Dosage form preference consultation study in children and young adults:paving the way for patient-centred and patient-informed dosage form development

Objectives: The current study aims to evaluate dosage form preferences in children and young adults together with identifying the key pragmatic dosage form characteristics that would enable appropriate formulation of orally disintegrating tablets (ODTs). Methods: International, multisite, cross-sectional questionnaire of children and young adults aged from 6 to 18 years. Eligibility was based on age, ability to communicate and previous experience in taking medications. The study was carried out at three locations: the UK, Saudi Arabia and Jordan. The questionnaire instrument was designed for participant self-completion under supervision of the study team.Results 104 questionnaires were completed by the study cohort (n=120, response rate 87%). Results: showed that ODTs were the most preferred oral dosage forms (58%) followed by liquids (20%), tablets (12%) and capsules (11%). The preferred colours were pink or white while the preferred size was small (<8 mm) with a round shape. With regard to flavour, strawberry was the most preferred (30.8%), while orange was the least preferred (5.8%). The results also showed that the most important physical characteristics of ODTs were disintegration time followed by taste, size and flavour, respectively. Conclusions: The results of our study support the WHO's claim for a shift of paradigm from liquid towards ODTs dosage forms for drug administration to young children older than 6 years. Data from this study will also equip formulators to prioritise development of key physical/performance attributes within the delivery system

Needs of parents and carers of children and young people with mental health difficulties: protocol for a systematic review

Introduction Having a child or young person (CYP) with mental health problems can be highly distressing for parents/carers. The impact can include parental/carer depression, anxiety, lost productivity and poor family relationships. Currently, there is no synthesis of this evidence, which is needed to provide clarity around what support parents/carers may need, to meet the needs of family mental health. This review aims to identify the needs of the parents/carers of CYP who are receiving mental health services. Methods and analysis A systematic review will be conducted to identify potentially relevant studies that provide evidence concerning the needs and impact on parents/carers linked to their CYP having mental health difficulties. CYP mental health conditions included are anxiety disorders, depression, psychoses, oppositional defiant and other externalising disorders, labels of emerging personality disorders, eating disorders and attention deficit (hyperactive) disorders. The following databases were searched on November 2022 with no date restriction applied: Medline; PsycINFO; CINAHL; AMED; EMBASE; Web of Science; Cochrane Library; WHO International Clinical Trials Registry Platform; Social Policy and Practice; Applied Social Sciences Index and Abstracts; and Open Grey. Only studies reported in English will be included. The quality of the included studies will be assessed using Joanna Briggs Institute Critical Appraisal Checklist for qualitative studies and the Newcastle Ottawa Scale for quantitative studies. Qualitative data will be analysed thematically and inductively

Does the Formulation of Oral Solid Dosage Forms Affect Acceptance and Adherence in Older Patients?:A Mixed Methods Systematic Review

OBJECTIVES: Age-related changes mean that the older population can encounter barriers toward taking medication orally. Further work is needed to identify the characteristics of oral solid dosage forms that will improve patient acceptance and adherence. The aim of this systematic review was to identify if and how formulation aspects of oral solid dosage forms affect acceptance and adherence in older people. DESIGN: Mixed methods systematic review using a data-based convergent synthesis design. SETTING AND PARTICIPANTS: Articles were selected if they included participants aged 60 years and older, or included health care professionals, social care professionals, and informal carers of patients aged 60 years and older. METHODS: A systematic search of the following databases was undertaken: Web of Science, MEDLINE, Scopus, and The Cochrane Databases. The search of databases was supplemented by a search of gray literature, and reference lists of included papers were manually searched. RESULTS: A total of 16 studies were included in the final synthesis. Three themes were generated from the thematic analysis: (1) dimensions, (2) palatability, and (3) appearance. The dimensions and palatability are often modified to improve swallowability by breaking tablets in half or taste masking with food. Polypharmacy can lead to patients using the appearance to identify tablets; however, this can lead to confusion when products appear similar. No study was identified that explored formulation characteristics across all 3 categories directly in the older population. CONCLUSION AND IMPLICATIONS: Manufacturers should take into account practical problems older people may encounter when considering the dimensions, palatability, and appearance of the final drug product. These characteristics should be optimized to aid visual identification and swallowability. Medical providers and pharmacists have an important role in ensuring that these patient-centric drug products are prescribed and dispensed appropriately so that patients receive the most suitable formulation

Literature review of medication administration problems in paediatrics by parent/caregiver and the role of health literacy

Objective: To identify studies that highlighted medication administration problems experienced by parents and children, which also looked at health literacy aspect using a validated tool to assess for literacy. Study design: Ten electronic databases were systematically searched and supplemented by hand searching through reference lists using the following search terms: (1) paediatric, (2) medication error including dosing error, medication administration error, medication safety and medication optimisation and (3) health literacy. Results: Of the (1230) records screened, 14 studies were eligible for inclusion. Three analytical themes emerged from the synthesis. The review highlighted that frequencies and magnitudes of dosing errors vary by the measurement tools used, the dose prescribed and by the administration instruction provided. Parent's sociodemographic, such as health literacy and language, is a key factor to be considered when designing an intervention aimed at averting medication administration errors at home. The review summarised some potential strategies that could help in reducing medication administration errors among children at home. Among these recommendations is to show the prescribed dose to the parents or young people along with the verbal instructions, as well as to match the prescribed dose with the measuring tool dispensed, to provide an explicit dose intervals and pictographic dosing instructions. Conclusion: The findings suggest that in order to optimise medication use by parents, further work is needed to address the nature of these issues at home. Counselling, medication administration instructions and measurement tools are some of the areas in addition to the sociodemographic characteristics of parents and young people that need to be considered when designing any future potential intervention aimed at reducing medication errors among children and young people at home

Characterising Long Covid: a living systematic review update with controlled studies

The authors have withdrawn their manuscript owing to a reporting error that we have identified in the conduct of this updated systematic review

Availability, scope and quality of monkeypox clinical management guidelines globally : a systematic review

This work was supported by the UK Foreign, Commonwealth and Development Office and Wellcome (215091/Z/18/Z) and the Bill & Melinda Gates Foundation (OPP1209135). The GloPID-R Secretariat is a project that receives funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 874667. SL is an MRC Clinical Research Training fellow (MR/T001151/1).Background Monkeypox (MPX) is an important human Orthopoxvirus infection. There has been an increase in MPX cases and outbreaks in endemic and non-endemic regions in recent decades. We appraised the availability, scope, quality and inclusivity of clinical management guidelines for MPX globally. Methods For this systematic review, we searched six databases from inception until 14 October 2021, augmented by a grey literature search until 17 May 2022. MPX guidelines providing treatment and supportive care recommendations were included, with no exclusions for language. Two reviewers assessed the guidelines. Quality was assessed using the Appraisal of Guidelines for Research and Evaluation II tool. Results Of 2026 records screened, 14 guidelines were included. Overall, most guidelines were of low-quality with a median score of 2 out of 7 (range: 1–7), lacked detail and covered a narrow range of topics. Most guidelines focused on adults, five (36%) provided some advice for children, three (21%) for pregnant women and three (21%) for people living with HIV. Treatment guidance was mostly limited to advice on antivirals; seven guidelines advised cidofovir (four specified for severe MPX only); 29% (4/14) tecovirimat, and 7% (1/14) brincidofovir. Only one guideline provided recommendations on supportive care and treatment of complications. All guidelines recommended vaccination as post-exposure prophylaxis (PEP). Three guidelines advised on vaccinia immune globulin as PEP for severe cases in people with immunosuppression. Conclusion Our results highlight a lack of evidence-based clinical management guidelines for MPX globally. There is a clear and urgent need for research into treatment and prophylaxis including for different risk populations. The current outbreak provides an opportunity to accelerate this research through coordinated high-quality studies. New evidence should be incorporated into globally accessible guidelines, to benefit patient and epidemic outcomes. A ‘living guideline’ framework is recommended. PROSPERO registration number CRD42020167361.Publisher PDFPeer reviewe

Preparing for pandemics: a systematic review of pandemic influenza clinical management guidelines

Background: The COVID-19 pandemic has highlighted the importance of evidence-based clinical decision-making. Clinical management guidelines (CMGs) may help reduce morbidity and mortality by improving the quality of clinical decisions. This systematic review aims to evaluate the availability, inclusivity, and quality of pandemic influenza CMGs, to identify gaps that can be addressed to strengthen pandemic preparedness in this area. Methods: Ovid Medline, Ovid Embase, TRIP (Turning Research Into Practice), and Guideline Central were searched systematically from January 2008 to 23rd June 2022, complemented by a grey literature search till 16th June 2022. Pandemic influenza CMGs including supportive care or empirical treatment recommendations were included. Two reviewers independently extracted data from the included studies and assessed their quality using AGREE II (Appraisal of Guidelines for Research & Evaluation). The findings are presented narratively. Results: Forty-eight CMGs were included. They were produced in high- (42%, 20/48), upper-middle- (40%, 19/48), and lower-middle (8%, 4/48) income countries, or by international organisations (10%, 5/48). Most CMGs (81%, 39/48) were over 5 years old. Guidelines included treatment recommendations for children (75%, 36/48), pregnant women (54%, 26/48), people with immunosuppression (33%, 16/48), and older adults (29%, 14/48). Many CMGs were of low quality (median overall score: 3 out of 7 (range 1–7). All recommended oseltamivir; recommendations for other neuraminidase inhibitors and supportive care were limited and at times contradictory. Only 56% (27/48) and 27% (13/48) addressed oxygen and fluid therapy, respectively. Conclusions: Our data highlights the limited availability of up-to-date pandemic influenza CMGs globally. Of those identified, many were limited in scope and quality and several lacked recommendations for specific at-risk populations. Recommendations on supportive care, the mainstay of treatment, were limited and heterogeneous. The most recent guideline highlighted that the evidence-base to support antiviral treatment recommendations is still limited. There is an urgent need for trials into treatment and supportive care strategies including for different risk populations. New evidence should be incorporated into globally accessible guidelines, to benefit patient outcomes. A ‘living guideline’ framework is recommended and further research into guideline implementation in different resourced settings, particularly low- and middle-income countries

Preparing for pandemics: a systematic review of pandemic influenza clinical management guidelines

Background: The COVID-19 pandemic has highlighted the importance of evidence-based clinical decision-making. Clinical management guidelines (CMGs) may help reduce morbidity and mortality by improving the quality of clinical decisions. This systematic review aims to evaluate the availability, inclusivity, and quality of pandemic influenza CMGs, to identify gaps that can be addressed to strengthen pandemic preparedness in this area. Methods: Ovid Medline, Ovid Embase, TRIP (Turning Research Into Practice), and Guideline Central were searched systematically from January 2008 to 23rd June 2022, complemented by a grey literature search till 16th June 2022. Pandemic influenza CMGs including supportive care or empirical treatment recommendations were included. Two reviewers independently extracted data from the included studies and assessed their quality using AGREE II (Appraisal of Guidelines for Research & Evaluation). The findings are presented narratively. Results: Forty-eight CMGs were included. They were produced in high- (42%, 20/48), upper-middle- (40%, 19/48), and lower-middle (8%, 4/48) income countries, or by international organisations (10%, 5/48). Most CMGs (81%, 39/48) were over 5 years old. Guidelines included treatment recommendations for children (75%, 36/48), pregnant women (54%, 26/48), people with immunosuppression (33%, 16/48), and older adults (29%, 14/48). Many CMGs were of low quality (median overall score: 3 out of 7 (range 1–7). All recommended oseltamivir; recommendations for other neuraminidase inhibitors and supportive care were limited and at times contradictory. Only 56% (27/48) and 27% (13/48) addressed oxygen and fluid therapy, respectively. Conclusions: Our data highlights the limited availability of up-to-date pandemic influenza CMGs globally. Of those identified, many were limited in scope and quality and several lacked recommendations for specific at-risk populations. Recommendations on supportive care, the mainstay of treatment, were limited and heterogeneous. The most recent guideline highlighted that the evidence-base to support antiviral treatment recommendations is still limited. There is an urgent need for trials into treatment and supportive care strategies including for different risk populations. New evidence should be incorporated into globally accessible guidelines, to benefit patient outcomes. A ‘living guideline’ framework is recommended and further research into guideline implementation in different resourced settings, particularly low- and middle-income countries

An evaluation of global Chikungunya clinical management guidelines: A systematic review.

Background Chikungunya virus (CHIKV) has expanded its geographical reach in recent decades and is an emerging global health threat. CHIKV can cause significant morbidity and lead to chronic, debilitating arthritis/arthralgia in up to 40% of infected individuals. Prevention, early identification, and clinical management are key for improving outcomes. The aim of this review is to evaluate the quality, availability, inclusivity, and scope of evidence-based clinical management guidelines (CMG) for CHIKV globally. Methods We conducted a systematic review. Six databases were searched from Jan 1, 1989, to 14 Oct 2021 and grey literature until Sept 16, 2021, for CHIKV guidelines providing supportive care and treatment recommendations. Quality was assessed using the appraisal of Guidelines for Research and Evaluation tool. Findings are presented in a narrative synthesis. PROSPERO registration: CRD42020167361. Findings 28 CMGs were included; 54% (15/28) were produced more than 5 years ago, and most were of low-quality (median score 2 out of 7 (range 1–7)). There were variations in the CMGs’ guidance on the management of different at-risk populations, long-term sequelae, and the prevention of disease transmission. While 54% (15/28) of CMGs recommended hospitalisation for severe cases, only 39% (11/28) provided guidance for severe disease management. Further, 46% (13/28) advocated for steroids in the chronic phase, but 18% (5/28) advised against its use. Interpretation There was a lack of high-quality CMGs that provided supportive care and treatment guidance, which may impact patient care and outcomes. It is essential that existing guidelines are updated and adapted to provide detailed evidence-based treatment guidelines for different at-risk populations. This study also highlights a need for more research into the management of the acute and chronic phases of CHIKV infection to inform evidence-based care