United Kingdom: transfers of genomic data to third countries.

In the United Kingdom (UK), transfer of genomic data to third countries is regulated by data protection legislation. This is a composite of domestic and European Union (EU) law, with EU law to be adopted as domestic law when Brexit takes place. In this paper we consider the content of data protection legislation and the likely impact of Brexit on transfers of genomic data from the UK to other countries. We examine the advice by regulators not to rely upon consent as a lawful basis for processing under data protection law, at least not when personal data are used for research purposes, and consider some of the other ways in which the research context can qualify an individual's ability to exercise control over processing operations. We explain how the process of pseudonymization is to be understood in the context of transfer of genomic data to third parties, as well as how adequacy of data protection in a third country is to be determined in general terms. We conclude with reflections on the future direction of UK data protection law post Brexit with the reclassification of the UK itself as a third country.

Audio-visual presentation of information for informed consent for participation in clinical trials.

BACKGROUND: Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented for example on the Internet, DVD, or video cassette) are one such method. OBJECTIVES: To assess the effects of providing audio-visual information alone, or in conjunction with standard forms of information provision, to potential clinical trial participants in the informed consent process, in terms of their satisfaction, understanding and recall of information about the study, level of anxiety and their decision whether or not to participate. SEARCH STRATEGY: We searched: the Cochrane Consumers and Communication Review Group Specialised Register (searched 20 June 2006); the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 2, 2006; MEDLINE (Ovid) (1966 to June week 1 2006); EMBASE (Ovid) (1988 to 2006 week 24); and other databases. We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or oral information as usually employed in the particular service setting), with standard forms of information provision alone, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to participate in a real (not hypothetical) clinical study. DATA COLLECTION AND ANALYSIS: Two authors independently assessed studies for inclusion and extracted data. Due to heterogeneity no meta-analysis was possible; we present the findings in a narrative review. MAIN RESULTS: We included 4 trials involving data from 511 people. Studies were set in the USA and Canada. Three were randomised controlled trials (RCTs) and the fourth a quasi-randomised trial. Their quality was mixed and results should be interpreted with caution. Considerable uncertainty remains about the effects of audio-visual interventions, compared with standard forms of information provision (such as written or oral information normally used in the particular setting), for use in the process of obtaining informed consent for clinical trials. Audio-visual interventions did not consistently increase participants' levels of knowledge/understanding (assessed in four studies), although one study showed better retention of knowledge amongst intervention recipients. An audio-visual intervention may transiently increase people's willingness to participate in trials (one study), but this was not sustained at two to four weeks post-intervention. Perceived worth of the trial did not appear to be influenced by an audio-visual intervention (one study), but another study suggested that the quality of information disclosed may be enhanced by an audio-visual intervention. Many relevant outcomes including harms were not measured. The heterogeneity in results may reflect the differences in intervention design, content and delivery, the populations studied and the diverse methods of outcome assessment in included studies. AUTHORS' CONCLUSIONS: The value of audio-visual interventions for people considering participating in clinical trials remains unclear. Evidence is mixed as to whether audio-visual interventions enhance people's knowledge of the trial they are considering entering, and/or the health condition the trial is designed to address; one study showed improved retention of knowledge amongst intervention recipients. The intervention may also have small positive effects on the quality of information disclosed, and may increase willingness to participate in the short-term; however the evidence is weak. There were no data for several primary outcomes, including harms. In the absence of clear results, triallists should continue to explore innovative methods of providing information to potential trial participants. Further research should take the form of high-quality randomised controlled trials, with clear reporting of methods. Studies should conduct content assessment of audio-visual and other innovative interventions for people of differing levels of understanding and education; also for different age and cultural groups. Researchers should assess systematically the effects of different intervention components and delivery characteristics, and should involve consumers in intervention development. Studies should assess additional outcomes relevant to individuals' decisional capacity, using validated tools, including satisfaction; anxiety; and adherence to the subsequent trial protocol.

Contracts between patients and healthcare practitioners for improving patients' adherence to treatment, prevention and health promotion activities.

BACKGROUND: Contracts are a verbal or written agreement that a patient makes with themselves, with healthcare practitioners, or with carers, where participants commit to a set of behaviours related to the care of a patient. Contracts aim to improve the patients' adherence to treatment or health promotion programmes. OBJECTIVES: To assess the effects of contracts between patients and healthcare practitioners on patients' adherence to treatment, prevention and health promotion activities, the stated health or behaviour aims in the contract, patient satisfaction or other relevant outcomes, including health practitioner behaviour and views, health status, reported harms, costs, or denial of treatment as a result of the contract. SEARCH STRATEGY: We searched: the Cochrane Consumers and Communication Review Group's Specialised Register (in May 2004); the Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library 2004, issue 1); MEDLINE 1966 to May 2004); EMBASE (1980 to May 2004); PsycINFO (1966 to May 2004); CINAHL (1982 to May 2004); Dissertation Abstracts. A: Humanities and Social Sciences (1966 to May 2004); Sociological Abstracts (1963 to May 2004); UK National Research Register (2000 to May 2004); and C2-SPECTR, Campbell Collaboration (1950 to May 2004). SELECTION CRITERIA: We included randomised controlled trials comparing the effects of contracts between healthcare practitioners and patients or their carers on patient adherence, applied to diagnostic procedures, therapeutic regimens or any health promotion or illness prevention initiative for patients. Contracts had to specify at least one activity to be observed and a commitment of adherence to it. We included trials comparing contracts with routine care or any other intervention. DATA COLLECTION AND ANALYSIS: Selection and quality assessment of trials were conducted independently by two review authors; single data extraction was checked by a statistician. We present the data as a narrative summary, given the wide range of interventions, participants, settings and outcomes, grouped by the health problem being addressed. MAIN RESULTS: We included thirty trials, all conducted in high income countries, involving 4691 participants. Median sample size per group was 21. We examined the quality of each trial against eight standard criteria, and all trials were inadequate in relation to three or more of these standards. Trials evaluated contracts in addiction (10 trials), hypertension (4 trials), weight control (3 trials) and a variety of other areas (13 trials). Sixteen trials reported at least one outcome that showed statistically significant differences favouring the contracts group, five trials reported at least one outcome that showed differences favouring the control group and 26 trials reported at least one outcome without differences between groups. Effects on adherence were not detected when measured over longer periods. AUTHORS' CONCLUSIONS: There is limited evidence that contracts can potentially contribute to improving adherence, but there is insufficient evidence from large, good quality studies to routinely recommend contracts for improving adherence to treatment or preventive health regimens.

Interventions for improving communication with children and adolescents about a family member's cancer.

BACKGROUND: A diagnosis of cancer creates multiple problems for affected families, including major changes in living patterns, roles and relationships. It has not been common practice for families and health practitioners to share information with children or adolescents about a family member's cancer, or to allow them to express their feelings about this. In recent years, however, researchers and practitioners have begun to recognise that children and adolescents might appreciate and benefit by being better informed about, and having more opportunity to communicate their responses to, cancer in the family. OBJECTIVES: To examine the effects of different ways of enhancing communication with children and/or adolescents about a family member's cancer and its treatment. SEARCH STRATEGY: We searched the following sources: Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, Issue 1 2003; MEDLINE (1966 to January week 2 2003); EMBASE (1985 to 2003 week 6); CINAHL (1982 to February Week 1 2003); ERIC (1966 to 23 January 2003); PsycINFO (1985 to February week 1 2003). For the original (1999) version of this review we also searched the following databases: CancerLIT, Health Management Information Consortium, British Nursing Index, IAC Health & Wellness, JICSTE-Plus, Pascal, Linguistics and Language Behavior Abstracts, Mental Health Abstracts, AMED, HUMN, MANTIS and ASSIA. Bibliographies of identified studies were also checked and contact made with experts in the field. SELECTION CRITERIA: Randomised and non-randomised controlled trials, and controlled and uncontrolled before and after studies that evaluated the effects of interventions to enhance communication with children and/or adolescents about a family member's cancer and its treatment. DATA COLLECTION AND ANALYSIS: Data on knowledge and understanding, coping, adjustment and wellbeing were extracted by one reviewer and checked by another reviewer. Study quality was assessed using six criteria. A qualitative synthesis of the results is presented. MAIN RESULTS: Five studies satisfied the selection criteria: one non-randomised controlled before and after study, and four uncontrolled before and after studies. They differed in terms of the interventions evaluated and the outcomes measured. One study of a camping program and two studies of structured group interventions reported improvements in cancer-related knowledge. One out of two structured group intervention studies found significant reductions in psychological and social problems. The camping program study reported significant improvements in siblings' behaviour. One structured group intervention study reported significantly more positive mood states after the intervention. Another structured group intervention study reported significantly lower levels of anxiety after the intervention. REVIEWER'S CONCLUSIONS: Different methods of communicating with children and adolescents about a family member's cancer have not been widely evaluated in controlled trials. There is weak evidence to suggest that some interventions, such as structured group interventions, may lead to improvements in knowledge and understanding, in coping, anxiety, adjustment and wellbeing. More research is needed to investigate the comparative value of these interventions.

Interventions for improving communication with children and adolescents about their cancer.

BACKGROUND: Communication with children and adolescents with cancer about their disease and treatment and the implications of these is an important aspect of good quality care. It is often poorly performed in practice. Various interventions have been developed that aim to enhance communication involving children or adolescents with cancer. OBJECTIVES: To examine the effects of interventions to enhance communication with children and/or adolescents about their cancer, its treatment and their implications. SEARCH STRATEGY: We searched the following sources: Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, Issue 1 2003; MEDLINE (1966 to January week 2 2003); EMBASE (1985 to 2003 week 4); CINAHL (1982 to December week 4 2002); Dissertation Abstracts (1861 to January 2003); ERIC (1966 to January 2003); PsycINFO (1985 to January week 4 2003); Sociological Abstracts (1963 to January 2003).For the initial (2001) publication of this review we also searched the following databases: PsycLIT; Cancerlit;; Sociofile; Health Management Information Consortium; ASSIA; LISA; PAIS; Information Science Abstracts; JICST; Pascal; Linguistics and Language Behavior Abstracts; Mental Health Abstracts; AMED; MANTIS. We also searched the bibliographies of studies assessed for inclusion, and contacted experts in the field. SELECTION CRITERIA: Randomised and non-randomised controlled trials and before and after studies that evaluated the effects of interventions to enhance communication with children and/or adolescents about their cancer, treatment and related issues. DATA COLLECTION AND ANALYSIS: Data relating to the interventions, populations and outcomes studied and the design and methodological quality of included studies were extracted by one reviewer and checked by another reviewer. A narrative summary of the results is presented. MAIN RESULTS: Nine studies met the criteria for inclusion. They were diverse in terms of the interventions evaluated, study designs used, types of people who participated and the outcomes measured. One study of a computer-assisted education programme reported improvements in knowledge and understanding about blood counts and cancer symptoms. One study of a CD-ROM about leukemia reported an improvement in children's feelings of control over their health. One study of art therapy as support for children during painful procedures reported an increase in positive, collaborative behaviour. Two out of two studies of school reintegration programs reported improvements in some aspects of psychosocial wellbeing (one in anxiety and one in depression), social wellbeing (two in social competence and one in social support) and behavioural problems; and one reported improvements in physical competence. REVIEWER'S CONCLUSIONS: Interventions to enhance communication involving children and adolescents with cancer have not been widely or rigorously assessed. The weak evidence that exists suggests that some children and adolescents with cancer may derive some benefit from specific information-giving programs and from interventions that aim to facilitate their reintegration into school and social activities. More research is needed to investigate the effects of these and other related interventions.

Recordings or summaries of consultations for people with cancer.

BACKGROUND: Many people find it difficult to remember information provided during medical consultations. One way of improving this may be to provide a record of the conversation. OBJECTIVES: This review examined the effects of providing recordings or summaries of their consultations to people with cancer and their families. SEARCH STRATEGY: We searched the following sources: The Cochrane Library (issue 4 2002); MEDLINE (1966 to January week 1 2003); CINAHL (1982 to December week 4 2002); Dissertation Abstracts (1861 to week 2 2003); EMBASE (1985 to week 2 2003); PsycINFO (1967 to January week 2 2003); AMED (1985 to December 2002); and Sociological Abstracts (1998 to week 2 2003). For the initial (1999) publication of this review we also searched the following databases: Sociofile; Cancerlit; IAC Health & Wellness; JICST; Pascal; ERIC; ASSIA; Linguistics and Language Behavior Abstracts; Mental Health Abstracts; CAB Health; DHSS-Data; MANTIS. SELECTION CRITERIA: Randomised and non-randomised controlled trials that evaluate the effects of providing recordings (e.g. audiotapes) or summaries (e.g. letter with reminders of key points) of consultations to people with cancer or their families. Two reviewers assessed studies for inclusion. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer and checked by another reviewer. The quality of studies was assessed on six criteria. MAIN RESULTS: Twelve studies satisfied the selection criteria. All involved adult participants. The studies did not all measure similar outcomes. In seven studies, between 83% and 96% of participants found recordings or summaries of their consultations valuable. Five out of nine studies reported better recall of information for those receiving recordings or summaries. Four out of seven studies found that participants provided with a recording or summary were more satisfied with the information received. No studies (out of seven) found any statistically significant effect on anxiety or depression. One study evaluated the effects on quality of life, but found no main effects. No study evaluated the effects on survival. REVIEWER'S CONCLUSIONS: The provision of recordings or summaries of key consultations may benefit most adults with cancer. Although more research is needed to improve our understanding of these interventions, most patients find them very useful. Practitioners should consider offering people tape recordings or written summaries of their consultations