An overall strategy based on regression models to estimate relative survival and model the effects of prognostic factors in cancer survival studies.

Relative survival provides a measure of the proportion of patients dying from the disease under study without requiring the knowledge of the cause of death. We propose an overall strategy based on regression models to estimate the relative survival and model the effects of potential prognostic factors. The baseline hazard was modelled until 10 years follow-up using parametric continuous functions. Six models including cubic regression splines were considered and the Akaike Information Criterion was used to select the final model. This approach yielded smooth and reliable estimates of mortality hazard and allowed us to deal with sparse data taking into account all the available information. Splines were also used to model simultaneously non-linear effects of continuous covariates and time-dependent hazard ratios. This led to a graphical representation of the hazard ratio that can be useful for clinical interpretation. Estimates of these models were obtained by likelihood maximization. We showed that these estimates could be also obtained using standard algorithms for Poisson regression

The Italian National Rare Diseases Registry.

INTRODUCTION:Rare disease registries are a priority at European level and specific actions are being implemented by the European Commission to support their development.In Italy, a National Registry of rare diseases has been established in 2001 as a network of regional registries. The latter have gradually been established and the full coverage of the Italian territory was attained during 2011. METHODS:Here we describe the basic features of the National Registry of rare diseases; the activities carried out to promote consistent operations in the regional registries; and the overall quality and composition of the records collected. RESULTS:After a validation process, including removal of duplicate records, 110,841 records of patients with rare diseases, single and with group denominations, are stored in the National Registry of rare diseases. They correspond to the overall diagnoses communicated to national registry by regional registries up to 30 June 2012.The quality of the data collected by the the National Registry of rare diseases has been assessed with respect to completeness and consistency of procedures. Variables characterising case and diagnosis showed a very limited number of missing values. Records reported at least one case of 485 rare conditions. DISCUSSION:To date, the National Registry of rare diseases is a surveillance system with the main objective of producing epidemiologic evidence on rare diseases in Italy, and of supporting policy making and health services planning.Data quality still represents a limitation for any sound epidemiological estimate of rare diseases in Italy. However, improvements of the quality of collected data and the completeness of case notifications should be strengthened.

Womens satisfaction with their breast prosthesis: What determines a quality prosthesis

The aim of this study is to determine what factors constitute a quality prosthesis and ascertain which factors affect prosthesis satisfaction. Sixty-four women who received full funding for their prosthesis and 38 women who received their hospital&rsquo;s usual fundingwere recruited. Women rated the information provided about breast prostheses very highly, with 85% reporting that it was &quot;very good&quot; or &quot;excellent.&quot; Satisfaction was significantly associatedwith how well the prosthesis fit (1 week,p=.001; 3 months,p=.01), level of comfort (3 months,p=.005), and appearance of the prosthesis when worn (6 months,p = .001). Quality was significantly associated with how well it fit (1 week,p = .001; 3months,p = .001), how natural it felt (1 week,p = .001; 6months,p=.01), the weight of the prosthesis (3 months,p=.003), and appearance when worn (6 months,p = .03). The results will be used to improve women&rsquo;s access to a quality prosthesis. <br /

Efficacy and cost-effectiveness of an outcall program to reduce carer burden and depression among carers of cancer patients (PROTECT) : rationale and design of a randomized controlled trial

Published: 6 January 2014BACKGROUND: Carers provide extended and often unrecognized support to people with cancer. The aim of this study is to test the hypothesis that excessive carer burden is modifiable through a telephone outcall intervention that includes supportive care, information and referral to appropriate psycho-social services. Secondary aims include estimation of changes in psychological health and quality of life. The study will determine whether the intervention reduces unmet needs among patient dyads. A formal economic program will also be conducted. METHODS/DESIGN: This study is a single-blind, multi-centre, randomized controlled trial to determine the efficacy and cost-efficacy of a telephone outcall program among carers of newly diagnosed cancer patients. A total of 230 carer/patient dyads will be recruited into the study; following written consent, carers will be randomly allocated to either the outcall intervention program (n = 115) or to a minimal outcall / attention control service (n = 115). Carer assessments will occur at baseline, at one and six months post-intervention. The primary outcome is change in carer burden; the secondary outcomes are change in carer depression, quality of life, health literacy and unmet needs. The trial patients will be assessed at baseline and one month post-intervention to determine depression levels and unmet needs. The economic analysis will include perspectives of both the health care sector and broader society and comprise a cost-consequences analysis where all outcomes will be compared to costs. DISCUSSION: This study will contribute to our understanding on the potential impact of a telephone outcall program on carer burden and provide new evidence on an approach for improving the wellbeing of carers.Patricia M Livingston, Richard H Osborne, Mari Botti, Cathy Mihalopoulos, Sean McGuigan, Leila Heckel, Kate Gunn, Jacquie Chirgwin, David M Ashley and Melinda William

Direct and Indirect Effectiveness of mRNA Vaccination against Severe Acute Respiratory Syndrome Coronavirus 2 in Long-Term Care Facilities, Spain

We conducted a registries-based cohort study of long-term care facility residents >65 years of age offered vaccination against severe acute respiratory syndrome coronavirus 2 before March 10, 2021, in Spain. Risk for infection in vaccinated and nonvaccinated persons was compared with risk in the same persons in a period before the vaccination campaign, adjusted by daily-varying incidence and reproduction number. We selected 299,209 persons; 99.0% had >1 dose, 92.6% had 2 doses, and 99.8% of vaccines were Pfizer/BioNTech (BNT162b2). For vaccinated persons with no previous infection, vaccine effectiveness was 81.8% (95% CI 81.0%-82.7%), and 11.6 (95% CI 11.3-11.9) cases were prevented per 10,000 vaccinated/day. In those with previous infection, effectiveness was 56.8% (95% CI 47.1%-67.7%). In nonvaccinated residents with no previous infection, risk decreased by up to 81.4% (95% CI 73.3%-90.3%). Our results confirm vaccine effectiveness in this population and suggest indirect protection in nonvaccinated persons.S

Breast cancer by migrant background in Belgium:Lower risk, but worse survival in women of non-European origin

Foreign and native populations differ in terms of breast cancer outcomes. Studies rarely distinguish between premenopausal and postmenopausal breast cancer, although the risk profile is different; nor between migrants of the first and second generation (FG and SG), which is crucial to examine genetic and environmental influences on breast cancer. This research fills these gaps by investigating patterns in breast cancer incidence and survival in different migrant groups by menopausal and migrant generational status, taking various risk factors into account. To this end, individually linked data from the 2001 census, the Belgian Cancer Registry and the Crossroads Bank for Social Security are used. Age-standardised incidence rates and incidence rate ratios are calculated by migrant background group, stratified according to ages 30–50 (premenopausal) and 50–70 (postmenopausal). Incidence rate ratios are examined with and without taking reproductive factors and socioeconomic position (SEP) into account. Relative survival percentages and relative excess risks of dying among premenopausal and postmenopausal patients are computed with and without controlling for the stage at diagnosis and SEP. Premenopausal breast cancer is further examined by migrant generational status. Breast cancer incidence is lower among non-European migrants compared to Belgians. Keeping SEP and known risk factors constant reduces much, but not all of the observed discrepancies. A risk convergence between SG migrants and Belgians for the development of premenopausal breast cancer is observed. Premenopausal breast cancer survival is worse among Moroccan patients due to a higher stage at diagnosis. This disadvantage is concentrated in the FG

Protecting Young Children Against Skin Cancer: Parental Beliefs, Roles, And Regret

Objective: To examine the role of parental beliefs, roles, and anticipated regret toward performing childhood sun-protective behaviours. Methods: Parents (N = 230; 174 mothers, 56 fathers), recruited using a nonrandom convenience sample, of at least 1 child aged between 2 and 5 years completed an initial questionnaire assessing demographics and past behaviour as well as theory of planned behaviour global (attitude, subjective norm, and perceived behavioural control) and belief-based (behavioural, normative, and control beliefs) measures, role construction, and anticipated regret regarding their intention and behaviour to protect their child from the sun. Two weeks later, participants completed a follow-up questionnaire assessing their sun protection of their child during the previous 2 weeks. Results: Hierarchical multiple regression analysis identified attitude, perceived behavioural control, role construction, anticipated regret, past behaviour, and a normative belief (“current partner/other family members”) as significant predictors of parents' intention to participate in sun-protective behaviour for their child. Intention and past behaviour were significant predictors of parents' follow-up sun-protective behaviour. The regression models explained 64% and 36% of the variance in intention and behaviour, respectively. Conclusions: The findings of this study highlight the importance of anticipated regret and role-related beliefs alongside personal, normative, and control beliefs in determining parents' intentional sun-protective behaviour for their children. Findings may inform the development of parent- and community-based sun protection intervention programs to promote parents' sun-safety behaviours for their children to prevent future skin cancer incidence

Cancer incidence in type 2 diabetes patients - first results from a feasibility study of the D2C cohort

<p>Abstract</p> <p>Background</p> <p>A large prospective study in patients with type 2 diabetes (T2D), the German D2C cohort, is presently being enumerated to investigate risk factors of incident cancer in diabetic patients.</p> <p>Study setting</p> <p>A disease management program was offered, on a voluntary basis, to all T2D patients who were members of a statutory health insurance fund in Germany. This first feasibility report uses data from 26.742 T2D patients, who were 40 to 79 years old, resided in the Muenster District, and who were enrolled between June 2003 and July 2008. Cancer cases were identified through the regional Cancer Registry.</p> <p>Methods</p> <p>Invasive cancer cases were identified using probabilistic record linkage procedures and pseudonymised personal identifiers. Censoring date was December 31, 2008. We included only first cancers, leaving 12.650 male and 14.092 female T2D with a total of 88.778 person-years (py). We computed standardised incidence ratios (SIR) for external comparisons and we employed Cox regression models and hazard ratios (HR) within the cohort.</p> <p>Results</p> <p>We identified 759 first cancers among male T2D patients (18.7 per 1,000 py) and 605 among females (12.7 per 1,000 py). The risk of any incident cancer in T2D was raised (SIR = 1.14; 95% confidence interval [1.10 - 1.21]), in particular for cancer of the liver (SIR = 1.94 [1.15 - 2.94]) and pancreas (SIR = 1.45 [1.07-1.92]). SIRs decreased markedly with time after T2D diagnosis. In Cox models, adjusting for diabetes duration, body mass index and sex, insulin therapy was related to higher cancer risk (HR = 1.25 [1.17 - 1.33]). No effect was seen for metformin.</p> <p>Discussion</p> <p>Our study demonstrates feasibility of record linkage between DMP and cancer registries. These first cohort results confirm previous reports. It is envisaged to enhance this cohort by inclusion of further regions of the state, expansion of the follow-up times, and collection of a more detailed medication history.</p

Documentation of ethically relevant information in out-of-hospital resuscitation is rare: a Danish nationwide observational study of 16,495 out-of-hospital cardiac arrests

Abstract Background Decision-making in out-of-hospital cardiac arrest should ideally include clinical and ethical factors. Little is known about the extent of ethical considerations and their influence on prehospital resuscitation. We aimed to determine the transparency in medical records regarding decision-making in prehospital resuscitation with a specific focus on ethically relevant information and consideration in resuscitation providers’ documentation. Methods This was a Danish nationwide retrospective observational study of out-of-hospital cardiac arrests from 2016 through 2018. After an initial screening using broadly defined inclusion criteria, two experienced philosophers performed a qualitative content analysis of the included medical records according to a preliminary codebook. We identified ethically relevant content in free-text fields and categorised the information according to Beauchamp and Childress’ four basic bioethical principles: autonomy, non-maleficence, beneficence, and justice. Results Of 16,495 medical records, we identified 759 (4.6%) with potentially relevant information; 710 records (4.3%) contained ethically relevant information, whereas 49 did not. In general, the documentation was vague and unclear. We identified four kinds of ethically relevant information: patients’ wishes and perspectives on life; relatives’ wishes and perspectives on patients’ life; healthcare professionals’ opinions and perspectives on resuscitation; and do-not-resuscitate orders. We identified some “best practice” examples that included all perspectives of decision-making. Conclusions There is sparse and unclear evidence on ethically relevant information in the medical records documenting resuscitation after out-of-hospital cardiac arrests. However, the “best practice” examples show that providing sufficient documentation of decision-making is, in fact, feasible. To ensure transparency surrounding prehospital decisions in cardiac arrests, we believe that it is necessary to ensure more systematic documentation of decision-making in prehospital resuscitation