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2021
Elvidge, J., and D. Dawoud, "Assessing Technologies for COVID-19: What are the Challenges for Health Technology Assessment Agencies? Findings From a Survey and Roundtable Workshop.", PharmacoEconomics, vol. 39, issue 12, pp. 1455-1463, 2021. Abstract

BACKGROUND: To date, health technology assessment (HTA) agencies have not been at the forefront of decision making regarding the adoption of interventions for coronavirus disease 2019 (COVID-19). Instead, policymakers have prioritised rapid action in response to the pandemic emergency, with no assessment of value for money. As COVID-19 vaccination coverage increases and healthcare systems begin to recover, HTA agencies will be expected to assess technologies for COVID-19.

OBJECTIVE: We aimed to identify the key challenges when assessing therapeutic and diagnostic technologies for COVID-19, from the perspective of HTA agencies, and identify whether there is a case for novel HTA methods and/or processes to address them.

METHODS: We used a mixed-methods approach, by conducting an online survey of HTA agencies, to collect data about the challenges faced when assessing or planning to assess diagnostic and therapeutic technologies for COVID-19. The online survey was followed by a 'roundtable' workshop of HTA agencies' representatives to discuss the results and to elaborate on their responses.

RESULTS: We received 21 completed surveys (response rate of 45%) and 11 of the respondents joined the roundtable discussion. Five themes emerged from the responses: assessing clinical effectiveness (44%), assessing cost effectiveness (19%), practical (19%), political (11%), and decision making (11%) challenges. At the roundtable, attendees elaborated on the challenges and identified two additional themes: how HTA agencies have responded to the pandemic to date, and how their role might change over time.

CONCLUSION: HTA agencies face both methodological and logistical challenges when assessing or planning to assess technologies for COVID-19. An interim best-practice HTA framework to address the key challenges would be valuable.

Recalde, M., E. Roel, A. Pistillo, A. G. Sena, A. Prats-Uribe, W. - U. - R. Ahmed, H. Alghoul, T. M. Alshammari, O. Alser, C. Areia, et al., "Characteristics and outcomes of 627 044 COVID-19 patients living with and without obesity in the United States, Spain, and the United Kingdom.", International journal of obesity (2005), vol. 45, issue 11, pp. 2347-2357, 2021. Abstract

BACKGROUND: A detailed characterization of patients with COVID-19 living with obesity has not yet been undertaken. We aimed to describe and compare the demographics, medical conditions, and outcomes of COVID-19 patients living with obesity (PLWO) to those of patients living without obesity.

METHODS: We conducted a cohort study based on outpatient/inpatient care and claims data from January to June 2020 from Spain, the UK, and the US. We used six databases standardized to the OMOP common data model. We defined two non-mutually exclusive cohorts of patients diagnosed and/or hospitalized with COVID-19; patients were followed from index date to 30 days or death. We report the frequency of demographics, prior medical conditions, and 30-days outcomes (hospitalization, events, and death) by obesity status.

RESULTS: We included 627 044 (Spain: 122 058, UK: 2336, and US: 502 650) diagnosed and 160 013 (Spain: 18 197, US: 141 816) hospitalized patients with COVID-19. The prevalence of obesity was higher among patients hospitalized (39.9%, 95%CI: 39.8-40.0) than among those diagnosed with COVID-19 (33.1%; 95%CI: 33.0-33.2). In both cohorts, PLWO were more often female. Hospitalized PLWO were younger than patients without obesity. Overall, COVID-19 PLWO were more likely to have prior medical conditions, present with cardiovascular and respiratory events during hospitalization, or require intensive services compared to COVID-19 patients without obesity.

CONCLUSION: We show that PLWO differ from patients without obesity in a wide range of medical conditions and present with more severe forms of COVID-19, with higher hospitalization rates and intensive services requirements. These findings can help guiding preventive strategies of COVID-19 infection and complications and generating hypotheses for causal inference studies.

Roel, E., A. Pistillo, M. Recalde, A. G. Sena, S. Fernández-Bertolín, M. Aragón, D. Puente, W. - U. - R. Ahmed, H. Alghoul, O. Alser, et al., "Characteristics and Outcomes of Over 300,000 Patients with COVID-19 and History of Cancer in the United States and Spain.", Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, vol. 30, issue 10, pp. 1884-1894, 2021. Abstract

BACKGROUND: We described the demographics, cancer subtypes, comorbidities, and outcomes of patients with a history of cancer and coronavirus disease 2019 (COVID-19). Second, we compared patients hospitalized with COVID-19 to patients diagnosed with COVID-19 and patients hospitalized with influenza.

METHODS: We conducted a cohort study using eight routinely collected health care databases from Spain and the United States, standardized to the Observational Medical Outcome Partnership common data model. Three cohorts of patients with a history of cancer were included: (i) diagnosed with COVID-19, (ii) hospitalized with COVID-19, and (iii) hospitalized with influenza in 2017 to 2018. Patients were followed from index date to 30 days or death. We reported demographics, cancer subtypes, comorbidities, and 30-day outcomes.

RESULTS: We included 366,050 and 119,597 patients diagnosed and hospitalized with COVID-19, respectively. Prostate and breast cancers were the most frequent cancers (range: 5%-18% and 1%-14% in the diagnosed cohort, respectively). Hematologic malignancies were also frequent, with non-Hodgkin's lymphoma being among the five most common cancer subtypes in the diagnosed cohort. Overall, patients were aged above 65 years and had multiple comorbidities. Occurrence of death ranged from 2% to 14% and from 6% to 26% in the diagnosed and hospitalized COVID-19 cohorts, respectively. Patients hospitalized with influenza ( = 67,743) had a similar distribution of cancer subtypes, sex, age, and comorbidities but lower occurrence of adverse events.

CONCLUSIONS: Patients with a history of cancer and COVID-19 had multiple comorbidities and a high occurrence of COVID-19-related events. Hematologic malignancies were frequent.

IMPACT: This study provides epidemiologic characteristics that can inform clinical care and etiologic studies.

Reyes, C., A. Pistillo, S. Fernández-Bertolín, M. Recalde, E. Roel, D. Puente, A. G. Sena, C. Blacketer, L. Lai, T. M. Alshammari, et al., "Characteristics and outcomes of patients with COVID-19 with and without prevalent hypertension: a multinational cohort study.", BMJ open, vol. 11, issue 12, pp. e057632, 2021. Abstract

OBJECTIVE: To characterise patients with and without prevalent hypertension and COVID-19 and to assess adverse outcomes in both inpatients and outpatients.

DESIGN AND SETTING: This is a retrospective cohort study using 15 healthcare databases (primary and secondary electronic healthcare records, insurance and national claims data) from the USA, Europe and South Korea, standardised to the Observational Medical Outcomes Partnership common data model. Data were gathered from 1 March to 31 October 2020.

PARTICIPANTS: Two non-mutually exclusive cohorts were defined: (1) individuals diagnosed with COVID-19 (diagnosed cohort) and (2) individuals hospitalised with COVID-19 (hospitalised cohort), and stratified by hypertension status. Follow-up was from COVID-19 diagnosis/hospitalisation to death, end of the study period or 30 days.

OUTCOMES: Demographics, comorbidities and 30-day outcomes (hospitalisation and death for the 'diagnosed' cohort and adverse events and death for the 'hospitalised' cohort) were reported.

RESULTS: We identified 2 851 035 diagnosed and 563 708 hospitalised patients with COVID-19. Hypertension was more prevalent in the latter (ranging across databases from 17.4% (95% CI 17.2 to 17.6) to 61.4% (95% CI 61.0 to 61.8) and from 25.6% (95% CI 24.6 to 26.6) to 85.9% (95% CI 85.2 to 86.6)). Patients in both cohorts with hypertension were predominantly >50 years old and female. Patients with hypertension were frequently diagnosed with obesity, heart disease, dyslipidaemia and diabetes. Compared with patients without hypertension, patients with hypertension in the COVID-19 diagnosed cohort had more hospitalisations (ranging from 1.3% (95% CI 0.4 to 2.2) to 41.1% (95% CI 39.5 to 42.7) vs from 1.4% (95% CI 0.9 to 1.9) to 15.9% (95% CI 14.9 to 16.9)) and increased mortality (ranging from 0.3% (95% CI 0.1 to 0.5) to 18.5% (95% CI 15.7 to 21.3) vs from 0.2% (95% CI 0.2 to 0.2) to 11.8% (95% CI 10.8 to 12.8)). Patients in the COVID-19 hospitalised cohort with hypertension were more likely to have acute respiratory distress syndrome (ranging from 0.1% (95% CI 0.0 to 0.2) to 65.6% (95% CI 62.5 to 68.7) vs from 0.1% (95% CI 0.0 to 0.2) to 54.7% (95% CI 50.5 to 58.9)), arrhythmia (ranging from 0.5% (95% CI 0.3 to 0.7) to 45.8% (95% CI 42.6 to 49.0) vs from 0.4% (95% CI 0.3 to 0.5) to 36.8% (95% CI 32.7 to 40.9)) and increased mortality (ranging from 1.8% (95% CI 0.4 to 3.2) to 25.1% (95% CI 23.0 to 27.2) vs from 0.7% (95% CI 0.5 to 0.9) to 10.9% (95% CI 10.4 to 11.4)) than patients without hypertension.

CONCLUSIONS: COVID-19 patients with hypertension were more likely to suffer severe outcomes, hospitalisations and deaths compared with those without hypertension.

Tan, E. H., A. G. Sena, A. Prats-Uribe, S. C. You, W. - U. - R. Ahmed, K. Kostka, C. Reich, S. L. DuVall, K. E. Lynch, M. E. Matheny, et al., "COVID-19 in patients with autoimmune diseases: characteristics and outcomes in a multinational network of cohorts across three countries.", Rheumatology (Oxford, England), vol. 60, issue SI, pp. SI37-SI50, 2021. Abstract

OBJECTIVE: Patients with autoimmune diseases were advised to shield to avoid coronavirus disease 2019 (COVID-19), but information on their prognosis is lacking. We characterized 30-day outcomes and mortality after hospitalization with COVID-19 among patients with prevalent autoimmune diseases, and compared outcomes after hospital admissions among similar patients with seasonal influenza.

METHODS: A multinational network cohort study was conducted using electronic health records data from Columbia University Irving Medical Center [USA, Optum (USA), Department of Veterans Affairs (USA), Information System for Research in Primary Care-Hospitalization Linked Data (Spain) and claims data from IQVIA Open Claims (USA) and Health Insurance and Review Assessment (South Korea). All patients with prevalent autoimmune diseases, diagnosed and/or hospitalized between January and June 2020 with COVID-19, and similar patients hospitalized with influenza in 2017-18 were included. Outcomes were death and complications within 30 days of hospitalization.

RESULTS: We studied 133 589 patients diagnosed and 48 418 hospitalized with COVID-19 with prevalent autoimmune diseases. Most patients were female, aged ≥50 years with previous comorbidities. The prevalence of hypertension (45.5-93.2%), chronic kidney disease (14.0-52.7%) and heart disease (29.0-83.8%) was higher in hospitalized vs diagnosed patients with COVID-19. Compared with 70 660 hospitalized with influenza, those admitted with COVID-19 had more respiratory complications including pneumonia and acute respiratory distress syndrome, and higher 30-day mortality (2.2-4.3% vs 6.32-24.6%).

CONCLUSION: Compared with influenza, COVID-19 is a more severe disease, leading to more complications and higher mortality.

Hussain, R., D. M. Dawoud, and Z. - U. - D. Babar, "Drive-thru pharmacy services: A way forward to combat COVID-19 pandemic.", Research in social & administrative pharmacy : RSAP, vol. 17, issue 1, pp. 1920-1924, 2021. Abstract

Countries around the globe have responded to pandemic preparedness and developed strategies to cope with the COVID-19 crisis. In this context, the role of healthcare professionals is of paramount importance. Pharmacists are playing a vital role in dealing, preparedness, prevention, protection, promoting access to medicines and to improve health outcomes during this crisis. In this context, "Drive-thru" pharmacy services improve access to medicines while ensuring the preventive measures suggested by the World Health Organization. This commentary provides an overview of opportunities and challenges related to the implementation of "drive-thru pharmacy services" and their role in improving public health during this crisis.

Dawoud, D., "Emerging from the other end: Key measures for a successful COVID-19 lockdown exit strategy and the potential contribution of pharmacists.", Research in social & administrative pharmacy : RSAP, vol. 17, issue 1, pp. 1950-1953, 2021. Abstract

As the world edges towards relaxing the lockdown measures taken to control the spread of the novel coronavirus SARS-CoV-2 (COVID-19), governments have started putting in place a variety of measures to avoid a second peak in the number of infections. The implementation of and adherence to such measures will be key components of any successful lockdown exit strategy. Ranging from expanded testing and widespread use of technology to building the public's trust in the post COVID-19 world, there is a role for pharmacists to play. In this commentary, these measures and the potential contribution of pharmacists to their successful implementation are outlined and discussed.

Dawoud, D., A. M. H. Chen, C. V. Rossing, V. Garcia-Cardenas, A. V. Law, P. Aslani, I. Bates, Z. - U. - D. Babar, and S. Desselle, "Pharmacy practice research priorities during the COVID-19 pandemic: Recommendations of a panel of experts convened by FIP Pharmacy Practice Research Special Interest Group.", Research in social & administrative pharmacy : RSAP, vol. 17, issue 1, pp. 1903-1907, 2021. Abstract

Across the globe, pharmacists on the frontline continue to fight COVID-19 and its continuously evolving physical, mental, and economic consequences armed by their knowledge, professionalism, and dedication. Their need for credible scientific evidence to inform their practice has never been more urgent. Despite the exponentially increasing number of publications since the start of the pandemic, questions remain unanswered, and more are created, than have been resolved by the increasing number of publications. A panel of leading journal editors was convened by the International Pharmaceutical Federation (FIP) Pharmacy Practice Research Special Interest Group to discuss the current status of COVID-19 related research, provide their recommendations, and identify focal points for pharmacy practice, social pharmacy, and education research moving forward. Key priorities identified spanned a wide range of topics, reflecting the need for good quality research to inform practice and education. The panel insisted that a foundation in theory and use of rigorous methods should continue forming the basis of inquiry and its resultant papers, regardless of topic area. From assessing the clinical and cost effectiveness of COVID-19 therapies and vaccines to assessing different models of pharmaceutical services and education delivery, these priorities will ensure that our practice is informed by the best quality scientific evidence at this very challenging time.

Prats-Uribe, A., A. G. Sena, L. Y. H. Lai, W. - U. - R. Ahmed, H. Alghoul, O. Alser, T. M. Alshammari, C. Areia, W. Carter, P. Casajust, et al., "Use of repurposed and adjuvant drugs in hospital patients with covid-19: multinational network cohort study.", BMJ (Clinical research ed.), vol. 373, pp. n1038, 2021. Abstract

OBJECTIVE: To investigate the use of repurposed and adjuvant drugs in patients admitted to hospital with covid-19 across three continents.

DESIGN: Multinational network cohort study.

SETTING: Hospital electronic health records from the United States, Spain, and China, and nationwide claims data from South Korea.

PARTICIPANTS: 303 264 patients admitted to hospital with covid-19 from January 2020 to December 2020.

MAIN OUTCOME MEASURES: Prescriptions or dispensations of any drug on or 30 days after the date of hospital admission for covid-19.

RESULTS: Of the 303 264 patients included, 290 131 were from the US, 7599 from South Korea, 5230 from Spain, and 304 from China. 3455 drugs were identified. Common repurposed drugs were hydroxychloroquine (used in from <5 (<2%) patients in China to 2165 (85.1%) in Spain), azithromycin (from 15 (4.9%) in China to 1473 (57.9%) in Spain), combined lopinavir and ritonavir (from 156 (<2%) in the VA-OMOP US to 2,652 (34.9%) in South Korea and 1285 (50.5%) in Spain), and umifenovir (0% in the US, South Korea, and Spain and 238 (78.3%) in China). Use of adjunctive drugs varied greatly, with the five most used treatments being enoxaparin, fluoroquinolones, ceftriaxone, vitamin D, and corticosteroids. Hydroxychloroquine use increased rapidly from March to April 2020 but declined steeply in May to June and remained low for the rest of the year. The use of dexamethasone and corticosteroids increased steadily during 2020.

CONCLUSIONS: Multiple drugs were used in the first few months of the covid-19 pandemic, with substantial geographical and temporal variation. Hydroxychloroquine, azithromycin, lopinavir-ritonavir, and umifenovir (in China only) were the most prescribed repurposed drugs. Antithrombotics, antibiotics, H2 receptor antagonists, and corticosteroids were often used as adjunctive treatments. Research is needed on the comparative risk and benefit of these treatments in the management of covid-19.

Hasan, S. S., W. Sunter, N. Ahmed, D. Dawoud, and S. T. R. Zaidi, "Venous thromboembolism prophylaxis in patients undergoing knee replacements: comparison of real-world outcomes.", International journal of clinical pharmacy, vol. 43, issue 3, pp. 621-628, 2021. Abstract

Background Increasing evidence for the use of the aspirin in patients undergoing an orthopaedic surgery for venous thromboembolism prophylaxis has led to a change in the national guidelines substituting anticoagulants with aspirin. Little is known about the impact of such substitution on real-world outcomes from clinical practice. Objective The study was designed to examine clinical outcomes associated with the use of aspirin and apixaban. Setting Two large-scale general hospitals in West Yorkshire region of England. Method A 1-year observational study among adults who underwent elective knee replacements and received venous thromboembolism prophylaxis within the first 14 days post replacements. Main outcome measure The incidence of postoperative venous thromboembolism, leaking wounds during the hospital stay, and 30-day any readmission for the two drugs. Results A total of 420 patients were included. There was a significant drop in apixaban prescribing (from 80.37 to 10.51%) and increase in aspirin use (from 19.02 to 81.71%) after the implementation of the revised guidelines. There were 52 (12.38%) cases of leaking wound, 16 (3.81%) cases of postoperative venous thromboembolism, 45 (10.71%) cases of 30-day readmission and no case of 30-day major bleeding. The leaking wounds and 30-day readmissions were almost twice more frequent in obese compared to non-obese patients. Multivariate logistic regression found an increased risk of leaking wound with apixaban and postoperative venous thromboembolism and 30-day readmission with aspirin use but the differences were not statistically significant. Conclusion The results suggest aspirin to be as effective as apixaban in preventing venous thromboembolism and readmission. Apixaban usage decreased with a corresponding increase in Aspirin use. The impact of obesity and length of hospital stay need further investigations.

2020
Dawoud, D. M., and K. Y. Soliman, "Cost-Effectiveness of Antiviral Treatments for Pandemics and Outbreaks of Respiratory Illnesses, Including COVID-19: A Systematic Review of Published Economic Evaluations.", Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, vol. 23, issue 11, pp. 1409-1422, 2020. Abstract

OBJECTIVE: To review published economic evaluations of antiviral treatment for pandemics and outbreaks of respiratory illnesses.

METHODS: We conducted a systematic review to identify economic evaluations of antiviral treatment for pandemics and outbreaks of respiratory illnesses, including coronavirus disease 2019 (COVID-19). We searched Medline (EBSCOhost), EMBASE (Ovid), EconLit (Ovid), National Health Service Economic Evaluation Database (Ovid), and Health Technology Assessment (Ovid). The search was last rerun on July 5, 2020. Citation tracking and reference checking were used. Only full economic evaluations published as peer-reviewed articles in the last 10 years were included. Studies were quality assessed using the National Institute for Health and Care Excellence economic evaluation checklist.

RESULTS: Overall, 782 records were identified, of which 14 studies met the inclusion criteria. The studies were mostly conducted in high-income countries. All were model-based. Seven (50%) were cost-utility analyses, 4 (28.6%) were cost-effectiveness analyses, 2 (14.3%) were cost-consequences analyses, and 1 (7.1%) was a cost-benefit analysis. Strategies including antiviral treatment were found to be either cost-saving or cost-effective, at the study-specific willingness-to-pay thresholds. Empirical treatment was more cost-effective than test-guided treatment for young adults but less so for older adults.

CONCLUSIONS: Antiviral treatment for managing pandemics and outbreaks of respiratory illnesses that have very high case fatality rate, similar to COVID-19 pandemic, are likely to be cost-effective either as a standalone intervention or part of a multifaceted strategy. Investing in the development of such curative treatments and promptly evaluating their cost-effectiveness, relative to other strategies in use at the time of their introduction should be the focus going forward to inform resource allocation decisions particularly in low- and middle-income countries.

Kharroubi, S. A., Y. Beyh, M. D. E. Harake, D. Dawoud, D. Rowen, and J. Brazier, "Examining the Feasibility and Acceptability of Valuing the Arabic Version of SF-6D in a Lebanese Population.", International journal of environmental research and public health, vol. 17, issue 3, pp. 1052, 2020. Abstract

The SF-6D is a preference-based measure of health developed to generate utility values from the SF-36. The aim of this pilot study was to examine the feasibility and acceptability of using the standard gamble (SG) technique to generate preference-based values for the Arabic version of SF-6D in a Lebanese population. The SF-6D was translated into Arabic using forward and backward translations. Forty-nine states defined by the SF-6D were selected using an orthogonal design and grouped into seven sets. A gender-occupation stratified sample of 126 Lebanese adults from the American University of Beirut were recruited to value seven states and the pits using SG. The sample size is appropriate for a pilot study, but smaller than the sample required for a full valuation study. Both interviewers and interviewees reported their understanding and effort levels in the SG tasks. Mean and individual level multivariate regression models were fitted to estimate preference weights for all SF-6D states. The models were compared with those estimated in the UK. Interviewers reported few problems in completing SG tasks (0.8% with a lot of problems) and good respondent understanding (5.6% with little effort and concentration), and 25% of respondents reported the SG task was difficult. A total of 992 SG valuations were useable for econometric modeling. There was no significant change in the test-retest values from 21 subjects. The mean absolute errors in the mean and individual level models were 0.036 and 0.050, respectively, both of which were lower than the UK results. The random effects model adequately predicts the SG values, with the worst state having a value of 0.322 compared to 0.271 in the UK. This pilot confirmed that it was feasible and acceptable to generate preference values with the SG method for the Arabic SF-6D in a Lebanese population. However, further work is needed to extend this to a more representative population, and to explore why no utility values below zero were observed.

Desselle, S. P., A. M. Chen, M. Amin, P. Aslani, D. Dawoud, M. J. Miller, and L. S. Norgaard, "Generosity, collegiality, and scientific accuracy when writing and reviewing original research.", Research in social & administrative pharmacy : RSAP, vol. 16, issue 2, pp. 261-265, 2020. Abstract

In spite of concerns about the lack of recognition for its conduct, peer review remains the backbone of scientific evaluation and advancement of scientific knowledge. Given the challenges and evolution in the peer review system, collegiality among authors, reviewers, editors, and even consumers of content is more important than ever. While general guidance has been provided recently in the pharmacy literature, this commentary provides both philosophical underpinnings and specific mechanics for enhancing effectiveness of reviews and improving the quality of writing for authors concurrently, thus examining each major section in an original research contribution. Generosity, courtesy, diligence, thoroughness, and empathy are required of us all to advance the scientific paradigm of our discipline and profession.

Elnady, B., T. Elkhouly, N. M. Dawoud, D. E. Desouky, H. H. Kewan, D. M. Dawoud, and C. Ritchlin, "New onset of axial spondyloarthropathy in patients treated with isotretinoin for acne vulgaris: incidence, follow-up, and MRI findings.", Clinical rheumatology, vol. 39, issue 6, pp. 1829-1838, 2020. Abstract

INTRODUCTION: Oral isotretinoin is commonly prescribed for acne vulgaris. Several case reports and observational studies have reported serious musculoskeletal side effects; however, the incidence, imaging findings, and longitudinal follow-up data are limited for patients who develop inflammatory back pain (IBP).

OBJECTIVE: To assess the incidence of isotretinoin-triggered axial spondyloarthropathy (SpA) in acne vulgaris patients based on clinical features and MRI findings and to examine clinical and radiological outcomes following drug withdrawal.

METHODS: Five hundred thirteen acne patients receiving isotretinoin were screened for IBP; IBP patients were assessed for CRP, plain radiographs, and MRI of the sacroiliac joint. MRI-proven sacroiliitis was scored semi-quantitatively. Patients were followed longitudinally to assess SpA clinical course and longitudinal MRI sacroiliac joints, and CRP levels were reassessed 3 weeks after patients were symptom-free, following isotretinoin discontinuation.

RESULTS: Of the 513 patients, 23.98% developed IBP. MRI-proven sacroiliitis was detected in 42.3% of the symptomatic patients or 10.1% of the cohort. Among MRI-proven sacroiliitis cases, 51.9% fulfilled the Assessment of Spondyloarthritis International Society criteria for axial SpA. Mean CRP level was 32.05 ± 17.23 mg/L at pain onset and 3.4 ± 2.7 mg/L after symptom resolution. MRI findings completely resolved within 9 months (mean 6.27 ± 1.7) after isotretinoin discontinuation. MRI scores positively correlated with baseline CRP levels and global acne grading system score, pain, and the Ankylosing Spondylitis Disease Activity Score.

CONCLUSION: Isotretinoin-induced axial SpA is a prevalent side effect in acne vulgaris patients. Early detection and follow-up of isotretinoin-induced sacroiliitis can be facilitated by MRI. Cessation of isotretinoin resulted in complete resolution in all affected patients.Key Points• Detection of underdiagnosed isotretinoin side effects which are common but not always correctly diagnosed and managed.• Incidence, diagnosis, and management of these side effects in a real-world setting.• This is the first large prospective longitudinal cohort study to report on axial manifestations in patients treated with isotretinoin as well as the effect of drug cessation upon the clinical, laboratory, and radiological findings.

Dawoud, D. M., F. El-Dahiyat, A. Abojedi, N. Dawoud, A. M. Soliman, M. Hussein, O. Mohamed, S. S. Hasan, Z. - U. - D. Babar, and S. A. Kharroubi, "Translation, cultural adaptation and psychometric validation of the SF-6D measure of health-related quality of life for use in Arabic-Speaking countries.", Research in social & administrative pharmacy : RSAP, vol. 16, issue 12, pp. 1754-1759, 2020. Abstract

BACKGROUND: The SF-6D is a generic, six-dimensional health-related quality of life (HRQoL) measure derived from a selection of items from the SF-36.

OBJECTIVES: To translate, culturally adapt and validate the SF-6D for use in Arabic-speaking countries.

METHODS: The International Quality of Life Assessment (IQOLA) methodology was followed. Two forward translations, one consensus and one backward translation were undertaken. Difficulties encountered were categorized as grammatical, idiomatic, semantic/conceptual, and cultural. The content validity of the final version was tested and Cronbach's alpha test of internal consistency was used for assessing reliability. Confirmatory factor analysis (CFA), was also used to assess construct validity and to test a pre-specified relationship of observed measures.

RESULTS: Minor changes were made to the forward translation to improve cultural appropriateness. The Backward translation did not reveal major problems and equivalence to the original was confirmed following committee review. A total of 470 participants from Jordan, Egypt, UAE, Qatar and Palestine completed the translated SF-6D. All the incremental indices values are ≥0.90 and close to 1. Item loading values ranged from 0.52 to 0.87. The measurement model weight for those with chronic health conditions ranged from 0.68 to 0.91, and from 0.42 to 0.73 for those without. The percentage of variation in self-reported health state was about 55%. The measurement weight of SF-6D on self-reported health state among chronic responders was 0.87 while among responders reporting no chronic disease was 0.61. The t-value for the difference in measurement weight was -8.93 (p ≤ 0.01).

CONCLUSION: Arabic translation and cultural adaptation of SF-6D has resulted in an acceptable and culturally-adapted version that can be used in Arabic-speaking countries. Reliability and validity have been confirmed as well as ability to assess the difference in quality of life between patients with chronic health conditions and healthy individuals.

Dawoud, D., K. Chalkidou, R. Sullivan, F. J. Ruiz, and A. Adler, "USA stockpiling of remdesivir: How should the world respond?", Journal of comparative effectiveness research, vol. 9, issue 18, pp. 1243-1246, 2020. Abstract

The race to find an effective treatment for coronavirus disease 2019 (COVID-19) is still on, with only two treatment options currently authorized for emergency use and/or recommended for patients hospitalized with severe respiratory symptoms: low-dose dexamethasone and remdesivir. The USA decision to stockpile the latter has resulted in widespread condemnation and in similar action being taken by some other countries. In this commentary we discuss whether stockpiling remdesivir is justified in light of the currently available evidence.

2019
Dawoud, D. M., A. Haines, D. Wonderling, J. Ashe, J. Hill, M. Varia, P. Dyer, and J. Bion, "Cost Effectiveness of Advanced Pharmacy Services Provided in the Community and Primary Care Settings: A Systematic Review.", PharmacoEconomics, vol. 37, issue 10, pp. 1241-1260, 2019. Abstract

BACKGROUND: Pharmacists working in community and primary care are increasingly developing advanced skills to provide enhanced services, particularly in dealing with minor acute illness. These services can potentially free-up primary care physicians' time; however, it is not clear whether they are sufficiently cost effective to be recommended for wider provision in the UK.

OBJECTIVE: The aim of this study was to review published economic evaluations of enhanced pharmacy services in the community and primary care settings.

METHODS: We undertook a systematic review of economic evaluations of enhanced pharmacy services to inform NICE guidelines for emergency and acute care. The review protocol was developed and agreed with the guideline committee. The National Health Service Economic Evaluation Database, Health Technology Assessment Database, Health Economic Evaluations Database, MEDLINE and EMBASE were searched in December 2016 and the search was updated in March 2018. Studies were assessed for applicability and methodological quality using the NICE Economic Evaluation Checklist.

RESULTS: Of 3124 records, 13 studies published in 14 papers were included. The studies were conducted in the UK, Spain, The Netherlands, Australia, Italy and Canada. Settings included community pharmacies, primary care/general practice surgeries and patients' homes. Most of the studies were assessed as partially applicable with potentially serious limitations. Services provided in community and primary care settings were found to be either dominant or cost effective, at a £20,000 per quality-adjusted life-year threshold, compared with usual care. Those delivered in the patient's home were not found to be cost effective.

CONCLUSIONS: Advanced pharmacy services appear to be cost effective when delivered in community and primary care settings, but not in domiciliary settings. Expansion in the provision of these services in community and primary care can be recommended for wider implementation.

Dawoud, D., "Discrete choice experiment", Encyclopedia of Pharmacy Practice and Clinical Pharmacy: Elsevier, 2019.
Dawoud, D. M., M. Smyth, J. Ashe, T. Strong, D. Wonderling, J. Hill, M. Varia, P. Dyer, and J. Bion, "Effectiveness and cost effectiveness of pharmacist input at the ward level: a systematic review and meta-analysis.", Research in social & administrative pharmacy : RSAP, vol. 15, issue 10, pp. 1212-1222, 2019. Abstract

BACKGROUND: Pharmacists play important role in ensuring timely care delivery at the ward level. The optimal level of pharmacist input, however, is not clearly defined.

OBJECTIVE: To systematically review the evidence that assessed the outcomes of ward pharmacist input for people admitted with acute or emergent illness.

METHODS: The protocol and search strategies were developed with input from clinicians. Medline, EMBASE, Centre for Reviews and Dissemination, The Cochrane Library, NHS Economic Evaluations, Health Technology Assessment and Health Economic Evaluations databases were searched. Inclusion criteria specified the population as adults and young people (age >16 years) who are admitted to hospital with suspected or confirmed acute or emergent illness. Only randomised controlled trials (RCTs) published in English were eligible for inclusion in the effectiveness review. Economic studies were limited to full economic evaluations and comparative cost analysis. Included studies were quality-assessed. Data were extracted, summarised. and meta-analysed, where appropriate.

RESULTS: Eighteen RCTs and 7 economic studies were included. The RCTs were from USA (n = 3), Sweden (n = 2), Belgium (n = 2), China (n = 2), Australia (n = 2), Denmark (n = 2), Northern Ireland, Norway, Canada, UK and Netherlands. The economic studies were from UK (n = 2), Sweden (n = 2), Belgium and Netherlands. The results showed that regular pharmacist input was most cost effective. It reduced length-of-stay (mean = -1.74 days [95% CI: 2.76, -0.72], and increased patient and/or carer satisfaction (Relative Risk (RR) = 1.49 [1.09, 2.03] at discharge). At £20,000 per quality-adjusted life-year (QALY)-gained cost-effectiveness threshold, it was either cost-saving or cost-effective (Incremental Cost Effectiveness Ratio (ICER) = £632/QALY-gained). No evidence was found for 7-day pharmacist presence.

CONCLUSIONS: Pharmacist inclusion in the ward multidisciplinary team improves patient safety and satisfaction and is cost-effective when regularly provided throughout the ward stay. Research is needed to determine whether the provision of 7-day service is cost-effective.

Atif, M., iram Malik, D. Dawoud, A. Gilani, N. Ahmed, and Z. - U. - D. Babar, "Essential Medicine List, Policies, and the World Health Organization", Encyclopedia of Pharmacy Practice and Clinical Pharmacy: Elsevier, 2019.
Ibrahim, O., N. K. Al-tameemi, and D. Dawoud, "Knowledge and Perceptions of Vitamin D deficiency among the United Arab Emirates Population", Asian Journal of Pharmaceutical and Clinical Research, vol. 12, issue 8, pp. 183-186, 2019.
Desselle, S. P., M. Amin, P. Aslani, A. M. Chen, D. Dawoud, M. J. Miller, and L. S. Norgaard, "Moving the needle-what does RSAP look for and what does it aim to do?", Research in social & administrative pharmacy : RSAP, vol. 15, issue 1, pp. 1-2, 2019.
Stansby, G., I. Donald, P. Barry, D. Dawoud, and C. Sharpin, "NICE NG89 recommendations for extended pharmacological thromboprophylaxis - is it justified and is it cost effective: a rebuttal from the British Society for Haematology - response to Lester et al.", British journal of haematology, vol. 186, issue 5, pp. 788-789, 2019.
Hasan, S. S., C. S. Kow, D. Dawoud, O. Mohamed, D. Baines, and Z. - U. - D. Babar, "Pharmaceutical Policy Reforms to Regulate Drug Prices in the Asia Pacific Region: The Case of Australia, China, India, Malaysia, New Zealand, and South Korea.", Value in health regional issues, vol. 18, pp. 18-23, 2019. Abstract

Medicine price directly affects affordability and access to medicines particularly in countries where a major portion of pharmaceutical spending is through out-of-pocket payment, such as in the Asia Pacific region. We have undertaken a detailed appraisal of the pharmaceutical policy reforms to regulate drug prices in 3 developed (Australia, New Zealand, and South Korea) and 3 emerging (China, India, and Malaysia) economies of the Asia Pacific region. Despite continuous efforts by the authorities in adopting a wide range of reformatory pharmaceutical pricing policies to ensure affordability of medicines, these policies may not be optimal where drug prices were not lowered as expected (eg, in Korea). On the contrary, considerable price reductions of various pharmaceuticals have been observed in New Zealand and India because of the reform in pharmaceutical pricing policy. This review of pharmaceutical pricing reforms reinforces the need for constant monitoring by policy makers in Asia Pacific countries to regulate drug prices and to undertake reform in pharmaceutical pricing policies when necessary to ensure affordability and access to medicines.

Lewis, S., J. Glen, D. Dawoud, S. Dias, J. Cobb, X. Griffin, M. Reed, C. Sharpin, G. Stansby, and P. Barry, "Venous Thromboembolism Prophylaxis Strategies for People Undergoing Elective Total Hip Replacement: A Systematic Review and Network Meta-Analysis.", Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, vol. 22, issue 8, pp. 953-969, 2019. Abstract

OBJECTIVES: To assess the efficacy and safety of venous thromboembolism prophylaxis in people undergoing elective total hip replacement.

METHODS: Systematic review and Bayesian network meta-analyses of randomized controlled trials were conducted for 3 outcomes: deep vein thrombosis (DVT), pulmonary embolism (PE), and major bleeding (MB). MEDLINE, EMBASE, and Cochrane Library (CENTRAL) databases were searched. Study quality was assessed using the Cochrane risk-of-bias checklist. Fixed- and random-effects models were fitted and compared. The median relative risk (RR) and odds ratio (OR) compared with no prophylaxis, with their 95% credible intervals (CrIs), rank, and probability of being the best, were calculated.

RESULTS: Forty-two (n = 24 374, 26 interventions), 30 (n = 28 842, 23 interventions), and 24 (n = 31 792, 15 interventions) randomized controlled trials were included in the DVT, PE, and MB networks, respectively. Rivaroxaban had the highest probability of being the most effective intervention for DVT (RR 0.06 [95% CrI 0.01-0.29]). Strategy of low-molecular-weight heparin followed by aspirin had the highest probability of reducing the risk of PE and MB (RR 0.0011 [95% CrI 0.00-0.096] and OR 0.37 [95% CrI 0.00-26.96], respectively). The ranking of efficacy estimates across the 3 networks, particularly PE and MB, had very wide CrIs, indicating high degree of uncertainty.

CONCLUSIONS: A strategy of low-molecular-weight heparin given for 10 days followed by aspirin for 28 days had the best benefit-risk balance, with the highest probability of being the best on the basis of the results of the PE and MB network meta-analyses. Nevertheless, there is considerable uncertainty around the median ranks of the interventions.