A qualitative process evaluation within a clinical trial that used healthcare technologies for children with asthma-insights and implications.

Background: Healthcare technologies are becoming more commonplace, however clinical and patient perspectives regarding the use of technology in the management of childhood asthma have yet to be investigated. Within a clinical trial of asthma management in children, we conducted a qualitative process evaluation that provided insights into the experiences and perspectives of healthcare staff and families on (i) the use of smart inhalers to monitor medication adherence and (ii) the use of algorithm generated treatment recommendations.

Methods: We interviewed trial staff (n = 15) and families (n = 6) who were involved in the trial to gauge perspectives around the use of smart inhalers to monitor adherence and the algorithm to guide clinical decision making.

The relative importance of information items and preferred mode of delivery when disseminating results from trials to participants: A mixed-methods study.

Background: Participants want to receive the results of trials that they have participated in. Dissemination practices are disparate, and there is limited guidance available on what information to provide to participants and how to deliver it.

Objectives: This study aimed to establish what trial participants believe should be included in a results summary and how this information should be delivered.

Five-Year Outcomes of a Randomized Trial of Treatments for Varicose Veins.

Background: Endovenous laser ablation and ultrasound-guided foam sclerotherapy are recommended alternatives to surgery for the treatment of primary varicose veins, but their long-term comparative effectiveness remains uncertain.

Methods: In a randomized, controlled trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of laser ablation, foam sclerotherapy, and surgery. Primary outcomes at 5 years were disease-specific quality of life and generic quality of life, as well as cost-effectiveness based on models of expected costs and quality-adjusted life-years (QALYs) gained that used data on participants' treatment costs and scores on the EuroQol EQ-5D questionnaire.

Estimating Site Performance (ESP): can trial managers predict recruitment success at trial sites? An exploratory study.

Background: Multicentre randomised trials provide some of the key evidence underpinning healthcare practice around the world. They are also hard work and generally expensive. Some of this work and expense are devoted to sites that fail to recruit as many participants as expected.

The influence of early research experience in medical school on the decision to intercalate and future career in clinical academia: a questionnaire study.

Background: Currently, only one in three UK medical students undertake an intercalated degree. This has often been implicated as a result of financial obstacles or a lack of interest in research due to inadequate exposure to academic medicine. The aims of this study were to determine whether exposure to research early in medical school, through the initiation of an early years clinical academic training programme has a positive influence on the decision-making related to intercalating and a career long interest in research.

Decision aids for people considering taking part in clinical trials.

Background: Several interventions have been developed to promote informed consent for participants in clinical trials. However, many of these interventions focus on the content and structure of information (e.g.

SMS text pre-notification and delivery of reminder e-mails to increase response rates to postal questionnaires in the SUSPEND trial: a factorial design, randomised controlled trial.

Background: Patient-reported outcomes are vital in informing randomised controlled trials (RCTs) and health-care interventions and policies from the patient's perspective. However, participant non-response may introduce bias and can affect the generalisability of the trial. This study evaluates two interventions aimed at increasing response rates to postal questionnaires within a large, UK-wide RCT: pre-notification via short messenger service (SMS) text prior to sending the initial mailing of trial questionnaires versus no pre-notification; for non-responders to the initial mailing of the questionnaires, an e-mail reminder (containing a hyperlink to complete the questionnaire online) versus a postal reminder.

Long-Term Worries after Colposcopy: Which Women Are at Increased Risk?

Background: A colposcopy examination is the main management option for women with an abnormal cervical screening test result. Although some women experience adverse psychological effects after colposcopy, those at greatest risk are unknown. We investigated predictors of worries about cervical cancer, sex, future fertility and general health during 12 to 30 months after colposcopy.

Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial.

Background: Foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins, but uncertainty exists regarding their effectiveness in the medium to longer term.

Objectives: To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins.

Design: A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation.

A randomized trial comparing treatments for varicose veins.

Background: Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain.

Methods: In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales.

Measuring the psychosocial burden in women with low-grade abnormal cervical cytology in the TOMBOLA trial: psychometric properties of the Process and Outcome Specific Measure (POSM).

Background: There is a need for an instrument to measure the psychosocial burden of receiving an abnormal cervical cytology result which can be used regardless of the clinical management women receive.Methods: 3331 women completed the POSM as part of baseline psychosocial assessment in a trial of management of low grade cervical cytological abnormalities. Factor analysis and reliability assessment of the POSM were conducted.

Postcolposcopy management of women with histologically proven CIN 1: results from TOMBOLA.

Objectives: This study aimed to determine during 36 months of follow-up the (1) clinical outcomes and (2) influence of high-risk human papillomavirus (HPV) status on the risk of progression to cervical intraepithelial neoplasia 2+ (CIN 2+), among women with histologically proven CIN 1.

Materials And Methods: This is an ad hoc analysis of women with CIN 1 within TOMBOLA, a randomized trial of the management of women with low-grade cervical cytology. Women from the colposcopy arm with CIN 1 confirmed on punch biopsies and managed conservatively by cytology every 6 months in primary care were included.

Protocol: does sodium nitrite administration reduce ischaemia-reperfusion injury in patients presenting with acute ST segment elevation myocardial infarction? Nitrites in acute myocardial infarction (NIAMI).

Background: Whilst advances in reperfusion therapies have reduced early mortality from acute myocardial infarction, heart failure remains a common complication, and may develop very early or long after the acute event. Reperfusion itself leads to further tissue damage, a process described as ischaemia-reperfusion-injury (IRI), which contributes up to 50% of the final infarct size. In experimental models nitrite administration potently protects against IRI in several organs, including the heart.

Impact of alternative management policies on health-related quality of life in women with low-grade abnormal cervical cytology referred for colposcopy.

Objective: To assess the health-related quality of life (HRQoL) over 30 months among women who received colposcopy following low-grade abnormal cervical cytology.

Design: 751 women with low-grade abnormal cytology were seen for colposcopy. Of these, 350 additionally underwent either immediate treatment by large loop excision of the transformation zone (LLETZ) or investigation by punch biopsy followed by treatment of high-grade cervical intraepithelial neoplasia if present.

A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery--the FOCCUS study.

Introduction: Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery.

Methods: This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial.

Human papillomavirus infection and anxiety: analyses in women with low-grade cervical cytological abnormalities unaware of their infection status.

Background: Women testing positive for human papillomavirus (HPV) infection experience increased levels of anxiety that have been attributed to fears of stigmatization and developing cervical cancer. The objective of this study was to investigate the association between HPV infection and anxiety in women who were unaware they had been tested specifically for HPV, to determine if any anxiety experienced by HPV-positive women could be due to causes other than learning of test results.

Methods: This study was nested within a randomised controlled trial of management of women with abnormal cervical cytology conducted in the United Kingdom with recruitment between 1999 and 2002.

Polymorphisms in the methylenetetrahydrofolate reductase (MTHFR) gene, intakes of folate and related B vitamins and colorectal cancer: a case-control study in a population with relatively low folate intake.

Folate is key in one-carbon metabolism, disruption of which can interfere with DNA synthesis, repair, and methylation. Efficient one-carbon metabolism requires other B vitamins and the optimal activity of enzymes including 5,10-methylenetetrahydrofolate reductase (MTHFR). We report a population-based case-control study of folate intake, related dietary factors and MTHFR polymorphisms (C677T, A1298C) and colorectal cancer in a population with relatively high colorectal cancer incidence and relatively low folate intake.

United Kingdom cervical cancer screening and the costs of time and travel.

Objectives: The aim of this study was to estimate the time and travel costs generated by women when attending for Papanicolaou (Pap) smear tests or colposcopy appointments in the United Kingdom, both absolutely and relative to the health service cost of the national cervical cancer screening programs.

Methods: Data were obtained from questionnaires completed by two samples of women participating in a three-center trial of management of low-grade abnormalities detected by screening (n = 1,106 for Pap smears and n = 1,203 for colposcopy appointments). Women were 20 to 59 years of age and resident in Grampian or Tayside, Scotland, or Nottingham, England.

Colorectal cancer and genetic polymorphisms of CYP1A1, GSTM1 and GSTT1: a case-control study in the Grampian region of Scotland.

Cytochrome P-450 CYP1A1 is involved in the metabolism of polycyclic aromatic hydrocarbons (PAHs) that are derived from meat intake and tobacco smoking. Expression of the CYP1A1 gene is induced by compounds present in cruciferous vegetables. The glutathione S-transferases play a central role in the detoxification of carcinogens, including PAHs.

Enclosing a pen with a postal questionnaire can significantly increase the response rate.

Background And Objectives: It is important to maximize response rates to postal questionnaires. We compared the impact of three low-cost interventions on response rates.

Methods: A 2 x 2 x 2 factorial trial was conducted, nested within TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears).

Trial of management of borderline and other low-grade abnormal smears (TOMBOLA): Trial design.

Cervical screening reduces the risk of cervical cancer by detecting and treating cervical intraepithelial neoplasia (CIN). The management of women with low-grade cervical abnormalities is controversial. Two management policies exist: repeat smears in primary care and colposcopy examination.