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BACKGROUND: Women with pathogenic variants (PV) of the genes BRCA1/2 have a choice of preventive options. To help these women decide for themselves, we developed and implemented a decision coaching (DC) program and evaluated it for congruence between the participants' desired and actual roles in decision-making. METHODS: Healthy BRCA1/2 PV carriers (25-60 years of age) were recruited at six centers in Germany. Those who returned baseline (T1) questionnaires were randomly assigned to the intervention group (IG) or the control group (CG). The IG attended a nurse-led DC program. The primary outcome was congruence between the participants' preferred and actual roles in decision-making. The secondary outcomes were an active role, satisfaction, decisional conflict, and knowledge. The follow-up questionnaires were administered at 12 weeks (T2) and 6 months (T3). RESULTS: Of the 413 women who were recruited, 389 returned the T1 questionnaires. At T2, the groups did not differ significantly in congruence between their preferred and actual roles in decision-making (0.12, 95% confidence interval [-0.03; 0.28], p = 0.128), with a slightly higher congruence in the CG. Women in both groups played a more active role at T2 than their stated preference at T1, with a notably higher percentage in the IG than the CG (IG: 40%, CG: 24.4% [-25.1; -6.1]). IG participants were more satisfied with their role and had less decisional conflict and greater knowledge. CONCLUSION: This DC program can help women who are carriers of BRCA1/2 PV participate actively in decision-making with regard to preventive measures.
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Neoplasias da Mama , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Alemanha , Neoplasias da Mama/genética , Neoplasias da Mama/psicologia , Tomada de Decisões , Proteína BRCA1/genética , Tutoria/métodos , Proteína BRCA2/genética , Predisposição Genética para Doença/genética , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Inappropriate drug prescriptions for patients with polypharmacy can have avoidable adverse consequences. We studied the effects of a clinical decision-support system (CDSS) for medication management on hospitalizations and mortality. METHODS: This stepped-wedge, cluster-randomized, controlled trial involved an open cohort of adult patients with polypharmacy in primary care practices (=clusters) in Westphalia-Lippe, Germany. During the period of the intervention, their medication lists were checked annually using the CDSS. The CDSS warns against inappropriate prescriptions on the basis of patient-related health insurance data. The combined primary endpoint consisted of overall mortality and hospitalization for any reason. The secondary endpoints were mortality, hospitalizations, and high-risk prescription. We analyzed the quarterly health insurance data of the intention- to-treat population with a mixed logistic model taking account of clustering and repeated measurements. Sensitivity analyses addressed effects of the COVID-19 pandemic and other effects. RESULTS: 688 primary care practices were randomized, and data were obtained on 42 700 patients over 391 994 quarter years. No significant reduction was found in either the primary endpoint (odds ratio [OR] 1.00; 95% confidence interval [0.95; 1.04]; p = 0.8716) or the secondary endpoints (hospitalizations: OR 1.00 [0.95; 1.05]; mortality: OR 1.04 [0.92; 1.17]; high-risk prescription: OR 0.98 [0.92; 1.04]). CONCLUSION: The planned analyses did not reveal any significant effect of the intervention. Pandemicadjusted analyses yielded evidence that the mortality of adult patients with polypharmacy might potentially be lowered by the CDSS. Controlled trials with appropriate follow-up are needed to prove that a CDSS has significant effects on mortality in patients with polypharmacy.
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Sistemas de Apoio a Decisões Clínicas , Hospitalização , Polimedicação , Humanos , Alemanha , Feminino , Masculino , Idoso , Sistemas de Apoio a Decisões Clínicas/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Pessoa de Meia-Idade , Prescrição Inadequada/estatística & dados numéricos , Prescrição Inadequada/prevenção & controle , Atenção Primária à Saúde/estatística & dados numéricos , Idoso de 80 Anos ou mais , COVID-19/mortalidade , Adulto , SARS-CoV-2RESUMO
BACKGROUND: Understanding how to implement innovations in primary care practices is key to improve primary health care. Aiming to contribute to this understanding, we investigate the implementation of a clinical decision support system (CDSS) as part of the innovation fund project AdAM (01NVF16006). Originating from complexity theory, the practice change and development model (PCD) proposes several interdependent factors that enable organizational-level change and thus accounts for the complex settings of primary care practices. Leveraging the PCD, we seek to answer the following research questions: Which combinations of internal and external factors based on the PCD contribute to successful implementation in primary care practices? Given these results, how can implementation in the primary care setting be improved? METHODS: We analyzed the joint contributions of internal and external factors on implementation success using qualitative comparative analysis (QCA). QCA is a set-theoretic approach that allows to identify configurations of multiple factors that lead to one outcome (here: successful implementation of a CDSS in primary care practices). Using survey data, we conducted our analysis based on a sample of 224 primary care practices. RESULTS: We identified two configurations of internal and external factors that likewise enable successful implementation. The first configuration enables implementation based on a combination of Strong Inside Motivation, High Capability for Development, and Strong Outside Motivation; the second configuration based on a combination of Strong Inside Motivators, Many Options for Development and the absence of High Capability for Development. CONCLUSION: In line with the PCD, our results demonstrate the importance of the combination of internal and external factors for implementation outcomes. Moreover, the two identified configurations show that different ways exist to achieve successful implementation in primary care practices. TRIAL REGISTRATION: AdAM was registered on ClinicalTrials.gov ( NCT03430336 ) on February 6, 2018.
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Sistemas de Apoio a Decisões Clínicas , Humanos , Cuidados Paliativos , Atenção Primária à Saúde/métodosRESUMO
BACKGROUND: The adoption of digital health technologies can improve the quality of care for polypharmacy patients, if the underlying complex implementation mechanisms are better understood. Context effects play a critical role in relation to implementation mechanisms. In primary care research, evidence on the effects of context in the adoption of digital innovation for polypharmacy management is lacking. STUDY AIM: This study aims to identify contextual factors relevant to physician behavior and how they might mediate the adoption process. METHODS: The physicians who participated in this formative evaluation study (n = 218) were part of the intervention group in a cluster-randomized controlled trial (AdAM). The intervention group implemented a digital innovation for clinical decision making in polypharmacy. A three-step methodological approach was used: (1) a realist inquiry approach, which involves the description of a context-mechanism-outcome configuration for the primary care setting; (2) a belief elicitation approach, which involves qualitative content analysis and the development of a quantitative latent contextualized scale; and (3) a mediation analysis using structural equation modeling (SEM) based on quantitative survey data from physicians to assess the mediating role of the contextualized scale (n = 179). RESULTS: The key dimensions of a (1) context-mechanism-outcome model were mapped and refined. A (2) latent construct of the physicians' innovation beliefs related to the effectiveness of polypharmacy management practices was identified. Innovation beliefs play a (3) mediating role between the organizational readiness to implement change (p < 0.01) and the desired behavioral intent of physicians to adopt digital innovation (p < 0.01; R2 = 0.645). Our contextualized model estimated significant mediation, with a relative size of 38% for the mediation effect. Overall, the model demonstrated good fit indices (CFI = 0.985, RMSEA = 0.034). CONCLUSION: Physician adoption is directly affected by the readiness of primary care organizations for the implementation of change. In addition, the mediation analysis revealed that this relationship is indirectly influenced by primary care physicians' beliefs regarding the effectiveness of digital innovation. Both individual physician beliefs and practice organizational capacity could be equally prioritized in developing implementation strategies. The methodological approach used is suitable for the evaluation of complex implementation mechanisms. It has been proven to be an advantageous approach for formative evaluation. TRIAL REGISTRATION: NCT03430336 . First registration: 12/02/2018. CLINICALTRIALS: gov.
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Médicos , Humanos , Análise de Classes Latentes , Inquéritos e Questionários , Atenção Primária à SaúdeRESUMO
Women who are found to carry a BRCA1/2 pathogenic variant experience psychological distress due to an increased risk of breast and ovarian cancer. They may decide between different preventive options. In this secondary analysis of data collected alongside a larger randomized controlled trial, we are looking at 130 newly found BRCA1/2 pathogenic variant carriers and how their coping self-efficacy immediately after genetic test result disclosure is related to their psychological burden and status of preventive decision making. Participants received the Coping Self-Efficacy Scale, the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the Decisional Conflict Scale, and the Stage of Decision-Making Scale after positive genetic test result disclosure. We found that women with higher coping self-efficacy showed fewer symptoms of anxiety or depression and were less affected by receiving the genetic test result in terms of post-traumatic stress. However, coping self-efficacy had no relationship with any decision-related criteria, such as decisional conflict or stage of decision making. This shows that despite its buffering capacity on psychological burden, possessing coping self-efficacy does not lead to more decisiveness in preference-sensitive decisions.
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Adaptação Psicológica , Neoplasias da Mama , Testes Genéticos , Neoplasias Ovarianas , Autoeficácia , Feminino , Humanos , Proteína BRCA1/genética , Neoplasias da Mama/genética , Neoplasias da Mama/psicologia , Genes BRCA1 , Genes BRCA2 , Morbidade , Mutação , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/genética , Neoplasias Ovarianas/psicologiaRESUMO
Analysis of internet search queries (ISQ) could be useful to study public interest and medical need for corneal, cataract, and refractive surgery. To date, there are preliminary data on seasonal trends in ophthalmic conditions, but only few studies correlate these data with real data from healthcare systems. The aim of this study is to analyze ISQ and correlate it with real healthcare system data. Data were retrieved from the KBV registry of patients who underwent outpatient ophthalmic surgery in Germany from 2017 to 2019 and from Statista GmbH from 2010 to 2020 for corneal refractive surgery. Time Series analysis of ISQ was analyzed from 2004 to 2020 and correlated with healthcare system data using bivariate correlation analysis. ISQ correlated significantly with the incidence of ophthalmic procedures such as corneal transplantations (r = 0.69, p < 0.05), cataract- (r = 0.59, p < 0.05) and refractive laser surgery (r = 0.83, p < 0.05) in Germany. In addition, specific trends were observed with respect to individual surgical procedures. The correlation between search intensities and surgical procedures varied significantly. Thus, interests in surgical procedures can be tracked by observing changes in ISQ over time. These data correlate with real healthcare data and could be used in the future for now-casting or even forecasting.
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Extração de Catarata , Catarata , Procedimentos Cirúrgicos Refrativos , Humanos , Extração de Catarata/métodos , Incidência , Córnea/cirurgia , Catarata/epidemiologiaRESUMO
BACKGROUND: The Implementation Leadership Scale (ILS) was developed to assess leadership behavior with regard to being proactive, knowledgeable, supportive, or perseverant in implementing evidence-based practices (EBPs). As part of a study on the implementation of a digitally supported polypharmacy management application in primary care, the original ILS was translated and validated for use in the German language. RATIONALE: This study aimed to translate the original ILS into German and evaluate its psychometric properties. METHODS: The validation sample consisted of 198 primary care physicians in a cluster-randomized controlled trial in which the intervention group implemented a digitally supported clinical decision support system for polypharmacy management. The ILS was assessed using a 12-item scale. The study included a process evaluation with two evaluation waves between 2019 and 2021. The ILS was used within this process evaluation study to assess the leadership support with regard to the implementation of the polypharmacy management. The ILS was translated in a multi-step process, including pre-testing of the instrument and triple, back-and-forth translation of the instrument. We tested the reliability (Cronbach's alpha) and validity (construct and criterion-related validity) of the scale. RESULTS: The four-dimensional structure of the instrument was confirmed (comparative fit index = .97; root mean square error of approximation = .06). Convergent validity was demonstrated by correlations with organizational innovation climate, social capital, and workload, which was consistent with the proposed hypothesis. Criterion-related validity of the ILS was demonstrated by predicting the organizational readiness for change scores using structural equation modeling. The reliability of the scale was good (α = .875). CONCLUSION: The German version of the ILS created in this study is a reliable and valid measure. The original four-dimensional structure of the ILS was confirmed in a primary care setting. Further psychometric testing is needed to establish the validity and reliability of the ILS and to transfer it to other health care settings. It is a useful tool for identifying the areas for implementation leadership development. Further research is needed on how, why, and when distinct types of leadership behaviors have different effects on healthcare organizations in implementation processes.
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Idioma , Liderança , Análise Fatorial , Humanos , Atenção Primária à Saúde , Psicometria , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
Polypharmacy is associated with a risk of negative health outcomes. Potentially inappropriate medications, interactions resulting from contradicting medical guidelines, and inappropriate monitoring, all increase the risk. This process evaluation (PE) of the AdAM study investigates implementation and use of a computerized decision-support system (CDSS). The CDSS analyzes medication appropriateness by including claims data, and hence provides general practitioners (GPs) with full access to patients' medical treatments. We based our PE on pseudonymized logbook entries into the CDSS and used the four dimensions of the Medical Research Council PE framework. Reach, which examines the extent to which the intended study population was included, and Dose, Fidelity, and Tailoring, which examine how the software was actually used by GPs. The PE was explorative and descriptive. Study participants were representative of the target population, except for patients receiving a high level of nursing care, as they were treated less frequently. GPs identified and corrected inappropriate prescriptions flagged by the CDSS. The frequency and intensity of interventions documented in the form of logbook entries lagged behind expectations, raising questions about implementation barriers to the intervention and the limitations of the PE. Impossibility to connect the CDSS to GPs' electronic medical records (EMR) of GPs due to technical conditions in the German healthcare system may have hindered the implementation of the intervention. Data logged in the CDSS may underestimate medication changes in patients, as documentation was voluntary and already included in EMR.
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BACKGROUND: Women with BRCA1/2 mutations are at high risk to develop breast and ovarian cancer. To support these women to participate in shared decision-making, structured nurse-led decision coaching combined with an evidence-based decision aid may be employed. In preparation of the interprofessional randomized controlled trial to evaluate a decision coaching program to support preventive decisions of healthy female BRCA 1/2 gene mutation carriers (EDCP-BRCA), we adapted and piloted an existing training program for specialized nurses and included elements from an existing physician communication training. METHODS: The training was adapted according to the six-step-approach for medical curriculum development. The educational design is based on experience- and problem-based learning. Subsequently, we conducted a qualitative pilot study. Nurses were recruited from six German centers for familial breast and ovarian cancer. The acceptability and feasibility were assessed by structured class observations, field notes and participants' feedback. Data were analyzed using qualitative content analysis. The training was revised according to the results. Due to the COVID-19 pandemic, the patient intervention was adapted as a virtual coaching and a brief additional training for nurses was added. RESULTS: The training consists of two modules (2 + 1 day) that teach competences in evidence-based medicine and patient information, (risk) communication and decision coaching. One pilot test was conducted with six nurses of which three were specialized and experienced in patient counselling. A final set of eight main categories was derived from the data: framework conditions; interaction; schedule, transparency of goals, content, methods, materials and practical relevance and feasibility. Overall, the training was feasible and comprehensible. Decision coaching materials were awkward to handle and decision coaching role plays were set too short. Therefore, materials will be sent out in advance and the training was extended. CONCLUSIONS: Specialized nurses are rarely available and nurse-led counselling is not routinely implemented in the centers of familial breast and ovarian cancer. However, training of less qualified nurses seems feasible. Decision coaching in a virtual format seems to be a promising approach. Further research is needed to evaluate its feasibility, acceptability and effectiveness. TRIAL REGISTRATION: The main trial is registered under DRKS-ID: DRKS00015527 .
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BACKGROUND: Interventional studies on polypharmacy often fail to significantly improve patient-relevant outcomes, or confine themselves to measuring surrogate parameters. Interventions and settings are complex, with many factors affecting results. The AdAM study's aim is to reduce hospitalization and death by requiring general practitioners (GPs) to use a computerized decision-support system (CDSS). The study will undergo a process evaluation to identify factors for successful implementation and to assess whether the intervention was implemented as intended. OBJECTIVE: To evaluate our complex intervention, based on the Medical Research Council's guideline dimensions. RESEARCH QUESTIONS: We will assess implementation (reach, fidelity, dose, tailoring) by asking: (1) Who took part in the intervention (proportion of GPs using the CDSS, proportion of patients enrolled in them)? Information on GPs' and patients' characteristics will also be collected. (2) How many and which medication alerts were dealt with? (3) Was the intervention implemented as intended? (4) On what days did GPs use the intervention tool? METHODS: The process evaluation is part of a stepped-wedge cluster-randomized controlled trial. Characteristics of practices, GPs and patients using the CDSS will be compared with the non-participating population. CDSS log data will be analyzed to evaluate how the number of medication alerts changed between baseline and 2 months later, and to identify the kind of alerts that were dealt with. Comparison of enrolled patients on weekdays versus weekends will shed light on GPs' use of the CDSS in the absence or presence of patients. Outcomes will be presented using descriptive statistics, and significance tests will be used to identify associations between them. We will conduct subgroup analyses, including time effects to account for software improvements. DISCUSSION: This study protocol is the basis for conducting analyses of the quantitative process evaluation. By providing insight into how GPs conduct medication reviews, the evaluation will provide context to the trial results and support their interpretation. The evaluation relies on the proper documentation by GPs, potentially limiting its explanatory power.
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INTRODUCTION: Clinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy. METHODS AND ANALYSIS: Planned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter. SCOPE: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients. POPULATION: patients (≥18 years) with polypharmacy (≥5 prescriptions). SAMPLE SIZE: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved. INTERVENTION: complex intervention eMMa. FOLLOW-UP: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa. OUTCOMES: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse. STATISTICAL ANALYSIS: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints. ETHICS AND DISSEMINATION: Trial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences. TRIAL REGISTRATION: NCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336).
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Medicina Geral , Polimedicação , Eletrônica , Humanos , Conduta do Tratamento Medicamentoso , Lista de Medicamentos Potencialmente Inapropriados , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: Formative evaluation of the implementation process for a digitally supported intervention in polypharmacy in Germany. Qualitative research was conducted within a cluster randomized controlled trial (C-RCT). It focused on understanding how the intervention influences behavior-related outcomes in the prescription and medication review process. METHODS/SETTING: Twenty-seven general practitioners (GPs) were included in the study in the two groups of the C-RCT, the intervention, and the wait list control group. Behavior-related outcomes were investigated using three-step data analysis (content analytic approach, documentary method, and design of a model of implementation pathways). RESULTS: Content analysis showed that physicians were more intensely aware of polypharmacy-related risks, described positive learning effects of the digital technology on their prescribing behavior, and perceived a change in communication with patients and pharmacists. Conversely, they felt uncertain about their own responsibility when prescribing. Three main dimensions were discovered which influenced adoption behavior: (1) the physicians' interpretation of the relevance of pharmaceutical knowledge provided by the intervention in changing decision-making situations in polypharmacy; (2) their medical code of ethics for clinical decision making in the context of progressing digitalization; and (3) their concepts of evidence-based medicine on the basis of professional experiences with polypharmacy in primary care settings. In our sample, both simple and complex pathways from sensitization to adoption were observed. The resulting model on adoption behavior includes a paradigmatic description of different pathways and a visualization of different observed levels and applied methodological approaches. We assumed that the GP habitus can weaken or strengthen interventional effects towards intervention uptake. This formative evaluation strategy is beneficial for the identification of behavior-related implementation barriers and facilitators. CONCLUSION: Our analyses of the adoption behavior of a digitally supported intervention in polypharmacy revealed both simple and complex pathways from awareness to adoption, which may impact the implementation of the intervention and therefore, its effectiveness. Future consideration of adoption behavior in the planning and evaluation of digitally supported interventions may enhance uptake and support the interpretation of effects. TRIAL REGISTRATION: NCT03430336 , 12 February 2018.
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Clínicos Gerais , Polimedicação , Tomada de Decisão Clínica , Humanos , Atenção Primária à Saúde , Pesquisa QualitativaRESUMO
BACKGROUND: Medication Reconciliation leads to quick detection of drug-related problems, studies in ambulatory care are scarce. The recently introduced Medication Plan in Germany serves as an ideal basis for Medication Reconciliation. OBJECTIVE: The study aim was to provide accurate data on the magnitude of discrepancy between the prescription and the actually taken medicine. Clinical relevance of discrepancies was assessed to estimate the impact on medication safety. METHODS: Patients were assessed at home, data was reconciled with the physician's documentation. Discrepancies were analyzed and stratified. Risk for hospitalization, risk for falls and the potential for drug-drug interactions was estimated based on literature. Drugs were tested for its origin and grouped to indication clusters. Detected DRPs at a Medication Review were linked to the results at Medication Reconciliation. RESULTS: Medication of 142 elderly patients from 12 practices was reconciled. 1498 drugs were found at the home assessment, 1099 (73.4%) of which were detected in the physician's documentation. 94.4% of the patients were affected by discrepancies. A total of 2.8 ± 2.4 drugs was undocumented per patient. 26.6% of missing drugs were prescribed by medical specialists, 42.5% of drugs of unknown origin were prescription drugs. 53.9% of the patients used a undocumented drug, which carried a high risk for hospitalization. 23.1% of the drugs not covered were used for treatment of cardiovascular diseases. 65.8% of the differing drugs caused at least one DRP. CONCLUSION: A high discrepancy between the drugs used by the patient and the medication documented by the primary care physician could be found. Relating drugs had a profound systemic effect and were particular relevant to medication safety. Many drugs were prescription drugs. The majority of differing drugs caused DRPs. A collaborative Medication Reconciliation as part of a Medication Management could compile the entire medication and increase patient safety.
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Reconciliação de Medicamentos , Acidentes por Quedas , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial , Interações Medicamentosas , Feminino , Hospitalização , Humanos , Masculino , Erros de Medicação , Polimedicação , Atenção Primária à Saúde , Risco , AutoadministraçãoRESUMO
INTRODUCTION: Occurring from ultraviolet radiation combined with impairing ozone levels, uncritical sun exposure and use of tanning beds an increasing number of people are affected by different types of skin cancer. But preventive interventions like skin cancer screening are still missing the evidence for effectiveness and therefore are criticised. Fundamental for an appropriate course of action is to approach the defined parameters as measures for effectiveness critically. A prerequisite should be the critical application of used parameter that are defined as measures for effectiveness. This research seeks to establish, through the available literature, the effects and conditions that prove the effectiveness of prevention strategies in skin cancer. METHOD AND ANALYSIS: A mixed-method approach is employed to combine quantitative to qualitative methods and answer what effects can display effectiveness considering time horizon, perspective and organisational level and what are essential and sufficient conditions to prove effectiveness and cost-effectiveness in skin cancer prevention strategies. A systematic review will be performed to spot studies from any design and assess the data quantitatively and qualitatively. Included studies from each key question will be summarised by characteristics like population, intervention, comparison, outcomes, study design, endpoints, effect estimator and so on. Beside statistical relevancies for a systematic review the qualitative method of qualitative comparative analysis (QCA) will be performed. The estimated outcomes from this review and QCA are the accomplishment and absence of effects that are appropriate for application in effectiveness assessments and further cost-effectiveness assessment. ETHICS AND DISSEMINATION: Formal ethical approval is not required as primary data will not be collected. TRIAL REGISTRATION NUMBER: International Prospective Register for Systematic Reviews number CRD42017053859.
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Detecção Precoce de Câncer/métodos , Neoplasias Cutâneas/economia , Neoplasias Cutâneas/prevenção & controle , Raios Ultravioleta/efeitos adversos , Análise Custo-Benefício , Estudos de Avaliação como Assunto , Humanos , Projetos de Pesquisa , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Routine data of statutory health insurance (SHI) provide a great potential for evaluating the healthcare situation in Germany by providing, e. g., morbidity estimates. In the context of secondary data, analyses based on insurance data were conducted using the outpatient medical billing diagnosis. If, however, medical billing data, which are collected for this primary purpose, are the only source of these morbidity estimates, a limited validity of outpatient medical diagnostic data will have to be assumed or validity will have to be assured. This investigation aimed to analyse the quality of family practitioners' documentation regarding diagnostic data in patients with thyroid disease based on medical records for billing purposes. METHODS: As part of the pilot study General practitioners' Views on Polypharmacy and its Consequences for Patient Health Care, the medical records of 548 multi-morbid patients with thyroid disease from six general practices in Dresden, Saxony, were analysed with respect to the congruence of prescriptions of thyroid medication and associated thyroid diagnosis. Logistic regression was used to investigate predictors of limited diagnostic data of thyroid disease. RESULTS: There was insufficient documentation of thyroid diagnoses in 26.8% (n=147) of the included patients diagnosed with or treated for thyroid disease. The proportion of undocumented (1.1 to 35.8%), imprecise (4.6 to 22.3%) and non-specific documented (14.9 to 73.8%) thyroid diagnoses varied in all general practices. Due to undocumented thyroid disease, the corrected prevalence of thyroid diseases summarised for all practices was 5.5 percentage points higher than the originally documented prevalence (29.7 instead of 24.2%). An increasing number of prescribed drugs was a significant predictor for inadequate documentation of thyroid disease (for 5 to 8 routinely taken medications: OR=2.4/p<0.001; for 9 to 12: OR=4.0/p<0.001; for 13 to 20: OR=7.4/p<0.001). CONCLUSIONS: Due to the limited data quality of outpatient medical billing diagnoses as a basis for morbidity estimates, GPs' diagnostic data should be subjected to regular internal and external diagnostic validation in SHI routine data. Additional case-related interviews with documenting GPs would significantly increase data validity. Also, intelligent e-tools supporting electronic patient documentation could be helpful to improve the quality of primary care documentation.
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Grupos Diagnósticos Relacionados , Atenção Primária à Saúde , Doenças da Glândula Tireoide/diagnóstico , Clínicos Gerais , Alemanha , Humanos , Classificação Internacional de Doenças , Projetos Piloto , Glândula TireoideRESUMO
BACKGROUND: Medication reviews and medication management are being used more and more around the world to improve medication safety. Both of these tools were originally conceived as pharmaceutical care activities and have recently been developed into interdisciplinary approaches. We studied the efficacy of interprofessional medication management for multimorbid patients that takes their medical conditions, but also their general living situation into account. METHODS: A comprehensive medication management was performed, which involved the collection of information on the drugs each patient took, the way they were stored, the patient's drug intake and handling, and any problems that arose with pharmacotherapy. The interventional approach was evaluated over a period of 15 months in a cluster-randomized controlled trial with a stepped wedge design. The primary endpoint was the quality of pharmacotherapy, as assessed with the Medication Appropriateness Index (MAI). A mixed model was used to analyze efficacy. RESULTS: 162 patients were enrolled in the study; 142 were included in the intention-to-treat analysis (53.3% women, mean age 76.8 ± 6.3 years). The mean total MAI score decreased significantly (p ≤ 0.001) from the control phase (29.21, 95% CI [26.09; 32.33]) to the intervention phase (22.27 [19.00; 25.54]), with an effect strength (Cohen's d) of -0.24 [-0.36; -0.13]. The number of drug-related problems declined as well. CONCLUSION: In this study, interprofessional collaboration increased medication safety. Working across disciplinary boundaries allowed for a decrease in drugrelated problems and brought up aspects outside the purview of the primary care physician.
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Relações Interprofissionais , Conduta do Tratamento Medicamentoso , Polimedicação , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , MultimorbidadeRESUMO
BACKGROUND: Based on changes in pharmacokinetics and -dynamics in elderly patients, there are potentially inappropriate medications (PIM) that should be avoided in patients aged ≥ 65 years. Current studies showed prescription rates of PIM between 22.5 and 28.4 % in the primary care setting. The evidence concerning reasons for PIM prescription by FPs is limited. METHODS: This mixed method study consisted of three research parts: 1) semi-standardized content analysis of patients' records, 2) qualitative interviews with FPs using a) open questions and b) selected patient-specific case vignettes and 3) qualitative interviews with FPs' medical assistants. The integration of qualitative interviews was used to explain the quantitative results (triangulation design). PIM were identified according to the German PRISCUS list. Descriptive and multivariate statistical analysis was done using SPSS 22.0. Qualitative content analysis of interviews was used to classify the content of the interviews for indicating pertinent categories. All data were pseudonymously recorded and analyzed. RESULTS: Content analysis of 1846 patients' records and interviews with 7 related FPs were conducted. Elderly patients [n = 1241, mean age: 76, females: 56.6 %] were characterized in average by 8.3 documented chronic diagnosis. 23.9 % of elderly patients received at least one PIM prescription. Sedatives/hypnotics were the most frequent prescribed PIM-drugs (13.7 %). Mental disorders, gender and number of long-term medication were detected as predictors for the probability of a PIM prescription. Common reported reasons for PIM prescription by FPs concerned limited knowledge regarding PIM, limited applicability of PIM lists in daily practice, lack of time, having no alternatives in medication, stronger patient-related factors than age that influence prescription, own bad experiences regarding changes of medication or refusal of following prescriptions of sedative/hypnotics. CONCLUSIONS: It is essential to see FPs in a complex decision making situation with several influencing factors on their prescribing, including: patient-oriented prioritization, FPs' experiences in daily practice, FPs' knowledge regarding existing recommendations and their trust in it and organizational characteristics of FPs' daily medical practice. These pros and cons of PIM prescription in elderly patients should be considered in FPs' advanced training.