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2016
Ridyard, C. H., D. M. M. Dawoud, L. V. Tuersley, and D. A. Hughes, "A Systematic Review of Patients' Perspectives on the Subcutaneous Route of Medication Administration.", The patient, 2016 Jan 20. Abstract

BACKGROUND: Subcutaneous injections allow for self-administration, but consideration of patients' perspectives on treatment choice is important to ensure adherence. Previous systematic reviews have been limited in their scope for assessing preferences in relation to other routes of administration.

OBJECTIVE: Our objective was to examine patients' perspectives on subcutaneously administered self-injectable medications when compared with other routes or methods of administration for the same medicines.

METHODS: Nine electronic databases were searched for publications since 2000 using terms pertaining to methods of administration, choice behavior, and adverse effects. Eligibility for inclusion was determined through reference to specific criteria by two independent reviewers. Results were described narratively.

RESULTS: Of the 1726 papers screened, 85 met the inclusion criteria. Studies were focused mainly on methods of insulin administration for diabetes but also included treatments for pediatric growth disorders, multiple sclerosis, HIV, and migraine. Pen devices and autoinjectors were favored over administration with needle and syringe, particularly with respect to ergonomics, convenience, and portability. Inhalation appeared to be more acceptable than subcutaneous injection (in the case of insulin), but how subcutaneous infusion, intramuscular injection, and needle-free injection devices compare with subcutaneous injections in terms of patient preference is less certain.

CONCLUSIONS: The review identified a number of studies showing the importance of the methods and routes of drug delivery on patient choice. However, studies were prone to bias, and further robust evidence based on methodologically sound approaches is required to demonstrate how patient choice might translate to improved adherence.

Hughes, D., J. Charles, D. Dawoud, R. T. Edwards, E. Holmes, C. Jones, P. Parham, C. Plumpton, C. Ridyard, H. Lloyd-Williams, et al., "Conducting Economic Evaluations Alongside Randomised Trials: Current Methodological Issues and Novel Approaches.", PharmacoEconomics, 2016 Jan 11. Abstract

Trial-based economic evaluations are an important aspect of health technology assessment. The availability of patient-level data coupled with unbiased estimates of clinical outcomes means that randomised controlled trials are effective vehicles for the generation of economic data. However there are methodological challenges to trial-based evaluations, including the collection of reliable data on resource use and cost, choice of health outcome measure, calculating minimally important differences, dealing with missing data, extrapolating outcomes and costs over time and the analysis of multinational trials. This review focuses on the state of the art of selective elements regarding the design, conduct, analysis and reporting of trial-based economic evaluations. The limitations of existing approaches are detailed and novel methods introduced. The review is internationally relevant but with a focus towards practice in the UK.

Sabry, N., S. Farid, and D. Dawoud, "Drug-related problems in cardiac children.", Minerva pediatrica, vol. 68, issue 2, pp. 89-95, 2016 Apr. Abstract

BACKGROUND: A drug-related problem (DRP) may be defined as "an event or circumstance involving drug therapy that actually or potentially interferes with the desired health outcome". Our aim was to determine the frequency and characteristics of DRPs in pediatric patients admitted to a tertiary cardiac care center in the Egyptian capital, Cairo.

METHODS: A prospective observational cohort study involving review of case notes for children aged 0-18 years, admitted to the medical ward and intensive care unit (ICU), was conducted at a tertiary cardiac care center in Egypt. Data collection took place over a three-month period. Daily reviews of patients' records, medication charts and laboratory data were undertaken by the clinical pharmacists to identify DRPs.

RESULTS: A total of 60 patients were included in the study (mean age 4.8 years; 53.33% males). Over a three-month period, a total of 313 DRPs were recorded corresponding to an average of 5.22 problems per patient. The most commonly recorded problems related to drug-drug interaction (45.69%), prescribing unnecessary medication (31.95%), under-dosing (21.09%), inappropriate medication (0.96%) and adverse drug reaction (0.32%). Prophylactic antibiotics represented the only unnecessarily prescribed medications. Of the pharmacist suggested interventions, 65% were accepted by the responsible physician.

CONCLUSIONS: DRPs occurred frequently during the study period. Drug-drug interactions, drug choice and drug dosing problems represented the majority of the identified DRPs, necessitating targeted prescriber education interventions in these areas. There is a clear need for clinical pharmacists' involvement on the ward level to identify and rectify these frequently occurring and very costly problems.

Dawoud, D., and D. Baines, "Economic Evaluation and Its Types", Economic Evaluation of Pharmacy Services, London, Academic Press (imprint of Elsevier), 2016. Abstract

In this chapter, we provide a basic introduction to the different forms of economic evaluation, including cost-minimization analysis, cost-effectiveness analysis, cost–benefit analysis, and cost–utility analysis. In particular, we discuss the measurement of costs and outcomes in these types of economic evaluation and explain how the perspective of an evaluation affects these forms of analysis. We discuss the measurement of costs and patient outcomes and introduce the main measurement tools used by health economists. The chapter also introduces the concepts of incremental analysis, the cost-effectiveness plane, and cost-effectiveness acceptability curves. Finally, we discuss how the results of economic evaluations can be used in decision-making.

A.Sabry, N., D. Dawoud, A. Al-Ansary, and N. Hounsome, "Outcomes of a protocol-based intervention to promote timely switching from intravenous to oral paracetamol: an interrupted time series analysis.", Journal of Evaluation in Clinical Practice, vol. 21, issue 6, pp. 1081-1088, 2016.
2015
Roberts, E., D. M. Dawoud, D. A. Hughes, and C. Cefai, "Evaluation of a consultant audit and feedback programme to improve the quality of antimicrobial prescribing in acute medical admissions.", The International journal of pharmacy practice, vol. 23, issue 5, pp. 333-9, 2015 Oct. Abstract

OBJECTIVES: This study aims to evaluate the effectiveness and acceptability of a pharmacist-led antimicrobial stewardship intervention, consisting of consultant performance audit and feedback, on antimicrobial prescribing quality.

METHODS: From October 2010 to September 2012, the prescribing performance of medical consultant teams rotating on the acute medical admissions unit was measured against four quality indicators. Measurements were taken at baseline then at quarterly intervals during which time consultants received feedback. Proportion of prescriptions adhering to each indicator was compared with baseline using paired sample z-test (significance level P < 0.01, Bonferroni corrected). Consultants' views were explored using anonymous questionnaires.

KEY FINDINGS: Overall, 2609 antimicrobial prescriptions were reviewed. Improvement from baseline was statistically significant in all follow-up periods for two indicators: 'antimicrobials should have a documented indication in the medical notes' and 'antimicrobials should adhere to guideline choice or have a justification for deviation', reaching 6.0% (95% CI 2.5, 9.6) and 8.7% (95% CI 3.7, 13.7), respectively. Adherence to the indicator 'antimicrobials should have a documented stop/review prompt' improved significantly in all but the first follow-up period. For the indicator: 'antimicrobial assessed by antimicrobial specialists as unnecessary', improvement was statistically significant in the first (-4.7%, 95% CI -8.0, -1.4) and fourth (-4.2%, 95% CI -7.7%, -0.8%) periods. Service evaluation showed support for the pharmacist-led stewardship activities.

CONCLUSIONS: There were significant and sustained improvements in prescribing quality as a result of the intervention. Consultants' engagement and acceptance of stewardship activities were demonstrated.

Amiel, S. A., N. Pursey, B. Higgins, and D. Dawoud, "Diagnosis and management of type 1 diabetes in adults: summary of updated NICE guidance.", BMJ (Clinical research ed.), vol. 351, pp. h4188, 2015.
Neilson, J., F. O'Neill, D. Dawoud, and P. Crean, "Intravenous fluids in children and young people: summary of NICE guidance.", BMJ (Clinical research ed.), vol. 351, pp. h6388, 2015.
2014
Sabry, N. A., S. F. Farid, and D. M. Dawoud, "Antibiotic dispensing in Egyptian community pharmacies: an observational study.", Research in social & administrative pharmacy : RSAP, vol. 10, issue 1, pp. 168-84, 2014 Jan-Feb. Abstract

BACKGROUND: Antibiotics are commonly dispensed medications from community pharmacies, and they are frequently prescribed for inappropriate indications. In many countries, they are easily accessible without prescriptions. The inappropriate use of antibiotics results in the emergence of resistant bacterial strains, which represents a considerable public health problem, particularly in developing countries.

OBJECTIVE: This study aimed to describe the pattern of antibiotics dispensing from Egyptian community pharmacies and to collect baseline descriptive data on the antibiotics dispensed and their appropriateness.

METHODS: A cross-sectional, observational study of antibiotic dispensing encounters was conducted at 36 randomly selected pharmacies in Greater Cairo, Egypt. Data were collected during one shift at each pharmacy. Structured questionnaires recording patient demographics, antibiotics dispensed and reasons for dispensing were completed for each antibiotic dispensing encounter. The data were descriptively analysed.

RESULTS: Overall, 1158 antibiotics were dispensed during the study period with a total cost of L.E. 24,487 (approximately 3,673 $USD). While self-medication and purchasing without medical prescriptions were common, representing around 23.3% of the antibiotics (n = 270), most antibiotics were prescribed by a doctor or dentist (n = 736, 63.6%). Pharmacist recommendations accounted for the remainder (n = 152, 13.1%). The main reasons for antibiotic use were respiratory tract ailments and gastroenteritis symptoms. The antibiotics most commonly dispensed were: penicillins, erythromycin, metronidazole, neomycin, clotrimoxazole and tetracyclines. Approximately 70% of the antibiotics dispensed on prescriptions were judged to be appropriate for the indications while this percentage was around 61% for antibiotics dispensed on pharmacist recommendation and patient's request.

CONCLUSIONS: The results of this study show that antibiotics are frequently dispensed from community pharmacies in Egypt without appropriate prescriptions and for inappropriate indications. These findings support the need for strict enforcement of pharmacy laws through improved inspection processes. They highlight the need for evidence-based guidelines and educational interventions to improve antibiotic prescribing and dispensing practices.

Ramanan, A. V., A. D. Dick, D. Benton, S. Compeyrot-Lacassagne, D. Dawoud, B. Hardwick, H. Hickey, D. Hughes, A. Jones, P. Woo, et al., "A randomised controlled trial of the clinical effectiveness, safety and cost-effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis (SYCAMORE Trial).", Trials, vol. 15, pp. 14, 2014. Abstract

BACKGROUND: Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children. Children with JIA are at risk of inflammation of the uvea in the eye (uveitis). Overall, 20% to 25% of paediatric uveitis is associated with JIA. Major risk factors for development of uveitis in JIA are oligoarticular pattern of arthritis, an age at onset of arthritis of less than seven years of age, and antinuclear antibody positivity. In the initial stages of mild to moderate inflammation the uveitis is asymptomatic. This has led to current practice of screening all children with JIA for uveitis. Approximately 12% to 38% of patients with JIA develop uveitis in seven years following onset of arthritis. In 30% to 50% of children with JIA-associated uveitis structural complications are present at diagnosis. Furthermore about 50% to 75% of those with severe uveitis will eventually develop visual impairment secondary to ocular complications such as cataract and glaucoma. Defining the severity of inflammation and structural complications in uveitis patients is now possible following Standardised Uveitis Nomenclature (SUN) guidelines, and modified to incorporate the consensus of end point and outcome criteria into the design of randomised trials. Despite current screening and therapeutic options (pre-biologics) 10% to 15% of children with JIA-associated uveitis may develop bilateral visual impairment and certified legally blind. To date, there remains no controlled trial evidence of benefits of biologic therapy.

METHODS/DESIGN: This study will randomise 154 patients aged 2 to 18 years with active JIA-associated uveitis (despite methotrexate (MTX) treatment for at least 12 weeks). All participants will be treated for 18 months, with follow up of 3 years from randomisation (continuing on MTX throughout). All participants will receive a stable dose of MTX and in addition either adalimumab (20 mg/0.8 ml for patients<30 kg or 40 mg/0.8 ml for patients weighing 30 kg or more, subcutaneous (s/c) injection every 2 weeks based on body weight), or placebo (0.8 ml as appropriate according to body weight) s/c injection every 2 weeks.

DISCUSSION: This is the first randomised controlled trial that will assess the clinical effectiveness, safety and cost effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis.

TRIAL REGISTRATION: ISRCTN10065623.

2013
Alhyas, L., J. J. D. Nielsen, D. Dawoud, and A. Majeed, "Factors affecting the motivation of healthcare professionals providing care to Emiratis with type 2 diabetes.", JRSM short reports, vol. 4, issue 2, pp. 14, 2013 Feb. Abstract

OBJECTIVE: We aimed to identify facilitators of and barriers to healthcare professionals' motivation in a diabetes centre in the United Arab Emirates (UAE).

DESIGN: A qualitative research approach was employed using semistructured interviews to assess perception of and attitudes regarding healthcare professionals' motivation in providing good quality diabetes care.

SETTING: A diabetes centre located in Abu-Dhabi, UAE.

PARTICIPANTS: Healthcare professionals including specialist physicians, dieticians, podiatrists, health educators and nurses were recruited through purposive sampling.

MAIN OUTCOME MEASURES: After data collection, the audiotaped interviews were transcribed verbatim and subjected to content analysis.

RESULTS: Nine semistructured interviews were conducted with healthcare professionals of various professional backgrounds. Important facilitators and barriers related to patient, professional, organization and cultural factors were identified. Barriers that related to heavy workload, disjointed care, lack of patient compliance and awareness, and cultural beliefs and attitudes about diabetes were common. Key facilitators included the patient's role in achieving therapeutic outcomes as well as compliance, cooperation and communication.

CONCLUSION: This qualitative study provides some unique insights about factors affecting healthcare professionals' motivation in providing good quality care. To improve the motivation of healthcare professionals in the management of diabetes and therefore the quality of diabetes care, several steps are needed. Importantly, the role of primary care should be reinforced and strengthened regarding the management of type 2 diabetes mellitus, privacy of the consultation time should be highly protected and regulated, and awareness of the Emirate culture and its impact on health should be disseminated to the healthcare professionals providing care to Emirates with diabetes. Also, greater emphasis should be placed on educating Emiratis with diabetes on, and involving them in, the management of their condition.

2012
Hsia, Y., D. Dawoud, A. G. Sutcliffe, R. M. Viner, S. Kinra, and I. C. K. Wong, "Unlicensed use of metformin in children and adolescents in the UK.", British journal of clinical pharmacology, vol. 73, issue 1, pp. 135-9, 2012 Jan. Abstract

AIM: Metformin is the most commonly prescribed oral anti-diabetic drug in young people. It is also prescribed for polycystic ovarian syndrome (PCOS) and obesity treatment in adults in an unlicensed fashion. Little is known as to the extent metformin has been used in young people. We investigated the use of metformin in children and adolescents aged 0-18 years in the UK.

METHODS: Population-based prescribing data were obtained from the UK IMS Disease Analyzer between January 2000 and December 2010.

RESULTS: A total of 2674 metformin prescriptions were issued to 337 patients (80% female) between 2000 and 2010. The prevalence of metformin prescribing increased from 0.03 per 1000 person-years [95% confidence interval (CI) 0.02, 0.05] to 0.16 per 1000 person-years (95% CI 0.12, 0.20) (P= 0.001). There was a steady increase in metformin prescribing in girls aged 16-18 years. There were 290 metformin treated patients (81% female; n= 235) who had at least one diagnosis of diabetes, PCOS or obesity. Among these patients, PCOS was the most common indication for metformin prescribing in girls (n= 120) followed by diabetes. There were 22 patients (7.6%) who received metformin for obesity treatment only.

CONCLUSIONS: Prescribing of metformin increased between 2000 and 2010, in particular amongst girls aged 16-18 years. The main indication for metformin prescribing was PCOS. At present, metformin is not licensed for PCOS and obesity treatment in adults or children. As there is a steady increase in the prescribing of metformin in young people, further studies are required to investigate the efficacy and safety of these prescriptions.

2011
Dawoud, D., P. Griffiths, J. Maben, L. Goodyer, and R. Greene, "Pharmacist supplementary prescribing: a step toward more independence?", Research in social & administrative pharmacy : RSAP, vol. 7, issue 3, pp. 246-56, 2011 Sep. Abstract

BACKGROUND: Supplementary prescribing (SP) is a drug therapy management model implemented in the United Kingdom since 2003. It is a voluntary partnership between an independent prescriber; a supplementary prescriber, for example, nurse or pharmacist; and the patient, to implement an agreed patient-specific clinical management plan (CMP).

OBJECTIVE: To investigate pharmacist prescribers' views and experiences of the early stages of SP implementation.

METHODS: A qualitative, longitudinal study design was used. A purposive, maximum variability sample of 16 pharmacist supplementary prescribers, trained in Southern England, participated. Eleven were hospital pharmacists, owing to the overrepresentation of hospital pharmacists in the first cohort. Two semistructured interviews were conducted with each participant, at 3 and 6 months after their registration as prescribers. The Framework approach was used for data collection, management, and analysis.

RESULTS: Three typologies of pharmacists' experiences were identified: "a blind alley", "a stepping stone" and "a good fit". Despite some delays in its implementation, SP was seen as a step forward. Some participants also believed that it improved patient care and pharmacists' integration in the health care team and increased their job satisfaction. However, there was a concern that SP, as first implemented, was bureaucratic and limited pharmacists' freedom in their decision making. Hence, pharmacists were more supportive of the then imminent introduction of a pharmacist independent prescribing (IP) role.

CONCLUSIONS: Despite challenges, the SP role represented a step forward for pharmacists in the United Kingdom. It is possible that pharmacist SP can coexist with IP in the areas suitable for CMP use. Elsewhere, SP is likely to become more of a "stepping stone" to an IP role than the preferred model for pharmacist prescribing. Future research needs to objectively assess the outcomes of pharmacist SP, preferably in comparison with IP, to inform decision making among pharmacists regarding the adoption of such an innovative role.

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