RESUMO
BACKGROUND: Governments are facing tough choices about whether to fund new, promising but highly expensive drugs within the public healthcare system. Decisions that some drugs are not sufficiently beneficial relative to their cost to merit public funding are often contentious. The importance of making decisions that stakeholders can understand and accept as legitimate is increasingly recognized and is commonly understood to be a crucial component for stakeholder support and successful implementation. Yet, little is known about clinicians' perceptions of legitimate limit-setting. This study aimed to examine oncologists' perceptions of the legitimacy of governmental decisions to deny patients access to new cancer drugs because effectiveness and cost-effectiveness of the drugs has not been demonstrated. METHODS: Semi-structured in-depth interviews with 12 Norwegian oncologists were carried out. Data were interpreted with the use of theory driven thematic analysis. The analytical framework of Accountability for reasonableness aided data gathering and interpretation. RESULTS: The participants endorsed the ideal of explicit criteria-based priority setting. Yet, when confronted with actual rationing decisions, they were far more equivocal. They advocated for increased access to drugs and were not always prepared to accept rationing of drugs they felt would benefit their patient. Distrust in the Norwegian centralised drug review process was found and different rationales were identified: i) Lack of engagement with the process, ii) Disagreement with the use of rationing criteria, iii) Lack of transparency and lack of dispute resolution procedures. Concerns about the wider implications of rationing decisions were reported. Most importantly, these related to negative impact on patient-doctor relationship of micro-level rationing and to inequities in drug availability resulting from privatisation of high-cost cancer treatment. CONCLUSIONS: Drawing on the analytical framework, we conclude that perceptions of legitimacy regarding rationing of high-cost drugs include procedural fairness. However, notions of substantive justice also seem to be important for accepting reasons given for decisions. Regulatory legitimacy may further warrant a more sophisticated theoretical account of second-order beliefs about the justifiability of rationing new technologies. These findings indicate a need for a broader concept of legitimacy than is commonly used in the literature on healthcare prioritisation.
Assuntos
Tomada de Decisões , Custos de Medicamentos , Alocação de Recursos para a Atenção à Saúde , Neoplasias/tratamento farmacológico , Comportamento de Escolha , Análise Custo-Benefício , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Prioridades em Saúde , Humanos , Entrevistas como Assunto , Noruega , Relações Médico-Paciente , Pesquisa Qualitativa , Responsabilidade SocialRESUMO
The aim of the present study was to relate the time trends in breast cancer incidence and mortality to the introduction of mammography screening in the Nordic capitals. Helsinki offered screening to women aged 50-59 starting in 1986. The other three capitals offered screening to women aged 50-69 starting in 1989 in Stockholm, 1991 in Copenhagen, and 1996 in Oslo. Prevalence peaks in breast cancer incidence depended on the age groups covered by the screening, the length of the implementation of screening, and the extent of background opportunistic screening. No mortality reduction following the introduction of screening was visible after seven to 12 years of screening in any of the three capitals where significant effects of the screening on the breast cancer mortality had already been demonstrated by using other analytical methods for the evaluation. No visible effect on mortality reduction was expected in Oslo due to too short an observation period. The study showed that the population-based breast cancer mortality trend is too crude a measure to detect the effect of screening on breast cancer mortality during the first years after the start of a programme.
Assuntos
Neoplasias da Mama/diagnóstico , Neoplasias da Mama/mortalidade , Mamografia/tendências , Programas de Rastreamento/tendências , Fatores Etários , Idoso , Dinamarca/epidemiologia , Feminino , Finlândia/epidemiologia , Humanos , Incidência , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prevalência , Taxa de Sobrevida , Suécia/epidemiologia , Fatores de TempoRESUMO
PURPOSE: To retrospectively investigate whether different review designs have an influence on the estimate of missed interval cancer in a population-based breast cancer screening program. MATERIALS AND METHODS: The Norwegian Breast Cancer Screening Program invites women aged 50-69 years to undergo biennial screening mammography. The current study was part of the evaluation and scientific aspects of the screening program and thus was covered by the general ethical approval of the screening program as a part of the Cancer Registry of Norway. All participants signed an informed consent that specified that data related to their screening visit could be used for evaluation and scientific purposes. Six radiologists (9-34 years of experience in mammography) reviewed previously obtained bilateral two-view screening and diagnostic mammograms of 231 interval cancers, 117 screening-detected cancers, and 373 normal cases. Four review designs were used: individual and paired blinded review and individual and consensus informed review. A five-point interpretation scale was used to reclassify the cancers into missed cancers, minimal signs, and true cancers. The number and proportion of subgroups were estimated with 95% confidence intervals. RESULTS: Of 231 interval cancers, 46 (19.9%) were reclassified as missed cancers with the mixed blinded individual review and 54 (23.4%) were classified as missed cancers with the mixed blinded paired review. Eighty-three cancers (35.9%) were classified as missed cancers with individual informed review, and 78 (33.8%) were classified as missed cancers with consensus informed review. Thirty-nine cancers (16.8%) were reclassified as missed when four or more radiologists assigned a score of 2 or more (probably benign or more suspicious); three cancers (1.3%) were reclassified as missed when a score of 4 or more (probably malignant or more suspicious) was assigned. CONCLUSION: The percentage of interval cancers classified as missed ranged from 1.3% to 35.9% according to review design. To encourage learning, a review protocol should include both blinded and informed designs.
Assuntos
Neoplasias da Mama/diagnóstico por imagem , Erros de Diagnóstico , Mamografia/normas , Programas de Rastreamento/normas , Idoso , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/patologia , Competência Clínica , Feminino , Humanos , Pessoa de Meia-Idade , Noruega/epidemiologia , Valor Preditivo dos Testes , Controle de Qualidade , Sistema de Registros , Estudos RetrospectivosRESUMO
Interval breast cancer reduce the effectiveness of mammography screening programs. We studied 95 interval cancers, diagnosed during 1996 to 2001 as part of the population-based Norwegian Breast Cancer Screening Program. These cases were matched on size (+/-2.0 mm) to 95 screen-detected breast cancers, and the tumors were compared by immunohistochemical methods using tissue microarrays. Patients with interval cancers were more likely to be younger [odds ratio (OR), 4.7; P = 0.0001], to have dense breasts (OR, 3.4; P = 0.004), and to have estrogen receptor-negative tumors (OR, 2.6, P = 0.01), and p53 expression was more frequent (OR, 4.0; P = 0.001). Notably, interval cancers were more likely to have a basal epithelial phenotype, in that expression of cytokeratin 5/6 (OR, 2.3; P = 0.04) and P-cadherin (OR, 2.5; P = 0.04) was more frequent in interval cases than in size-matched, screen-detected tumors. In a logistic regression model, p53 expression, age, and breast density were independent predictors of interval cancers. Our data suggest that breast cancers with a basal epithelial phenotype are more likely than nonbasal breast cancers to present between regular mammograms.
Assuntos
Biomarcadores Tumorais/análise , Neoplasias da Mama/diagnóstico por imagem , Carcinoma Basocelular/diagnóstico por imagem , Mamografia , Programas de Rastreamento/métodos , Adulto , Fatores Etários , Idoso , Biomarcadores Tumorais/imunologia , Mama/fisiologia , Neoplasias da Mama/genética , Neoplasias da Mama/imunologia , Caderinas , Carcinoma Basocelular/genética , Carcinoma Basocelular/imunologia , Estudos de Casos e Controles , Corantes , Feminino , Genes p53 , Humanos , Imuno-Histoquímica , Queratinas , Modelos Logísticos , Pessoa de Meia-Idade , Noruega , Análise de Sequência com Séries de Oligonucleotídeos , Fenótipo , Receptores de Estrogênio , Fatores de RiscoRESUMO
Continuous emphases of quality control are required to achieve reduction in mortality from breast cancer as a consequence of breast cancer screening. Results of the process indicators in the first 6 years in 4 counties in the Norwegian Breast Cancer Screening Program are evaluated and will be presented. Data from women who had their initial (n = 173402) and subsequent (n = 220 058) screening provide the basis for the analysis. The breast cancer detection ratio was 3.2 the expected incidence (based on the incidence before the screening started, 1991-1995) among the initially screened women, decreasing to 2.3 among the subsequently screened. The ratio of interval cancer among the initially screened was 0.25 and 0.72 of the expected incidence, 0-12 and 13-23 months after screening, respectively. For those subsequently screened the proportions were 0.22 and 0.64, respectively. More than 50% of the invasive tumors were less than 15 mm in size, and more than 75% were lymph node negative, among both the initially and subsequently screened. The process indicators achieved in the NBCSP are promising as regards future mortality reduction. The incidence of interval cancer 13-24 months after screening is higher than recommended in the European guidelines.
Assuntos
Neoplasias da Mama/epidemiologia , Idoso , Neoplasias da Mama/mortalidade , Neoplasias da Mama/prevenção & controle , Feminino , Humanos , Mamografia , Programas de Rastreamento , Pessoa de Meia-Idade , Noruega/epidemiologia , Sensibilidade e EspecificidadeRESUMO
OBJECTIVE: To survey factors of importance for attendance in the Norwegian Breast Cancer Screening Program (NBCSP). METHODS: Simple forced choice questionnaires were sent to 1221 women, in four categories: not attended, screened negative, false positive, and breast cancer cases. The response rate was 80.7%. RESULTS: Women who were invited to the NBCSP reported positive opinions about being invited and the provided information. This response was independent of attendance and screening result. An experience of pain during screening examination was reported in the same proportion among women who were screened negative and false positive (p = 0.27). Unsatisfactory care was reported in a significantly lower rate among women who were screened negative, compared to the false positive (p = 0.02) and breast cancer cases (p < 0.01). Re-attendance was significantly higher among women who were screened negative (91.8%), compared to the false positive (83.9%, p < 0.01). Experienced pain seemed to influence re-attendance among the false positive, while care seemed to influence re-attendance among women who were screened negative. Intention to re-attend was significantly associated with the rate of re-attendance (p < 0.01) and it was the only significant predictor for re-attendance (OR = 5.4, 95% CI: 1.8-16.7) in a multiple logistic regression analysis with intention, age, experienced pain, experienced care and waiting time included in the model. Age did not have much influence on results. CONCLUSION: Women, who were invited to the NBCSP, reported positive opinions about the program. Re-attendance was related to previous screening results, partly by, experienced pain and care.