Development and Preliminary Validation of the Patient Outcome Planning Calculator (POP-C): A Tool for Determining Treatment Dosage in Applied Behavior Analysis.

Board certified behavior analysts (BCBA) are responsible for determining the medically necessary treatment dosage for patients (i.e., the number of hours of therapy a patient should receive per week to optimize progress) during applied behavior analysis (ABA) therapy. However, because there is currently no standard method for making these determinations, BCBAs must rely on their own clinical judgment. Given that clinical judgment may be underdeveloped in some BCBAs, particularly those who are newly certified, more formal strategies are needed to guide decision making as it relates to medical necessity and treatment dosage. In this article we describe the development of the Patient Outcome Planning Calculator (POP-C), a standardized decision-making tool designed to assist novice practitioners in determining the medically necessary ABA treatment intensity and appropriate treatment setting for individuals with autism spectrum disorder (ASD). We present preliminary reliability data as well as construct validity data indicating statistically significant correlations between the POP-C and several norm-referenced and criterion-referenced assessments commonly used to estimate skill level and the corresponding degree of support needed within the ASD population to inform the ABA treatment model and goals. Supplementary Information: The online version contains supplementary material available at 10.1007/s40617-023-00861-6.

Understanding patient demand for and use of antibiotics for upper respiratory tract infection: A qualitative application of the Necessity-Concerns Framework in Saudi Arabia.

Background: Reducing antimicrobial resistance (AMR) is a priority for public health. Inappropriate patient demand is an important driver of unnecessary antibiotic use. To develop an effective intervention to reduce inappropriate demand for antibiotics in upper respiratory tract infections (URTIs), it is important to identify patient perceptions that influence demand for, and appropriate use of antibiotics. Aim: To identify and describe the beliefs about antibiotics necessity and concerns that patients with URTIs have, in Riyadh, Saudi Arabia. Method: An exploratory qualitative approach was used. One-to-one, face-to-face or telephone semi-structured interviews were conducted with participants recruited using purposive sampling (based on age and gender) from primary healthcare centre in Riyadh, Saudi Arabia were conducted. Only adult patients who currently experience URTIs symptoms and agreed to participate were recruited. Recruitment for interviews continued until data saturation point was reached. The interview guide explored patients' necessity beliefs and concerns about antibiotics, AMR perceptions, and expectations from URTIs consultation. Interview transcripts were coded using QSR NVivo 12 using framework analysis informed by the Necessity-Concerns Framework to identify key motivations driving antibiotic requests and consultations. Results: the study interviewed 32 participants (44% were male, average age was 36.84). Results identified that the patients often relate their personal need for antibiotics when encountering an URTIs symptoms to the type, severity and duration of symptoms. Patients also linked antibiotics with quicker recovery, generally expressing few concerns about antibiotics mainly because of its short duration of use. However, some conveyed their concern about frequent administration of antibiotics and effect on the body's immune system function, which may make them more prone to infections in the future. Participants varied widely in their awareness of AMR; this was associated with many misconceptions, such as confusing AMR with antibiotics efficacy and tolerance. Interestingly, the interplay between necessity beliefs and concerns was observed to influence the decision to start and stop antibiotic, potentially impacting inappropriate antibiotic demand and unnecessary use. Conclusion: This study highlighted important beliefs and misconceptions about antibiotics and AMR in Saudi population which can be targeted in future interventions to reduce inappropriate demand for antibiotics and optimise appropriate usage.

Demographic determinants of happiness in Andalusia: insights from the 2022 social survey data.

The Social Survey of Andalusia is an instrument for monitoring the Andalusian reality developed by the regional government of Andalusia, whose dataset is open access to the citizens. The 2022 edition included questions related to happiness, social relations as well as socio-demographic factors. Based on this dataset, the present study aimed to analyse the relationship between socio-demographic factors and people's experiences of happiness. It also set out to explore which factors might be indispensable for experiencing moments of happiness as measured in the survey. A sample of 4,968 cases was gotten, conducting a descriptive analysis, a logit regression in complex samples, and a Necessary Conditions Analysis. The results found two very different social profiles in terms of the experience of happiness, determined by age, sex, educational level and economic status. However, neither factor proved to be a necessary condition for happiness. Both conclusions should be taken into consideration in any socio-community intervention.

Ground by Status.

What is the explanatory role of 'status-truths' such as essence-truths, necessity-truths and law-truths? A plausible principle, suggested by various authors, is Ground by Status, according to which status truths ground their prejacents. For instance, if it is essential to a that p, then this grounds the fact that p. But Ground by Status faces a forceful objection: it is inconsistent with widely accepted principles regarding the logic of grounding (Glazier in Philos Stud 174(11):2871-2889, 2017a, Synthese 174(198):1409-1424, 2017b; Kappes in Synthese 199(1-2):2575-2595, 2020, Philos Stud 178(4):1267-1284, 2021). I defend Ground by Status against this objection.

Cause for coercion: cause for concern?

In his 2000 book, From Chaos to Coercion: Detention and the Control of Tuberculosis, Richard Coker makes a number of important observations and arguments regarding the use of coercive public health measures in response to infectious disease threats. In particular, Coker argues that we have a tendency to neglect public health threats and then demand immediate action, which can leave policymakers with fewer effective options and may require (or may be perceived as requiring) more aggressive, coercive measures to achieve public health goals. While Coker makes a convincing case as to why we should find it ethically problematic when governments find themselves in this position and resort to coercion, left outstanding is the question of whether this should preclude governments and health authorities from using coercion if and when they do find themselves in this position. In this paper, I argue that, while we should consider it ethically objectionable when governments resort to coercion because they have neglected a public health threat, its causes, and other possible responses to that threat, this should not then necessarily rule out the use of coercion in such circumstances; that there are ethically objectionable antecedents for why coercion is being considered should not necessarily or automatically cause us to think coercion in such cases cannot be justified. I address an objection to this argument and draw several conclusions about how governments' use of coercion in public health should be evaluated.

The Necessity to Investigate In Vivo Fate of Nanoparticle-Loaded Dissolving Microneedles.

Transdermal drug delivery systems are rapidly gaining prominence and have found widespread application in the treatment of numerous diseases. However, they encounter the challenge of a low transdermal absorption rate. Microneedles can overcome the stratum corneum barrier to enhance the transdermal absorption rate. Among various types of microneedles, nanoparticle-loaded dissolving microneedles (DMNs) present a unique combination of advantages, leveraging the strengths of DMNs (high payload, good mechanical properties, and easy fabrication) and nanocarriers (satisfactory solubilization capacity and a controlled release profile). Consequently, they hold considerable clinical application potential in the precision medicine era. Despite this promise, no nanoparticle-loaded DMN products have been approved thus far. The lack of understanding regarding their in vivo fate represents a critical bottleneck impeding the clinical translation of relevant products. This review aims to elucidate the current research status of the in vivo fate of nanoparticle-loaded DMNs and elaborate the necessity to investigate the in vivo fate of nanoparticle-loaded DMNs from diverse aspects. Furthermore, it offers insights into potential entry points for research into the in vivo fate of nanoparticle-loaded DMNs, aiming to foster further advancements in this field.

Treating the innocent victims of trolleys and war.

Both trolleys and war leave innocent victims to suffer death and injury. Trolley problems accounting for the injured, and not only the dead, tease out intuitions about liability that enhance our understanding of the obligation to provide compensation and medical care to civilian victims of war. Like many trolley victims, civilians in war may suffer justifiable, excusable, or negligent harms that demand compensation. Chief among these is collateral harm befalling civilians. Collateral harm is endemic to war and comprises permissible but unavoidable death or injury following necessary and proportionate military operations. Although state armies sometimes offer condolence payments for civilian death, injury, and property loss, they deny liability. Instead, they use compensation to enhance counterinsurgency efforts and assuage feelings of agent regret. As part of the medical rules of eligibility, Coalition forces in Iraq and Afghanistan also provided medical care to victims of collateral harm. However, they denied care to similarly sick or injured civilians. While compensation is often justified to cure the harm civilians suffer, the differential use of medical resources is not. Rather, medical care remains subject to the principle of beneficence and medical need. The duty to provide civilian healthcare in war, particularly in wars of humanitarian intervention, is far-reaching and imposes significant costs that military and medical ethics are yet to recognize.

Microdiscectomy Insurance Medical Necessity Criteria Are Inconsistent and Unnecessarily Restrictive.

BACKGROUND: Microdiscectomy for patients with chronic lumbar radiculopathy refractory to conservative therapy has significantly better outcomes than continued nonoperative management. The North American Spine Society (NASS) outlined specific criteria to establish medical necessity for elective lumbar microdiscectomy. We hypothesized that insurance providers have substantial variability among one another and from the NASS guidelines. METHODS: A cross-sectional analysis of US national and local insurance companies was conducted to assess policies on coverage recommendations for lumbar microdiscectomy. Insurers were selected based on their enrollment data and market share of direct written premiums. The top 4 national insurance providers and the top 3 state-specific providers in New Jersey, New York, and Pennsylvania were selected. Insurance coverage guidelines were accessed through a web-based search, provider account, or telephone call to the specific provider. If no policy was provided, it was documented as such. Preapproval criteria were entered as categorical variables and consolidated into 4 main categories: symptom criteria, examination criteria, imaging criteria, and conservative treatment. RESULTS: The 13 selected insurers composed roughly 31% of the market share in the United States and approximately 82%, 62%, and 76% of the market share for New Jersey, New York, and Pennsylvania, respectively. Insurance descriptions of symptom criteria, imaging criteria, and the definition of conservative treatment had substantial differences as compared with those defined by NASS. CONCLUSION: Although a guideline to establish medical necessity was developed by NASS, many insurance companies have created their own guidelines, which have resulted in inconsistent management based on geographic location and selected provider. CLINICAL RELEVANCE: Providers must be cognizant of the differing preapproval criteria needed for each in-network insurance company in order to provide effective and efficient care for patients with lumbar radiculopathy.

Surrogacy and the Fiction of Medical Necessity.

A number of countries and states prohibit surrogacy except in cases of "medical necessity" or for those with specific medical conditions. Healthcare providers in some countries have similar policies restricting the provision of clinical assistance in surrogacy. This paper argues that surrogacy is never medically necessary in any ordinary understanding of this term. The author aims to show first that surrogacy per se is a socio-legal intervention and not a medical one and, second, that the intervention in question does not treat, prevent, or mitigate any actual or potential harm to health. Legal regulations and healthcare-provider policies of this kind therefore codify a fiction-one which both obscures the socio-legal motivations for surrogacy and inhibits critical examination of those motivations while mobilizing normative connotations of appeals to medical need. The persisting distinction, in law and in moral discourse, between "social" and "medical" surrogacy, is unjustified.

Development and validation of a scoring system to predict esophagogastroduodenoscopy necessity.

OBJECTIVE: This study aimed to develop and validate a scoring system for predicting the need for esophagogastroduodenoscopy (EGD) in clinical practice to enhance accuracy and reduce misapplications. METHODS: From February 2021 to April 2022, outpatients scheduled for EGD at the Department of Gastroenterology in our hospital were recruited. Patients completed the system evaluation by providing clinical symptoms, relevant medical history, and endoscopic findings. Patients were randomly divided into the training and validation cohorts (at 2:1 ratio). The optimal algorithm was selected from five alternatives including a parallel test. Six physicians participated in a human-computer comparative validation. Sensitivity and negative likelihood ratio (-LR) were used as the primary indicators. RESULTS: Altogether 865 patients were enrolled, with 578 in the training cohort and 287 in the validation cohort. The scoring system comprised 21 variables, including age, 13 typical clinical symptoms, and seven medical history variables. The parallel test was selected as the final algorithm. Positive EGD findings were reported in 54.5% of the training cohort and 62.7% of the validation cohort. The scoring system demonstrated a sensitivity of 79.0% in the training cohort and 83.9% in the validation cohort, with -LR being 0.627 and 0.615, respectively. Compared to physicians, the scoring system exhibited higher sensitivity (84.0% vs 68.7%, P = 0.02) and a lower -LR (1.11 vs 2.41, P = 0.439). CONCLUSIONS: We developed a scoring system to predict the necessity of EGD using a parallel test algorithm, which was user-friendly and effective, as evidenced by single-center validation.

Qualitatively exploring the application of the necessity concerns framework to antenatal physical activity.

BACKGROUND: Adherence to physical activity (PA) recommendations during pregnancy is low. A common reason for low adherence is concern of harm to mother and/or baby. The Necessity-Concerns Framework (NCF), is a well-established framework in medicine adherence, however it has not been used to explore adherence to antenatal PA. This study aims to explore (1) what influences pregnant women's PA in the context of the NCF; and (2) if the NCF is an appropriate framework to understand antenatal PA engagement. METHODS: Semi-structured interviews were conducted with 18 pregnant women in the UK and Ireland (mean gestation 27 weeks). Interviews explored beliefs, experiences, perceived necessities and concerns about PA. Interviews were transcribed verbatim and analysed using thematic framework analysis. RESULTS: Five themes were identified as influential to antenatal PA: (1) Perceived benefits and necessity of PA, (2) Concerns regarding antenatal PA, (3) Balancing the necessity and concern, (4) Barriers to antenatal PA, (5) Facilitators of antenatal PA. Women described a number of perceived necessities and concerns regarding antenatal PA. These necessities and concerns were described as being consciously balanced, supporting the NCF. However, a number of additional influences (for example, feelings of nausea and lack of advice and knowledge) seemed to impact antenatal PA engagement before women could consider their perceived necessities and concerns around antenatal PA. CONCLUSIONS: The Necessity Concerns Framework is a useful framework to help explain how and why women engage with antenatal PA, more specifically why women do and do not engage in antenatal PA at different times during their pregnancy. However, there are a number of other interpersonal and intrapersonal influences on antenatal PA (e.g. physical symptoms, motivation and time), suggesting the NCF alone may be too simplistic to understand and influence complex behaviour such as antenatal PA.

Medical need and health need.

I introduce a distinction between health need and medical need, and raise several questions about their interaction. Health needs are needs that relate directly to our health condition. Medical needs are needs which bear some relation to medical institutions or processes. I suggest that the question of whether medical insurance or public care should cover medical needs, health needs, or only needs which fit both categories is a political question that cannot be resolved definitionally. I also argue against an overly strict definition of medical need on the grounds that this presupposes, wrongly, that medical intervention should always be a last resort.

What is 'medical necessity'?

Imagine that we are considering whether our healthcare system (or insurer) should fund treatment or procedure X. One factor that may be cited is that of so-called 'medical necessity'. The claim would be that treatment X should be eligible for funding if it is medically necessary, but ineligible if this does not apply. Similarly, (and relevant to the debates in this special issue), if considering whether a particular treatment should be ethically and/or legally permitted, we may wish to distinguish between cases where the treatment is medically necessary, and those were it is not. But what do we mean by this concept? Here I will propose and briefly defend one plausible and practical definition.

[Early Prediction of Support Necessity for Pharmacy Clinical Internship Using Deep Learning].

The duration of undergraduate study was extended in 2006 to six years for pharmaceutical education aimed at training highly qualified pharmacists. Clinical internship in current pharmaceutical education is positioned as being important for fostering the qualities required of a pharmacist, and the support of faculty members is essential. Based on the above, we thought that support from faculty members should be provided easily and positively, which would enrich community pharmacy clinical internships. This study aimed to examine the method of predicting the need for support from weekly reports of community pharmacy practice trainees at Showa Pharmaceutical University. It became evident that the level of necessary support could not be predicted by using the support needs listed. However, application of deep learning to the contents of the weekly report for the first to fifth weeks in 2019 enabled the prediction of the level of support needed in 2020 with 97% accuracy. Although this research is currently limited to predicting the level of support required for community pharmacy practical internship at our university, it demonstrates the use of deep learning to predict the level of support needed based on five weeks' worth of weekly reports.

Are humans still necessary?

Our long accepted and historically-persistent human narrative almost exclusively places us at the motivational centre of events. The wellspring of this anthropocentric fable arises from the unitary and bounded nature of personal consciousness. Such immediate conscious experience frames the heroic vision we have told to, and subsequently sold to ourselves. But need this centrality necessarily be a given? The following work challenges this, oft unquestioned, foundational assumption, especially in light of developments in automated, autonomous, and artificially-intelligent systems. For, in these latter technologies, human contributions are becoming ever more peripheral and arguably unnecessary. The removal of the human operator from the inner loops of momentary control has progressed to now an ever more remote function as some form of supervisory monitor. The natural progression of that line of evolution is the eventual excision of humans from access to any form of control loop at all. This may even include system maintenance and then, prospectively, even initial design. The present argument features a 'unit of analysis' provocation which explores the proposition that socially, and even ergonomically, the human individual no longer occupies priority or any degree of pre-eminent centrality. Rather, we are witnessing a transitional phase of development in which socio-technical collectives are evolving as the principle sources of what, may well be profoundly unhuman motivation. These developing proclivities occupy our landscape of technological innovations that daily act to magnify, rather than diminish, such progressive inhumanities. Where this leaves a science focused on work as a human-centred enterprise serves to occupy the culminating consideration of the present discourse.

Understanding the changes in discretionary, as compared to obligatory, roles of human users and operators in systems is central to Ergonomic practice. Envisioning this path of potential progress, and then witnessing and impacting its actual realisation, permits practitioners to optimise their professional and personal strategies as they deal with this next critical step in the relationship between humans and technology.

Radiology's Ionising Radiation Paradox: Weighing the Indispensable Against the Detrimental in Medical Imaging.

Ionising radiation stands as an indispensable protagonist in the narrative of medical imaging, underpinning diagnostic evaluations and therapeutic interventions across an array of medical conditions. However, this protagonist poses a paradox - its inestimable service to medicine coexists with an undercurrent of potential health risks, primarily DNA damage and subsequent oncogenesis. The narrative of this comprehensive review unfurls around this intricate enigma, delicately balancing the indispensable diagnostic utility against the non-negotiable commitment to patient safety. In this critical discourse, the intricacies of ionising radiation are dissected, illuminating not only its sources but also the associated biological and health hazards. The exploration delves into the labyrinth of strategies currently deployed to minimise exposure and safeguard patients. By casting light on the scientific nuances of X-rays, computed tomography (CT), and nuclear medicine, it traverses the complex terrain of radiation use in radiology, to promote safer medical imaging practices, and to facilitate an ongoing dialogue about diagnostic necessity and risk. Through a rigorous examination, the pivotal relationship between radiation dose and dose response is elucidated, unravelling the mechanisms of radiation injury and distinguishing between deterministic and stochastic effects. Moreover, protection strategies are illuminated, demystifying concepts such as justification, optimisation, the As Low As Reasonably Achievable (ALARA) principle, dose and diagnostic reference levels, along with administrative and regulatory approaches. With an eye on the horizon, promising avenues of future research are discussed. These encompass low-radiation imaging techniques, long-term risk assessment in large patient cohorts, and the transformative potential of artificial intelligence in dose optimisation. This exploration of the nuanced complexities of radiation use in radiology aims to foster a collaborative impetus towards safer medical imaging practices. It underscores the need for an ongoing dialogue around diagnostic necessity and risk, thereby advocating for a continual reassessment in the narrative of medical imaging.

The Role of Medication Beliefs in COVID-19 Vaccine and Booster Uptake in Healthcare Workers: An Exploratory Study.

Illness and medication beliefs have shown to predict COVID-19 vaccination behaviour in the general population, but this relationship has yet to be demonstrated in healthcare staff. This research aimed to explore the potential explanatory value of illness and medication beliefs on the COVID-19 vaccination uptake of a sample of patient-facing healthcare workers (HCWs). A web-based questionnaire-measuring beliefs about vaccinations (the BMQ), perceptions of COVID-19 (the BIPQ), vaccine hesitancy, and vaccine uptake-was targeted to HCWs via social media platforms between May-July 2022. Open text responses allowed participants to provide explanations for any delay in vaccine uptake. A total of 91 participants completed the questionnaire. Most respondents (77.1%, n = 64) had received three doses of the COVID-19 vaccination, and vaccination uptake (number of doses received) was predicted by Vaccine Concerns, Vaccine Hesitancy, and their Necessity-Concerns Differential score. Vaccine Hesitancy was predicted by Necessity, Concerns, and Overuse scores, as well as Necessity-Concerns Differential scores. Delay in Vaccine Uptake could only be predicted for Dose 3 (Booster). Qualitative data revealed that hesitant respondents were "unable to take time off work" for vaccination and that some had concerns over vaccine safety. In conclusion, illness and medication beliefs have potential value in predicting vaccine hesitancy and uptake in healthcare workers. Interventions to improve vaccination uptake in this population should address concerns about vaccine safety and releasing staff for vaccination booster appointments should be prioritised. Future research should further investigate the relationship between illness and medication beliefs and COVID-19 vaccine uptake in a larger sample of healthcare workers.

Clinical chemistry laboratory test overuse in a cardiology clinic: a single-center study.

Diagnostic laboratory tests are frequently overused in healthcare entities, leading to an increased strain on laboratory resources, additional workload, and wastage of resources. Continuous monitoring of test ordering behavior is crucial to evaluate clinical necessity. This cross-sectional study aimed to estimate the necessity of ordering clinical chemistry tests in the cardiology clinic of a tertiary center in Saudi Arabia. We retrieved medical records of patients diagnosed with cardiovascular problems admitted at the cardiology clinic in 2020. The frequency and percentages of the ordered tests were calculated upon admission and follow-up, and the difference between necessary and unnecessary tests was compared for each category. Test ordering assessment included cardiac, renal, and liver functions, blood gases, thyroid and diabetic profile, iron indices, hormones, water and electrolytes, and inflammatory markers. The results showed a large number of clinical chemistry tests ordered without clinical necessity. While the number of necessary tests was significantly higher than that of unnecessary tests, 21% of the tests ordered between June-December 2021 at the center were unnecessary. Further studies are necessary to identify driving factors and develop strategies to reduce the overutilization of diagnostic laboratory tests in clinical practice. Eliminating this phenomenon will reduce the risk of unnecessary medical interventions and associated costs, improve patient outcomes, and reduce the overall burden on the healthcare system.

Emerging treatment for Sjögren's disease: a review of recent phase II and III trials.

INTRODUCTION: Sjögren's Disease, SjD, is a systemic autoimmune disorder characterized by reduced function of the salivary and lacrimal glands. Patients suffer from dryness, fatigue, and pain and may present with or without extra-glandular organ involvement. Symptoms limit SjD patients' quality of life and are the most difficult to improve with therapy. SjD patients are heterogeneous and clustering them into biologically similar subgroups might improve the efficacy of therapies. The need for therapies that address both the symptoms and extra glandular organ involvement of SjD presents an unmet opportunity that has recently attracted a growing interest in the pharmaceutical industry. AREAS COVERED: The goal of this report is to review recent phase II/III studies in SjD. To accomplish our goal, we performed a literature search for phase II/III studies and abstracts recently presented at conferences. EXPERT OPINION: This review allows updates the reader on the multitude of recent phase II/III clinical trials. We speculate on how subtypes of SjD will drive future therapeutic targeting and inform pathogenesis.

Medication Adherence and Its Associated Factors Among Outpatients with Heart Failure.

Background: Poor adherence to heart failure (HF) medications represents a major barrier to achieve the desired health outcomes in those patients. Objective: To assess medication adherence and to explore the factors associated with medication non-adherence among patient with HF in Jordan. Methods: The current cross-sectional study was conducted at the outpatient cardiology clinics at two main hospitals in Jordan from August 2021 through April 2022. Variables including socio-demographics, biomedical variables, in addition to disease and medication characteristics were collected using medical records and custom-designed questionnaire. Medication adherence was assessed using the 4-item Morisky Medication Adherence Scale. Multinomial logistic regression analysis was performed to identify the factors that are significantly and independently associated with medication non-adherence. Results: Of the 427 participating patients, 92.5% had low to moderate medication adherence. Results of the regression analysis revealed that that patients who had higher education level (OR=3.36; 95% CI 1.08-10.43; P=0.04) and were not suffering from medication-related side effects (OR=4.7; 95% CI 1.91-11.5; P=0.001) had significantly higher odds of being in the moderate adherence group. Patients who were taking statins (OR=16.59; 95% CI 1.79-153.98; P=0.01) or ACEIs/ ARBs (OR=3.95; 95% CI 1.01-15.41; P=0.04) had significantly higher odds of being in the high adherence group. Furthermore, Patients who were not taking anticoagulants had higher odds of being in the moderate (OR=2.77; 95% CI 1.2-6.46; P=0.02) and high (OR=4.11; 95% CI 1.27-13.36; P=0.02) adherence groups when compared to patients who were taking anticoagulants. Conclusion: The poor medication adherence in the present study sheds the light on the importance of implementing intervention programs which focus on improving patients' perception about the prescribed medications particularly for patients who have low educational levels, receive an anticoagulant, and do not receive a statin or an ACEI/ ARB.