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1. Patient and health professional attitudes towards the use of telemedicine for abortion care in Britain: Findings from the SACHA study

Author

Rebecca Meiksin, Maria Lewandowska, Rachel H Scott, Melissa Palmer, Ona McCarthy, Natasha Salaria, Patricia A Lohr, Jill Shawe, Rebecca Sophia French, and Kaye Wellings

Subjects
Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Introduction Use of telemedicine in abortion care is safe and effective. Patient satisfaction with telemedically supported abortion is high, but as use expands in Britain, little is known about patients’ or health professionals’ views on how it is best used. We sought the views of both groups on telemedicine's role in abortion provision and how its use might be optimised. Methods We administered a structured survey with an additional free-text response option to a range of health professionals from services identified via clustered random sampling. We conducted semi-structured interviews with patients with recent experience of abortion, purposively sampled from abortion services. Participants were recruited from England, Scotland and Wales. We analysed qualitative data using thematic analysis alongside framework analysis. Results Support for telemedicine was high among participants, which included 771 health professionals from a range of services and 48 patients. Among health professionals, 23% opposed the use of telemedicine in abortion provision. Opposition was highest among those uninvolved, or who did not feel skilled, in remote provision. Reported benefits included patient convenience and comfort. Patient concerns centred on adequate provision of emotional support. Participants made suggestions for augmenting and extending the use of telemedicine to meet some patients’ needs, including combining telemedical consultation with in-person care and providing information and follow-up via digital methods. Conclusions Acceptability of telemedically supported abortion, which offers logistical and emotional benefits to patients, is high in Britain. Novel ways of providing telemedical support should be explored to enhance remote abortion provision. In-person care should remain an option for patients.

Published
2024
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2. How can patient experience of abortion care be improved? Evidence from the SACHA study

Author

Maria Lewandowska, Rachel Scott, Rebecca Meiksin, Jennifer Reiter, Natasha Salaria, Patricia A Lohr, Sharon Cameron, Melissa Palmer, Rebecca S French, and Kaye Wellings

Subjects
Medicine
Abstract

Background: Models of abortion care have changed significantly in the last decade, most markedly during the COVID-19 pandemic, when home management of early medical abortion with telemedical support was approved in Britain. Objective: Our study aimed to examine women’s satisfaction with abortion care and their suggestions for improvements. Design: Qualitative, in-depth, semi-structured interviews. Methods: A purposive sample of 48 women with recent experience of abortion was recruited between July 2021 and August 2022 from independent sector and National Health Service abortion services in Scotland, Wales and England. Interviews were conducted by phone or via video call. Women were asked about their abortion experience and for suggestions for any improvements that could be made along their patient journey – from help-seeking, the initial consultation, referral, treatment, to aftercare. Data were analyzed using the Framework Method. Results: Participants were aged 16–43 years; 39 had had a medical abortion, 8 a surgical abortion, and 1 both. The majority were satisfied with their clinical care. The supportive, kind and non-judgmental attitudes of abortion providers were highly valued, as was the convenience afforded by remotely supported home management of medical abortion. Suggestions for improvement across the patient journey centred around the need for timely care; greater correspondence between expectations and reality; the importance of choice; and the need for greater personal and emotional support. Conclusion: Recent changes in models of care present both opportunities and challenges for quality of care. The perspectives of patients highlight further opportunities for improving care and support. The principles of timely care, choice, management of expectations, and emotional support should inform further service configuration.

Published
2024
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3. Selectivity matters: selective ROCK2 inhibitor ameliorates established liver fibrosis via targeting inflammation, fibrosis, and metabolism

Author

Alexandra Zanin-Zhorov, Wei Chen, Julien Moretti, Melanie S. Nyuydzefe, Iris Zhorov, Rashmi Munshi, Malavika Ghosh, Cindy Serdjebi, Kelli MacDonald, Bruce R. Blazar, Melissa Palmer, and Samuel D. Waksal

Subjects
Biology (General), QH301-705.5
Abstract

Abstract The pathogenesis of hepatic fibrosis is driven by dysregulated metabolism precipitated by chronic inflammation. Rho-associated coiled-coil-containing protein kinases (ROCKs) have been implicated in these processes, however the ability of selective ROCK2 inhibition to target simultaneously profibrotic, pro-inflammatory and metabolic pathways remains undocumented. Here we show that therapeutic administration of GV101, a selective ROCK2 inhibitor with more than 1000-fold selectivity over ROCK1, attenuates established liver fibrosis induced by thioacetamide (TAA) in combination with high-fat diet in mice. GV101 treatment significantly reduces collagen levels in liver, associated with downregulation of pCofilin, pSTAT3, pAkt, while pSTAT5 and pAMPK levels are increased in tissues of treated mice. In vitro, GV101 inhibits profibrogenic markers expression in fibroblasts, adipogenesis in primary adipocytes and TLR-induced cytokine secretion in innate immune cells via targeting of Akt-mTOR-S6K signaling axis, further uncovering the ROCK2-specific complex mechanism of action and therapeutic potential of highly selective ROCK2 inhibitors in liver fibrosis.

Published
2023
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4. The impact of COVID-19 lockdown on abortion care: a time series analysis of data from Marie Stopes Nepal

Author

Corrina Horan, Melissa Palmer, Raman Shrestha, Chelsey Porter Erlank, and Kathryn Church

Subjects
abortion, COVID-19, sexual and reproductive health and rights, Diseases of the genitourinary system. Urology, RC870-923, The family. Marriage. Woman, HQ1-2044
Abstract

The COVID-19 pandemic significantly impacted sexual and reproductive health and rights. Nepal implemented a nationwide lockdown in March 2020, limiting population movement and service access. The 36 clinics run by Marie Stopes Nepal (MSN) closed for varying periods at the beginning of lockdown. This study assesses the impact of lockdown and associated clinic closures on abortion services within MSN’s network. An interrupted time-series analysis of clinic-level MSN data compared abortion service use in the pre-closure and post-reopening periods, focusing on the following outcomes: number of abortion care visits, proportion of abortion-related visits, gestational age at time of abortion care and demographics of patients accessing abortion care. Subsequent meta-analyses combined clinic-level results to generate outcome-specific pooled effect estimates. As MSN clinics reopened, during ongoing wider lockdown, weekly visits for abortion care decreased by 37% on average, but abortion increased as a proportion of services post-reopening (OR: 1.53) compared with pre-closure, with no evidence of a change in the proportion of higher gestation abortions. The demographic profile of abortion care clients was altered, with post-reopening clients more likely to have completed primary education (OR: 1.54) and be aged 25 years or older (OR: 1.31) compared with pre-closure clients. COVID-19 lockdown and associated clinic closures reduced the absolute number of abortion services provided within MSN’s network, impacting the composition of service provision. Reductions in safe abortion and wider SRH access will have wide-ranging consequences, curtailing crucial reproductive rights. Policy-makers must ensure ongoing abortion access to protect rights and ensure access.

Published
2022
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5. A randomized controlled trial of an intervention delivered by mobile phone text message to increase the acceptability of effective contraception among young women in Palestine

Author

Ona L. McCarthy, Hanadi Zghayyer, Amina Stavridis, Samia Adada, Irrfan Ahamed, Baptiste Leurent, Phil Edwards, Melissa Palmer, and Caroline Free

Subjects
Palestine, Contraception, mHealth, Family planning, Young adults, Medicine (General), R5-920
Abstract

Abstract Background Research has shown that mobile phone contraceptive behavioral interventions can increase knowledge and use of contraception, but other studies have failed to demonstrate a beneficial effect. The objective of this trial was to estimate the effect of a contraceptive behavioral intervention delivered by mobile phone text message on young Palestinian women’s attitudes towards effective contraception. Methods We conducted a randomized controlled trial among women aged 18–24 years living in the West Bank, who were not using an effective method of contraception. The intervention group received zero to three messages per day (113 messages for female-not married and 120 messages for female-married) for 120 days. The control group received 16 messages over 120 days about trial participation. The primary outcome was acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception at 4 months and any use during the study, acceptability of individual methods, service uptake, unintended pregnancy and abortion. Process outcomes included knowledge, perceived norms, personal agency and intention. All outcomes were self-reported. We analyzed the outcomes using logistic and linear regression. Results A total of 578 participants were enrolled and 464 (80%) completed follow up at 4 months. Intervention group participants were more likely to find at least one method of effective contraception acceptable (31% in the intervention group versus 17% in the control group, adjusted OR 2.34, 95% CI 1.48–3.68, p

Published
2019
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6. A randomised, double-blind, placebo-controlled phase 1 study of the safety, tolerability and pharmacodynamics of volixibat in overweight and obese but otherwise healthy adults: implications for treatment of non-alcoholic steatohepatitis

Author

Melissa Palmer, Lee Jennings, Debra G. Silberg, Caleb Bliss, and Patrick Martin

Subjects
Volixibat, SHP626, LUM002, Non-alcoholic steatohepatitis, Non-alcoholic fatty liver disease, Apical sodium-dependent bile acid transporter (ASBT), Therapeutics. Pharmacology, RM1-950, Toxicology. Poisons, RA1190-1270
Abstract

Abstract Background Accumulation of toxic free cholesterol in hepatocytes may cause hepatic inflammation and fibrosis. Volixibat inhibits bile acid reuptake via the apical sodium bile acid transporter located on the luminal surface of the ileum. The resulting increase in bile acid synthesis from cholesterol could be beneficial in patients with non-alcoholic steatohepatitis. This adaptive dose-finding study investigated the safety, tolerability, pharmacodynamics, and pharmacokinetics of volixibat. Methods Overweight and obese adults were randomised 3:1 to double-blind volixibat or placebo, respectively, for 12 days. Volixibat was initiated at a once-daily dose of 20 mg, 40 mg or 80 mg. Based on the assessment of predefined safety events, volixibat dosing was either escalated or reduced. Other dose regimens (titrations and twice-daily dosing) were also evaluated. Assessments included safety, tolerability, stool hardness, faecal bile acid (FBA) excretion, and serum levels of 7α-hydroxy-4-cholesten-3-one (C4) and lipids. Results All 84 randomised participants (volixibat, 63; placebo, 21) completed the study, with no serious adverse events at doses of up to 80 mg per day (maximum assessed dose). The median number of daily bowel evacuations increased from 1 (range 0–4) to 2 (0–8) during volixibat treatment, and stool was looser with volixibat than placebo. Volixibat was minimally absorbed; serum levels were rarely quantifiable at any dose or sampling time point, thereby precluding pharmacokinetic analyses. Mean daily FBA excretion was 930.61 μmol (standard deviation [SD] 468.965) with volixibat and 224.75 μmol (195.403) with placebo; effects were maximal at volixibat doses ≥20 mg/day. Mean serum C4 concentrations at day 12 were 98.767 ng/mL (standard deviation, 61.5841) with volixibat and 16.497 ng/mL (12.9150) with placebo. Total and low-density lipoprotein cholesterol levels decreased in the volixibat group, with median changes of − 0.70 mmol/L (range − 2.8 to 0.4) and − 0.6990 mmol/L (− 3.341 to 0.570), respectively. Conclusions This study indicates that maximal inhibition of bile acid reabsorption, as assessed by FBA excretion, occurs at volixibat doses of ≥20 mg/day in obese and overweight adults, without appreciable change in gastrointestinal tolerability. These findings guided dose selection for an ongoing phase 2 study in patients with non-alcoholic steatohepatitis. Trial registration ClinicalTrials.gov identifier: NCT02287779 (registration first received 6 November 2014).

Published
2018
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7. A randomized controlled trial of an intervention delivered by mobile phone app instant messaging to increase the acceptability of effective contraception among young people in Tajikistan

Author

Ona McCarthy, Irrfan Ahamed, Firuza Kulaeva, Ravshan Tokhirov, Salokhiddin Saibov, Marieka Vandewiele, Sarah Standaert, Baptiste Leurent, Phil Edwards, Melissa Palmer, and Caroline Free

Subjects
Randomized controlled trial, Tajikistan, Contraception, Smart phone, Reproductive health, Young adults, Gynecology and obstetrics, RG1-991
Abstract

Abstract Background Unintended pregnancy is associated with poorer health outcomes for women and their families. In Tajikistan, around 26% of married 15–24 year old women have an unmet need for contraception. There is some evidence that interventions delivered by mobile phone can affect contraceptive-related behaviour and knowledge. We developed an intervention delivered by mobile phone app instant messaging to improve acceptability of effective contraceptive methods among young people in Tajikistan. Methods This was a randomized controlled trial among Tajik people aged 16–24. Participants allocated to the intervention arm had access to an app plus intervention messages. Participants allocated to the control arm had access to the app plus control messages. The primary outcome was acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception at 4 months and during the study, acceptability of individual methods, service uptake, unintended pregnancy and induced abortion. Process outcomes were knowledge, perceived norms, personal agency and intention. Outcomes were analysed using logistic and linear regression. We conducted a pre-specified subgroup analysis and a post-hoc analysis of change in acceptability from baseline to follow-up. Results Five hundred and seventy-three participants were enrolled. Intervention content was included on the app, causing contamination. Four hundred and seventy-two (82%) completed follow-up for the primary outcome. There was no evidence of a difference in acceptability of effective contraception between the groups (66% in the intervention arm vs 64% in the control arm, adjusted OR 1.21, 95% CI .80–1.83, p = 0.36). There were no differences in the secondary or process outcomes between groups. There was some evidence that the effect of the intervention was greater among women compared to men (interaction test p = 0.03). There was an increase in acceptability of effective contraception from baseline to follow-up (2% to 65%, p

Published
2018
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8. Safety, tolerability and pharmacodynamics of apical sodium-dependent bile acid transporter inhibition with volixibat in healthy adults and patients with type 2 diabetes mellitus: a randomised placebo-controlled trial

Author

Renger G. Tiessen, Ciara A. Kennedy, Bradley T. Keller, Nancy Levin, Lisette Acevedo, Bronislava Gedulin, Andre A. van Vliet, Alejandro Dorenbaum, and Melissa Palmer

Subjects
Apical sodium-dependent bile acid transporter, Bile acids, Clinical pharmacology, Non-alcoholic steatohepatitis, Non-alcoholic fatty liver disease, Phase 1 clinical trial, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background Pathogenesis in non-alcoholic steatohepatitis (NASH) involves abnormal cholesterol metabolism and hepatic accumulation of toxic free cholesterol. Apical sodium-dependent bile acid transporter (ASBT) inhibition in the terminal ileum may facilitate removal of free cholesterol from the liver by reducing recirculation of bile acids (BAs) to the liver, thereby stimulating new BA synthesis from cholesterol. The aim of this phase 1 study in adult healthy volunteers (HVs) and patients with type 2 diabetes mellitus (T2DM) was to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASBT inhibition with volixibat (SHP626; formerly LUM002). Methods Participants were randomised 3:1 to receive once-daily oral volixibat (0.5 mg, 1 mg, 5 mg or 10 mg) or placebo for 28 days in two cohorts (HV and T2DM). Assessments included safety, faecal BA and serum 7α-hydroxy-4-cholesten-3-one (C4; BA synthesis biomarker). Results Sixty-one individuals were randomised (HVs: placebo, n = 12; volixibat, n = 38; T2DM: placebo, n = 3; volixibat, n = 8). No deaths or treatment-related serious adverse events were reported. Mild or moderate gastrointestinal adverse events were those most frequently reported with volixibat. With volixibat, mean total faecal BA excretion on day 28 was ~1.6–3.2 times higher in HVs (643.73–1239.3 μmol/24 h) and ~8 times higher in T2DM (1786.0 μmol/24 h) than with placebo (HVs: 386.93 μmol/24 h; T2DM: 220.00 μmol/24 h). With volixibat, mean C4 concentrations increased by ~1.3–5.3-fold from baseline to day 28 in HVs and by twofold in T2DM. Conclusions Volixibat was generally well tolerated. Increased faecal BA excretion and serum C4 levels support the mechanistic rationale for exploring ASBT inhibition in NASH. The study was registered with the Dutch clinical trial authority (Centrale Commissie Mensgebonden Onderzoek; trial registration number NL44732.056.13; registered 24 May 2013).

Published
2018
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9. Apical sodium-dependent bile acid transporter inhibition with volixibat improves metabolic aspects and components of non-alcoholic steatohepatitis in Ldlr-/-.Leiden mice.

Author

Kanita Salic, Robert Kleemann, Cynthia Wilkins-Port, John McNulty, Lars Verschuren, and Melissa Palmer

Subjects
Medicine, Science
Abstract

Interruption of bile acid recirculation through inhibition of the apical sodium-dependent bile acid transporter (ASBT) is a promising strategy to alleviate hepatic cholesterol accumulation in non-alcoholic steatohepatitis (NASH), and improve the metabolic aspects of the disease. Potential disease-attenuating effects of the ASBT inhibitor volixibat (5, 15, and 30 mg/kg) were investigated in high-fat diet (HFD)-fed Ldlr-/-.Leiden mice over 24 weeks. Plasma and fecal bile acid levels, plasma insulin, lipids, and liver enzymes were monitored. Final analyses included liver histology, intrahepatic lipids, mesenteric white adipose tissue mass, and liver gene profiling. Consistent with its mechanism of action, volixibat significantly increased the total amount of bile acid in feces. At the highest dose, volixibat significantly attenuated the HFD-induced increase in hepatocyte hypertrophy, hepatic triglyceride and cholesteryl ester levels, and mesenteric white adipose tissue deposition. Non-alcoholic fatty liver disease activity score (NAS) was significantly lower in volixibat-treated mice than in the HFD controls. Gene profiling showed that volixibat reversed the inhibitory effect of the HFD on metabolic master regulators, including peroxisome proliferator-activated receptor-γ coactivator-1β, insulin receptor, and sterol regulatory element-binding transcription factor 2. Volixibat may have beneficial effects on physiological and metabolic aspects of NASH pathophysiology.

Published
2019
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10. The effectiveness of smoking cessation, physical activity/diet and alcohol reduction interventions delivered by mobile phones for the prevention of non-communicable diseases: A systematic review of randomised controlled trials.

Author

Melissa Palmer, Jennifer Sutherland, Sharmani Barnard, Aileen Wynne, Emma Rezel, Andrew Doel, Lily Grigsby-Duffy, Suzanne Edwards, Sophie Russell, Ellie Hotopf, Pablo Perel, and Caroline Free

Subjects
Medicine, Science
Abstract

BACKGROUND:We conducted a systematic review to assess the effectiveness of smoking cessation, physical activity (PA), diet, and alcohol reduction interventions delivered by mobile technology to prevent non-communicable diseases (NCDs). METHODS:We searched for randomised controlled trials (RCTs) of mobile-based NCD prevention interventions using MEDLINE, EMBASE, Global Health, CINAHL (Jan 1990-Jan 2016). Two authors extracted data. FINDINGS:71 trials were included: smoking cessation (n = 18); PA (n = 15), diet (n = 3), PA and diet (n = 25); PA, diet, and smoking cessation (n = 2); and harmful alcohol consumption (n = 8). 4 trials had low risk of bias. The effect of SMS-based smoking cessation support on biochemically verified continuous abstinence was pooled relative risk [RR] 2.19 [95% CI 1.80-2.68], I2 = 0%) and on verified 7 day point prevalence of smoking cessation was pooled RR 1.51 [95% CI 1.06-2.15], I2 = 0%, with no reported adverse events. There was no difference in peak oxygen intake at 3 months in a trial of an SMS-based PA intervention. The effect of SMS-based diet and PA interventions on: incidence of diabetes was pooled RR 0.67 [95% CI 0.49, 0.90], I2 = 0.0%; end-point weight was pooled MD -0.99Kg [95% CI -3.63, 1.64] I2 = 29.4%; % change in weight was pooled MD -3.1 [95%CI -4.86- -1.3] I2 0.3%; and on triglyceride levels was pooled MD -0.19 mmol/L [95% CI -0.29, -0.08], I2 = 0.0%. The results of other pooled analyses of the effect of SMS-based diet and PA interventions were heterogenous (I2 59-90%). The effects of alcohol reduction interventions were inconclusive. CONCLUSIONS:Smoking cessation support delivered by SMS increases quitting rates. Trials of PA interventions reporting outcomes ≥3 months showed no benefits. There were at best modest benefits of diet and PA interventions. The effects of the most promising SMS-based smoking, diet and PA interventions on morbidity and mortality in high-risk groups should be established in adequately powered RCTs.

Published
2018
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11. Can text messages increase safer sex behaviours in young people? Intervention development and pilot randomised controlled trial

Author

Caroline Free, Ona McCarthy, Rebecca S French, Kaye Wellings, Susan Michie, Ian Roberts, Karen Devries, Sujit Rathod, Julia Bailey, Jonathan Syred, Phil Edwards, Graham Hart, Melissa Palmer, and Paula Baraitser

Subjects
sexual health, behaviour change, intervention design, randomised controlled trial, safer sex, young people, partner notification, condom use, sexually transmitted infections, Medical technology, R855-855.5
Abstract

Background: Younger people bear the heaviest burden of sexually transmitted infections (STIs). Partner notification, condom use and STI testing can reduce infection but many young people lack the knowledge, skills and confidence needed to carry out these behaviours. Text messages can provide effective behavioural support. The acceptability and feasibility of a randomised controlled trial of safer sex support delivered by text message are not known. Objectives: To assess the acceptability and feasibility of a randomised controlled trial of a safer sex intervention delivered by text message for young people aged 16–24 years. Design: (1) Intervention development; (2) follow-up procedure development; (3) a pilot, parallel-arm randomised controlled trial with allocation via remote automated randomisation (ratio of 1 : 1) (participants were unmasked, whereas researchers analysing samples and data were masked); and (4) qualitative interviews. Setting: Participants were recruited from sexual health services in the UK. Participants: Young people aged 16–24 years diagnosed with chlamydia or reporting unprotected sex with more than one partner in the last year. Interventions: A theory- and evidence-based safer sex intervention designed, with young people’s input, to reduce the incidence of STIs by increasing the correct treatment of STIs, partner notification, condom use and STI testing before unprotected sex with a new partner. The intervention was delivered via automated mobile phone messaging over 12 months. The comparator was a monthly text message checking contact details. Main outcome measures: (1) Development of the intervention based on theory, evidence and expert and user views; (2) follow-up procedures; (3) pilot trial primary outcomes: full recruitment within 3 months and follow-up rate for the proposed primary outcomes for the main trial; and (4) participants’ views and experiences regarding the acceptability of the intervention. Results: In total, 200 participants were randomised in the pilot trial, of whom 99 were allocated to the intervention and 101 were allocated to the control. We fully recruited early and achieved an 81% follow-up rate for our proposed primary outcome of the cumulative incidence of chlamydia at 12 months. There was no differential follow-up between groups. In total, 97% of messages sent were successfully delivered to participants’ mobile phones. Recipients reported that the tone, language, content and frequency of messages were appropriate. Messages reportedly increased knowledge of and confidence in how to use condoms and negotiate condom use and reduced stigma about STIs, enabling participants to tell a partner about a STI. Conclusions: Our research shows that the intervention is acceptable and feasible to deliver. Our pilot trial demonstrated that a main trial is feasible. It remains unclear which behaviour change techniques and elements of the intervention or follow-up procedures are associated with effectiveness. A further limitation is that in the trial one person entering data and the participants were unmasked. A randomised controlled trial to establish the effects of the intervention on STIs at 12 months is needed. Trial registration: Current Controlled Trials ISRCTN02304709. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 57. See the NIHR Journals Library website for further project information.

Published
2016
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12. Correction to: A randomized controlled trial of an intervention delivered by mobile phone app instant messaging to increase the acceptability of effective contraception among young people in Tajikistan

Author

Ona McCarthy, Irrfan Ahamed, Firuza Kulaeva, Ravshan Tokhirov, Salokhiddin Saibov, Marieka Vandewiele, Sarah Standaert, Baptiste Leurent, Phil Edwards, Melissa Palmer, and Caroline Free

Subjects
Gynecology and obstetrics, RG1-991
Abstract

Abstract After publication of the original article [1], it came to the authors’ attention that there is a typo in the Results section.

Published
2018
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13. Redefinition of Fatty Liver Disease from NAFLD to MAFLD through the Lens of Drug Development and Regulatory Science

Author

R. Myers, Muhammad Y. Sheikh, Ramy Younes, David A. Shapiro, Robert Riccio, Arie Regev, Melissa Palmer, Richard Torstenson, Detlef Schuppan, Steven Bollipo, Minjun Chen, Puneet S. Arora, Henrik Landgren, Rajarshi Banerjee, Yasser Fouad, Martin Blake, Bradley Freilich, Dina Attia, Alastair D. Smith, Morten A. Karsdal, Hans-Juergen Gruss, and Robert G. Gish

Subjects
education.field_of_study, medicine.medical_specialty, Hepatology, business.industry, Public health, Fatty liver, Population, Disease, Public relations, medicine.disease, Terminology, Drug development, Nonalcoholic fatty liver disease, medicine, Regulatory science, business, education
Abstract

Metabolic (dysfunction)-associated fatty liver disease (MAFLD) affects a third of the population and is a leading cause of liver-related death. Since no effective treatments exist, novel approaches to drug development are required. Unfortunately, outdated terminology and definitions of the disease are hampering efforts to develop new drugs and treatments. An international consensus panel has put forth an influential proposal for the disease to be renamed from nonalcoholic fatty liver disease (NAFLD) to MAFLD, including a proposal for how the disease should be diagnosed. As allies with the many stakeholders in MAFLD care―including patients, patients’ advocates, clinicians, researchers, nurse and allied health groups, regional societies, and others―we are aware of the negative consequences of the NAFLD term and definition. We share the sense of urgency for change and will act in new ways to achieve our goals. Although there is much work to be done to overcome clinical inertia and reverse worrisome recent trends, the MAFLD initiative provides a firm foundation to build on. It provides a roadmap for moving forward toward more efficient care and affordable, sustainable drug and device innovation in MAFLD care. We hope it will bring promising new opportunities for a brighter future for MAFLD care and improve care and outcomes for patients of one of the globe’s largest and costliest public health burdens. From this viewpoint, we have revisited this initiative through the perspectives of drug development and regulatory science.

Published
2021
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14. Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials

Author

Denise Coffey, Ann Marie Stanley, Liliam Pineda-Salgado, Don C. Rockey, Meenal Patwardhan, Melissa Palmer, Raúl J. Andrade, Ritu Raheja, John Caminis, Sandzhar Abdullaev, Lara Dimick-Santos, David L. Bourdet, Paul H. Hayashi, Daniel Seekins, J. Hey-Hadavi, Haifa Tyler, and Alvin Estilo

Subjects
Knowledge management, Standardization, Best practice, MEDLINE, Leading Article, Toxicology, 030226 pharmacology & pharmacy, 03 medical and health sciences, 0302 clinical medicine, Humans, Medicine, Pharmacology (medical), 030212 general & internal medicine, Expert Testimony, Adjudication, Pharmacology, Clinical Trials as Topic, business.industry, Data Collection, Causality, Clinical trial, Subject-matter expert, Chemical and Drug Induced Liver Injury, business, Working group
Abstract

Causality assessment for suspected drug-induced liver injury (DILI) during drug development and following approval is challenging. The IQ DILI Causality Working Group (CWG), in collaboration with academic and regulatory subject matter experts (SMEs), developed this manuscript with the following objectives: (1) understand and describe current practices; (2) evaluate the utility of new tools/methods/practice guidelines; (3) propose a minimal data set needed to assess causality; (4) define best practices; and (5) promote a more structured and universal approach to DILI causality assessment for clinical development. To better understand current practices, the CWG performed a literature review, took a survey of member companies, and collaborated with SMEs. Areas of focus included best practices for causality assessment during clinical development, utility of adjudication committees, and proposals for potential new avenues to improve causality assessment. The survey and literature review provided renewed understanding of the complexity and challenges of DILI causality assessment as well as the use of non-standardized approaches. Potential areas identified for consistency and standardization included role and membership of adjudication committees, standardized minimum dataset, updated assessment tools, and best practices for liver biopsy and rechallenge in the setting of DILI. Adjudication committees comprised of SMEs (i.e., utilizing expert opinion) remain the standard for DILI causality assessment. A variety of working groups continue to make progress in pursuing new tools to assist with DILI causality assessment. The minimum dataset deemed adequate for causality assessment provides a path forward for standardization of data collection in the setting of DILI. Continued progress is necessary to optimize and advance innovative tools necessary for the scientific, pharmaceutical, and regulatory community. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01051-5.

Published
2021
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15. Volixibat in adults with non-alcoholic steatohepatitis: 24-week interim analysis from a randomized, phase II study

Author

Guruprasad P. Aithal, Robert Herring, Hak-Myung Lee, Harry Sarles, Melissa Palmer, Muhammad Y. Sheikh, Philip N. Newsome, Parvez S. Mantry, Tarek Hassanein, Aasim Sheikh, Zeid Kayali, and Bradley Freilich

Subjects
Male, 0301 basic medicine, medicine.medical_specialty, Cirrhosis, Side effect, medicine.drug_class, Organic Anion Transporters, Sodium-Dependent, Benzothiepins, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Non-alcoholic Fatty Liver Disease, Internal medicine, medicine, Clinical endpoint, Humans, Glycosides, Cholestenones, Lipid Regulating Agents, Symporters, Hepatology, Bile acid, business.industry, Fatty liver, Patient Acuity, Alanine Transaminase, Middle Aged, medicine.disease, Interim analysis, Magnetic Resonance Imaging, Cholesterol, Treatment Outcome, 030104 developmental biology, Liver, Tolerability, Female, 030211 gastroenterology & hepatology, Steatohepatitis, business, Biomarkers
Abstract

Background & Aims Volixibat is an inhibitor of the apical sodium-dependent bile acid transporter (ASBT) that has been hypothesized to improve non-alcoholic steatohepatitis (NASH) by blocking bile acid reuptake and stimulating hepatic bile acid production. We studied the safety, tolerability and efficacy of volixibat in patients with NASH. Methods In this double-blind, phase II dose-finding study, adults with ≥5% steatosis and NASH without cirrhosis (N = 197) were randomized to receive volixibat (5, 10 or 20 mg) or placebo once daily for 48 weeks. The endpoints of a predefined interim analysis (n = 80), at week 24, were: ≥5% reduction in MRI-proton density fat fraction and ≥20% reduction in serum alanine aminotransferase levels. The primary endpoint was a ≥2-point reduction in non-alcoholic fatty liver disease activity score without worsening fibrosis at week 48. Results Volixibat did not meet either interim endpoint; the study was terminated owing to lack of efficacy. In participants receiving any volixibat dose, mean serum 7-alpha-hydroxy-4-cholesten-3-one (C4; a biomarker of bile acid synthesis) increased from baseline to week 24 (+38.5 ng/ml [SD 53.18]), with concomitant decreases in serum total cholesterol (−14.5 mg/dl [SD 28.32]) and low-density lipoprotein cholesterol (−16.1 mg/dl [SD 25.31]). These changes were generally dose-dependent. On histological analysis, a greater proportion of participants receiving placebo (38.5%, n = 5/13) than volixibat (30.0%, n = 9/30) met the primary endpoint. Treatment-emergent adverse events (TEAEs) were mainly mild or moderate. No serious TEAEs were related to volixibat. Diarrhoea was the most common TEAE overall and the most common TEAE leading to discontinuation. Conclusions Increased serum C4 and decreased serum cholesterol levels provide evidence of target engagement. However, inhibition of ASBT by volixibat did not elicit a liver-related therapeutic benefit in adults with NASH. Lay summary A medicine called volixibat has previously been shown to reduce cholesterol levels in the blood. This study investigated whether volixibat could reduce the amount of fat in the liver and reduce liver injury in adults with an advanced form of non-alcoholic fatty liver disease. Volixibat did not reduce the amount of fat in the liver, nor did it have any other beneficial effect on liver injury. Participants in the study generally tolerated the side effects of volixibat and, as in previous studies, the main side effect was diarrhoea. These results show that volixibat is not an effective treatment for people with fatty liver disease. Clinical trial identifier NCT02787304 .

Published
2020
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16. A dynamic and collaborative approach to trial recruitment in safetxt, a UK sexual health randomised controlled trial

Author

Lauren Jerome, Kimberley Potter, Ona McCarthy, Melissa Palmer, Megan Knight, and Caroline Free

Subjects
Pharmacology, Text Messaging, Patient Selection, Sample Size, Humans, General Medicine, Sexual Health, Research Personnel, Randomized Controlled Trials as Topic
Abstract

Background/Aims: Recruiting to target in randomised controlled trials is crucial for providing reliable results, yet many trials struggle to achieve their target sample size. Many trials do not report sufficient, if any, details of their recruitment strategy for others to adapt for their own trials. Furthermore, much of the available evidence describes strategies to improve recruitment aimed at participants, as opposed to strategies aimed at engaging and motivating recruiting staff who are deemed essential for recruitment success. The safetxt trial aimed to recruit 6250 participants, aged 16–24 years, who had either tested positive, or received treatment, for chlamydia/gonorrhoea/non-specific urethritis in the last 2 weeks, from across the United Kingdom into a randomised controlled trial investigating a text message intervention to improve sexual health outcomes. In this article, we describe in detail the recruitment strategies we employed that were primarily aimed at recruiters. Methods: Recruitment began in April 2016. We built on our recruitment methods established in the pilot trial and developed several strategies to increase recruitment as the trial progressed including optimising site set-up, monitoring recruitment progress and identifying issues, facilitating shared learning, tailored recruitment materials, sustaining motivation, and communication. We describe these strategies in detail and provide practical examples for each. Results: We combine our strategies for increasing recruitment into one cyclical approach whereby progress is continuously monitored, and interventions to improve recruitment are implemented. The site initiation visits were used to develop a clear recruitment plan and establish good relationships with local site staff. Screening logs were particularly helpful for monitoring recruitment challenges. We facilitated shared learning by organising meetings with recruiting sites and conducting site visits. Tailored recruitment materials helped to promote the trial in clinic environments, and rewards and goals helped sustain motivation among recruiting staff. Finally, at the centre of the approach is good communication which ensured we maintained good relationships with local site staff. Conclusion: We conducted a large, multi-centre trial and successfully recruited to target. Our dynamic collaborative approach to recruitment described in this paper builds upon previous research by combining suggested good practice into one cyclical approach to recruitment, and providing detailed examples of each strategy. It is not possible to attribute a causal link between our approach and recruitment success overall, or with specific sites or recruiting staff. Nonetheless we describe the processes we used to build a good relationship with recruiting staff and sites, and maintain recruitment of large numbers of participants over the 32 months of the trial. Other researchers can use our approach and adapt our examples for their own trials.

Published
2022

17. Global multi-stakeholder endorsement of the MAFLD definition

Author

Nahum Méndez-Sánchez, Elisabetta Bugianesi, Robert G Gish, Frank Lammert, Herbert Tilg, Mindie H Nguyen, Shiv K Sarin, Núria Fabrellas, Shira Zelber-Sagi, Jian-Gao Fan, Gamal Shiha, Giovanni Targher, Ming-Hua Zheng, Wah-Kheong Chan, Shlomo Vinker, Takumi Kawaguchi, Laurent Castera, Yusuf Yilmaz, Marko Korenjak, C Wendy Spearman, Mehmet Ungan, Melissa Palmer, Mortada El-Shabrawi, Hans-Juergen Gruss, Jean-François Dufour, Anil Dhawan, Heiner Wedemeyer, Jacob George, Luca Valenti, Yasser Fouad, Manuel Romero‐Gomez, Mohammed Eslam, Maria Lorena Abate, Bahaa Abbas, Ahmed Amr Abbassy, Waleed Abd El Ghany, Amira Abd Elkhalek, Emad Abd ElMajeed, Mohammad Abdalgaber, Mohamed AbdAllah, Marwa Abdallah, Nourhan Abdallah, Shereen Abdelaleem, Yasser Abdelghani, Wael Abdelghany, Safaa Mohamed Abdelhalim, Wafaa Abdelhamid, Nehal Abdelhamid, Nadia A. Abdelkader, Elsayed Abdelkreem, Aly Mohamed Abdelmohsen, Awny Ali Abdelrahman, Sherief M Abd-elsalam, Doaa Abdeltawab, Abdulbaset Abduh, Nada Abdulhakam, Maheeba Abdulla, Navid Abedpoor, Ludovico Abenavoli, Fredrik Åberg, Omala Ablack, Mostafa Abo elftouh, Yousry Esam-Eldin Abo-Amer, Ashraf Aboubkr, Alaa Aboud, Amr M. Abouelnaga, Galal A. Aboufarrag, Ashraf Aboutaleb, Leticia Abundis, Gupse Adalı, Enrique Adames, Leon Adams, Danjuma Adda, Noor Adel, Nada Adel, Muhammad Adel Sayed, Taiba Jibril Afaa, Nawal Afredj, Gulnara Aghayeva, Alessio Aghemo, Carlos A. Aguilar-Salinas, Golo Ahlenstiel, Walid Ahmady, Wafaa Ahmed, Amira Ahmed, Samah Nasser Ahmed, Heba Mostafa Ahmed, Rasha Ahmed, Elmar Aigner, Mesut Akarsu, Maisam Akroush, Umit Akyuz, Mamun Al Mahtab, Tahani Al Qadiri, Yusriya Al Rawahi, Razzaq AL rubaee, Muna Al Saffar, Shahinul Alam, Zaid Al-Ani, Agustín Albillos, Mohamed Alboraie, Said Al-Busafi, Mohamed Al-Emam, Jawaher Alharthi, Kareem Ali, Basma Abdelmoez Ali, Mohammad Ali, Raja Affendi Raja Ali, Anna Alisi, Ali Raad AL-Khafaji, Maryam Alkhatry, Rocio Aller, Yahya Almansoury, Khalid Al-Naamani, Alaa Alnakeeb, Anna Alonso, Saleh A. Alqahtani, Leina Alrabadi, Khalid Alswat, Mahir Altaher, Turki Altamimi, Jose Altamirano, Mario R. Alvares-da-Silva, Elsragy Adel M. Aly, Amgad Alzahaby, Ahmed Alzamzamy, Keisuke Amano, Maysa A. Amer, Mona A. Amin, Sayed A. Amin, Ashraf A. Amir, Javier Ampuero, Noha Anas, Pietro Andreone, Soa Fy Andriamandimby, Mahmoud Anees, Peltec Angela, Manal Antonios, Wael Arafat, Jose Moreno Araya, Juan Armendariz-Borunda, Matthew J. Armstrong, Hassan Ashktorab, Patricia Aspichueta, Fathia Assal, Mira Atef, Dina Attia, Hoda Atwa, Reham Awad, Mohyeldeen Abd Elaziz Awad, Sally Awny, Obafemi Awolowo, Yaw Asante Awuku, Ibrahim Ayada, Than Than Aye, Sherif Ayman, Hedy Ayman, Hesham Ayoub, Hosny M. Azmy, Romiro P. Babaran, Omneya Badreldin, Ahmed Badry, İbrahim Halil Bahçecioğlu, Amira Bahour, Jiajia Bai, Yasemin Balaban, Muthuswamy Balasubramanyam, Khaled Bamakhrama, Jesus M Banales, Babu Bangaru, Jianfeng Bao, Jorge Suazo Barahona, Salma Barakat, Sandra Maria Barbalho, Bikwa Barbra, Beatriz Barranco, Francisco Barrera, Ulrich Baumann, Shamardan Bazeed, Eva Bech, Aourarh Benayad, Andreas Benesic, David Bernstein, Fernando Bessone, Susie Birney, Cyrille Bisseye, Martin Blake, Bilal Bobat, Leonilde Bonfrate, Dmitry S Bordin, Francisco Bosques-Padilla, Jerome Boursier, Boushab Mohamed Boushab, David Bowen, Patricia Medina Bravo, Paul N Brennan, Bisi Bright, Ilse Broekaert, Xabier Buque, Diego Burgos-Santamaría, Julio Burman, Luca Busetto, Chris D. Byrne, Patricia Anne I. Cabral-Prodigalidad, Guillermo Cabrera-Alvarez, Wei Cai, Francesca Cainelli, Ali Riza Caliskan, Ali Canbay, Ana Cano-Contreras, Hai-Xia Cao, Zhujun Cao, Andres Carrion, Francesca Carubbi, Teresa Casanovas, Marlen Ivón Castellanos Fernández, Jin Chai, Siew Pheng Chan, Phunchai Charatcharoenwitthaya, Norberto Chavez-Tapia, Kazuaki Chayama, Jinjun Chen, Lin Chen, Zhong-Wei Chen, Huiting Chen, Sui-Dan Chen, Qiang Chen, Yaxi Chen, Gang Chen, En-Quang Chen, Fei Chen, Pei-Jer Chen, Robert Cheng, Wendy Cheng, Jack Tan Wei Chieh, Imad Chokr, Evangelos Cholongitas, Ashok Choudhury, Abhijit Chowdhury, Evaristus Sunday Chukwudike, Stefano Ciardullo, Michelle Clayton, Karine Clement, Marie Michelle Cloa, Cecilia Coccia, Cristina Collazos, Massimo Colombo, Arif Mansur Cosar, Helma Pinchemel Cotrim, Joris Couillerot, Alioune Coulibaly, Gonzalo Crespo, Javier Crespo, Maria Cruells, Ian Homer Y. Cua, Hesham K. Dabbous, George N Dalekos, Patricia D'Alia, Li Dan, Viet Hang Dao, Mostafa Darwish, Christian Datz, Milagros B Davalos-Moscol, Heba Dawoud, Blanca Olaechea de Careaga, Robert de Knegt, Victor de Ledinghen, Janaka de Silva, Nabil Debzi, Marie Decraecker, Elvira Del Pozo, Teresa C Delgado, Manuel Delgado-Blanco, Łukasz Dembiński, Adilson Depina, Moutaz Derbala, Hailemichael Desalegn, Christèle Desbois-Mouthon, Mahmoud Desoky, Anouk Dev, Agostino Di Ciaula, Moisés Diago, Ibrahima Diallo, Luis Antonio Díaz, Melisa Dirchwolf, Paola Dongiovanni, Andrriy Dorofeyev, Xiaoguang Dou, Mark W. Douglas, Michael Doulberis, Cecil K. Dovia, Adam Doyle, Ivana Dragojević, Joost PH Drenth, Xuefei Duan, Audrius Dulskas, Dan L Dumitrascu, Oliver Duncan, Vincent Dusabejambo, Rev. Shem N.A. Dwawhi, Sho Eiketsu, Doaa El Amrousy, Ahmed El Deeb, Ghada El Deriny, Hesham Salah El Din, Salwa El Kamshishy, Mohamed El Kassas, Maissa El Raziky, Osama A Elagamy, Wafaa Elakel, Dina Elalfy, Hanaa Elaraby, Heba ElAwady, Reda Elbadawy, Hanaa Hassan Eldash, Manal S. Eldefrawy, Carol Lezama Elecharri, Amel Elfaramawy, Mohammed Elfatih, Mahmoud Elfiky, Mohamed Elgamsy, Mohamed Elgendy, Mohamed A. El-Guindi, Nagi Elhussieny, Ahmed Maher Eliwa, Zeineb Elkabbany, Hesham El-Khayat, Nehal M. El-Koofy, Alaa Elmetwalli, Amr Elrabat, Fathiya El-Raey, Fatma Elrashdy, Medhat Elsahhar, Esraa M. Elsaid, Shimaa Elsayed, Hany Elsayed, Aly Elsayed, Amr M. Elsayed, Hamdy Elsayed, Magdy El-Serafy, Ahmed M. Elsharkawy, Reem Yehia Elsheemy, Eman Elsayed Elshemy, Sara Elsherbini, Naglaa Eltoukhy, Reda Elwakil, Ola Emad, Shaimaa Emad, Mohamed Embabi, Ilkay Ergenç, Tatiana Ermolova, Gamal Esmat, Doaa M. Esmat, Enrique Carrera Estupiñan, Said Ettair, Tcaciuc Eugen, Mohammed Ezz-Eldin, Lidia Patricia Valdivieso Falcón, Yu-Chen Fan, Samah Fandari, Mahmoud Farag, Taghreed Mohamed Farahat, Eman M. Fares, Michael Fares, Eduardo Fassio, Hayam Fathy, Dina Fathy, Wael Fathy, Soheir Fayed, Dan Feng, Gong Feng, Miguel Fernández-Bermejo, Cristina Targa Ferreira, Javier Díaz Ferrer, Alastair Forbes, Rabab Fouad, Hanan M. Fouad, Tove Frisch, Hideki Fujii, Shuhei Fukunaga, Shinya Fukunishi, Hacer Fulya, Masato Furuhashi, Yasmine Gaber, Augusto Jose G. Galang, Jacqueline Cordova Gallardo, Rocío Galloso, Mahmoud Gamal, Reham Gamal, Hadeel Gamal, Jian Gan, Anar Ganbold, Xin Gao, George Garas, Tony Garba, Miren García-Cortes, Carmelo García-Monzón, Javier García-Samaniego, Amalia Gastaldelli, Manuel Gatica, Elizabeth Gatley, Tamar Gegeshidze, Bin Geng, Hasmik Ghazinyan, Salma Ghoneem, Luca Giacomelli, Gianluigi Giannelli, Edoardo G. Giannini, Matthew Giefer, Pere Ginès, Marcos Girala, Pablo J Giraudi, George Boon-Bee Goh, Ahmed Ali Gomaa, Benbingdi Gong, Dina Hilda C. Gonzales, Humberto C. Gonzalez, Maria Saraí Gonzalez-Huezo, Isabel Graupera, Ivica Grgurevic, Henning Grønbæk, Xuelian Gu, Lin Guan, Ibrahima Gueye, Alice Nanelin Guingané, Ozen Oz Gul, Cuma Bulent Gul, Qing Guo, Pramendra Prasad Gupta, Ahmet Gurakar, Juan Carlos Restrepo Gutierrez, Ghada Habib, Azaa Hafez, Emilia Hagman, Eman Halawa, Osama Hamdy, Abd Elkhalek Hamed, Dina H. Hamed, Saeed Hamid, Waseem Hamoudi, Yu Han, James Haridy, Hanan Haridy, David C H Harris Harris, Michael Hart, Fuad Hasan, Almoutaz Hashim, Israa Hassan, Ayman Hassan, Essam Ali Hassan, Adel Ahmed Hassan, Magda Shehata Hassan, Fetouh Hassanin, Alshymaa Hassnine, John Willy Haukeland, Amr Ismael M. Hawal, Jinfan He, Qiong He, Yong He, Fang-Ping He, Mona Hegazy, Adham Hegazy, Osama Henegil, Nelia Hernández, Manuel Hernández-Guerra, Fatima Higuera-de-la-Tijera, Ibrahim Hindy, Keisuke Hirota, Lee Chi Ho, Alexander Hodge, Mohamed Hosny, Xin Hou, Jiao-Feng Huang, Yan Huang, Zhifeng Huang, Yuan Huang, Ang Huang, Xiao-Ping Huang, Sheng Hui-ping, Bela Hunyady, Mennatallah A. Hussein, Osama Hussein, Shahinaz Mahmoud Hussien, Luis Ibáñez-Samaniego, Jamal Ibdah, Luqman Ibrahim, Miada Ibrahim, Ibrahim Ibrahim, Maria E. Icaza-Chávez, Sahar Idelbi, Ramazan Idilman Idilman, Mayumi Ikeda, Giuseppe Indolfi, Federica Invernizzi, Iram Irshad, Hasan Mohamed Ali Isa, Natacha Jreige Iskandar, Abdulrahman Ismaiel, Mariam Ismail, Zulkifli Ismail, Faisal Ismail, Hideki Iwamoto, Kathryn Jack, Rachael Jacob, Fuad Jafarov, Wasim Jafri, Helen Jahshan, Prasun K Jalal, Ligita Jancoriene, Martin Janicko, Hiruni Jayasena, Meryem Jefferies, Vivekanand Jha, Fanpu Ji, Yaqiu Ji, Jidong Jia, Changtao Jiang, Ni Jiang, Zong-zhe Jiang, Xing Jin, Yi Jin, Xu Jing, Qian Jingyu, Maia Jinjolava, FX Himawan Haryanto Jong, Alina Jucov, Ibecheole Julius, Mona Kaddah, Yoshihiro Kamada, Abobakr kamal, Enas Mohamed Kamal, Ashraf Sayed Kamel, Jia-Horng Kao, Maja Karin, Thomas Karlas, Mohammad Kashwaa, Leolin Katsidzira, Eda Kaya, M.Azzam Kayasseh, Bernadette Keenan, Caglayan Keklikkiran, William Keml, Deia K. Khalaf, Rofida Khalefa, Sherin Khamis, Doaa Khater, Hamed khattab, Anatoly Khavkin, Olga Khlynova, Nabil Khmis, Nazarii Kobyliak, Apostolos Koffas, Kazuhiko Koike, Kenneth Y.Y. Kok, Tomas Koller, Narcisse Patrice Komas, Nataliya V. Korochanskaya, Yannoula Koulla, Shunji Koya, Colleen Kraft, Bledar Kraja, Marcin Krawczyk, Mohammad Shafi Kuchay, Anand V Kulkarni, Ashish Kumar, Manoj Kumar, Sulaiman Lakoh, Philip Lam, Ling Lan, Naomi F. Lange, Kamran Bagheri Lankarani, Nicolas Lanthier, Kateryna Lapshyna, Sameh A. Lashen, Konang Nguieguia Justine Laure, Leonid Lazebnik, Didier Lebrec, Samuel S. Lee, Way Seah Lee, Yeong Yeh Lee, Diana Julie Leeming, Nathalie Carvalho Leite, Roberto Leon, Cosmas Rinaldi Adithya Lesmana, Junfeng Li, Qiong Li, Jun Li, Yang-Yang Li, Yufang Li, Lei Li, Min Li, Yiling li, Huiqing Liang, Tang Lijuan, Seng Gee Lim, Lee-Ling Lim, Shumei Lin, Han-Chieh Lin, Rita Lin, Rania Lithy, Yaru Liu, Yuanyuan Liu, Xin Liu, Wen-Yue Liu, Shourong Liu, Ken Liu, Tian Liu, Amedeo Lonardo, Mariana Bravo López, Eva López-Benages, Patricio Lopez-Jaramillo, Huimin Lu, Lun Gen Lu, Yan Lu, John Lubel, Rashid Lui, Iulianna Lupasco, Elena Luzina, Xiao-Hui Lv, Kate Lynch, Hong-Lei Ma, Mariana Verdelho Machado, Nonso Maduka, Katerina Madzharova, Russellini Magdaong, Sanjiv Mahadeva, Amel Mahfouz, Nik Ritza Kosai Nik Mahmood, Eman Mahmoud, Mohamed Mahrous, Rakhi Maiwall, Ammar Majeed, Avik Majumdar, Loey Mak, Madiha M Maklouf, Reza Malekzadeh, Claudia Mandato, Alessandra Mangia, Jake Mann, Hala Hussien Mansour, Abdellah Mansouri, Alessandro Mantovani, Jun qian Mao, Flor Maramag, Giulio Marchesini, Claude Marcus, Rui António Rocha Tato Marinho, Maria L Martinez-Chantar, Antonieta A. Soares Martins, Rana Marwan, Karen Frances Mason, Ghadeer Masoud, Mohamed Naguib Massoud, Maria Amalia Matamoros, Rosa Martín Mateos, Asmaa Mawed, Jean Claude Mbanya, Charles Mbendi, Lone McColaugh, Duncan McLeod, Juan Francisco Rivera Medina, Ahmed Megahed, Mai Mehrez, Iqbal Memon, Shahin Merat, Randy Mercado, Ahmed Mesbah, Taoufik Meskini, Mayada Metwally, Rasha Metwaly, Lei Miao, Eileen Micah, Luca Miele, Vladimir Milivojevic, Tamara Milovanovic, Yvonne L. Mina, Milan Mishkovik, Amal Mishriki, Tim Mitchell, Alshaimaa Mohamed, Mona Mohamed, Sofain Mohamed, Shady Mohammed, Ahmed Mohammed, Viswanathan Mohan, Sara Mohie, Aalaa Mokhtar, Reham Moniem, Mabel Segura Montilla, Jose Antonio Orozco Morales, María María Sánchez Morata, Jose Maria Moreno-Planas, Silvia Morise, Sherif Mosaad, Mohamed Moselhy, Alaa Mohamed Mostafa, Ebraheem Mostafa, Nezha Mouane, Nasser Mousa, Hamdy Mahfouz Moustafa, Abeer Msherif, Kate Muller, Christopher Munoz, Ana Beatriz Muñoz-Urribarri, Omar Alfaro Murillo, Feisul Idzwan Mustapha, Emir Muzurović, Yehia Nabil, Shaymaa Nafady, Ayu Nagamatsu, Atsushi Nakajima, Dan Nakano, Yuemin Nan, Fabio Nascimbeni, Mirella S. Naseef, Nagwa Nashat, Taran Natalia, Francesco Negro, Alexander V. 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Peltekian, Xuebin Peng, Liang Peng, Ying Peng, Rahul Pengoria, Martina Perez, José Luis Pérez, Norma Marlene Pérez, Marcello Persico, Mário Guimarães Pessoa, Salvatore Petta, Mathew Philip, Maria Corina Plaz Torres, Naveen Polavarapu, Jaime Poniachik, Piero Portincasa, Chunwen Pu, Tuğrul Pürnak, Edhie Purwanto, Xiaolong Qi, Xingshun Qi, Zibing Qian, Zhao Qiang, Zengpei Qiao, Liang Qiao, Alberto Queiroz, Atoosa Rabiee, Manal Radwan, Alain Marcel Rahetilahy, Yasmin Ramadan, Dina Ramadan, Anis Safura Ramli, Grant A. Ramm, Ao Ran, Ivan Rankovic, Huiying RAO, Sara Raouf, Sayantan Ray, Nancy Reau, Ahmed Refaat, Thomas Reiberger, Jose M Remes-Troche, Eira Cerda Reyes, Ben Richardson, Ezequiel Ridruejo, Sergio Riestra Jimenez, Ibrahim Rizk, Stuart Roberts, Juan Pablo Roblero, Jorge Alberto Prado Robles, Don Rockey, Manuel Rodríguez, Heriberto Rodríguez Hernández, Eva Román, Fernando Gomes Romeiro, Stefano Romeo, Jose Miguel Rosales-Zabal, Georgina R. Roshdi, Natalia Rosso, Andres Ruf, Patricia Cordero Ruiz, Nelia R. Runes, Andrea Ruzzenente, Marno Ryan, Ahmed Saad, Eman BE Sabbagh, Meriam Sabbah, Shimaa Saber, Reham Sabrey, Ramy Sabry, Maysaa Abdallah Saeed, Dina Said, Ebada M Said, Mohammad Amin Sakr, Yara Salah, Rabab Maamoun Salama, Asmaa Salama, Hussein Saleh, Ahmed Saleh, Ahmed Salem, Ahmed Thabet Salem, Alkassoum Salifou, Aso Faeq Salih, Abdallah Salman, Hanen Samouda, Faisal Sanai, Juan Francisco Sánchez-Ávila, Lakshumanan Sanker, Tomoya Sano, Miquel Sanz, Tobokalova Saparbu, Rohit Sawhney, Fatma Sayed, Sayed A. Sayed, Ashraf Othman Sayed, Manar Sayed, Giada Sebastiani, Laura Secadas, Khawaja Qamaruddin Sediqi, Sameh Seif, Nady Semida, Ebubekir Şenateş, Elena Daniela Serban, Lawrence Serfaty, Wai-Kay Seto, Ikram Sghaier, Min Sha, Hamada M. Shabaan, Lobna Shalaby, Inass Shaltout, Ala I. Sharara, Vishal Sharma, Isaac Thom Shawa, Ahmed Shawkat, Nehal Shawky, Osama Shehata, Sinead Sheils, Abate Bane Shewaye, Guojun Shi, Junping Shi, Shigeo Shimose, Tomotake Shirono, Lan Shou, Ananta Shrestha, Guanghou Shui, William Sievert, Solveig Sigurdardottir, Mostafa Mohamed Sira, Riyadh Siradj, Cecilia Sison, Linda Smyth, Reham Soliman, Jose D Sollano, Roger Sombie, Mark Sonderup, Siddharth Sood, German Soriano, Catherine A M Stedman, Oksana Stefanyuk, Davor Štimac, Simone Strasser, Pavel Strnad, Katherine Stuart, Wen Su, Minghua Su, Yoshio Sumida, Shuji Sumie, Dan-Qin Sun, Jing Sun, Hiroyuki Suzuki, Gianluca Svegliati-Baroni, Mohamed Osman Swar, S. TAHARBOUCHT, Zenab Taher, Saori Takamura, Lin Tan, Soek-Siam Tan, Tawesak Tanwandee, Sara Tarek, Ghelimici Tatiana, Federica Tavaglione, Gina Y. 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Neuman, M, Ng'Wanasayi, M, Ni, Y, Nicoll, A, Niizeki, T, Nikolova, D, Ningning, W, Niriella, M, Nogoibaeva, K, Nordien, R, O Sullivan, C, O'Beirne, J, Obekpa, S, Ocama, P, Ochwoto, M, Ogolodom, M, Ojo, O, Okrostsvaridze, N, Oliveira, C, Omana, R, Omar, O, Omar, H, Omar, M, Omran, S, Omran, R, Osman, M, Owise, N, Owusu-Ansah, T, Padilla- Machaca, P, Palle, S, Pan, Z, Pan, X, Pan, Q, Papaefthymiou, A, Paquissi, F, Par, G, Parkash, A, Payawal, D, Peltekian, K, Peng, X, Peng, L, Peng, Y, Pengoria, R, Perez, M, Perez, J, Perez, N, Persico, M, Pessoa, M, Petta, S, Philip, M, Plaz Torres, M, Polavarapu, N, Poniachik, J, Portincasa, P, Pu, C, Purnak, T, Purwanto, E, Qi, X, Qian, Z, Qiang, Z, Qiao, Z, Qiao, L, Queiroz, A, Rabiee, A, Radwan, M, Rahetilahy, A, Ramadan, Y, Ramadan, D, Ramli, A, Ramm, G, Ran, A, Rankovic, I, Rao, H, Raouf, S, Ray, S, Reau, N, Refaat, A, Reiberger, T, Remes-Troche, J, Reyes, E, Richardson, B, Ridruejo, E, Riestra Jimenez, S, Rizk, I, Roberts, S, Roblero, J, Robles, 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Strasser, S, Strnad, P, Stuart, K, Su, W, Su, M, Sumida, Y, Sumie, S, Sun, D, Sun, J, Suzuki, H, Svegliati-Baroni, G, Swar, M, Taharboucht, S, Taher, Z, Takamura, S, Tan, L, Tan, S, Tanwandee, T, Tarek, S, Tatiana, G, Tavaglione, F, Tecson, G, Tee, H, Teschke, R, Tharwat, M, Thong, V, Thursz, M, Tine, T, Tiribelli, C, Tolmane, I, Tong, J, Tongo, M, Torkie, M, Torre, A, Torres, E, Trajkovska, M, Treeprasertsuk, S, Tsutsumi, T, Tu, T, Tur, J, Turan, D, Turcan, S, Turkina, S, Tutar, E, Tzeuton, C, Ugiagbe, R, Uygun, A, Vacca, M, Vajro, P, Van der Poorten, D, Van Kleef, L, Vashakidze, E, Velazquez, C, Velazquez, M, Vento, S, Verhoeven, V, Vespasiani-Gentilucci, U, Vethakkan, S, Vilaseca, J, Vitek, L, Volkanovska, A, Wallace, M, Wan, W, Wang, Y, Wang, X, Wang, C, Wang, M, Wangchuk, P, Weltman, M, White, M, Wiegand, J, Wifi, M, Wigg, A, Wilhelmi, M, William, R, Wittenburg, H, Wu, S, Wubeneh, A, Xia, H, Xiao, J, Xiao, X, Xiaofeng, W, Xiong, W, Xu, L, Xu, J, Xu, W, Xu, K, Xu, Y, Xu, S, Xu, M, Xu, A, Xu, C, Yan, H, Yang, J, Yang, R, Yang, Y, Yang, Q, Yang, N, Yao, J, Yara, J, Yaras, S, Yilmaz, N, Younes, R, Younes, H, Young, S, Youssef, F, Yu, Y, Yu, M, Yuan, J, Yue, Z, Yuen, M, Yun, W, Yurukova, N, Zakaria, S, Zaky, S, Zaldastanishvili, M, Zapata, R, Zare, N, Zerem, E, Zeriban, N, Zeshuai, X, Zhang, H, Zhang, X, Zhang, Y, Zhang, W, Zhang, Z, Zhao, J, Zhao, R, Zhao, H, Zheng, C, Zheng, Y, Zheng, R, Zheng, T, Zheng, K, Zhou, X, Zhou, Y, Zhou, H, Zhou, L, Zhu, L, Zhu, Y, Zhu, P, Ziada, E, Ziring, D, Ziyi, L, Zou, S, Zou, Z, Zou, H, Zuart Ruiz, R, and Global Multi-Stakeholder Consensus on the Redefinition of Fatty Liver Disease

Subjects
Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11], Hepatology, Non-alcoholic Fatty Liver Disease, NAFLD, consensu, Gastroenterology, MAFLD, definition, Humans, MAFLD, NAFLD, Human medicine
Abstract

Contains fulltext : 252162.pdf (Publisher’s version ) (Closed access)

Published
2022
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18. Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis

Author

Frank A. Anania, John Marcinak, Mark I. Avigan, Arun J. Sanyal, Melissa Palmer, Gopal Krishna, Lara Dimick-Santos, Daniel Seekins, Arie Regev, James H. Lewis, Naga Chalasani, William R. Treem, and James W. Freston

Subjects
medicine.medical_specialty, Best practice, MEDLINE, Review Article, Chronic liver disease, 03 medical and health sciences, 0302 clinical medicine, Liver Function Tests, Non-alcoholic Fatty Liver Disease, Consensus Guideline, Nonalcoholic fatty liver disease, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Disease management (health), Intensive care medicine, Clinical Trials as Topic, Hepatology, business.industry, Gastroenterology, Disease Management, medicine.disease, Discontinuation, Clinical trial, Practice Guidelines as Topic, Inclusion and exclusion criteria, 030211 gastroenterology & hepatology, Chemical and Drug Induced Liver Injury, business
Abstract

Background The last decade has seen a rapid growth in the number of clinical trials enrolling patients with nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (NASH). Due to the underlying chronic liver disease, patients with NASH often require different approaches to the assessment and management of suspected drug-induced liver injury (DILI) compared to patients with healthy livers. However, currently no regulatory guidelines or position papers systematically address best practices pertaining to DILI in NASH clinical trials. Aims This publication focuses on best practices concerning the detection, monitoring, diagnosis and management of suspected acute DILI during clinical trials in patients with NASH. Methods This is one of several papers developed by the IQ DILI Initiative, comprised of members from 15 pharmaceutical companies, in collaboration with DILI experts from academia and regulatory agencies. This paper is based on extensive literature review, and discussions between industry members with expertise in drug safety and DILI experts from outside industry to achieve consensus on common questions related to this topic. Results Recommended best practices are outlined pertaining to hepatic inclusion and exclusion criteria, monitoring of liver tests, DILI detection, approach to a suspected DILI signal, causality assessment and hepatic discontinuation rules. Conclusions This paper provides a framework for the approach to assessment and management of suspected acute DILI during clinical trials in patients with NASH.

Published
2019
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25. Vinnie the Dove

Author

Melissa Palmer

Subjects
media_common.quotation_subject, Art, Humanities, Dove, media_common
Published
2020
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27. Magic Licking Lollipops

Author

Melissa Palmer

Subjects
Literature, Magic (illusion), business.industry, media_common.quotation_subject, Art, Licking, business, media_common
Published
2020
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29. Speech Bubbles 2 User Guide

Author

Melissa Palmer

Subjects
Read aloud, Speech sound, Picture books, Set (psychology), Psychology, Home setting, Speech therapy, Linguistics
Abstract

This book is the supporting guide for Speech Bubbles 2, an exciting series created for speech language therapists and pathologists, parents and caregivers, teachers and other professionals working with children who have delayed or disordered speech sound development. The guide contains detailed notes to support the effective use of all of the picture books in the series, targeting the following sounds: /v/, /z/, /sh/, /ch/, /h/, /y/, /j/, /r/, /l/, /w/, /r/ blends and /l/ blends. Speech Bubbles 2 is the second set in a series of picture books designed to be used by those working with children who have delayed or disordered speech sound development, children receiving speech therapy or those wanting to provide sound awareness activities for children. The set includes 12 beautifully illustrated storybooks, each targeting a different speech sound in different positions within words, and a user guide with notes on each individual story. Designed to be read aloud to the child in a therapy, classroom or home setting, the stories create a fun and engaging activity that can be returned to again and again. The full set includes: Twelve bright and engaging stories targeting the following early developing sounds and sounds frequently targeted in speech therapy: /v/, /z/, /sh/, /ch/, /h/, /y/, /j/, /r/, /l/, /w/, /r/ blends and /l/ blends. A user guide supporting the use of the stories, with individual notes on each. Perfect not just for therapy but also for encouraging early sound awareness and development, this is an engaging and invaluable resource for speech language therapists and pathologists, parents and caregivers and teachers working with children aged 2–8 years.

Published
2020
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37. Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis

Author

I. Lonjon-Domanec, Lara Dimick-Santos, John Marcinak, James W. Freston, Raúl J. Andrade, Mark I. Avigan, James H. Lewis, Adrian M. Di Bisceglie, Melissa Palmer, Daniel Seekins, Don C. Rockey, Meenal Patwardhan, Ajit Dash, Arie Regev, E Maller, Naga Chalasani, and William R. Treem

Subjects
Adult, Liver Cirrhosis, medicine.medical_specialty, Cirrhosis, Consensus, Population, Toxicology, 030226 pharmacology & pharmacy, 03 medical and health sciences, Liver disease, Special Article, 0302 clinical medicine, Non-alcoholic Fatty Liver Disease, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, education, Hepatitis, Chronic, Pharmacology, education.field_of_study, Clinical Trials as Topic, biology, business.industry, Hepatitis B, medicine.disease, Hepatitis C, Clinical trial, Alanine transaminase, Practice Guidelines as Topic, biology.protein, Liver function, Chemical and Drug Induced Liver Injury, business, Viral hepatitis
Abstract

With the widespread development of new drugs to treat chronic liver diseases (CLDs), including viral hepatitis and nonalcoholic steatohepatitis (NASH), more patients are entering trials with abnormal baseline liver tests and with advanced liver injury, including cirrhosis. The current regulatory guidelines addressing the monitoring, diagnosis, and management of suspected drug-induced liver injury (DILI) during clinical trials primarily address individuals entering with normal baseline liver tests. Using the same laboratory criteria cited as signals of potential DILI in studies involving patients with no underlying liver disease and normal baseline liver tests may result in premature and unnecessary cessation of a study drug in a clinical trial population whose abnormal and fluctuating liver tests are actually due to their underlying CLD. This position paper focuses on defining best practices for the detection, monitoring, diagnosis, and management of suspected acute DILI during clinical trials in patients with CLD, including hepatitis C virus (HCV) and hepatitis B virus (HBV), both with and without cirrhosis and NASH with cirrhosis. This is one of several position papers developed by the IQ DILI Initiative, comprising members from 16 pharmaceutical companies in collaboration with DILI experts from academia and regulatory agencies. It is based on an extensive literature review and discussions between industry members and experts from outside industry to achieve consensus regarding the recommendations. Key conclusions and recommendations include (1) the importance of establishing laboratory criteria that signal potential DILI events and that fit the disease indication being studied in the clinical trial based on knowledge of the natural history of test fluctuations in that disease; (2) establishing a pretreatment value that is based on more than one screening determination, and revising that baseline during the trial if a new nadir is achieved during treatment; (3) basing rules for increased monitoring and for stopping drug for potential DILI on multiples of baseline liver test values and/or a threshold value rather than multiples of the upper limit of normal (ULN) for that test; (4) making use of more sensitive tests of liver function, including direct bilirubin (DB) or combined parameters such as aspartate transaminase:alanine transaminase (AST:ALT) ratio or model for end-stage liver disease (MELD) to signal potential DILI, especially in studies of patients with cirrhosis; and (5) being aware of potential confounders related to complications of the disease being studied that may masquerade as DILI events. Electronic supplementary material The online version of this article (10.1007/s40264-020-01014-2) contains supplementary material, which is available to authorized users.

Published
2020

39. Guideline implementation is effective at reducing proton pump inhibitor use in hematology-oncology units: A multidisciplinary intervention for reducing Clostridioides difficile risk

Author

Erin Lightheart, Craig W. Freyer, Cheryl Gilmar, Daniel J. Landsburg, Warren B. Bilker, David A. Pegues, Jennifer H. Han, Melissa Palmer, Rebecca L. Hirsh, Colleen Kucharczuk, Christina Harker, Matthew J Ziegler, and Theresa Gorman

Subjects
Microbiology (medical), medicine.medical_specialty, Gastrointestinal bleeding, Epidemiology, medicine.drug_class, business.industry, MEDLINE, Proton-pump inhibitor, Guideline, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, Infectious Diseases, Guideline implementation, Multidisciplinary approach, 030220 oncology & carcinogenesis, Intervention (counseling), medicine, 030212 general & internal medicine, Intensive care medicine, business, Clostridioides
Abstract

We implemented a guideline for appropriate acid suppressant use in hematology-oncology patients. This intervention resulted in a sustained reduction in proton pump inhibitor (PPI) use without an increase in rates of gastrointestinal bleeding. Practice guidelines are effective in reducing PPI use, which is associated with risk of Clostridioides difficile infection.

Published
2019
Full Text
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40. Magic Licking Lollipops : Targeting the L Sound

Author

Melissa Palmer and Melissa Palmer

Subjects
PE1119.2
Abstract

Lynn and Lily love licking lollipops, and lollies of all colours, shapes and sizes. But this time, have they bitten off more than they can chew?This picture book targets the /l/ sound and is part of Speech Bubbles 2, a series of picture books that target specific speech sounds within the story.The series can be used for children receiving speech therapy, for children who have a speech sound delay/disorder, or simply as an activity for children's speech sound development and/or phonological awareness. They are ideal for use by parents, teachers or caregivers.Bright pictures and a fun story create an engaging activity perfect for sound awareness.Picture books are sold individually, or in a pack. There are currently two packs available – Speech Bubbles 1 and Speech Bubbles 2. Please see further titles in the series for stories targeting other speech sounds.

Published
2021

41. Harry the Hopper : Targeting the H Sound

Author

Melissa Palmer and Melissa Palmer

Subjects
PE1119.2
Abstract

Harry loves to hop, and believes he is a ‘hopper'– but not everyone agrees…This picture book targets the /h/ sound and is part of Speech Bubbles 2, a series of picture books that target specific speech sounds within the story.The series can be used for children receiving speech therapy, for children who have a speech sound delay/disorder, or simply as an activity for children's speech sound development and/or phonological awareness. They are ideal for use by parents, teachers or caregivers.Bright pictures and a fun story create an engaging activity perfect for sound awareness.Picture books are sold individually, or in a pack. There are currently two packs available – Speech Bubbles 1 and Speech Bubbles 2. Please see further titles in the series for stories targeting other speech sounds.

Published
2021

42. Catch That Chicken! : Targeting the Ch Sound

Author

Melissa Palmer and Melissa Palmer

Subjects
PE1119.2
Abstract

Archie has stolen Charlie's prize hat – the race is on to get it back. Catch that chicken!This picture book targets the /ch/ sound and is part of Speech Bubbles 2, a series of picture books that target specific speech sounds within the story.The series can be used for children receiving speech therapy, for children who have a speech sound delay/disorder, or simply as an activity for children's speech sound development and/or phonological awareness. They are ideal for use by parents, teachers or caregivers.Bright pictures and a fun story create an engaging activity perfect for sound awareness.Picture books are sold individually, or in a pack. There are currently two packs available – Speech Bubbles 1 and Speech Bubbles 2. Please see further titles in the series for stories targeting other speech sounds.

Published
2021

43. Platypus and Fly : Targeting L Blends

Author

Melissa Palmer and Melissa Palmer

Subjects
Speech therapy for children--Juvenile literature, Speech therapy--Juvenile literature, Articulation disorders in children--Juvenile lit, Flies--Juvenile literature
Abstract

Fly is sneaky and very cheeky. He likes to tease and annoy other creatures around him. Then he meets Platypus, who is ready for lunch. The race is on, but who will win?This picture book targets /l/ blends and is part of Speech Bubbles 2, a series of picture books that target specific speech sounds within the story.The series can be used for children receiving speech therapy, for children who have a speech sound delay/disorder, or simply as an activity for children's speech sound development and/or phonological awareness. They are ideal for use by parents, teachers or caregivers.Bright pictures and a fun story create an engaging activity perfect for sound awareness.Picture books are sold individually, or in a pack. There are currently two packs available – Speech Bubbles 1 and Speech Bubbles 2. Please see further titles in the series for stories targeting other speech sounds.

Published
2021

44. The Dragon Drawing War : Targeting R Blends

Author

Melissa Palmer and Melissa Palmer

Subjects
Speech therapy for children--Juvenile literature, Speech therapy--Juvenile literature, Articulation disorders in children--Juvenile lit, Dragons--Juvenile literature
Abstract

This is a tale of two brothers, duelling to become a dragon drawing champion. Great skill and imagination must be used to become the victor! If you don't succeed today, do not fear. There will be another war to fight tomorrow.This picture book targets /r/ blends and is part of Speech Bubbles 2, a series of picture books that target specific speech sounds within the story.The series can be used for children receiving speech therapy, for children who have a speech sound delay/disorder, or simply as an activity for children's speech sound development and/or phonological awareness. They are ideal for use by parents, teachers or caregivers.Bright pictures and a fun story create an engaging activity perfect for sound awareness.Picture books are sold individually, or in a pack. There are currently two packs available – Speech Bubbles 1 and Speech Bubbles 2. Please see further titles in the series for stories targeting other speech sounds.

Published
2021

45. Speech Bubbles 2 (Picture Books and Guide) : Supporting Speech Sound Development in Children

Author

Melissa Palmer and Melissa Palmer

Subjects
Articulation disorders in children--Handbooks, manuals, etc, Speech therapy for children--Exercises, Speech therapy for children--Handbooks, manuals, etc
Abstract

Speech Bubbles 2 is the second set in a series of picture books designed to be used by those working with children who have delayed or disordered speech sound development, children receiving speech therapy or those wanting to provide sound awareness activities for children. The set includes 12 beautifully illustrated storybooks, each targeting a different speech sound in different positions within words, and a user guide with notes on each individual story. Designed to be read aloud to the child in a therapy, classroom or home setting, the stories create a fun and engaging activity that can be returned to again and again. The full set includes: Twelve bright and engaging stories targeting the following early developing sounds and sounds frequently targeted in speech therapy: /v/, /z/, /sh/, /ch/, /h/, /y/, /j/, /r/, /l/, /w/, /r/ blends and /l/ blends. A user guide supporting the use of the stories, with individual notes on each. Perfect not just for therapy but also for encouraging early sound awareness and development, this is an engaging and invaluable resource for speech and language therapists and pathologists, parents and caregivers and teachers working with children aged 2– 8 years.

Published
2021

46. Rick's Carrot : Targeting the R Sound

Author

Melissa Palmer and Melissa Palmer

Subjects
PE1119.2
Abstract

Rick is hungry, but his carrot has disappeared! Who has taken it? Come along on the mission to find it.This picture book targets the /r/ sound and is part of Speech Bubbles 2, a series of picture books that target specific speech sounds within the story.The series can be used for children receiving speech therapy, for children who have a speech sound delay/disorder, or simply as an activity for children's speech sound development and/or phonological awareness. They are ideal for use by parents, teachers or caregivers.Bright pictures and a fun story create an engaging activity perfect for sound awareness.Picture books are sold individually, or in a pack. There are currently two packs available – Speech Bubbles 1 and Speech Bubbles 2. Please see further titles in the series for stories targeting other speech sounds.

Published
2021

47. Will the Wolf : Targeting the W Sound

Author

Melissa Palmer and Melissa Palmer

Subjects
PE1119.2
Abstract

Will sits and watches the world go by, feeling all alone. Will he be alone forever?This picture book targets the /w/ sound and is part of Speech Bubbles 2, a series of picture books that target specific speech sounds within the story.The series can be used for children receiving speech therapy, for children who have a speech sound delay/disorder, or simply as an activity for children's speech sound development and/or phonological awareness. They are ideal for use by parents, teachers or caregivers.Bright pictures and a fun story create an engaging activity perfect for sound awareness.Picture books are sold individually, or in a pack. There are currently two packs available – Speech Bubbles 1 and Speech Bubbles 2. Please see further titles in the series for stories targeting other speech sounds.

Published
2021

48. Jasper the Badger : Targeting the J Sound

Author

Melissa Palmer and Melissa Palmer

Subjects
PE1119.2
Abstract

Jasper the badger has a plan to get some peace and quiet so he can eat his piece of fudge by himself. But will his plan work?This picture book targets the /j/ sound and is part of Speech Bubbles 2, a series of picture books that target specific speech sounds within the story.The series can be used for children receiving speech therapy, for children who have a speech sound delay/disorder, or simply as an activity for children's speech sound development and/or phonological awareness. They are ideal for use by parents, teachers or caregivers.Bright pictures and a fun story create an engaging activity perfect for sound awareness.Picture books are sold individually, or in a pack. There are currently two packs available – Speech Bubbles 1 and Speech Bubbles 2. Please see further titles in the series for stories targeting other speech sounds.

Published
2021

49. Vinnie the Dove : Targeting the V Sound

Author

Melissa Palmer and Melissa Palmer

Subjects
PE1119.2
Abstract

Vinnie loves to dive in water, but it always makes him so cold! Join him on his mission to find a way to finally get warmed up.This picture book targets the /v/ sound and is part of Speech Bubbles 2, a series of picture books that target specific speech sounds within the story.The series can be used for children receiving speech therapy, for children who have a speech sound delay/disorder, or simply as an activity for children's speech sound development and/or phonological awareness. They are ideal for use by parents, teachers or caregivers.Bright pictures and a fun story create an engaging activity perfect for sound awareness.Picture books are sold individually, or in a pack. There are currently two packs available – Speech Bubbles 1 and Speech Bubbles 2. Please see further titles in the series for stories targeting other speech sounds.

Published
2021

50. Asher the Thresher Shark : Targeting the Sh Sound

Author

Melissa Palmer and Melissa Palmer

Subjects
PE1119.2
Abstract

Asher the thresher shark is very shy. Will it stop him from being a hero?This picture book targets the /sh/ sound and is part of Speech Bubbles 2, a series of picture books that target specific speech sounds within the story.The series can be used for children receiving speech therapy, for children who have a speech sound delay/disorder, or simply as an activity for children's speech sound development and/or phonological awareness. They are ideal for use by parents, teachers or caregivers.Bright pictures and a fun story create an engaging activity perfect for sound awareness.Picture books are sold individually, or in a pack. There are currently two packs available – Speech Bubbles 1 and Speech Bubbles 2. Please see further titles in the series for stories targeting other speech sounds.

Published
2021

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