"Improving the legitimacy of medicines funding decisions: A critical literature review"

Many healthcare systems globally provide publicly subsidised access to prescribed medicines. Decisions about which medicines to fund affect a range of stakeholders and it is not reasonable to expect that medicines funding decisions are supported by all stakeholder groups all the time. A more realistic aim may be for decisions to be understood and accepted as legitimate by stakeholders, however several shortcomings of existing processes make it difficult to achieve this aim. To date, the main strategy to address these shortcomings has been to increase stakeholder involvement in decision-making, either by eliciting stakeholder values or increasing stakeholder participation in decision-making. Despite these efforts, there is growing evidence that decision-makers are falling short when it comes to the perceived legitimacy of their resource allocation processes and decisions. As such, there is a pressing need for decision-makers to think seriously and creatively about ways to increase the legitimacy of their processes and to make them more acceptable to a wider range of stakeholders. In this article we summarise and critique existing literature on the legitimacy of public resource allocation processes, and make some practical suggestions for those who are concerned about this issue. Keywords: pharmaceutical funding decisions, legitimacy, stakeholder engagement, resource allocation, priority setting.NHMR

A review of strategies to improve rational prescribing in asthma.

Background: There are well-recognised gaps between evidence-based recommendations and prescribing practices in asthma. While different strategies have been devised to improve rational prescribing, the impact of these is uncertain. Aim: To examine the characteristics and effectiveness of strategies to improve rational prescribing in asthma. Method: We systematically searched electronic databases to find studies that reported on strategies to improve prescribing in asthma, or included rational prescribing as one of the main components of the program. Results: There were thirteen relevant studies. All of the strategies described in these studies involved physician education using a variety of modalities; two of the trials also included patient-specific prescribing direction. Twelve of thirteen studies reported improved prescribing practice. There was significant heterogeneity in the interventions and outcome criteria employed by the studies. Conclusion: Strategies to improve rational prescribing in asthma show promise, but the significant methodological heterogeneity, and the absence in most cases of demonstrable clinical benefit, raise concerns about their applicability in clinical practice. Keywords: asthma, inappropriate prescribing, medication therapy management, physician's practice patterns, quality improvemen

What factors determine the choice of public engagement undertaken by health technology assessment decision-making organizations?

Purpose: Public engagement in health technology assessment (HTA) is increasingly considered crucial for good decision-making. Determining the “right” type of engagement activity is key in achieving the appropriate consideration of public values. Little is known about the factors that determine how HTA organizations decide on their method of public engagement, and there are a number of possible factors that might shape these decisions. This paper seeks to understand the potential drivers of public engagement choice from an organizational perspective. Design/Methodology/: The published HTA literature is reviewed alongside existing frameworks of public engagement in order to elucidate key factors influencing the choice of public engagement process undertaken by HTA organizations. A conceptual framework is then developed to illustrate the factors identified from the literature that appear to influence public engagement choice. Findings: Determining the type of public engagement to be undertaken in HTA is based on multiple factors, some of which are not always explicitly acknowledged. These factors include: perceived complexity of the policymaking issue, perceived impact of the decision, transparency and opportunities for public involvement in governance, as well as time and resource constraints. The influence of these factors varies depending on the context, indicating that a one size fits all approach to public engagement may not be effective. Originality/value: Awareness of the various factors that might influence the type of public engagement undertaken would enable decision-makers to reflect on their choices and be more accountable and transparent about their choice of engagement process in eliciting public values and preferences in a HTA organization.SW was in receipt of an Australian Postgraduate Awar

Defining dormancy in mycobacterial disease.

Tuberculosis remains a threat to global health and recent attempts to shorten therapy have not succeeded mainly due to cases of clinical relapse. This has focussed attention on the importance of "dormancy" in tuberculosis. There are a number of different definitions of the term and a similar multiplicity of different in vitro and in vivo models. The danger with this is the implicit assumption of equivalence between the terms and models, which will make even more difficult to unravel this complex conundrum. In this review we summarise the main models and definitions and their impact on susceptibility of Mycobacterium tuberculosis. We also suggest a potential nomenclature for debate. Dormancy researchers agree that factors underpinning this phenomenon are complex and nuanced. If we are to make progress we must agree the terms to be used and be consistent in using them

A case-control study of lactation and cancer of the breast.

We have examined the relation of lactation, by total duration, with breast cancer risk among pre- and post-menopausal women. In a hospital-based case-control study conducted in Athens (1989-91), involving 820 patients with confirmed breast cancer and 795 orthopaedic patient controls and 753 hospital visitor controls, logistic regression was used to analyse the data controlling for demographic, nutritional and reproductive factors, including parity and age at any birth. Among post-menopausal women, there was no association between breastfeeding and breast cancer risk, but among premenopausal women those who has breastfed for > or = 24 months had an odds ratio of 0.50 (95% confidence interval 0.23-1.41). A reduction of the odds ration was also evident among premenopausal women who had breastfed between 12 and 23 months (odds ratio 0.70; 95% confidence interval 0.34-1.60). In conjunction with several other recent reports these results support the hypothesis that breastfeeding of prolonged duration may reduce the risk of breast cancer among premenopausal women but not among post-menopausal women. The biology underlying this different effect remains unknown, and the practical implication of the finding is a marginal importance

Case Series of Triathletes with Takotsubo Cardiomyopathy Presenting with Swimming-Induced Pulmonary Edema

OBJECTIVES: To report three cases of triathletes who presented with swimming-induced pulmonary edema (SIPE) following water immersion. They were subsequently diagnosed with Takotsubo cardiomyopathy (TCM). DESIGN: Retrospective case series. METHOD: All cases were recreational athletes competing in mass participation triathlons between June 2018 and 2019. They were initially managed by the event medical team and subsequently at the local tertiary level hospital. Written consent was gained from all the subjects. RESULTS: The three triathletes were aged between 50 and 60 years, two were females, and all presented with acute dyspnoea on exiting the water. Two also presented with chest pain and haemoptysis. A diagnosis of SIPE was suspected by the medical event team on initial presentation of low oxygen saturations and clinical signs of pulmonary oedema. All were transferred to the local emergency department and had signs of pulmonary oedema on chest radiographs. Further investigations led to a diagnosis of TCM with findings of T wave inversion in anterolateral electrocardiogram leads and apical hypokinesia on transthoracic echocardiogram and unobstructed coronary arteries. CONCLUSIONS: This case series presents triathletes diagnosed with SIPE and TCM following the open water swim phase. It is unclear whether the myocardial dysfunction contributed to causation of SIPE or was the result of SIPE. Mass participation race organizers must be prepared that both SIPE and TCM can present in this population. Those presenting with an episode of SIPE require prompt evaluation of their cardiac and pulmonary physiology. Further research is required to ascertain the exact nature of the relationship between TCM and SIPE

Beyond platitudes: a qualitative study of Australian Aboriginal people's perspectives on biobanking.

BACKGROUND: Biobanks are vital resources for genetics and genomics, and it is broadly recognised that for maximal benefit it is essential that they include samples and data from diverse ancestral groups. The inclusion of First Nations people, in particular, is important to prevent biobanking research from exacerbating existing health inequities, and to ensure that these communities share in the benefits arising from research. AIMS: To explore the perspectives of Australian Aboriginal people whose tissue - or that of their family members - has been stored in the biobank of the National Centre for Indigenous Genomics (NCIG). METHODS: Semi-structured interviews with 42 Aboriginal people from the Titjikala, Galiwinku, Tiwi Islands, Yarrabah, Fitzroy Crossing, Derby, One Arm Point and Mulan communities, as well as a formal discussion with A. Hermes, an Indigenous Community Engagement Coordinator at the NCIG who had conducted the interviews. The interviews and the structured discussion were double coded using a procedure informed by Charmaz's outline of grounded theory analysis and Morse's outline of the cognitive basis of qualitative research. RESULTS: In this article, we report on A. Hermes' interviews with members from the above Aboriginal communities, as well as on her personal views, experiences, and interpretations of the interviews she conducted with other community members. We found that participation in the NCIG biobank raised issues around broken trust, grief and loss, but also - somewhat unexpectedly - was perceived as a source of empowerment, hope and reconnection. CONCLUSIONS: This research reminds us (again) of the need to engage deeply with communities in order to respond appropriately with respect for their cultural values and norms, and to develop culturally relevant policies and processes that enhance the benefits of biobank participation and minimise potential harms

Dietary vitamin D and cancers of the oral cavity and esophagus

Background: Data on the association between vitamin D and upper digestive tract neoplasms are limited. Methods: In two case-control studies in Italy, we examined the relation between dietary vitamin D intake and squamous cell carcinoma of the esophagus (SCCE; 304 cases) and oral/pharyngeal cancer (804 cases). Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated by multiple logistic regression. Results: Adjusted ORs for SCCE and oral/pharyngeal cancer were 0.58 (95% CI 0.39-0.86) and 0.76 (95% CI 0.60-0.94), respectively, for the highest tertile of vitamin D intake. Using a reference group of those in the highest tertile of vitamin D who were never/former smokers, ORs were 8.7 (95% CI 4.1-18.7) for SCCE and 10.4 (95% CI 6.9-15.5) for oral/pharyngeal cancer among heavy smokers in the lowest vitamin D tertile; similarly, compared with those in the highest tertile of vitamin D who drank <3 alcoholic drinks/day, corresponding ORs were 41.9 (95% CI 13.7-128.6) for SCCE and 8.5 (95% CI 5.7-12.5) for oral/pharyngeal cancer, among heavy alcohol drinkers in the lowest vitamin D tertile. Conclusion: We observed inverse associations between dietary vitamin D intake and risk of SCCE and, perhaps, oral/pharyngeal cancer, which were most pronounced among heavy current smokers and heavy consumers of alcoho