Integrating the patients' voice in designing and delivering a research study: The Yorkshire Cancer Research funded PREHABS study's experience.

INTRODUCTION: Engaging with patients when designing a clinical or research project is beneficial; feedback from the intended audience provides invaluable insight form the patients' perspective. Working with patients can result in developing successful research grants and interventions. The benefit of including the voice of the patient in the Yorkshire Cancer Research funded PREHABS study is described in this article. METHODS: Patients were included in the PREHABS study from inception to completion. The Theory of Change methodology was used to provide a framework to implement patient feedback to refine the study intervention. RESULTS: In total, 69 patients engaged with the PREHABS project. Two patients were recruited as co-applicants on the grant and were members on the Trial Management Group. Six patients attended the pre application workshop and provided feedback on their lived experiences of being a lung cancer patient. Commentary from the patients influenced the interventions selected and the design of the prehabs study. Following ethical approval (21/EE/0048) and informed written consent, 61 patients were recruited into the PREHABS study between October 2021 and November 2022. The breakdown of recruited patients was 19 males: mean age 69.1 years (SD 8.91) and 41 females; mean age 74.9 years (SD 8.9). CONCLUSION: It is practicable and beneficial to include patients at all stages of designing and delivering a research study. Patient feedback can help refine the study interventions to allow for maximum acceptance, recruitment and retention. IMPLICATIONS FOR PRACTICE: Including patients in the design of radiotherapy research studies can provide invaluable insight that can support the selection and delivery of interventions that are acceptable to the patient cohort.

'Warning: allergic to penicillin': association between penicillin allergy status in 2.3 million NHS general practice electronic health records, antibiotic prescribing and health outcomes.

BACKGROUND: The prevalence of reported penicillin allergy (PenA) and the impact these records have on health outcomes in the UK general population are unknown. Without such data, justifying and planning enhanced allergy services is challenging. OBJECTIVES: To determine: (i) prevalence of PenA records; (ii) patient characteristics associated with PenA records; and (iii) impact of PenA records on antibiotic prescribing/health outcomes in primary care. METHODS: We carried out cross-sectional/retrospective cohort studies using patient-level data from electronic health records. Cohort study: exact matching across confounders identified as affecting PenA records. Setting: English NHS general practices between 1 April 2013 and 31 March 2014. Participants: 2.3 million adult patients. Outcome measures: prevalence of PenA, antibiotic prescribing, mortality, MRSA infection/colonization and Clostridioides difficile infection. RESULTS: PenA prevalence was 5.9% (IQR = 3.8%-8.2%). PenA records were more common in older people, females and those with a comorbidity, and were affected by GP practice. Antibiotic prescribing varied significantly: penicillins were prescribed less frequently in those with a PenA record [relative risk (RR)  = 0.15], and macrolides (RR = 4.03), tetracyclines (RR = 1.91) nitrofurantoin (RR = 1.09), trimethoprim (RR = 1.04), cephalosporins (RR = 2.05), quinolones (RR = 2.10), clindamycin (RR = 5.47) and total number of prescriptions were increased in patients with a PenA record. Risk of re-prescription of a new antibiotic class within 28 days (RR = 1.32), MRSA infection/colonization (RR = 1.90) and death during the year subsequent to 1 April 2013 (RR = 1.08) increased in those with PenA records. CONCLUSIONS: PenA records are common in the general population and associated with increased/altered antibiotic prescribing and worse health outcomes. We estimate that incorrect PenA records affect 2.7 million people in England. Establishing true PenA status (e.g. oral challenge testing) would allow more people to be prescribed first-line antibiotics, potentially improving health outcomes.

Erratum to: The SABRTooth feasibility trial protocol: a study to determine the feasibility and acceptability of conducting a phase III randomised controlled trial comparing stereotactic ablative radiotherapy (SABR) with surgery in patients with peripheral stage I non-small cell lung cancer (NSCLC) considered to be at higher risk of complications from surgical resection.

[This corrects the article DOI: 10.1186/s40814-016-0046-2.].

The SABRTooth feasibility trial protocol: a study to determine the feasibility and acceptability of conducting a phase III randomised controlled trial comparing stereotactic ablative radiotherapy (SABR) with surgery in patients with peripheral stage I non-small cell lung cancer (NSCLC) considered to be at higher risk of complications from surgical resection.

BACKGROUND: Stage I non-small cell lung cancer (NSCLC) is potentially curable, and surgery is considered to be the standard of care for patients with good performance status and minimal co-morbidity. However, a significant proportion of patients with stage I NSCLC have a poorer performance status and significant medical co-morbidity that make them at higher risk of morbidity and mortality from surgery. Stereotactic ablative radiotherapy (SABR), which uses modern radiotherapeutic techniques to deliver large doses of radiation, has shown superiority over conventional radiotherapy in terms of local control and toxicity and is a standard of care for patients with stage I NSCLC who are at too high risk for surgery. However, it is not known whether surgery or SABR is the most effective in patients with stage I NSCLC who are suitable for surgery but are less fit and at higher risk surgical complications. Previous randomised studies have failed to recruit in this setting, and therefore, a feasibility study is required to see whether a full randomised control trial would be possible. METHODS/DESIGN: SABRTooth is a UK-based, multi-centre, open-label, two-group individually (1:1) randomised controlled feasibility study in patients with peripheral stage I NSCLC considered to be at higher risk from surgical resection. The study will assess the feasibility of conducting a definitive large-scale phase III trial. The primary objective is to assess recruitment rates to provide evidence that, when scaled up, recruitment to a large phase III trial would be possible; the target recruitment being 54 patients in total, over a 21-month period. There are multiple secondary and exploratory objectives designed to explore the optimum recruitment and data collection strategies to help optimise the design of a future phase III trial. DISCUSSION: To know whether SABR is a better, equivalent or inferior alternative to surgery for higher risk patients is a key question in lung cancer. Other studies comparing SABR to surgery have closed early due to poor recruitment, and therefore, the SABRTooth feasibility study has been designed around the UK National Health Service (NHS) cancer pathway incorporating many design features in order to maximise recruitment for a future definitive phase III trial. TRIAL REGISTRATION: controlled-trials.com ISRCTN13029788.

Acceptability of prenatal testing and termination of pregnancy in Pakistan.

This study aimed to assess acceptability of prenatal testing (PNT) and termination of pregnancy (TOP) for a range of conditions in Pakistani parents with and without a child with a genetic condition. A structured questionnaire assessing acceptability of PNT and TOP for 30 conditions was completed by 400 Pakistani participants: 200 parents with a child with a genetic condition (100 fathers and 100 mothers) and 200 parents without an affected child (100 fathers and 100 mothers). There was a high level of interest in PNT, where over 80 % of parents in all four study groups would want PNT for the majority of the conditions. There was comparatively less interest in TOP for the same conditions (ranging from 5 to 70 % of parents, with mothers of an affected child being most interested). Parents were most likely to be interested in TOP for conditions at the serious end of the continuum. More than half of the participants in each group would consider TOP for anencephaly and quadriplegia. The interest in PNT and TOP for a range of conditions suggests that rapidly developing PNT technologies are likely to be acceptable in Pakistan, a low-middle income level and Muslim country. The comparatively lower level of interest in TOP for the same conditions highlights ethical dilemmas that such technologies are likely to raise.

Understanding of and attitudes to genetic testing for inherited retinal disease: a patient perspective.

BACKGROUND/AIMS: The views of people with inherited retinal disease are important to help develop health policy and plan services. This study aimed to record levels of understanding of and attitudes to genetic testing for inherited retinal disease, and views on the availability of testing. METHODS: Telephone questionnaires comprising quantitative and qualitative items were completed with adults with inherited retinal disease. Participants were recruited via postal invitation (response rate 48%), approach at clinic or newsletters of relevant charitable organisations. RESULTS: Questionnaires were completed with 200 participants. Responses indicated that participants' perceived understanding of genetic testing for inherited retinal disease was variable. The majority (90%) considered testing to be good/very good and would be likely to undergo genetic testing (90%) if offered. Most supported the provision of diagnostic (97%) and predictive (92%) testing, but support was less strong for testing as part of reproductive planning. Most (87%) agreed with the statement that testing should be offered only after the individual has received genetic counselling from a professional. Subgroup analyses revealed differences associated with participant age, gender, education level and ethnicity (p<0.02). Participants reported a range of perceived benefits (eg, family planning, access to treatment) and risks (eg, impact upon family relationships, emotional consequences). CONCLUSIONS: Adults with inherited retinal disease strongly support the provision of publicly funded genetic testing. Support was stronger for diagnostic and predictive testing than for testing as part of reproductive planning.

What can qualitative research do for randomised controlled trials? A systematic mapping review.

OBJECTIVE: To develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. DESIGN: Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. DATA SOURCES: MEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. ELIGIBILITY CRITERIA: Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. RESULTS: 296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. CONCLUSIONS: A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit within their articles about the learning for trials and evidence-based practice.

Comparing medical versus surgical termination of pregnancy at 13-20 weeks of gestation: a randomised controlled trial.

OBJECTIVE: To compare the psychological impact, acceptability and clinical effectiveness of medical versus surgical termination of pregnancy (TOP) at 13-20 weeks of gestation. DESIGN: Randomised trial. SETTING: Large UK tertiary centre. SAMPLE: Women accepted for TOP at 13-20 weeks of gestation. METHODS: Medical TOP (MTOP) using mifepristone and misoprostol or surgical TOP (STOP) by vacuum aspiration at <15 weeks of gestation, and by dilatation and evacuation at 15 or more weeks of gestation. MAIN OUTCOME MEASURES: Distress 2 weeks after TOP, measured by the impact of events scale (IES), and acceptability, measured by the proportion of women who would opt for the same procedure again. RESULTS: One hundred and twenty two women were randomised: 60 to the MTOP group and 62 to the STOP group. Twelve women opted to continue their pregnancy. Follow-up rates were low (n=66/110; 60%). At 2 weeks post-procedure there was no difference in total IES score between groups. However, compared with women undergoing STOP, women undergoing MTOP had a higher score on the IES intrusion subscale (mean difference 6.6; 95% CI 1.4-11.8), and a higher score on the general health questionnaire (GHQ) (P=0.033). Women found STOP more acceptable: compared with MTOP, more women would opt for the same procedure again (100% versus 53%, P≤0.001), and fewer women found the experience to be worse than expected (0% versus 53%, P=0.001). Women who had MTOP experienced more bleeding (P=0.003), more pain on the day of the procedure (P=0.008), and more days of pain (P=0.020). Of the 107 women who declined to participate, 58 (67%) preferred a STOP. CONCLUSIONS: Randomised trials of women requesting midtrimester TOP are challenging. Women found STOP less painful and more acceptable than MTOP.

Randomised preference trial of medical versus surgical termination of pregnancy less than 14 weeks' gestation (TOPS).

OBJECTIVES: To determine the acceptability, efficacy and costs of medical termination of pregnancy (MTOP) compared with surgical termination of pregnancy (STOP) at less than 14 weeks' gestation, and to understand women's decision-making processes and experiences when accessing the termination service. DESIGN: A partially randomised preference trial and economic evaluation with follow-up at 2 weeks and 3 months. SETTING: The Royal Victoria Infirmary, Newcastle upon Tyne, UK. PARTICIPANTS: Women accepted for termination of pregnancy (TOP) under the relevant Acts of Parliament with pregnancies < 14 weeks' gestation on the day of abortion. A further group of women attending contraception and sexual health clinics participated in a discrete choice experiment (DCE). INTERVENTIONS: STOP: all women > or = 6 weeks' and < 14 weeks' gestation were primed with misoprostol 400 micrograms 2 hours before the procedure. STOP was performed under general anaesthesia using vacuum aspiration. MTOP: all women < 14 weeks' gestation were given mifepristone 200 milligrams orally, returning 36-48 hours later for misoprostol. OUTCOME MEASURES: Main outcome measure was acceptability of TOP method. Secondary outcome measures included strength of preference by willingness to pay (WTP); distress, using the Impact of Event Scale (IES); anxiety and depression; satisfaction with care; experience of care; frequency and extent of symptoms including self-assessment of pain; clinical effectiveness; and complications. A DCE was used to identify attributes that shape women's preferences for abortion services. RESULTS: The trial recruited 1877 women, 349 in the randomised arms and 1528 in the preference arms. Of those in the preference arms, 54% chose MTOP. At 2 weeks after the procedure more women having STOP would choose the same method again in the future. Acceptability of MTOP declined with increasing gestational age. The difference in acceptability between STOP and MTOP persisted at 3 months. At 2 weeks after TOP, women in the preference arms were prepared to pay more to have their preferred option. There was no difference in anxiety or depression scores in women having MTOP or STOP. However, women randomised to MTOP had higher scores on subscales of the IES at both 2 weeks and 3 months. There was no difference in IES scores between MTOP and STOP in the preference arm. Women were more likely to be satisfied overall and with technical and interpersonal aspects of care if they had STOP rather than MTOP. Experience of care scores were lower after MTOP in both randomised and preference arms. During admission women undergoing MTOP had more symptoms and reported higher mean pain scores, and after discharge reported more nausea and diarrhoea. There were no differences in time taken to return to work between groups; around 90% had returned to work and normal activity by 2 weeks. Rates of unplanned or emergency admissions were higher after MTOP than after STOP. Overall complication rates were also higher after MTOP, although this only achieved statistical significance in the preference arm. Overall, STOP cost more than MTOP due to higher inpatient standard costs. Even though complication rates were higher with MTOP, it was still more cost-effective. DCE identified three attributes with an almost equal impact on women's preferences: provision of counselling, number of days delay to the procedure, and possibility of an overnight stay. CONCLUSIONS: MTOP was associated with more negative experiences of care and lower acceptability. Acceptability of MTOP declined with increasing gestational age. MTOP was less costly but also less effective than STOP. The majority of women choosing MTOP were satisfied with their care and found the procedure acceptable. RECOMMENDATIONS FOR FURTHER RESEARCH: An audit of provision of MTOP and STOP in England and Wales is urgently required. Further studies exploring the barriers to offering women the choice of method of TOP are needed, together with research on the acceptability and effectiveness of (1) MTOP and manual VA in pregnancies below 9 weeks' gestation and (2) MTOP and dilatation and evacuation after 14 weeks' gestation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN07823656.

Decision making about reproduction and pregnancy by women with cystic fibrosis.

With significant improvements in longevity, women with cystic fibrosis are increasingly likely to consider pregnancy and parenthood. This article reviews the literature relating to medical and psychosocial research that informs the decision-making process these women undertake.

Attitudes to prenatal testing and termination of pregnancy in Saudi Arabia.

OBJECTIVE: To assess the attitudes of Saudi parents towards prenatal diagnosis and termination of pregnancy for a range of different genetic disorders. METHODS: Two hundred Saudi parents (100 fathers and 100 mothers) completed a structured questionnaire which sought their views about each of 30 different conditions. RESULTS: The great majority of people would consider a termination of pregnancy for at least one of the conditions studied. Mothers and fathers held similar attitudes towards prenatal diagnosis, but mothers' attitudes towards termination of pregnancy were more favourable. Parents' collective attitudes towards prenatal diagnosis and towards termination of pregnancy were correlated. CONCLUSIONS: Saudi parents are favourably inclined towards prenatal diagnosis, and consider termination of pregnancy to be acceptable for some conditions. New technologies provide parents with more reproductive choices but also present them with more dilemmas.

Consent gained from patients after breast surgery for the use of surplus tissue in research: an exploration.

OBJECTIVES: (1) To investigate the quality of consent gained for the use in research of tissue that is surplus after surgery. (2) To compare the use of two consent forms: a simple locally introduced form and a more complex centrally instigated form. (3) To discuss the attitudes of patients towards the use of their surplus tissue in research. DESIGN: Data were collected through interviews and analysed with a combination of quantitative and qualitative analytical techniques. PARTICIPANTS AND SETTING: Patients of the breast care unit at a teaching hospital were interviewed at home or in a quiet room at the hospital. RESULTS: 57 people were interviewed out of 81 approached, between October 2003 and March 2004. Most participants had a poor level of knowledge about the consent they had given, but reported being happy about having given it. The patients who had signed the locally introduced form had considerably more knowledge than those who had signed the centrally instigated form (z = -2.56; p<0.05). Participants considered being well informed to be less important than believing that their opinions were valued and respected. CONCLUSIONS: The findings suggest that traditional models of informed consent are not universally applicable and, in this case, seem to overstate what people wish to know. The simple consent form achieved a better quality of informed consent and provided a better model of practice than the complex form, and it seemed that a focused approach to consent seeking is more effective and acceptable than more complex approaches.

A randomised trial of two methods of issuing prenatal test results: the ARIA (Amniocentesis Results: Investigation of Anxiety) trial.

BACKGROUND: Many pregnant women experience anxiety while waiting for the results of diagnostic tests. Policies and practices intended to reduce this anxiety require evaluation. OBJECTIVES: To test the following two hypotheses: * That giving amniocentesis results out on a fixed date alters maternal anxiety during the waiting period, compared with a policy of telling parents that the result will be issued "when available" (i.e. variable date). * That issuing early results from a rapid molecular test alters maternal anxiety during the waiting period, compared with not receiving any results prior to the karyotype. The effects of the two interventions on anxiety 1 month after receiving karyotype results were also examined. DESIGN: A multicentre, randomised, controlled, open fixed sample, 2 x 2 factorial design trial, with equal randomisation. SETTING: The prenatal diagnosis clinics in 12 hospitals in England offering amniocentesis as a diagnostic test for Down's syndrome. SAMPLE: Two hundred and twenty-six women who had had an amniocentesis were randomised between June 2002 and July 2004. Eight women with abnormal results or test failure were excluded post-randomisation. INTERVENTIONS: Issuing karyotype results on a prespecified fixed date, rather than issuing them as soon as they became available. Issuing karyotype results alone, or subsequent to issuing results from a rapid molecular test for the most common chromosomal abnormalities. MAIN OUTCOME MEASURES: Average anxiety during the waiting period, calculated using daily scores from the short version of the Spielberger State-Trait Anxiety Inventory (STAI). Anxiety 1 month after receiving karyotype results, measured using the short form STAI. RESULTS: Issuing early results from a partial but rapid test reduced maternal anxiety by a clinically significant amount during the waiting period (mean daily score 12.5 versus 14.8; scale score difference -2.36, 95% CI -1.2, -3.6), compared with receiving only the full karyotype results. There was no evidence that giving out karyotype results on a fixed or on a variable date altered maternal anxiety during the waiting period (mean daily score 13.2 versus 14.2; scale score difference -1.02, 95% CI -2.2, 0.2). One month after receiving normal karyotype results, anxiety was low in all groups, but women who had been given rapid test results tended to be more anxious than those who had not (mean single day score 9.2 versus 8.3; mean scale score difference 0.95, 95% CI -0.03, 1.9). This small to moderate effect did not reach conventional levels of statistical significance. CONCLUSIONS: Rapid testing was a beneficial addition to karyotyping, at least in the short term. This does not necessarily imply that early results would be preferred to comprehensive ones if women had to choose between them. Because there are no clear advantages in anxiety terms of issuing karyotype results as soon as they become available, or on a fixed date, women could be given a choice between them.

Amniocentesis results: investigation of anxiety. The ARIA trial.

OBJECTIVES: The Amniocentesis Results: Investigation of Anxiety (ARIA) trial tested two hypotheses: first, that giving amniocentesis results out on a fixed date alters maternal anxiety during the waiting period, compared with a policy of telling parents that the result will be issued 'when available' (i.e. a variable date), and secondly, that issuing early results from a rapid molecular test alters maternal anxiety during the waiting period, compared with not receiving any results prior to the karyotype. The effects of the two interventions on anxiety 1 month after receiving karyotype results were also examined. DESIGN: A multi-centre, randomised, controlled, open fixed sample, 2 x 2 factorial design trial, with equal randomisation. SETTING: Twelve hospitals in England offering amniocentesis as a diagnostic test for Down's syndrome. PARTICIPANTS: A total of 226 women who had had an amniocentesis were randomised between June 2002 and July 2004. Eight women with abnormal results or test failure were excluded post-randomisation. INTERVENTIONS: Issuing karyotype results on a prespecified fixed date, rather than issuing them as soon as they became available and issuing karyotype results alone, or subsequent to issuing results from a rapid molecular test for the most common chromosomal abnormalities. MAIN OUTCOME MEASURES: Average anxiety during the waiting period, calculated using daily scores from the short version of the Spielberger State-Trait Anxiety Inventory (STAI). Recalled anxiety, measured 1 month after receiving karyotype results, using a rating scale. Anxiety at the 1-month follow-up, measured using the short-form STAI. RESULTS: There was no evidence that giving out karyotype results on a fixed or on a variable date altered maternal anxiety during the waiting period. However, the analysis only had sufficient power to detect a moderate to large effect. Issuing early results from a partial, but rapid, test reduced maternal anxiety during the waiting period, compared with receiving only the full karyotype results. This was a moderate to large effect. In addition, group differences in recalled anxiety reflected fairly closely the differences in anxiety women had experienced while waiting for results. One month after receiving normal karyotype results, anxiety was low in all groups, but women who had been given rapid test results were more anxious than those who had not. This was a small to moderate effect. CONCLUSIONS: Since there are no clear advantages in anxiety terms of issuing karyotype results as soon as they become available, or on a fixed date, women could be given a choice between them. Rapid testing was a beneficial addition to karyotyping, at least in the short term. This does not necessarily imply that early results would be preferred to comprehensive ones if women had to choose between them. There should be further research, including more qualitative studies, into the causes, characteristics and consequences of anxiety associated with prenatal testing. The effects of different testing regimes on short- and long-term anxiety, on the preferences of women and on the relationship between anxiety and preference should be investigated. More research is needed on the ways in which information might be used to minimise anxiety in different testing regimes. Further research is also required into the policy implications of incorporating individual preferences for different testing regimes into prenatal testing programmes.

Attitudes to prenatal and preimplantation diagnosis in Saudi parents at genetic risk.

BACKGROUND: Prenatal diagnosis (PND) is only available for severe abnormality in Saudi Arabia, and preimplantation genetic diagnosis (PGD) has been proposed as a valuable alternative. The acceptability of PGD is unexplored, and may ultimately determine the value of this technology in Saudi Arabia. This study reports attitudes towards PND and PGD of Saudi couples offered genetic counselling following the birth of a child with a single gene or chromosomal condition. METHODS: Thirty couples attending the King Faisal Specialist Hospital and Research Centre in Riyadh were interviewed using a semi-structured questionnaire. One couple had previous experience of PND and none had experience of PGD or IVF. RESULTS: Eight of the 30 couples (27%) would only accept PGD; four (13%) only PND; three (10%) either technology; the remainder would accept neither test, or were unsure. The main concerns of those who would accept neither technology were related to personal religious views. Specific concerns about PGD related to the IVF procedure, the risk of multiple pregnancies, the chance of mistakes and the chance of not getting pregnant. A high proportion of couples (six out of seven; 86%) who had a child with thalassaemia expressed interest in PGD, and all would be prepared to use technology to avoid having an affected child. Views were more mixed for the other conditions. CONCLUSION: PGD is acceptable to many couples and for some, it represents a valuable alternative to PND. However, parents' concerns are complex, and the acceptability of different reproductive technologies must be established on an individual basis.

How should we measure informed choice? The case of cancer screening.

Informed choice is increasingly recognised as important in supporting patient autonomy and ensuring that people are neither deceived nor coerced. In cancer screening the emphasis has shifted away from just promoting the benefits of screening to providing comprehensive information to enable people to make an informed choice. Cancer screening programmes in the UK now have policies in place which state that it is their responsibility to ensure that individuals are making an individual informed choice. There is a need to evaluate whether such policies mean that those people invited for screening are making informed choices, and how comprehensive information affects other variables such as uptake, cost effectiveness, and satisfaction. At the present time, there is no validated measure of informed choice in cancer screening. Such a measure could be used to evaluate the effectiveness of interventions to increase informed choice and levels of informed choice in a population invited for screening. It could encourage health professionals to be accountable. Factors important when measuring informed choice in cancer screening include an individual's understanding of the limitations of screening, the ability to make an autonomous choice, and the difference between choice and behaviour.

Psychosocial aspects of genetic screening of pregnant women and newborns: a systematic review.

OBJECTIVES: To address five broad questions concerned with knowledge, anxiety, factors associated with participation/non-participation in screening programmes and the long-term sequelae of false-positive, true-positive in newborns and true-negative results. DATA SOURCES: Five electronic databases, two journals and attempts were made to locate unpublished work. REVIEW METHODS: This review started from a substantial literature base that provided the basis for (a) scoping the literature, (b) informing search strategy terms and (c) identifying preliminary article inclusion and exclusion criteria. The main eligibility criteria were: any screening programme aimed at pregnant women or newborn babies that included a 'genetic' target condition, this included chromosomal anomalies; any study that reported psychosocial data collected directly from parents. The data extraction form developed for this study elicited data from the selected studies. The data were entered into a database, which provided a summary of the included papers. RESULTS: A total of 288 candidate publications were identified, 106 of which were eligible: 78 were concerned with antenatal screening and 28 with newborn screening. It was found that levels of knowledge adequate for decision-making were not being achieved despite information leaflets and videos having some effect. Studies that have succeeded in increasing knowledge have not observed a corresponding increase in anxiety, although some anxiety might be an appropriate response and may aid coping and decision-making. Anxiety is clearly raised in women receiving positive screening results, especially young women. However, evidence is lacking of a beneficial (i.e. reassuring) effect of receiving a screen-negative result. Anxiety in screen-positive women falls on receipt of subsequent reassuring results, but some residual anxiety may remain. A minority (perhaps up to 30%) of women receiving a screen-positive result in pregnancy expressed regret about their screening decision. Uptake of neonatal screening has been treated as a 'given' and not as a research topic. CONCLUSIONS: The results of this review have many implications for the work of the National Screening Committee. The most pressing of these, in order of priority, relate to: the inadequacy of current procedures for achieving informed consent; the cost of providing a satisfactory service; the unmet needs of 'false-positives', and the unmet needs of women's partners, particularly in carrier screening. It is suggested that research is conducted on the above four topics in order to fill gaps in the evidence base that relate to screening technologies which have been available for many years. In addition, future screening programmes will create a new list of research questions, based on the same main agenda but applied to new areas, for example, new conditions such as haemoglobinopathies and fragile X syndrome; new client groups such as young women and minority ethnic groups; and new testing modalities such as ultrasound.