Dynamic needs and challenges of people with drug-resistant tuberculosis and HIV in South Africa: a qualitative study.

BACKGROUND: There is little evidence of patient acceptability for drug-resistant tuberculosis (DRTB) care in the context of new treatment regimens and HIV co-infection. We aim to describe experiences of DRTB-HIV care among patients in KwaZulu-Natal province, South Africa. METHODS: In this qualitative study using Bury's framework for chronic illness, we conducted 13 focus groups at a tertiary hospital with 55 patients co-infected with DRTB and HIV (28 women, 27 men) who were receiving new bedaquiline-based treatment for DRTB, concurrent with antiretroviral therapy. Eligible patients were consenting adults (aged >18 years) with confirmed DRTB and HIV who were enrolled into the PRAXIS study within 2 weeks of initiating bedaquiline-based treatment for DRTB. Participants were recruited from the PRAXIS cohort to participate in a focus group based on their time in DRTB treatment: early (2-6 weeks after treatment initiation), middle (2-6 months after discharge or treatment initiation if never hospitalised), and late (>6 months after treatment initiation). Focus groups were carried out in isiZulu language, audio recorded, and translated to English within 4 weeks. Participants were asked about their experiences of DRTB and HIV care and treatment, and qualitative data were coded and thematically analysed. FINDINGS: From March, 2017, to June, 2018, distinctive patient challenges were identified at four critical stages of DRTB care: diagnosis, marked by centralised hospitalisation, renunciation from routine life, systemic stigmatisation and, for patients with longstanding HIV, renewed destabilisation; treatment initiation, marked by side-effects, isolation, and social disconnectedness; discharge, marked by brief respite and resurgent therapeutic and social disruption; and continuity, marked by deepening socioeconomic challenges despite clinical recovery. The periods of diagnosis and discharge into the community were particularly difficult. Treatment information and agency in decision making was a persistent gap. Sources of stigmatisation shifted with movement between the hospital and community. Resilience was built by connecting to peers, self-isolating, financial and material security, and a focus on recovery. INTERPRETATION: People with DRTB and HIV undergo disruptive, life-altering experiences. The lack of information, agency, and social protections in DRTB care and treatment causes wider-reaching challenges for patients compared with HIV. Decentralised, community, peer-support, and differentiated care models for DRTB might be ameliorative and help to maximise the promise of new regimens. FUNDING: US National Institutes of Health. TRANSLATION: For the isiZulu translation of the abstract see Supplementary Materials section.

Patient and health-care worker perspectives on the short-course regimen for treatment of drug-resistant tuberculosis in Karakalpakstan, Uzbekistan.

INTRODUCTION: Standard multidrug-resistant tuberculosis (MDR-TB) treatment is lengthy, toxic, and insufficiently effective. New drugs and a shorter treatment regimen (SCR) are now recommended. However, patient and health-care worker (HCW) perspectives regarding the SCR are unknown. We aimed to determine the views and experiences of patients with MDR-TB and HCW regarding the SCR in Karakalpakstan, Uzbekistan. METHODS: In a qualitative study, we conducted 48 in-depth interviews with 24 people with MDR-TB and 20 HCW, purposively recruited to include those with a range of treatment-taking experiences and employment positions. Data were analysed thematically using Nvivo 12, to identify emergent patterns, concepts, and categories. Principles of grounded theory were drawn upon to generate findings inductively from participants' accounts. RESULTS: All patients viewed the SCR favourably. The SCR was seen as enabling an expedited return to work, studies, and "normality". This reduced the burden of treatment and difficulties with treatment fatigue. The SCR appeared to improve mental health, ease difficulties with TB-related stigma, and foster improved adherence. While patients wanted shorter treatment, it was also important that treatment be tolerable and effective. However, HCW doubted the appropriateness and effectiveness of the SCR, which influenced their confidence in prescribing the regimen. CONCLUSION: The SCR was said to benefit treatment completion and patients' lives. HCW concerns about SCR appropriateness and effectiveness may influence who receives the regimen. These are important considerations for SCR implementation and MDR-TB treatment developments, and dissonance between patient and HCW perspectives must be addressed for successful implementation of shorter regimens in the future.

"It made me more confident that I have it under control": Patient and provider perspectives on moving to a two-drug ART regimen in the United States and Spain.

BACKGROUND: Two-drug regimens (2DR) to treat HIV infection have the potential to reduce long-term toxicity and increase therapeutic options for people living with HIV (PLHIV). Prior phase III trials, SWORD-1 and SWORD-2, as well as GEMINI-1 and GEMINI-2, have demonstrated that a dolutegravir-based 2DR is as effective as three- or four-drug regimens among virologically suppressed patients. Limited information exists, however, on patient and provider experiences with 2DR to inform roll-out and integration into routine clinical care. METHODS: We conducted 39 in-depth interviews with PLHIV currently on 2DR in the context of routine care and 8 of their clinical care providers in the United States (U.S.) and Spain. Participants included 33 male and 6 female PLHIV and 8 providers. Interview topics explored perceptions of and experiences with 2DR compared to prior anti-retroviral regimens (ARVs), side effects, patient satisfaction, and clinical performance. Interviews were audio-recorded, transcribed and analyzed using thematic content analysis. RESULTS: Participants viewed 2DR as a significant and positive advance, in terms of its ability to effectively treat HIV with reduced toxicity and essentially no reported side effects. Patients noted the central role providers played in the decision to switch to a 2DR regimen and, among U.S. participants, the importance of insurance coverage making this preferred option feasible. Patients and providers agreed that a 2DR regimen would be appropriate for any PLHIV regardless of whether they were treatment naïve or had significant experience with ARVs. CONCLUSIONS: Participants' experiences with a 2DR regimen were positive with no participants, reporting side effects and all reporting continued viral suppression. Providers valued the reduced toxicity offered by 2DR and served as the primary gateway to a transition to 2DR for patients in both settings. This study provides a foundation for further research on the transition to 2DR regimens in other populations and contexts including low- and middle-income settings.

Pharmacological conditioning in the treatment of recent-onset rheumatoid arthritis: a randomized controlled trial study protocol.

BACKGROUND: In pharmacological conditioning associations are formed between the effects of medication and contextual factors related to the medication. Pharmacological conditioning with placebo medication can result in comparable treatment effects and reduced side effects compared to regular treatment in various clinical populations, and may be applied to achieve enhanced drug effects. In the current study protocol, pharmacological conditioning is applied to achieve enhanced treatment effects in patients with recent-onset rheumatoid arthritis (RA). The results from this study broaden the knowledge on the potential of pharmacological conditioning and provide a potential innovative treatment option to optimize long-term pharmacological treatment effectiveness for patients with inflammatory conditions, such as recent-onset RA. METHODS: A multicenter, randomized controlled clinical trial is conducted in patients with recent-onset RA. Participants start on standardized pharmacological treatment for 16 weeks, which consists of methotrexate (MTX) 15 mg/week and a tapered schedule of prednisone 60 mg or 30 mg. After 4 months, participants in clinical remission (based on the rheumatologist's opinion and a targeted score below 1.6 on a 44-joint disease activity score (DAS44)) are randomized to 1 of 2 groups: (1) the control group (C), which continues with a standardized treatment schedule of MTX 15 mg/week or (2) the pharmacological conditioning group (PC), which receives an MTX treatment schedule in alternating high and low dosages. In the case of persistent clinical remission after 8 months, treatment is tapered and discontinued linearly in the C group and variably in the PC group. Both groups receive the same cumulative amount of MTX during each period. Logistic regression analysis is used to compare the proportion of participants with drug-free clinical remission after 12 months between the C group and the PC group. Secondary outcome measures include clinical functioning, laboratory assessments, and self-reported measures after each 4-month period up to 18 months after study start. DISCUSSION: The results from this study broaden the knowledge on the potential of pharmacological conditioning and provide a potential innovative treatment option to optimize long-term pharmacological treatment effectiveness in patients with inflammatory conditions, such as recent-onset RA. TRIAL REGISTRATION: Netherlands Trial Register, NL5652. Registered on 3 March 2016.

Dopaminergic impact of cART and anti-depressants on HIV neuropathogenesis in older adults.

The success of combination antiretroviral therapy (cART) has transformed HIV infection into a chronic condition, resulting in an increase in the number of older, cART-treated adults living with HIV. This has increased the incidence of age-related, non-AIDS comorbidities in this population. One of the most common comorbidities is depression, which is also associated with cognitive impairment and a number of neuropathologies. In older people living with HIV, treating these overlapping disorders is complex, often creating pill burden or adverse drug-drug interactions that can exacerbate these neurologic disorders. Depression, NeuroHIV and many of the neuropsychiatric therapeutics used to treat them impact the dopaminergic system, suggesting that dopaminergic dysfunction may be a common factor in the development of these disorders. Further, changes in dopamine can influence the development of inflammation and the regulation of immune function, which are also implicated in the progression of NeuroHIV and depression. Little is known about the optimal clinical management of drug-drug interactions between cART drugs and antidepressants, particularly in regard to dopamine in older people living with HIV. This review will discuss those interactions, first examining the etiology of NeuroHIV and depression in older adults, then discussing the interrelated effects of dopamine and inflammation on these disorders, and finally reviewing the activity and interactions of cART drugs and antidepressants on each of these factors. Developing better strategies to manage these comorbidities is critical to the health of the aging, HIV-infected population, as the older population may be particularly vulnerable to drug-drug interactions affecting dopamine.

Physician experiences when discussing the need for additional oral medication with type 2 diabetes patients: Insights from the cross-national IntroDia® study.

AIMS: Physician-patient communication when discussing the need for additional oral medication for type 2 diabetes (add-on) may affect the self-care of people with this condition. We aimed to investigate physicians' recalled experiences of the add-on consultation. METHODS: We conducted a cross-sectional survey of physicians treating people with type 2 diabetes in 26 countries, as part of a large cross-national study of physician-patient communication during early treatment of type 2 diabetes (IntroDia®). The survey battery included novel questions about physician experiences at add-on and the Jefferson Scale of Physician Empathy. RESULTS: Of 9247 eligible physicians, 6753 responded (73.0% response rate). Most (82%) agreed that physician-patient discussions at add-on strongly influence patients' disease acceptance and treatment adherence. Half the physicians reported ≥1 challenge in most or all add-on conversations, with a significant inverse relationship between frequency of challenges and Jefferson Scale of Physician Empathy score (standardised ß coefficient: -0.313; p < 0.001). Physicians estimated that only around half their patients with type 2 diabetes follow their self-care advice. Exploratory factor analysis of physician beliefs about why their patients did not follow recommendations yielded two distinct dimensions: psychosocial barriers (e.g. depressed mood) and personal failings of the patient (e.g. not enough willpower) (r = 0.37, p < 0.001). CONCLUSIONS: Physicians' empathy and beliefs about their patients may play a significant role in their success with the add-on conversation and, consequently, promotion of patient engagement and self-care. Although the study was limited by its retrospective, cross-sectional nature, the findings from IntroDia® may inform efforts to improve diabetes care.

Cannabis use during alcohol treatment is associated with alcohol-related problems one-year post-treatment.

BACKGROUND: Prior research shows that cannabis use during treatment for Alcohol Use Disorders (AUD) is related to fewer abstinent days from alcohol, although only among those who use cannabis 1-2x/month. Here we extend prior research by assessing the relationship between the frequency of cannabis use during AUD treatment and post-treatment alcohol-related consequences. METHODS: Data come from the Combined Pharmacotherapies and Behavioral Interventions (COMBINE) Study, a large US randomized control trial of treatments for AUD. The current analyses include 206 cannabis users and 999 cannabis abstainers and compare longitudinal drinking data between those who used cannabis versus those who abstained during COMBINE treatment. The primary exposure was quartiles of cannabis use (Q1: less than 1x/month during treatment, Q2: 1-2x/month, Q3: 4-8x/month, Q4: 12x/month or more), with cannabis abstainers as the reference group. Outcomes were alcohol-related problems at the end of treatment and one-year post-treatment as measured by the Drinker Inventory Consequences. RESULTS: Compared to cannabis abstinence, the most frequent use during treatment was related to 1.44 times as many physical consequences one-year post-treatment. Cannabis use was not related to physical consequences immediately after treatment, or to intrapersonal, interpersonal, social responsibility or impulse control problems at either post-treatment time point. CONCLUSIONS: In a sample of individuals in treatment for AUD, using cannabis 12x/month or more during treatment is associated with increased rates of physical consequences attributed to alcohol use. Individuals in treatment for AUD who also use cannabis might benefit from reducing or stopping cannabis use to avoid alcohol-related physical problems.

Exploring the characteristics of patients with mesothelioma who chose active symptom control over chemotherapy as first-line treatment: a prospective, observational, single centre study.

BACKGROUND: Mesothelioma is an aggressive thoracic tumour with a poor prognosis. The only treatment that extends survival is chemotherapy. However, in the UK, up to 50% of patients who are suitable for chemotherapy choose not to receive it, opting for active symptom control instead. The aim of this prospective, single-centre observational study was to describe the characteristics of patients who chose active symptom control over chemotherapy and explore their reasons for doing so. METHODS: Two hundred consecutive patients with mesothelioma from one UK centre were included. Eligibility for chemotherapy and choice of first-line treatment were recorded prospectively. Patient characteristics and outcomes were compared using descriptive statistics, regression analysis and survival analysis. Reasons for choosing active symptom control over chemotherapy were extracted, retrospectively. RESULTS: People who chose active symptom control were older, more likely to be female and had worse performance statuses than patients who received front-line chemotherapy. Concern over side effects, the modest survival benefit and previous adverse experiences with chemotherapy were reported as reasons for the decision. Median survival was 13.9 months in the chemotherapy group compared with 6.7 months in the active symptom control group. CONCLUSIONS: This is the first study to describe the characteristics of patients with mesothelioma who chose active symptom control over chemotherapy, in the front-line setting. Important differences were seen between this group and patients who received chemotherapy, although confounding is likely to have affected some outcomes. Future research could use qualitative methods to explore patients' reasons for choosing active symptom control, and to further elucidate the decision-making process.

Factors associated with medication adherence among patients with diabetes in the Middle East and North Africa region: A systematic mixed studies review.

Multiple systematic reviews were conducted investigating factors associated with medication adherence worldwide. However, investigations from the Middle East and North Africa (MENA) region were largely underrepresented in those reviews. Therefore, the objective of this systematic review is to identify the factors influencing medication adherence among patients with diabetes in the MENA region. A systematic literature search was conducted through Cochrane Library, EBSCO, EMBASE, Google Scholar, ISI Web of Science, PubMed, ScienceDirect, SCOPUS, and ProQuest. Studies were included if they determined factors associated with medication adherence among patients with diabetes within the MENA region. Quality was assessed using Crow Critical Appraisal Tool. Thirty primary studies from 10 MENA countries were included. The factors associated with medication adherence were categorized into demographics-related; disease- and medication-related; perception, attitude and psychological feelings-related; and societal-related factors. Positively associated factors included knowledge about the disease and medications, regular follow-up visits, and patients' positive beliefs about effectiveness and motivations about medications, while negatively associated factors included forgetfulness, side effects, and polypharmacy. Factors associated with medication adherence among patients with diabetes in the MENA region are highly diverse. The identified factors can serve as potential targets for culturally-relevant interventions to improve medication adherence and overall health outcomes.

Markov Mixed Effects Modeling Using Electronic Adherence Monitoring Records Identifies Influential Covariates to HIV Preexposure Prophylaxis.

Adherence is a major factor in the effectiveness of preexposure prophylaxis (PrEP) for HIV prevention. Modeling patterns of adherence helps to identify influential covariates of different types of adherence as well as to enable clinical trial simulation so that appropriate interventions can be developed. We developed a Markov mixed-effects model to understand the covariates influencing adherence patterns to daily oral PrEP. Electronic adherence records (date and time of medication bottle cap opening) from the Partners PrEP ancillary adherence study with a total of 1147 subjects were used. This study included once-daily dosing regimens of placebo, oral tenofovir disoproxil fumarate (TDF), and TDF in combination with emtricitabine (FTC), administered to HIV-uninfected members of serodiscordant couples. One-coin and first- to third-order Markov models were fit to the data using NONMEM® 7.2. Model selection criteria included objective function value (OFV), Akaike information criterion (AIC), visual predictive checks, and posterior predictive checks. Covariates were included based on forward addition (α = 0.05) and backward elimination (α = 0.001). Markov models better described the data than 1-coin models. A third-order Markov model gave the lowest OFV and AIC, but the simpler first-order model was used for covariate model building because no additional benefit on prediction of target measures was observed for higher-order models. Female sex and older age had a positive impact on adherence, whereas Sundays, sexual abstinence, and sex with a partner other than the study partner had a negative impact on adherence. Our findings suggest adherence interventions should consider the role of these factors.

Percepção do estigma e repercussões sociais em indivíduos com hanseníase / Perception of stigma and social impacts on individuals with Hansen's disease / Percepción del estigma y efectos sociales en personas con enfermedad de Hansen

Os portadores de hanseníase vivenciam situações de preconceito que, com o estigma e a discriminação, culminam para o isolamento social e a restrição dos relacionamentos sociais. Este estudo teve o objetivo de avaliar a percepção do estigma nos indivíduos com hanseníase e suas repercussões sociais. Caracterizou-se por um estudo qualitativo mediante aplicação de entrevistas semiestruturadas em 20 usuários cadastrados para tratamento poliquimioterápico nas unidades de referência na Zona da Mata Mineira, no primeiro semestre de 2014. A análise foi realizada por meio da análise de conteúdo e foram definidas as seguintes categorias de análise: Desconhecimento sobre a doença; Diagnóstico e cura; Discriminação e medo; Encobrimento da doença; Apoio social; e Vínculo e participação social. O desconhecimento sobre a doença interfere no enfrentamento por parte dos indivíduos e, aliado ao receio da discriminação, foi suficiente para que eles ocultassem seu diagnóstico para os outros. Dessa forma, não foi possível perceber nenhuma alteração em seu vínculo social. Destacaram-se as diversas reações emocionais no momento do diagnóstico além da ênfase dada à cura pelos entrevistados. Neste trabalho, ficou evidente que o encobrimento da doença e o suporte social atuaram como fatores de proteção que impediram momentos de discriminação e restrição de participação social.

The individuals with Hansen's disease experience situations of prejudice that, together with stigma and discrimination, culminate in social isolation and restrictions in social relationships. This study aimed to evaluate the perception of stigma in individuals with Hansen's disease and its social repercussions. It was configured as a qualitative study, by means of semi-structured interviews with 20 users registered to chemotherapy treatment in reference units of Zona da Mata Mineira, in the first half of 2014. The analysis was performed through content analysis and the following categories were defined: Lack of knowledge about the disease; Diagnosis and cure; Discrimination and fear; Concealment of the disease; Social support; and Bond and social participation. Lack of knowledge about the disease interferes with the individual's ability to cope with it, and coupled with fear of discrimination, it was enough for them to conceal their diagnosis from others. Thus, it was not possible to notice any changes in their social bonds. The different emotional reactions at the moment of diagnosis stood out, in addition to the emphasis on healing given by respondents. In this study, it became clear that the concealment of the disease and the social support acted as protective factors that prevented moments of discrimination and restriction in social participation.

Las personas con enfermedad de Hansen viven situaciones de prejuicio que, junto con el estigma y la discriminación, culminó con el aislamiento social y la restricción de las relaciones sociales. Este estudio tuvo como objetivo evaluar la percepción de estigma en personas con enfermedad de Hansen y sus repercusiones sociales. Caracterizado por un estudio cualitativo mediante la aplicación de entrevistas semiestructuradas con 20 usuarios registrados a tratamiento de quimioterapia en las unidades de referencia en la Zona da Mata Mineira, en el primer semestre de 2014. Se realizó el análisis mediante el análisis de contenido y las siguientes categorías del análisis se definieron: La ignorancia sobre la enfermedad; El diagnóstico y la cura; La discriminación y el miedo; El ocultamiento de la enfermedad; El apoyo social; y Enlace y la participación social. La ignorancia sobre la enfermedad interfiere con afrontamiento de los individuos y, junto con el temor a la discriminación fuera suficiente para ellos para ocultar su diagnóstico a los demás. Por lo tanto, no fue posible notar cualquier cambio en su enlace social. Destacado las diferentes reacciones emocionales al momento del diagnóstico, además del énfasis en la curación por los encuestados. En este estudio, se hizo evidente que el ocultamiento de la enfermedad y el apoyo social actuó como factores de protección que impedían momentos de la discriminación y la restricción de la participación social.

Patient-reported outcomes among patients with type 2 diabetes mellitus treated with dapagliflozin in a triple-therapy regimen for 52 weeks.

Patients with type 2 diabetes (T2DM) and inadequate glycaemic control on combination metformin (MET) and sulphonylurea (SU) were enrolled in a 24-week, double-blind, randomized, placebo-controlled study with a 28-week extension. The five-dimension EuroQol questionnaire (EQ-5D), SHIELD Weight Questionnaire-9 (WQ-9), Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) were used to evaluate health status and health-related quality of life (HRQoL) at baseline and week 52. Patients with dapagliflozin 10 mg + MET + SU (n = 108) were compared with patients treated with placebo + MET + SU (n = 108), using a repeated-measures mixed model. EQ-5D visual analogue scale scores, IWQOL-Lite and DTSQ scores improved in the dapagliflozin and placebo groups from baseline to week 52; however, there was no significant difference between groups (p > 0.20). EQ-5D index scores remained the same from baseline to week 52 for dapagliflozin and placebo (p = 0.54). A numerically greater proportion of the dapagliflozin group reported improvement in all nine SHIELD WQ-9 items compared with placebo, and the difference was statistically significant for physical health (p = 0.017). Over 52 weeks of therapy, patients maintained their health status and HRQoL when dapagliflozin was added to the treatment.

Management of Hypertensive Patients With Multiple Drug Intolerances: A Single-Center Experience of a Novel Treatment Algorithm.

Multiple drug intolerance to antihypertensive medications (MDI-HTN) is an overlooked cause of nonadherence. In this study, 55 patients with MDI-HTN were managed with a novel treatment algorithm utilizing sequentially initiated monotherapies or combinations of maximally tolerated doses of fractional tablet doses, liquid formulations, transdermal preparations, and off-label tablet medications. A total of 10% of referred patients had MDI-HTN, resulting in insufficient pharmacotherapy and baseline office blood pressure (OBP) of 178±24/94±15 mm Hg. At baseline, patients were intolerant to 7.6±3.6 antihypertensives; they were receiving 1.4±1.1 medications. After 6 months on the novel MDI-HTN treatment algorithm, both OBP and home blood pressure (HBP) were significantly reduced, with patients receiving 2.0±1.2 medications. At 12 months, OBP was reduced from baseline by 17±5/9±3 mm Hg (P<.01, P<.05) and HBP was reduced by 11±5/12±3 mm Hg (P<.01 for both) while patients were receiving 1.9±1.1 medications. Application of a stratified medicine approach allowed patients to tolerate increased numbers of medications and achieved significant long-term lowering of blood pressure.

Enfermedad de Hansen y ginecomastia / No disponible

La lepra es una de las causas de ginecotelia, sin embargo poco se ha publicado sobre este signo común y generalmente ignorado. La prevalencia de ginecomastia, una complicación bien conocida de la lepra en pacientes varones adultos, es poco reportada. El tratamiento temprano tiene un efecto notable en la reducción de la misma. Presentamos el caso de un varón con lepra multibacilar con ginecotelia y ginecomastia, en el curso de la enfermedad

Leprosy is one of the causes of gynaecothelia, however little has been published on this common and generally ignored sign. The prevalence of gynecomastia, a well known leprosy complication in adult male patients, is little reported. Early treatment has a marked effect in reducing it. Here we present the case of a man with multibacillary leprosy who had been associated gynaecothelia and gynecomastia in the course of the disease

The effect of multivitamin supplements on continuation rate and side effects of combined oral contraceptives: A randomised controlled trial.

OBJECTIVES: This study aimed to assess the effect of multivitamin use during the pill-free interval on the continuation rate and side effects of combined oral contraceptives (COCs) within the first few cycles of use. METHODS: In this trial, 332 women presenting to public health centres in an Iranian city each received a COC pack containing 21 pills and were randomised to one of three groups: two of the groups also received 42 multivitamin pills or 42 placebo pills to be taken once a day for 7 days before starting COCs and again during the 7-day pill-free interval for five cycles, while the third group received no multivitamin or placebo pills with their COCs. The groups were compared using Cox regression and χ(2) tests. RESULTS: There were no losses to follow-up. Continuation rates at the sixth cycle were 88% for the multivitamin group, 75% for the placebo group and 67% for the no intervention group. Compared with the multivitamin group, the six-cycle discontinuation rate was significantly higher in the placebo group (hazard ratio [HR] 2.26, 95% confidence interval [CI] 1.15-4.45; p = 0.019) and no intervention group (HR 3.15, 95% CI 1.66-5.99; p < 0.001). Nausea, mood changes, weight gain and breast tenderness were significantly less common in the multivitamin group than in the other groups in all cycles, and spotting/irregular bleeding and dizziness were significantly less common in most of the second, third and sixth cycle follow-up. CONCLUSIONS: Multivitamin supplements could significantly reduce the side effects of COCs in the initial cycles and improve continuation rates. However, the study limitations do not allow for any definite conclusion for their use in clinical practice, especially in communities rich in nutrients.

[Complex drug regimen in multimorbid elderly patients after hospital discharge - a qualitative study]. / Komplexe Medikamentenregime bei multimorbiden älteren Menschen nach Spitalaufenthalt - eine qualitative Studie.

BACKGROUND: Older people often have multimorbidity requiring a complex regime of medications, which may change following hospital discharge, thus presenting new challenges. The experiences of older people, who manage their own medications, in particular following hospital discharge, have rarely been studied. AIM: This study investigates the experiences of older people with multimorbidity taking multiple medications after hospital discharge and how they cope with medication-taking. METHOD: A qualitative-descriptive approach with ten interviews was chosen. The data were coded openly into two groups according to Saldaña (2013). RESULTS: It is important for older people, in spite of their multimorbidity, to maintain their independence and maintain responsibility for taking their medications. Routines are developed from taking medications over many years and the new medications are easily integrated. Unclear information by the medical staff and the inability of the older people to obtain the medications after discharge may lead to mistakes or interruptions in the drug therapy at home. The key person for this group is the general practitioner, even concerning the drug therapy initiated in hospital. CONCLUSION: It is advisable to adapt discharge education to the needs of older people, especially with regard to their drug therapy, to its integration into their daily routine, and to any possible shortcomings in their medication management.

[The role of treatment compliance in combination therapy for heart failure and possibilities of its correction: generalization of Russian and world experience].

Chronic heart failure (CHF) is a serious health problem today. Despite all advances in modern medicine, the high morbidity and mortality rates of CHF force physicians to search for new more effective methods for its control. At the same time, the fact that the designing of new effective medicaments is complex and expensive and that patients show low compliance with drug therapy increases the value of non-drug treatments for heart failure, such as patient education, higher treatment compliance, which make it possible to significantly enhance the efficiency of current combined drug therapy, to improve quality of life, and, possibly, to reduce future heart failure death rates.

"Every drug goes to treat its own disease " - a qualitative study of perceptions and experiences of taking anti-retrovirals concomitantly with anti-malarials among those affected by HIV and malaria in Tanzania.

BACKGROUND: Little is known about how people living with human immunodeficiency virus (HIV) experience malaria and the concomitant use of anti-malarial treatments with anti-retrovirals (ARVs). An understanding of how patients make sense of these experiences is important to consider in planning and supporting the clinical management and treatment for co-infected individuals. METHODS: A qualitative study was conducted in Tanzania alongside a clinical trial of concomitant treatment for HIV and malaria co-infection. Focus group discussions were held with people receiving treatment for HIV and/or malaria, and in-depth interviews with health workers responsible for HIV care and members of the clinical trial team. Data were analysed inductively to identify themes and develop theoretical narratives. RESULTS: Results suggest that people living with HIV perceived malaria to be more harmful to them due to their compromised immune status but saw the disease as unavoidable. For those enrolled in the clinical controlled study, taking anti-malarials together with ARVs was largely seen as unproblematic, with health workers' advice and endorsement of concomitant drug taking influential in reported adherence. However, perceptions of drug strength appeared to compel some people not enrolled in the clinical study to take the drugs at separate times to avoid anticipated harm to the body. CONCLUSIONS: Management of HIV and malaria concurrently often requires individuals to cross the domains of different disease programmes. In the context of a trial concerned with both diseases, patients experienced the support of clinicians in guiding and reassuring them about when and how to take drugs concomitantly. This points towards the need to continue to strive for integrated care for patients with HIV.

Evaluación positiva de medicamentos: junio y julio 2014 / Positive assessment of drugs: June and July of 2014

Se reseñan los medicamentos ya evaluados por la Agencia Española de Medicamentos y Productos Sanitarios hechos públicos en junio, julio y agosto de 2014, y considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y comercialización del medicamento

The drugs assessed by the Spanish Agency for Medicines and Health Products made public in June, July and August of 2014, and considered of interest to the healthcare professional, are reviewed. These are positive technical reports prior to the autho-rization and placing on the market of the product

"Fighting an uphill battle": experience with the HCV triple therapy: a qualitative thematic analysis.

BACKGROUND: Hepatitis C virus (HCV) infections are a severe burden on public health worldwide, causing mortality rates triple that of the general population. Since 2011, for both therapy-naive and therapy-experienced genotype 1 patients, the first generation of direct acting antivirals (DAAs), i.e., the protease-inhibitors (PI) telaprevir and boceprevir have been added to existing dual therapies. The therapeutic effect of the resulting triple therapy is striking; however, treatment regimens are complex and commonly cause side effects. Little is known of how patients implement therapy in their daily lives, or of how they deal with these effects.This study aims to describe HCV patients' experiences with protease-inhibitor-based triple therapy and their support needs. METHODS: A qualitative design was used. Patients from three outpatient clinics, with ongoing, completed or discontinued PI treatment experience were recruited using a maximum variation sampling approach. Open-ended interviews were conducted and analyzed using thematic analysis according to Braun & Clarke (Qual Res Psychol 3:77-101, 2006). RESULTS: Thirteen patients participated in the interviews. All described themselves as highly motivated to undergo treatment, since they saw the new therapy as a "real chance" for a cure. However, all later described the therapy period as a struggle. The constitutive theme-"Fighting an uphill battle"- describes the common existential experience of and negative consequences of coping with side effects. The processes that fostered this common experience followed three sub-themes: "encountering surprises", "dealing with disruption" and "reaching the limits of systems". CONCLUSION: HCV patients undergoing outpatient protease-inhibitor-based triple therapy need systematic support in symptom management. This will require specially trained professionals to advise and support them and their families, and to provide rapid responses to their needs throughout this complex course of therapy. As the generation of DAAs for all genotypes, are expected to have less severe side effects, and many HCV patients require treatment, this knowledge can improve treatment support tremendously, especially for patients who are quite difficult to treat. Furthermore, these findings are helpful to illustrate development in HCV treatment.