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Abstract Background In response to concerns about high hospital mortality rates, patient and carer complaints, a Mid Staffordshire NHS Foundation Trust public inquiry was conducted at the request of the UK government. This inquiry found serious failures in the quality of basic care provided and as a consequence, recommended that patients should have more regular visits, organised at predictable times from nursing staff. Intentional rounding, also known as nursing ward rounds, was widely adopted to meet this need. Objective To test, refine or refute eight programme theories to understand what works, for whom, and in what circumstances. Setting Six wards (older people and acute wards) in three NHS trusts in England. Participants Board level and senior nursing managers (N = 17), nursing ward staff (N = 33), allied health and medical professionals (N = 26), patients (N = 34) and relatives (N = 28) participated in an individual, in-depth interview using the realist method. In addition, ward-based nurses (N = 39) were shadowed whilst they conduced intentional rounds (240 rounds in total) and the direct care of patients (188 h of patient care in total) was observed. Methods The mixed methods design included: Phase (1) Theory development - A realist synthesis was undertaken to identify any programme theories which were tested, refined and/or refuted, using data from phases 2 and 3; Phase (2) A survey of all English NHS acute Trusts; Phase (3) Six case studies of wards involving realist interviews, shadowing and non-participant observations, analysis of ward outcome and cost data; and Phase (4) Synthesis of findings from phases 1, 2 and 3. Results The realist synthesis identified eight programme theories of intentional rounding: ‘Consistency and comprehensiveness’, ‘Accountability’, ‘Visibility of nurses’, ‘Anticipation’, ‘Allocated time to care’, ‘Nurse-patient relationships’, ‘Multi-disciplinary teamwork and communication’ and ‘Patient empowerment’. Key findings showed that of the original eight programme theories of intentional rounding, only two partially explained how the intervention worked (‘Consistency and comprehensiveness’ and ‘Accountability’). Of the remaining six programme theories, the evidence for two was inconclusive (‘Visibility of nurses’ and ‘Anticipation’) and there was no evidence for four (‘Allocated time to care’; ‘Nurse-patient relationships’; ‘Multi-disciplinary teamwork and communication’; and ‘Patient empowerment’). Conclusions This first theory-informed evaluation of intentional rounding, demonstrates that the effectiveness of intentional rounding in the English healthcare context is very weak. Furthermore, the evidence collected in this study has challenged and refuted some of the underlying assumptions about how intentional rounding works. This study has demonstrated the crucial role context plays in determining the effectiveness of an intervention and how caution is needed when implementing interventions developed for the health system of one country into another.

The Delta variant became dominant during the second wave of the Covid-19 pandemic due to its competitive advantage, the ability to reduce close contact duration from minutes to seconds, and, consequently, increase the risk of exposure to COVID-19. We used game theory to model the most effective public health response to this new threat. We compared the absolute and relative risk of exposure to COVID-19 before and after the emergence of the Delta variant. The absolute risk of exposure was defined as the product of crowding (people within a six feet distance) and visit duration. Our epidemiological investigation used aggregated and anonymized mobility data from Google Maps to estimate the visit duration for 808 premises in the metropolitan area of Genoa, Italy, in June 2021. The relative risk of exposure was obtained by dividing the risk of exposure of each activity by the lowest value (gas stations = 1). The median absolute risk of exposure to COVID-19 increased by sixty-fold in the first semester of 2021, while the relative risk did not significantly differ from the risk of exposure to the ancestral form of Covid-19 (5.9 in 2021 vs. 2.5 in 2021). The Delta variant represents an evolution of the game against COVID-19, but it is not a game-changer. The best response is to commit to our original strategy based on population-wide vaccination and social distancing. Unilateral deviations from the dominant strategy could offer COVID-19 a fighting chance against humanity.

**Background:** The United Kingdom (UK) switched from using the 4-valent human papillomavirus (HPV) vaccine (Gardasil®) to the 9-valent vaccine (Gardasil 9®) in 2021. **Objective:** To estimate and compare the health and economic outcomes of 2 HPV vaccination programs in the UK targeting girls and boys aged 12-13 years from the perspective of the UK National Health Service. The 2 vaccination strategies were (1) universal vaccination 4-valent (UV4V), using the 4-valent HPV vaccine (4vHPV), and (2) universal vaccination 9-valent (UV9V), using the 9-valent HPV vaccine (9vHPV). **Methods:** A deterministic heterosexual compartmental disease transmission model was used to track health and economic outcomes over a 100-year time horizon. Outcomes were discounted at an annual rate of 3.5% and 1.5%. All costs were adjusted to 2020 British pounds (£). Health outcomes were measured in quality-adjusted life-years (QALYs), and the summary results were presented as incremental cost-effectiveness ratios (£/QALY gained) when comparing UV4V with UV9V. **Results:** Using the same vaccine coverage for both programs, the total cumulative cases of HPV-related health outcomes tracked over the 100-year horizon indicated that the relative number of cases averted (UV9V vs UV4V) ranged from 4% (anal male cancers and deaths) to 56% (cervical intraepithelial neoplasia [CIN1]). Assuming that 9vHPV cost £15.18 more than 4vHPV (a cost differential based on discounted list prices), the estimated incremental cost-effectiveness ratio was £8600/QALY gained when discounted at 3.5%, and £3300/QALY gained when discounted at 1.5%. The estimated incremental cost-effectiveness ratios from the sensitivity analyses remained

**Background:** The United Kingdom (UK) switched from using the 4-valent human papillomavirus (HPV) vaccine (Gardasil®) to the 9-valent vaccine (Gardasil 9®) in 2021. **Objective:** To estimate and compare the health and economic outcomes of 2 HPV vaccination programs in the UK targeting girls and boys aged 12-13 years from the perspective of the UK National Health Service. The 2 vaccination strategies were (1) universal vaccination 4-valent (UV4V), using the 4-valent HPV vaccine (4vHPV), and (2) universal vaccination 9-valent (UV9V), using the 9-valent HPV vaccine (9vHPV). **Methods:** A deterministic heterosexual compartmental disease transmission model was used to track health and economic outcomes over a 100-year time horizon. Outcomes were discounted at an annual rate of 3.5% and 1.5%. All costs were adjusted to 2020 British pounds (£). Health outcomes were measured in quality-adjusted life-years (QALYs), and the summary results were presented as incremental cost-effectiveness ratios (£/QALY gained) when comparing UV4V with UV9V. **Results:** Using the same vaccine coverage for both programs, the total cumulative cases of HPV-related health outcomes tracked over the 100-year horizon indicated that the relative number of cases averted (UV9V vs UV4V) ranged from 4% (anal male cancers and deaths) to 56% (cervical intraepithelial neoplasia [CIN1]). Assuming that 9vHPV cost £15.18 more than 4vHPV (a cost differential based on discounted list prices), the estimated incremental cost-effectiveness ratio was £8600/QALY gained when discounted at 3.5%, and £3300/QALY gained when discounted at 1.5%. The estimated incremental cost-effectiveness ratios from the sensitivity analyses remained

Background: The government response to the care failures at the Mid Staffordshire NHS Foundation Trust led to the policy imperative of ‘regular interaction and engagement between nurses and patients’ (Francis R. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. London: The Stationery Office; 2013. © Crown copyright 2013. Contains public sector information licensed under the Open Government Licence v3.0) in the NHS. The pressure on nursing to act resulted in the introduction of the US model, known as ‘intentional rounding’, into nursing practice. This is a timed, planned intervention that sets out to address fundamental elements of nursing care by means of a regular bedside ward round. Objectives: The study aims were to examine what it is about intentional rounding in hospital wards that works, for whom and in what circumstances. Design: A multimethod study design was undertaken using realist evaluation methodology. The study was conducted in four phases: (1) theory development; (2) a national survey of all NHS acute trusts in England; (3) in-depth case studies of six wards, involving individual interviews, observations, retrieval of routinely collected ward outcome data and analysis of costs; and (4) synthesis of the study findings. Setting: The study was conducted in acute NHS trusts in England. Participants: A total of 108 acute NHS trusts participated in the survey. Seventeen senior managers, 33 front-line nurses, 28 non-nursing professionals, 34 patients and 28 carers participated in individual interviews. Thirty-nine members of nursing staff were shadowed during their delivery of intentional rounding and the direct care received by 28 patients was observed. Review methods: A realist synthesis was undertaken to identify eight context–mechanism–outcome configurations, which were tested and refined using evidence collected in subsequent research phases. Results: The national survey showed that 97% of NHS trusts had implemented intentional rounding in some way. Data synthesis from survey, observation and interview findings showed that only two of the original eight mechanisms were partially activated (consistency and comprehensiveness, and accountability). The evidence for two mechanisms was inconclusive (visibility of nurses and anticipation); there was minimal evidence for one mechanism (multidisciplinary teamwork and communication) and no evidence for the remaining three (allocated time to care, nurse–patient relationships and communication, and patient empowerment). A total of 240 intentional rounds were observed within 188 hours of care delivery observation. Although 86% of all intentional rounding interactions were observed to be documented, fidelity to the original intervention [i.e. the Studer Group protocol (Studer Group. Best Practices: Sacred Heart Hospital, Pensacola, Florida. Hourly Rounding Supplement. Gulf Breeze, FL: Studer Group; 2007)] was generally low. Limitations: Intentional rounding was often difficult for researchers to observe, as it was rarely delivered as a discrete activity but instead undertaken alongside other nursing activities. Furthermore, a lack of findings about the influence of intentional rounding on patient outcomes in the safety thermometer data limits inferences on how mechanisms link to clinical outcomes for patients. Conclusions: The evidence from this study demonstrates that the effectiveness of intentional rounding, as currently implemented and adapted in England, is very weak and falls short of the theoretically informed mechanisms. There was ambivalence and concern expressed that intentional rounding oversimplifies nursing, privileges a transactional and prescriptive approach over relational nursing care, and prioritises accountability and risk management above individual responsive care. Future work: It is suggested that the insights and messages from this study inform a national conversation about whether or not intentional rounding is the optimum intervention to support the delivery of fundamental nursing care to patients, or if the time is right to shape alternative solutions. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

The use of multiple medications is becoming more common, with a correspondingly increased risk of untoward effects and drug-related morbidity and mortality. We aimed at estimating the prevalence of prescription of relevant potentially interacting drugs and at evaluating possible predictors of potentially interacting drug exposure. We retrospectively analyzed data on prescriptions dispensed from January 2004 to August 2005 to individuals of two Italian regions with a population of almost 2.1 million individuals. We identified 27 pairs of potentially interacting drugs by examining clinical relevance, documentation, and volume of use in Italy. Subjects who received at least one prescription of both drugs were selected. Co-prescribing denotes "two prescriptions in the same day", and concomitant medication "the prescription of two drugs with overlapping coverage". A logistic regression analysis was conducted to examine the predictors of potential Drug-Drug Interaction (pDDIs). 957,553 subjects (45.3% of study population) were exposed to at least one of the drugs/classes of the 27 pairs. Overall, pDDIs occurred 2,465,819 times. The highest rates of concomitant prescription and of co-prescription were for ACE inhibitors+NSAIDs (6,253 and 4,621/100,000 plan participants). Considering concomitance, the male/female ratio was

[This corrects the article on p. e49699 in vol. 7.].

IntroductionHuman papilloma virus (HPV) genotypes 6, 11, 16, and 18 impose a substantial burden of direct costs on the Italian National Health Service that has never been quantified fully. The main objective of the present study was to address this gap: (1) by estimating the total direct medical costs associated with nine major HPV-related diseases, namely invasive cervical cancer, cervical dysplasia, cancer of the vulva, vagina, anus, penis, and head and neck, anogenital warts, and recurrent respiratory papillomatosis, and (2) by providing an aggregate measure of the total economic burden attributable to HPV 6, 11, 16, and 18 infection.MethodsFor each of the nine conditions, we used available Italian secondary data to estimate the lifetime cost per case, the number of incident cases of each disease, the total economic burden, and the relative prevalence of HPV types 6, 11, 16, and 18, in order to estimate the aggregate fraction of the total economic burden attributable to HPV infection.ResultsThe total direct costs (expressed in 2011 Euro) associated with the annual incident cases of the nine HPV-related conditions included in the analysis were estimated to be €528.6 million, with a plausible range of €480.1-686.2 million. The fraction attributable to HPV 6, 11, 16, and 18 was €291.0 (range €274.5-315.7 million), accounting for approximately 55% of the total annual burden of HPV-related disease in Italy.ConclusionsThe results provided a plausible estimate of the significant economic burden imposed by the most prevalent HPV-related diseases on the Italian welfare system. The fraction of the total direct lifetime costs attributable to HPV 6, 11, 16, and 18 infections, and the economic burden of noncervical HPV-related diseases carried by men, were found to be cost drivers relevant to the making of informed decisions about future investments in programmes of HPV prevention.

BackgroundThe primary objective of this study was to make the first step in the modelling of pharmaceutical demand in Italy, by deriving a weighted capitation model to account for demographic differences among general practices. The experimental model was called ASSET (Age/Sex Standardised Estimates of Treatment).Methods and major findingsIndividual prescription costs and demographic data referred to 3,175,691 Italian subjects and were collected directly from three Regional Health Authorities over the 12-month period between October 2004 and September 2005. The mean annual prescription cost per individual was similar for males (196.13 euro) and females (195.12 euro). After 65 years of age, the mean prescribing costs for males were significantly higher than females. On average, costs for a 75-year-old subject would be 12 times the costs for a 25-34 year-old subject if male, 8 times if female. Subjects over 65 years of age (22% of total population) accounted for 56% of total prescribing costs. The weightings explained approximately 90% of the evolution of total prescribing costs, in spite of the pricing and reimbursement turbulences affecting Italy in the 2000-2005 period. The ASSET weightings were able to explain only about 25% of the variation in prescribing costs among individuals.ConclusionsIf mainly idiosyncratic prescribing by general practitioners causes the unexplained variations, the introduction of capitation-based budgets would gradually move practices with high prescribing costs towards the national average. It is also possible, though, that the unexplained individual variation in prescribing costs is the result of differences in the clinical characteristics or socio-economic conditions of practice populations. If this is the case, capitation-based budgets may lead to unfair distribution of resources. The ASSET age/sex weightings should be used as a guide, not as the ultimate determinant, for an equitable allocation of prescribing resources to regional authorities and general practices.