How the EMERGE guideline on medication adherence can improve the quality of clinical trials.

Medication adherence in drug trials is suboptimal, affecting the quality of these studies and adding significant costs. Nonadherence in this setting can lead to null findings, unduly large sample sizes and the need for dose modification after a drug has been approved. Despite these drawbacks, adherence behaviours are not consistently measured, analysed or reported appropriately in trial settings. The ESPACOMP Medication Adherence Reporting Guideline (EMERGE) offers a solution by facilitating a sound protocol design that takes this crucial factor into account. This article summarises key evidence on traditional and newer measurements of adherence, discusses implementation in clinical trial settings and makes recommendations about the analysis and interpretation of adherence data. Given the potential benefits of this approach, the authors call on regulators and the pharmaceutical industry to endorse the EMERGE guideline

Developing the Diagnostic Adherence to Medication Scale (the DAMS) for use in clinical practice

There is a need for an adherence measure, to monitor adherence services in clinical practice, which can distinguish between different types of non-adherence and measure changes over time. In order to be inclusive of all patients it needs to be able to be administered to both patients and carers and to be suitable for patients taking multiple medications for a range of clinical conditions. A systematic review found that no adherence measure met all these criteria. We therefore wished to develop a theory based adherence scale (the DAMS) and establish its content, face and preliminary construct validity in a primary care population

Quality of medication use in primary care - mapping the problem, working to a solution: a systematic review of the literature

Background: The UK, USA and the World Health Organization have identified improved patient safety in healthcare as a priority. Medication error has been identified as one of the most frequent forms of medical error and is associated with significant medical harm. Errors are the result of the systems that produce them. In industrial settings, a range of systematic techniques have been designed to reduce error and waste. The first stage of these processes is to map out the whole system and its reliability at each stage. However, to date, studies of medication error and solutions have concentrated on individual parts of the whole system. In this paper we wished to conduct a systematic review of the literature, in order to map out the medication system with its associated errors and failures in quality, to assess the strength of the evidence and to use approaches from quality management to identify ways in which the system could be made safer. Methods: We mapped out the medicines management system in primary care in the UK. We conducted a systematic literature review in order to refine our map of the system and to establish the quality of the research and reliability of the system. Results: The map demonstrated that the proportion of errors in the management system for medicines in primary care is very high. Several stages of the process had error rates of 50% or more: repeat prescribing reviews, interface prescribing and communication and patient adherence. When including the efficacy of the medicine in the system, the available evidence suggested that only between 4% and 21% of patients achieved the optimum benefit from their medication. Whilst there were some limitations in the evidence base, including the error rate measurement and the sampling strategies employed, there was sufficient information to indicate the ways in which the system could be improved, using management approaches. The first step to improving the overall quality would be routine monitoring of adherence, clinical effectiveness and hospital admissions. Conclusion: By adopting the whole system approach from a management perspective we have found where failures in quality occur in medication use in primary care in the UK, and where weaknesses occur in the associated evidence base. Quality management approaches have allowed us to develop a coherent change and research agenda in order to tackle these, so far, fairly intractable problems

Adherence to behavioural interventions in multiple sclerosis: Follow-up meeting report (AD@MS-2)

After an initial meeting in 2013 that reviewed adherence to disease modifying therapy, the AD@MS group conducted a follow-up meeting in 2014 that examined adherence to behavioural interventions in MS (e.g. physical activity, diet, psychosocial interventions). Very few studies have studied adherence to behavioural interventions in MS. Outcomes beyond six months are lacking, as well as implementation work in the community. Psychological interventions need to overcome stigma and other barriers to facilitate initiation and maintenance of behaviour change. A focus group concentrated on physical activity and exercise as one major behavioural intervention domain in MS. The discussion revealed that patients are confronted with multiple challenges when attempting to regularly engage in physical activity. Highlighted needs for future research included an improved understanding of patients’ and health experts’ knowledge and attitudes towards physical activity as well as a need for longitudinal research that investigates exercise persistence

Bikeability and methodological issues using the active commuting route environment scale (ACRES) in a metropolitan setting

<p>Abstract</p> <p>Background</p> <p>Route environments can positively influence people's active commuting and thereby contribute to public health. The Active Commuting Route Environment Scale (ACRES) was developed to study active commuters' perceptions of their route environments. However, bicycle commuters represent a small portion of the population in many cities and thus are difficult to study using population-based material. Therefore, the aim of this study is to expand the state of knowledge concerning the criterion-related validity of the ACRES and the representativity using an advertisement-recruited sample. Furthermore, by comparing commuting route environment profiles of inner urban and suburban areas, we provide a novel basis for understanding the relationship between environment and bikeability.</p> <p>Methods</p> <p>Bicycle commuters from Greater Stockholm, Sweden, advertisement- (n = 1379) and street-recruited (n = 93), responded to the ACRES. Traffic planning and environmental experts from the Municipality of Stockholm (n = 24) responded to a modified version of the ACRES. The criterion-related validity assessments were based on whether or not differences between the inner urban and the suburban route environments, as indicated by the experts and by four existing objective measurements, were reflected by differences in perceptions of these environments. Comparisons of ratings between advertisement- and street-recruited participants were used for the assessments of representativity. Finally, ratings of inner urban and suburban route environments were used to evaluate commuting route environment profiles.</p> <p>Results</p> <p>Differences in ratings of the inner urban and suburban route environments by the advertisement-recruited participants were in accord with the existing objective measurements and corresponded reasonably well with those of the experts. Overall, there was a reasonably good correspondence between the advertisement- and street-recruited participants' ratings. Distinct differences in commuting route environment profiles were noted between the inner urban and suburban areas. Suburban route environments were rated as safer and more stimulating for bicycle-commuting than the inner urban ones. In general, the findings applied to both men and women.</p> <p>Conclusions</p> <p>The overall results show: considerable criterion-related validity of the ACRES; ratings of advertisement-recruited participants mirroring those of street-recruited participants; and a higher degree of bikeability in the suburban commuting route environments than in the inner urban ones.</p

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

"It's a wonderful poison": Towards a system approach of understanding behaviour, theory and measurements relating to patient adherence to oral anticancer drugs

Oral anticancer drugs are increasingly prescribed and are often preferred to intravenous treatments by patients. With the introduction of new efficient drugs, cancer is becoming more like a chronic disease that can be managed at home. However, nonadherence to oral anticancer treatments exists and increased prescription of oral therapy prompts further opportunities for nonadherence. The aims of this thesis were to understand the medication-taking behaviours of chronic myeloid leukaemia (CML) patients prescribed imatinib; to explore the usefulness of the Accident Causation Framework (ACF) in explaining nonadherence; and to develop a self-report diagnostic adherence scale (DAS). Interviews were conducted with 21 patients whose adherence rates had previously been monitored using MEMS. Analysis was first conducted according to the constant comparison aspect of grounded theory. Subsequently, a framework analysis guided by the ACF was performed. Three pilot studies tested the validity and reliability of the DAS. Patients commonly missed doses to reduce side-effects or because of forgetting. Surprisingly, many patients did not think missing "the odd dose" mattered and expressed their assurance of this based on communication with health care professionals (HCPs). The ACF could explain reasons for nonadherence and strategies for facilitating adherence. The pilots of the DAS were promising. Causes of nonadherence should be addressed to improve care and clinical outcomes of CML patients. Patients should be made aware of the dangers of treatment interruptions and of missing relatively few doses. HCPs should avoid using unclear language such as "the odd dose" when discussing adherence issues. Different patterns of nonadherence were revealed, which exposed limitations of using MEMS without self-report measures to support interpretation. A system perspective, based on the ACF, contributed further understanding of medication- taking behaviours; highlighted causes of nonadherence external to the patient and the need for appropriate adherence monitoring; and may direct strategies to reduce nonadherence

How persons with mental illness experience the interaction with healthcare professionals when receiving care for somatic issues : a literature overview

Bakgrund   Nära en miljard människor i världen hade år 2019 ett psykiatriskt tillstånd. Detta inkluderade psykiska sjukdomar där depressiva syndrom och ångestsyndrom var vanligast, medan schizofreni var minst vanligt. Psykisk ohälsa inklusive psykiska sjukdomar medför stora ekonomiska samhällskostnader såväl som individuellt lidande. Somatiska sjukdomar och i synnerhet hjärt- och kärlsjukdomar har hög prevalens hos personer med psykisk sjukdom. Dessutom är överdödligheten av naturliga orsaker hög för denna patientgrupp, som därtill är stigmatiserad i samhället. Därmed kan dessa personers upplevelse av den somatiska vården och bemötandet som är en betydande aspekt av vården anses angeläget att studera. Syfte  Syftet var att beskriva hur personer med psykisk sjukdom upplever bemötandet från hälso- och sjukvårdspersonal vid somatiska besvär. Metod  För att besvara syftet genomfördes en icke systematisk litteraturöversikt. Urvalet avgränsades till peer-reviewed vetenskapliga originalartiklar publicerade på engelska under de tio senaste åren. Datainsamlingen gjordes i databaserna PubMed, CINAHL, och PsycInfo. Femton artiklar inkluderades och kvalitetsgranskades. Artiklarnas resultat sammanställdes med en integrerad dataanalys. Resultat Resultatet sammanställdes under fyra kategorier. Den första kategorin Att inte bli tagen på allvar inkluderade att vårdpersonal misstolkade somatiska symtom som psykiska. Den andra kategorin var Att vilja vårdas med ett helhetsperspektiv, där det framkom upplevelser av ett bristande holistiskt synsätt. Den tredje kategorin var Att vilja involveras i sin vård, och den inkluderade upplevelser av bristande information, delaktighet och tillit. Den sista kategorin var Positiva och negativa attityder från vårdpersonal, som handlade om varierande upplevelser av vårdpersonalens attityder i bemötandet.  Slutsats Resultatet visade främst på upplevelser som hindrade, men även upplevelser som främjade god somatisk vård. De beskrivna upplevelserna kan bidra till förbättrat bemötande samt ökad förståelse för patientgruppens perspektiv. Det behövs ytterligare forskning om bemötande och kommunikationen mellan vårdpersonal och personer med psykisk sjukdom, samt hur förbättringar kan implementeras i vården.Background Globally, nearly one billion people had a mental disorder in 2019. This included mental illnesses of which depressive and anxiety syndromes were most common, while schizophrenia was least common. Mental ill health including mental illnesses cause significant economic societal costs, as well as suffering for the affected individual. Somatic illnesses, especially cardiovascular diseases, have a high prevalence for people with mental illness. Additionally, the excess mortality from natural causes is high for these patients who are also subject to social stigmatization. Thus, these patients’ experiences of somatic care and the interaction with healthcare professionals, which is an important part of healthcare, can be seen as an important topic of study. Aim The aim was to describe how persons with mental illness experience the interaction with healthcare professionals when receiving care for somatic issues. Method A non systematic literature review was carried out to fulfill the aim of the study. The sample was limited to peer reviewed scientific original articles published in English during the previous ten years. Data collection was conducted in the databases PubMed, CINAHL, and PsycInfo. Fifteen articles were included and quality checked. The findings were compiled using an integrated data analysis. Results The results were presented under four categories. The first category Not being taken seriously included experiences of health professionals misinterpreting somatic symptoms as psychological. The second category was Wanting holistic care, which included experiences of lacking holistic care. The third category was Wanting to be included which included experiences of lacking information, participation in care, and trust. The last category was Positive and negative attitudes from health professionals which included experiences of varying attitudes from healthcare professionals. Conclusions The results mainly showed experiences that hindered, but also experiences that facilitated satisfactory somatic care. The experiences described have potential to contribute to improved interaction with and understanding of patients with mental illness. Additional research is needed on the topic of communication and interaction between healthcare professionals and persons with mental illness, as well as on how improvements can be implemented in healthcare

Effektivitet på marknaden : En studie av den svenska aktiemarknadens effektivitet vid publicering av kvartalsrapporter

En av de största och viktigaste marknaderna i dagens samhälle är den finansiella marknaden.Denna marknad består dels av valutamarknaden, där det handlas med olika konvertibla valutor, dels av kapital-marknaden som består av penningmarknaden och aktiemarknaden. Aktie- marknaden har en oerhört viktig roll när det gäller marknadsekonomin bland annat på grund av att den tillhandahåller riskvilligt kapital till företag samt ger möjlighet till spridning och omfördelning av risk. Aktörerna på aktiemarknaden strävar ständigt efter att öka värdet på sina placeringar. Värdet på dessa beror på hur företagets ekonomiska ställning ser ut. Aktörernas ambition att försöka öka värdet på sina placeringar förekommer främst på marknader som sägs vara effektiva. En effektiv aktiemarknad består av korrekt prissatta aktier och all tillgänglig information är avspeglad i aktiekursen. Här antas också att alla investerare har tillgång till samma information vilket minskar möjligheten för insatta placerare att skapa abnormala avkastningar. Hur effektiv är då den svenska aktiemarknaden? Studiens problemformulering lyder: Är aktiemarknaden effektiv vid publicering av kvartalsrapporter? Syftet är att genom en event study studera om aktiemarknaden är semi-starkt effektiv vid publicering av ny information i form av kvartals-rapporter. Vi ska studera om marknaden anpassar sig direkt till den nya informationen eller om det finns en anpassningsperiod då aktörer på marknaden kan göra abnormala avkastningar. Vi ska även se om marknaden är effektiv under dagarna innan publiceringen av kvartals- rapporten. Vi utgår från hypotesen om effektiva marknader för att med en kvantitativ metod studera problemet. Vi har studerat publiceringen av kvartalsrapporter under 2003 till 2006 för 30 stycken av de mest omsatta aktierna på Large Cap-listan på Stockholmsbörsen. Fyra kvartalsrapporter per år ger 480 kvartal som delas in i tre portföljer beroende på om det verkliga resultatet som publicerades i kvartalsrapporten var bättre, sämre eller ungefär lika som det prognostiserade resultatet. För aktierna har vi beräknat den kumulativa abnormala avkastningen från 10 dagar innan publiceringen av kvartalsrapporten till 20 dagar efter publiceringen och har genom statistiska test prövat hypotesen att marknaden är effektiv. De perioder vi studerar är 10 dagar efter publiceringen av kvartalsrapporten, 20 dagar efter publiceringen, publiceringsdagen och 10 dagar innan publiceringen. Resultatet visar att aktie- marknaden ej är effektiv fullt ut för de aktier vi valt att studera. För de aktier där det verkliga resultatet var sämre än förväntat eller ungefär lika som förväntat så är marknaden effektiv för perioderna omkring publiceringen av kvartalsrapporten förutom dagen då publiceringen sker. För de aktier där kvartalsrapporten visade ett resultat som var bättre än det prognostiserade fann vi att marknaden inte är effektiv för perioden direkt efter publiceringen, den längre perioden efter publiceringen, publiceringsdagen eller perioden innan publiceringen. Detta betyder att för de aktier där resultatet var bättre än det prognostiserade så kan aktörer på marknaden göra abnormala avkastningar

When the future is no longer a matter of course : a blog-based literaturestudy on young adults' experience of living with cancer

Bakgrund: Att drabbas av cancer som ung vuxen har en påverkan såväl psykiskt som fysiskt då de redan befinner sig en känslig fas i livet. Cancerdiagnosen innebär sjukhusvistelser och behandlingar som ger starka biverkningar, vilket gör att det vardagliga livet sätts på paus. Genom en ökad kunskap för de ungas upplevelser och förändrade livssituation möjliggörs god vård. Syfte: Syftet var att belysa unga vuxnas upplevelse av att leva med cancer.Metod: En kvalitativ studie baserad på fem bloggar skrivna av unga vuxna som diagnostiserats med cancer. Datamaterialet analyserades med en induktiv ansats enligt Graneheim och Lundmans mall för manifesta innehållsanalyser. Resultat: De unga vuxna upplevde att livet vände snabbt och varje dag blev viktig. Cancerdiagnosen skapade känslor som hopp och rädsla och ett stöd från omgivningen var viktigt. Tankar på döden var oundvikliga och skapade en rädsla att inte hinna uppleva saker de ville i livet. Slutsats: Att som ung vuxen leva med cancer påverkade deras liv och de frågade sig varför just dem drabbats. Det saknades behandlingsprogram för åldersgruppen unga vuxna och vården kunde inte tillgodose de aktiviteter de kände ett behov av. Ett mer anpassat behandlingsprogram hade gjort att unga vuxna haft en bättre upplevelse av behandlingstiden