosis, and treatment intensity.

CONCLUSION:
These outcomes illustrate the need for family-centered care. Future interventions aimed at improving parental functioning should take into account gender-specific differences in HRQoL to reach optimal efficacy.

© 2019 The Authors. Pediatric Blood & Cancer Published by Wiley Periodicals, Inc.

KEYWORDS:
cancer; child; oncology; parents; psychological stress; quality of life

PMID: 30916456 DOI: 10.1002/pbc.27728
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Select item 30916392
14.
Health Serv Res. 2019 Mar 27. doi: 10.1111/1475-6773.13137. [Epub ahead of print]
Impact of pediatric cardiac surgery regionalization on health care utilization and mortality.
Sakai-Bizmark R1,2,3, Mena LA1, Kumamaru H4, Kawachi I5, Marr EH1, Webber EJ1, Seo HH1,6, Friedlander SIM1, Chang RR1,2,3.
Author information
Abstract
OBJECTIVE:
Regionalization directs patients to high-volume hospitals for specialized care. We investigated regionalization trends and outcomes in pediatric cardiac surgery.

DATA SOURCES/STUDY SETTING:
Statewide inpatient data from eleven states between 2000 and 2012.

STUDY DESIGN:
Mortality, length of stay (LOS), and cost were assessed using multivariable hierarchical regression with state and year fixed effects. Primary predictor was hospital case-volume, categorized into low-, medium-, and high-volume tertiles.

DATA COLLECTION/EXTRACTION METHODS:
We used Risk Adjustment for Congenital Heart Surgery-1 (RACHS-1) to select pediatric cardiac surgery discharges.

PRINCIPAL FINDINGS:
In total, 2841 (8.5 percent), 8348 (25.1 percent), and 22 099 (66.4 percent) patients underwent heart surgeries in low-, medium-, and high-volume hospitals. Mortality decreased over time, but remained higher in low- and medium-volume hospitals. High-volume hospitals had lower odds of mortality and cost than low-volume hospitals (odds ratio [OR] 0.59, P < 0.01, and relative risk [RR] 0.91, P < 0.01, respectively). LOS was longer for high- and medium-volume hospitals, compared to low-volume hospitals (high-volume: RR 1.18, P < 0.01; medium-volume: RR 1.05, P < 0.01).

CONCLUSIONS:
Regionalization reduced mortality and cost, indicating fewer complications, but paradoxically increased LOS. Further research is needed to explore the full impact on health care utilization.

© Health Research and Educational Trust.

KEYWORDS:
case-volume; health care utilization; mortality; pediatric cardiology

PMID: 30916392 DOI: 10.1111/1475-6773.13137
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Select item 30916340
15.
Int Health. 2019 Mar 21. pii: ihz009. doi: 10.1093/inthealth/ihz009. [Epub ahead of print]
Providing oxygen to children and newborns: a multi-faceted technical and clinical assessment of oxygen access and oxygen use in secondary-level hospitals in southwest Nigeria.
Bakare AA1, Graham H1,2, Ayede AI1,3, Peel D4, Olatinwo O5, Oyewole OB1, Fowobaje KR1, Qazi S6, Izadnegahdar R7, Duke T2, Falade AG1,3.
Author information
Abstract
BACKGROUND:
Oxygen is an essential medical therapy that is poorly available globally. We evaluated the quality of oxygen therapy in 12 secondary-level Nigerian hospitals, including access to oxygen equipment, equipment functionality, healthcare worker knowledge and appropriateness of use.

METHODS:
We conducted a three-part evaluation of oxygen access and use involving: (1) facility assessment (including technical evaluation of oxygen equipment), (2) clinical audit (children and neonates admitted January 2014-December 2015) and (3) survey of healthcare worker training and experience on the clinical use of oxygen (November 2015).

RESULTS:
Oxygen access for children and newborns is compromised by faulty equipment, lack of pulse oximetry and inadequate care practices. One hospital used pulse oximetry for paediatric care. Eleven hospitals had some access to oxygen supplies. Testing of 57 oxygen concentrators revealed two (3.5%) that were ‘fit for use’. Overall, 14.4% (3708/25 677) of children and neonates received oxygen some time during their admission; 19.4% (1944/10 000) of hypoxaemic children received oxygen; 38.5% (1217/3161) of children who received oxygen therapy were not hypoxaemic.

CONCLUSIONS:
Oxygen access for children in Nigerian hospitals is poor, and likely results in substantial excess mortality. To improve oxygen access for children globally we must focus on actual provision of oxygen to patients-not simply the presence of oxygen equipment at the facility level. This requires a systematic approach to improve both oxygen (access [including equipment, maintenance and affordability]) and oxygen use (including pulse oximetry, guidelines and continuing education).

© The Author(s) 2019. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

KEYWORDS:
children; concentrators; hypoxaemia; newborns; oxygen therapy

PMID: 30916340 DOI: 10.1093/inthealth/ihz009
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Select item 30916178
16.
Cad Saude Publica. 2019 Mar 25;35(3):e00118118. doi: 10.1590/0102-311X00118118.
Prevalence of sexually transmitted infections and bacterial vaginosis among lesbian women: systematic review and recommendations to improve care.
Takemoto MLS1, Menezes MO1, Polido CBA2, Santos DS3, Leonello VM4, Magalhães CG5, Cirelli JF6, Knobel R7.
Author information
Abstract
Our aim was to systematically review data about the risk of sexually transmitted infections (STI) and bacterial vaginosis among lesbian women and to suggest strategies to improve prevention, diagnosis and treatment. A search strategy for lesbian, STI and bacterial vaginosis was applied to PubMed, LILACS and BDENF databases. Of 387 unique references retrieved, 22 fulfilled the inclusion criteria (cross-sectional studies reporting prevalence for 8 STIs/bacterial vaginosis and history of a STI). The most frequent infection reported was bacterial vaginosis, and none study reported data on hepatitis B. A wide range of prevalence was observed for most infections. In terms of risk factors, the number of sexual partners, the past or current smoking, a history of forced sex and sexual stigma seem to increase the risk of STI and bacterial vaginosis. The findings of this review are discussed considering guidelines directly addressing the LGBT community’s health and relevant studies investigating both safe sexual practices and the intricate relationship between LGBT people and their care providers. A set of recommendations to improve preventive care for lesbian women is proposed. Affirming that little is known about the extent of STIs and bacterial vaginosis transmission in female-to-female sexual activities or about the risk factors for STI and bacterial vaginosis among lesbian women is reasonable. In fact, the overall quality of the studies was low or very low with significant uncertainty around their findings. However, we consider that the available knowledge indicates some paths to be followed by care providers and policy decision-makers to improve their actions towards better sexual health of lesbian women.

PMID: 30916178 DOI: 10.1590/0102-311X00118118
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Select item 30916012
17.
Br J Anaesth. 2019 Feb 28. pii: S0007-0912(19)30064-9. doi: 10.1016/j.bja.2019.01.024. [Epub ahead of print]
Effectiveness of interdisciplinary interventions in paediatric chronic pain management: a systematic review and subset meta-analysis.
Liossi C1, Johnstone L2, Lilley S3, Caes L4, Williams G3, Schoth DE2.
Author information
Abstract
BACKGROUND:
Paediatric chronic pain is a significant problem that can have devastating impacts on quality of life. Multimodal interdisciplinary interventions are the mainstay of paediatric treatment. The aim of this article is to provide a comprehensive review of the effectiveness of interdisciplinary interventions in the management of paediatric chronic pain.

METHODS:
Studies were identified via a search of nine databases. The search strategy included concept blocks pertaining to type of pain, study population, and type of intervention. Eligible studies reported the effects of an intervention co-ordinated by two or more healthcare professionals of different disciplines, and recruited a sample aged 22 yr or below with chronic pain. Twenty-eight studies were included, and 21 provided data for inclusion in between- and within-groups meta-analyses.

RESULTS:
Patients randomised to interdisciplinary interventions reported significantly lower pain intensity 0-1 month post-intervention compared with patients randomised to the control groups. Within-groups analysis of patients receiving interdisciplinary interventions showed significant improvements pre- to post-intervention in pain intensity, functional disability, anxiety, depression, catastrophising, school attendance, school functioning, and pain acceptance. Few differences were found between interventions delivered in inpatient vs outpatient settings. Significant heterogeneity due mainly to differing outcome variables and intervention content was found in most analyses.

CONCLUSIONS:
Overall, interdisciplinary interventions show promise in providing a range of clinical benefits for children with chronic pain. Methodologically robust randomised controlled trials using standardised outcome measures are needed, however, to guide clinical care.

Copyright © 2019 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

KEYWORDS:
chronic pain; interdisciplinary pain clinic; meta-analysis; multimodal analgesia; paediatrics; systematic review

PMID: 30916012 DOI: 10.1016/j.bja.2019.01.024
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18.
Br J Anaesth. 2019 Mar 2. pii: S0007-0912(19)30059-5. doi: 10.1016/j.bja.2019.01.019. [Epub ahead of print]
Perioperative Quality Initiative consensus statement on postoperative blood pressure, risk and outcomes for elective surgery.
McEvoy MD1, Gupta R2, Koepke EJ3, Feldheiser A4, Michard F5, Levett D6, Thacker JKM7, Hamilton M8, Grocott MPW9, Mythen MG10, Miller TE3, Edwards MR9; POQI-3 workgroup; POQI chairs, Miller TE3, Mythen MG10, Grocott MP11, Edwards MR11; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group.
Collaborators (29)
Author information
Abstract
BACKGROUND:
Postoperative hypotension and hypertension are frequent events associated with increased risk of adverse outcomes. However, proper assessment and management is often poorly understood. As a part of the PeriOperative Quality Improvement (POQI) 3 workgroup meeting, we developed a consensus document addressing this topic. The target population includes adult, non-cardiac surgical patients in the postoperative phase outside of the ICU.

METHODS:
A modified Delphi technique was used, evaluating papers published in MEDLINE examining postoperative blood pressure monitoring, management, and outcomes. Practice recommendations were developed in line with National Institute for Health and Care Excellence guidelines.

RESULTS:
Consensus recommendations were that (i) there is evidence of harm associated with postoperative systolic arterial pressure <90 mm Hg; (ii) for patients with preoperative hypertension, the threshold at which harm occurs may be higher than a systolic arterial pressure of 90 mm Hg; (iii) there is insufficient evidence to precisely define the level of postoperative hypertension above which harm will occur; (iv) a greater frequency of postoperative blood pressure measurement is likely to identify risk of harm and clinical deterioration earlier; and (v) there is evidence of harm from withholding beta-blockers, angiotensin receptor blockers, and angiotensin-converting enzyme inhibitors in the postoperative period.

CONCLUSIONS:
Despite evidence of associations with postoperative hypotension or hypertension with worse postoperative outcome, further research is needed to define the optimal levels at which intervention is beneficial, to identify the best methods and timing of postoperative blood pressure measurement, and to refine the management of long-term antihypertensive treatment in the postoperative phase.

Copyright © 2019 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

KEYWORDS:
antihypertensive drugs; blood pressure; hypertension; hypotension; myocardial infarction; outcomes; postoperative; surgery

PMID: 30916008 DOI: 10.1016/j.bja.2019.01.019
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19.
Br J Anaesth. 2019 Mar 2. pii: S0007-0912(19)30057-1. doi: 10.1016/j.bja.2019.01.018. [Epub ahead of print]
Perioperative Quality Initiative consensus statement on preoperative blood pressure, risk and outcomes for elective surgery.
Sanders RD1, Hughes F2, Shaw A3, Thompson A4, Bader A5, Hoeft A6, Williams DA4, Grocott MPW7, Mythen MG8, Miller TE4, Edwards MR9; Perioperative Quality Initiative-3 Workgroup; POQI chairs; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group.
Collaborators (33)
Author information
Abstract
BACKGROUND:
A multidisciplinary international working subgroup of the third Perioperative Quality Initiative consensus meeting appraised the evidence on the influence of preoperative arterial blood pressure and community cardiovascular medications on perioperative risk.

METHODS:
A modified Delphi technique was used, evaluating papers published in MEDLINE on associations between preoperative numerical arterial pressure values or cardiovascular medications and perioperative outcomes. The strength of the recommendations was graded by National Institute for Health and Care Excellence guidelines.

RESULTS:
Significant heterogeneity in study design, including arterial pressure measures and perioperative outcomes, hampered the comparison of studies. Nonetheless, consensus recommendations were that (i) preoperative arterial pressure measures may be used to define targets for perioperative management; (ii) elective surgery should not be cancelled based solely upon a preoperative arterial pressure value; (iii) there is insufficient evidence to support lowering arterial pressure in the immediate preoperative period to minimise perioperative risk; and (iv) there is insufficient evidence that any one measure of arterial pressure (systolic, diastolic, mean, or pulse) is better than any other for risk prediction of adverse perioperative events.

CONCLUSIONS:
Future research should define which preoperative arterial pressure values best correlate with adverse outcomes, and whether modifying arterial pressure in the preoperative setting will change the perioperative morbidity or mortality. Additional research should define optimum strategies for continuation or discontinuation of preoperative cardiovascular medications.

Copyright © 2019 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

KEYWORDS:
arterial pressure; haemodynamics; perioperative care; preoperative blood pressure; surgical risk

PMID: 30916006 DOI: 10.1016/j.bja.2019.01.018
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20.
Br J Anaesth. 2019 Feb 27. pii: S0007-0912(19)30050-9. doi: 10.1016/j.bja.2019.01.013. [Epub ahead of print]
Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery.
Sessler DI1, Bloomstone JA2, Aronson S3, Berry C4, Gan TJ5, Kellum JA6, Plumb J7, Mythen MG8, Grocott MPW9, Edwards MR7, Miller TE10; Perioperative Quality Initiative-3 workgroup; POQI chairs, Miller TE, Mythen MG, Grocott MP, Edwards MR; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group.
Collaborators (29)
Author information
Abstract
BACKGROUND:
Intraoperative mortality is now rare, but death within 30 days of surgery remains surprisingly common. Perioperative myocardial infarction is associated with a remarkably high mortality. There are strong associations between hypotension and myocardial injury, myocardial infarction, renal injury, and death. Perioperative arterial blood pressure management was thus the basis of a Perioperative Quality Initiative consensus-building conference held in London in July 2017.

METHODS:
The meeting featured a modified Delphi process in which groups addressed various aspects of perioperative arterial pressure.

RESULTS:
Three consensus statements on intraoperative blood pressure were established. 1) Intraoperative mean arterial pressures below 60-70 mm Hg are associated with myocardial injury, acute kidney injury, and death. Injury is a function of hypotension severity and duration. 2) For adult non-cardiac surgical patients, there is insufficient evidence to recommend a general upper limit of arterial pressure at which therapy should be initiated, although pressures above 160 mm Hg have been associated with myocardial injury and infarction. 3) During cardiac surgery, intraoperative systolic arterial pressure above 140 mm Hg is associated with increased 30 day mortality. Injury is a function of arterial pressure severity and duration.

CONCLUSIONS:
There is increasing evidence that even brief durations of systolic arterial pressure <100 mm Hg and mean arterial pressure <60-70 mm Hg are harmful during non-cardiac surgery.

Copyright © 2019 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

KEYWORDS:
anaesthesia; arterial pressure; hypotension; mortality; myocardial injury; postoperative outcome; renal injury; surgery

PMID: 30916004 DOI: 10.1016/j.bja.2019.01.013
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Thu Mar 28, 2019 12:01


The Continued Search for Optimal Therapy in Patients With OSA and PTSD.
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www.ncbi.nlm.nih.gov?w=16&cs=3019999628

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Thu Mar 28, 2019 12:01


Adverse Effects of Hypnotic Medications.
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www.ncbi.nlm.nih.gov?w=16&cs=3019999628

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Thu Mar 28, 2019 12:01


Advancing Treatment of Comorbid PTSD and OSA.
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www.ncbi.nlm.nih.gov?w=16&cs=3019999628

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Thu Mar 28, 2019 12:01


Hypnotics and the Risks of Dementia.
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Thu Mar 28, 2019 12:01


Treatment of PTSD-Related OSA With CPAP is Associated With Only a Modest Improvement in PTSD: Possible Adjunctive Treatment With Mood Stabilizers.
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www.ncbi.nlm.nih.gov?w=16&cs=3019999628

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Thu Mar 28, 2019 12:01


Commentary on Healthy School Start Times.
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pubmed: sleep

Thu Mar 28, 2019 12:01

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Sleep Disorders