Perceived information needs and non‐adherence: evidence from Greek patients with hypertension

Background The role of information on patients’ decision to non‐adhere is important, yet not well explored. Objective To identify differences between perceived information needs for hypertension and medication to treat it, to explore the information channels used by patients and to test what type of information is more important to adhere to medication. Design, setting and participants A questionnaire study was designed and conducted by telephone in the Centre for the Treatment of Hypertension in Athens, Greece, among 743 individuals. Main variables studied The main variables included perceived information needs, information channels, non‐adherence to medication and socio‐demographic characteristics. Main outcome measures Non‐adherence to medication was measured using the Morisky scale. Results Patients reported feeling better informed about hypertension (90%) than medication to treat it (80%). The doctor remains the dominant information source, while the Media and magazines on health issues were reported more frequently than the family and the pharmacist. Feeling well informed about medication for hypertension was a predictor of better adherence. Other determinants of adherence were the use of the Internet and the Media. Discussion The results confirm the importance of patients leaving the consultation feeling well informed about their medication as this improves adherence. They also show that the use of the Internet and the Media can be beneficial for adherence. Conclusions Given the restricted time the doctor can usually spend with the patient, it is important to know that more emphasis on the information regarding medication is important.     

Epidemiology of non‐deferrable medical conditions in primary care in Italy

Non‐deferrable medical conditions (NDMC) are clinical entities other than exacerbations of chronic diseases which are too frequently managed by emergency departments. The primary care setting would be indeed the ideal environment to proficiently treat them. Few studies have investigated the epidemiology of NDMC in primary care, especially in Italy. With the aim to better identify NDMC sufferers, we assessed the accuracy of the NDMC definition by means of four algorithms, featured by different specificities and sensitivities. Four algorithms, based on the hierarchical definition of NDMC, were developed to calculate the incidence rate of NDMC in 2014. Each was tested using a Cox univariate model adjusted for gender, comparing patients aged <45 years old with older patients. Algorithms 1 and 3 gave similar results (408.1 vs. 405.5 per 1,000 person‐years); Algorithms 2 and 4 reported sensibly lower rates (84.7 and 84.0 per 1,000 person‐years). Incidence rate of NDMC for female patients was higher than in males and for older age group (i.e. 75–84 age group) than younger patients, for both gender groups. Regarding the regression model, a higher risk of NDMC was estimated in patients aged 45 years or more and in females. This study allowed us to assess the incidence rate of NDMC in Italy which was unexpectedly higher among older patients. Given the crucial role of general practitioners (GPs) in the diagnosis and management of these conditions, as well as the healthcare system reforms imposed by the ongoing financial crisis, our findings may contribute to informing the capacity and strategic workload planning in group of GPs to improve service quality and profitably to reduce the excessive use of emergency departments.     

Giving tape recordings or written summaries of consultations to people with cancer: a systematic review

Objective  To examine the effects of providing recordings or summaries of consultations to people with cancer and their families.
Design  Systematic review.
Data sources  MEDLINE, CINAHL, Cancerlit, EMBASE and other electronic bibliographic databases. Bibliographies of relevant papers.
Selection criteria  Randomized and non-randomized controlled trials of the provision of taped recordings or written summaries of consultations to people with cancer and/or their families.
Main results  Eight randomized controlled trials were found, all involving adult participants. No non-randomized controlled trials were found. The quality of the studies was generally poor. Between 83% and 96% of people who received recordings or summaries found them useful to remind them of what was said and/or to inform family members and friends about their illness and treatment. Of seven studies that assessed recall of information given during the consultation, four reported better recall among the groups that received recordings or summaries than among control groups. Receiving a recording or summary had no significant effect on anxiety or depression between the groups. None of the included studies assessed survival or health outcomes other than psychological outcomes.
Conclusions  Wider use of consultation tapes and summary letters could benefit many adults with cancer, without causing additional anxiety or depression, but consideration should be given to individuals' circumstances and preferences.     

Multivariate meta‐analysis: A method to summarize non‐linear associations

Multivariate meta‐analysis represents a promising statistical tool in several research areas. Here, we provide a brief overview of the application of this methodology to combining complex multi‐parameterized relationships, such as non‐linear or delayed associations, in multi‐site studies. The discussion focuses on the advantages over simpler univariate methods, estimation and computational issues and directions for further research. Copyright © 2011 John Wiley & Sons, Ltd.     

Correcting for non‐compliance in randomized non‐inferiority trials with active and placebo control using structural models

The three‐arm clinical trial design, which includes a test treatment, an active reference, and placebo control, is the gold standard for the assessment of non‐inferiority. In the presence of non‐compliance, one common concern is that an intent‐to‐treat (ITT) analysis (which is the standard approach to non‐inferiority trials), tends to increase the chances of erroneously concluding non‐inferiority, suggesting that the per‐protocol (PP) analysis may be preferable for non‐inferiority trials despite its inherent bias. The objective of this paper was to develop statistical methodology for dealing with non‐compliance in three‐arm non‐inferiority trials for censored, time‐to‐event data. Changes in treatment were here considered the only form of non‐compliance. An approach using a three‐arm rank preserving structural failure time model and G‐estimation analysis is here presented. Using simulations, the impact of non‐compliance on non‐inferiority trials was investigated in detail using ITT, PP analyses, and the present proposed method. Results indicate that the proposed method shows good characteristics, and that neither ITT nor PP analyses can always guarantee the validity of the non‐inferiority conclusion. A Statistical Analysis System program for the implementation of the proposed test procedure is available from the authors upon request. Copyright © 2014 John Wiley & Sons, Ltd.     

A comparison of the results of intent‐to‐treat,per‐protocol,and g‐estimation in the presence of non‐random treatment changes in a time‐to‐event non‐inferiority trial

While intent‐to‐treat (ITT) analysis is widely accepted for superiority trials, there remains debate about its role in non‐inferiority trials. It has often been said that ITT analysis tends to be anti‐conservative in demonstrating non‐inferiority, suggesting that per‐protocol (PP) analysis may be preferable for non‐inferiority trials, despite the inherent bias of such analyses. We propose using randomization‐based g‐estimation analyses that more effectively preserve the integrity of randomization than do the more widely used PP analyses. Simulation studies were conducted to investigate the impacts of different types of treatment changes on the conservatism or anti‐conservatism of analyses using the ITT, PP, and g‐estimation methods in a time‐to‐event outcome. The ITT results were anti‐conservative for all simulations. Anti‐conservativeness increased with the percentage of treatment change and was more pronounced for outcome‐dependent treatment changes. PP analysis, in which treatment‐switching cases were censored at the time of treatment change, maintained type I error near the nominal level for independent treatment changes, whereas for outcome‐dependent cases, PP analysis was either conservative or anti‐conservative depending on the mechanism underlying the percentage of treatment changes. G‐estimation analysis maintained type I error near the nominal level even for outcome‐dependent treatment changes, although information on unmeasured covariates is not used in the analysis. Thus, randomization‐based g‐estimation analyses should be used to supplement the more conventional ITT and PP analyses, especially for non‐inferiority trials. Copyright © 2010 John Wiley & Sons, Ltd.     

Public‐private partnerships in non‐profit hospitals: Case study of China

The gap between supply and demand for health care services is expanding rapidly in China. In order to resolve this problem, the government has implemented supply‐side reforms in the health care sector by inviting private capital to increase supply quantity and improve quality. However, health care institutions have high complexity and particular needs, while non‐profit hospitals have very strong public interests. This gives rise to complications in the implementation of public‐private partnerships (PPPs) for health care services. In this paper, the authors have selected one case each from three different models of non‐profit hospital PPP projects in the national PPP project database, operated by the Ministry of Finance, and compared how these projects were operated to identify the differences among them. A content analysis of the vital project documents is the primary analysis technique used for this comparison. Key issues investigated include reasons for model selection, requirements for private sectors and market competition level in different models, risk identification and sharing, design of payment mechanism, operation supervision, and performance appraisal of the project. Based on the comparison, some key lessons and recommendations are discussed to act as a useful reference for future non‐profit hospital PPP projects in China.     

A causal model for longitudinal randomised trials with time‐dependent non‐compliance

In the presence of non‐compliance, conventional analysis by intention‐to‐treat provides an unbiased comparison of treatment policies but typically under‐estimates treatment efficacy. With all‐or‐nothing compliance, efficacy may be specified as the complier‐average causal effect (CACE), where compliers are those who receive intervention if and only if randomised to it. We extend the CACE approach to model longitudinal data with time‐dependent non‐compliance, focusing on the situation in which those randomised to control may receive treatment and allowing treatment effects to vary arbitrarily over time. Defining compliance type to be the time of surgical intervention if randomised to control, so that compliers are patients who would not have received treatment at all if they had been randomised to control, we construct a causal model for the multivariate outcome conditional on compliance type and randomised arm. This model is applied to the trial of alternative regimens for glue ear treatment evaluating surgical interventions in childhood ear disease, where outcomes are measured over five time points, and receipt of surgical intervention in the control arm may occur at any time. We fit the models using Markov chain Monte Carlo methods to obtain estimates of the CACE at successive times after receiving the intervention. In this trial, over a half of those randomised to control eventually receive intervention. We find that surgery is more beneficial than control at 6months, with a small but non‐significant beneficial effect at 12months. © 2015 The Authors. Statistics in Medicine Published by JohnWiley & Sons Ltd.     

How do people interpret information about colorectal cancer screening: observations from a think‐aloud study

Background

The English NHS Bowel Cancer Screening Programme biennially invites individuals aged 60–74 to participate in screening. The booklet, ‘Bowel Cancer Screening: The Facts'' accompanies this invitation. Its primary aim is to inform potential participants about the aims, advantages and disadvantages of colorectal cancer screening.

Objective

To provide detailed commentary on how individuals process the information contained within ‘The Facts’ booklet.

Design, setting and participants

This study comprised of 18 interviews with individuals aged 45–60 and used a ‘think‐aloud’ paradigm in which participants read aloud the booklet. Participant utterances (verbal statements made in response to researcher‐led prompts) were transcribed and analysed using a combination of content and thematic analysis.

Results

A total of 776 coded utterances were analysed (mean = 43.1 per person; range = 8–95). While overall comprehension was satisfactory, several problem areas were identified such as the use of complex unfamiliar terminology and the presentation of numerical information. Specific sections such as colonoscopy risk information evoked negative emotional responses. Participants made several suggestions for ways in which comprehension might be improved.

Conclusion

Public perceptions of the NHS Bowel Cancer Screening Programme information materials indicated that specific aspects of the booklet were difficult to process. These materials may be an appropriate target to improve public understanding of the aims, benefits and disadvantages of colorectal cancer screening. These findings will contribute to a broader NIHR‐funded project that aims to design a supplementary ‘gist‐based’ information leaflet suitable for low literacy populations.     

Attitudes and beliefs of non‐participants in a population‐based screening programme for colorectal cancer

Background

Uptake of colorectal cancer screening programmes needs to be improved or at least maintained in order to achieve projected reductions in mortality and morbidity. Understanding the origins of non‐participation in screening is therefore important.

Objective

To explore the beliefs and experiences of individuals who had not responded either to their screening invitation or reminder.

Design

A qualitative study using in‐depth interviews with non‐participants from England''s population‐based colorectal cancer screening programme. Data collection and analysis were carried out using a grounded theory approach, with an emphasis on the constant comparison method, and continued until saturation (27 interviews).

Findings

The interviews provided an in‐depth understanding of a range of reasons and circumstances surrounding non‐participation in screening, including contextual and environmental influences as well as factors specific to the screening test. Non‐participation in screening was not necessarily associated with negative attitudes towards screening or a decision to not return a kit. Reasons for non‐participation in screening included not feeling that participation is personally necessary, avoiding or delaying decision making, and having some degree of intention to take part but failing to do so because of practicalities, conflicting priorities or external circumstances. Beliefs, awareness and intention change over time.

Discussion and conclusions

A range of approaches may be required to improve screening uptake. Some non‐participants may already have a degree of intention to take part in screening in the future, and this group may be more responsive to interventions based on professional endorsement, repeat invitations, reminders and aids to making the test more practical.     

Testing for non‐random mating: evidence for ancestry‐related assortative mating in the Framingham heart study

Population stratification leads to a predictable phenomenon—a reduction in the number of heterozygotes compared to that calculated assuming Hardy‐Weinberg Equilibrium (HWE). We show that population stratification results in another phenomenon—an excess in the proportion of spouse‐pairs with the same genotypes at all ancestrally informative markers, resulting in ancestrally related positive assortative mating. We use principal components analysis to show that there is evidence of population stratification within the Framingham Heart Study, and show that the first principal component correlates with a North‐South European cline. We then show that the first principal component is highly correlated between spouses (r = 0.58, p = 0.0013), demonstrating that there is ancestrally related positive assortative mating among the Framingham Caucasian population. We also show that the single nucleotide polymorphisms loading most heavily on the first principal component show an excess of homozygotes within the spouses, consistent with similar ancestry‐related assortative mating in the previous generation. This nonrandom mating likely affects genetic structure seen more generally in the North American population of European descent today, and decreases the rate of decay of linkage disequilibrium for ancestrally informative markers. Genet. Epidemiol. 34: 674‐679, 2010. © 2010 Wiley‐Liss, Inc.