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Biomedical subjects

I T Russell

Publications and source records attributed to I T Russell.

At least 19 recordsLinked to original sources

Design of trials with dying patients: a feasibility study of cluster randomisation versus randomised consent.

There is little rigorous evidence to underpin clinical guidelines for palliative care. However, research in palliative care is difficult, especially with dying patients. Consent is a major issue, since staff do not wish to invite dying patients to participate in trials. We, therefore, conducted a feasibility study in two units within the North West Wales NHS Trust. We explored two novel approaches to research in palliative care -cluster randomisation and randomised consent. All patients admitted to the two units during the study were asked for permission to use their data for research. We allocated the two units, at random, to use cluster randomisation or randomised consent for three months, and then to crossover to the other design. Of 24 patients dying during cluster-randomised phases, 13 gave consent on admission to use their data and were, thus, eligible to enter the trial; however, defined eligibility criteria reduced these to six active participants. Of 29 patients dying during randomised consent phases, seven gave consent on admission to use their data; although two were eligible for randomisation, neither entered the trial. We judge that cluster randomisation is the more effective design for research with dying patients. Computer simulation, based on data from 1500 dying patients on the Welsh Integrated Care Pathway, shows that crossover cluster trials need much smaller samples than simple cluster trials. Furthermore, this study has shown that crossover cluster trials are entirely feasible. We recommend a 'definitive' trial to test the crossover design more widely.

Adult↗

Short report: encouraging GPs to complete postal questionnaires--one big prize or many small prizes? A randomized controlled trial.

BACKGROUND: Low response rates to surveys are a problem in general practice. There is evidence that offering GPs incentives improves response rates to postal questionnaires. However, there is less evidence about the most effective form of incentive. OBJECTIVE: Our trial aimed to maximize response to a postal questionnaire and to test the most effective form of incentive. METHODS: The study involved a randomized controlled trial of a postal survey RESULTS: The incentive of a lottery for six bottles of champagne generated a response rate of 79%. Furthermore, one chance of six bottles generated 9% more responses than six chances of one bottle. CONCLUSIONS: This study has established that, among incentives for postal questionnaires, one big prize improves the yield more than many small prizes despite the lower odds of winning. It has also confirmed that offering a modest incentive to GPs generates good response rates for postal questionnaires.

Attitude of Health Personnel↗

Clinical guidelines online: do they improve compliance?

BACKGROUND: The introduction of intranet services in a district general hospital provided an opportunity to put evidence based national guidelines online to facilitate access and promote application of best practice in acute medical care. This study evaluated the effectiveness of this approach. METHOD: Local guidelines were made available online at ward terminals after they had been distributed in paper form. An interrupted time series design was used to evaluate the impact on compliance with three preselected guidelines, which addressed the management of suspected deep vein thrombosis, upper gastrointestinal bleeding, and stroke. This was supplemented by a qualitative assessment of the views of medical staff. RESULTS: There was a significant increase in the adherence to the guidelines for stroke when they were made available online, but this was not demonstrable for deep vein thrombosis or upper gastrointestinal bleeding. Qualitative interviews with junior medical staff and consultants after the study was completed revealed that there was confusion regarding the application of the guidelines for deep vein thrombosis and little active support from the gastroenterologists for the guidelines for upper gastrointestinal bleeding. The stroke guidelines were actively promoted by their author and widely supported. CONCLUSION: Making guidelines available online will not be effective unless they are actively promoted and represent a consensus view.

Algorithms↗

Estimating the marginal value of 'better' research output: 'designed' versus 'routine' data in randomised controlled trials.

We recently completed a study which demonstrated that the costs of health technology assessment (HTA) by randomised controlled trial (RCT) can be reduced by substituting routine datasets for data designed and collected specifically for a trial. This cost reduction, however, had the effect of reducing the quality of the research output. In the present study we attempted to tease out the values attached to the 'better' information provided by designed data RCTs using a mock grants committee. Two valuation techniques, implied values and willingness to pay, were used. Ex ante valuations were determined by comparing alternative research proposals - a more costly version using designed data and a cheaper version using routine data. Ex post valuations were determined by comparing results of both versions. The exercise was performed on four exemplar studies. Overall, the committee expressed a general lack of trust towards routine data both ex ante and ex post and placed high values on the better information from the designed data studies - particularly information on preferences. This suggests that currently available routine datasets are not perceived to be able to provide efficient alternatives to designed data for RCTs.

Blood Transfusion, Autologous↗

Can randomised trials rely on existing electronic data? A feasibility study to explore the value of routine data in health technology assessment.

OBJECTIVES: To estimate the feasibility, utility and resource implications of electronically captured routine data for health technology assessment by randomised controlled trials (RCTs), and to recommend how routinely collected data could be made more effective for this purpose. DATA SOURCES: Four health technology assessments that involved patients under care at five district general hospitals in the UK using four conditions from distinct classical specialties: inflammatory bowel disease, obstructive sleep apnoea, female urinary incontinence, and total knee replacement. Patient-identifiable, electronically stored routine data were sought from the administration and clinical database to provide the routine data. REVIEW METHODS: Four RCTs were replicated using routine data in place of the data already collected for the specific purpose of the assessments. This was done by modelling the research process from conception to final writing up and substituting routine for designed data activities at appropriate points. This allowed a direct comparison to be made of the costs and outcomes of the two approaches to health technology assessment. The trial designs were a two-centre randomised trial of outpatient follow-up; a single-centre randomised trial of two investigation techniques; a three-centre randomised trial of two surgical operations; and a single-centre randomised trial of perioperative anaesthetic intervention. RESULTS: Generally two-thirds of the research questions posed by health technology assessment through RCTs could be answered using routinely collected data. Where these questions required analysis of NHS resource use, data could usually be identified. Clinical effectiveness could also be judged, using proxy measures for quality of life, provided clinical symptoms and signs were collected in sufficient detail. Patient and professional preferences could not be identified from routine data but could be collected routinely by adapting existing instruments. Routine data were found potentially to be cheaper to extract and analyse than designed data, and they also facilitate recruitment as well as have the potential to identify patient outcomes captured in remote systems that may be missed in designed data collection. The study confirmed previous evidence that the validity of routinely collected data is suspect, particularly in systems that are not under clinical and professional control. Potential difficulties were also found in identifying, accessing and extracting data, as well as in the lack of uniformity in data structures, coding systems and definitions. CONCLUSIONS: Routine data have the potential to support health technology assessment by RCTs. The cost of data collection and analysis is likely to fall, although further work is required to improve the validity of routine data, particularly in central returns. Better knowledge of the capability of local systems and access to the data held on them is also essential. Routinely captured clinical data have real potential to measure patient outcomes, particularly if the detail and precision of the data could be improved.

Arthroplasty, Replacement, Knee↗

The development of a new site-specific measure of quality of life for breast problems: the Cardiff breast scales.

The management of women presenting to primary care with symptoms of breast disease is of increasing interest given recent organisational changes aimed at improving accuracy and speed of referrals. As part of a randomised controlled trial, 1063 women were recruited following a primary care consultation for a variety of breast-related problems. In the absence of a suitable outcome measure for such women, a site-specific instrument was developed to complement a generic quality of life scale (SF-36). Items were generated using key informant interviews with health professionals. Draft scale items were piloted using a postal questionnaire and subsequent patient debrief interviews. A sample of respondents were also sent the same questionnaire I month later to assess test-retest reliability. Across the whole sample (n = 848), three factors were identified: 'general well-being', 'concerns' and 'relationships'. These factors accounted for 60% of total variance. Evidence of scale validity, reliability and responsiveness are reported for this new outcome measure for use in women presenting with breast problems.

Breast Diseases↗

Shared care in gastroenterology: GPs' views of open access to out-patient follow-up for patients with inflammatory bowel disease.

OBJECTIVE: The aim of this study was to ascertain GPs' views about open access to out-patient follow-up for patients with inflammatory bowel disease (IBD). METHODS: Semi-structured interviews and a postal survey were carried out in general practices in West Glamorgan UK, each with at least one IBD patient taking part in a randomized trial of open access versus routine follow-up, which has been reported elsewhere. A total of 112 GPs from 53 general practices who referred the 180 study patients to specialist gastroenterological care in Neath or Swansea were included in the study. Main outcome measures were GPs' experience of the trial; preferences between methods of out-patient follow-up; and their views about enhancing open access follow-up. RESULTS: Sixty-nine GPs from 40 practices took part in the practice-specific data collection and 91 returned 156 patient-specific questionnaires. They expressed a strong preference for open access follow-up, for both specific patients (108/156 patients) and IBD patients in general (47/69 GPs). Preference for extending open access follow-up to other chronic conditions was not so strong (21/69 GPs). A substantial number of GPs considered their experience of the trial limited (30/69), and few GPs were aware of the shared care guideline distributed before the trial started (8/69). Few GPs encountered any problems in the management of the study patients (9/69) and <50% of the GPs used a Cumulative Encounter Form (29/69) developed for the study. Most GPs were supportive of giving patients written guidelines (56/69) and establishing a gastroenterological (GI) nurse practitioner (45/69). CONCLUSIONS: Open access follow-up of patients with IBD is supported by GPs. The approach would probably be improved by the distribution of written information to patients, the establishment of a GI nurse practitioner and an integrated approach between the nurse, hospital specialist, GP and patient.

Ambulatory Care↗

Statistical assessment of the learning curves of health technologies.

OBJECTIVES: (1) To describe systematically studies that directly assessed the learning curve effect of health technologies. (2) Systematically to identify 'novel' statistical techniques applied to learning curve data in other fields, such as psychology and manufacturing. (3) To test these statistical techniques in data sets from studies of varying designs to assess health technologies in which learning curve effects are known to exist. METHODS - STUDY SELECTION (HEALTH TECHNOLOGY ASSESSMENT LITERATURE REVIEW): For a study to be included, it had to include a formal analysis of the learning curve of a health technology using a graphical, tabular or statistical technique. METHODS - STUDY SELECTION (NON-HEALTH TECHNOLOGY ASSESSMENT LITERATURE SEARCH): For a study to be included, it had to include a formal assessment of a learning curve using a statistical technique that had not been identified in the previous search. METHODS - DATA SOURCES: Six clinical and 16 non-clinical biomedical databases were searched. A limited amount of handsearching and scanning of reference lists was also undertaken. METHODS - DATA EXTRACTION (HEALTH TECHNOLOGY ASSESSMENT LITERATURE REVIEW): A number of study characteristics were abstracted from the papers such as study design, study size, number of operators and the statistical method used. METHODS - DATA EXTRACTION (NON-HEALTH TECHNOLOGY ASSESSMENT LITERATURE SEARCH): The new statistical techniques identified were categorised into four subgroups of increasing complexity: exploratory data analysis; simple series data analysis; complex data structure analysis, generic techniques. METHODS - TESTING OF STATISTICAL METHODS: Some of the statistical methods identified in the systematic searches for single (simple) operator series data and for multiple (complex) operator series data were illustrated and explored using three data sets. The first was a case series of 190 consecutive laparoscopic fundoplication procedures performed by a single surgeon; the second was a case series of consecutive laparoscopic cholecystectomy procedures performed by ten surgeons; the third was randomised trial data derived from the laparoscopic procedure arm of a multicentre trial of groin hernia repair, supplemented by data from non-randomised operations performed during the trial. RESULTS - HEALTH TECHNOLOGY ASSESSMENT LITERATURE REVIEW: Of 4571 abstracts identified, 272 (6%) were later included in the study after review of the full paper. Some 51% of studies assessed a surgical minimal access technique and 95% were case series. The statistical method used most often (60%) was splitting the data into consecutive parts (such as halves or thirds), with only 14% attempting a more formal statistical analysis. The reporting of the studies was poor, with 31% giving no details of data collection methods. RESULTS - NON-HEALTH TECHNOLOGY ASSESSMENT LITERATURE SEARCH: Of 9431 abstracts assessed, 115 (1%) were deemed appropriate for further investigation and, of these, 18 were included in the study. All of the methods for complex data sets were identified in the non-clinical literature. These were discriminant analysis, two-stage estimation of learning rates, generalised estimating equations, multilevel models, latent curve models, time series models and stochastic parameter models. In addition, eight new shapes of learning curves were identified. RESULTS - TESTING OF STATISTICAL METHODS: No one particular shape of learning curve performed significantly better than another. The performance of 'operation time' as a proxy for learning differed between the three procedures. Multilevel modelling using the laparoscopic cholecystectomy data demonstrated and measured surgeon-specific and confounding effects. The inclusion of non-randomised cases, despite the possible limitations of the method, enhanced the interpretation of learning effects. CONCLUSIONS - HEALTH TECHNOLOGY ASSESSMENT LITERATURE REVIEW: The statistical methods used for assessing learning effects in health technology assessment have been crude and the reporting of studies poor. CONCLUSIONS - NON-HEALTH TECHNOLOGY ASSESSMENT LITERATURE SEARCH: A number of statistical methods for assessing learning effects were identified that had not hitherto been used in health technology assessment. There was a hierarchy of methods for the identification and measurement of learning, and the more sophisticated methods for both have had little if any use in health technology assessment. This demonstrated the value of considering fields outside clinical research when addressing methodological issues in health technology assessment. CONCLUSIONS - TESTING OF STATISTICAL METHODS: It has been demonstrated that the portfolio of techniques identified can enhance investigations of learning curve effects. (ABSTRACT TRUNCATED)

Cholecystectomy↗

The UK IBDQ-a British version of the inflammatory bowel disease questionnaire. development and validation.

Measurement of health-related quality of life (HRQL) is becoming more important in studies of patients with inflammatory bowel disease. The McMaster IBDQ is the most widely used HRQL instrument for these patients. However, its use with patients in the United Kingdom has not been validated. This study develops and validates a UK version of the McMaster IBDQ (UK IBDQ). The UK IBDQ was tested with two samples of patients for its reliability, validity, reproducibility, and responsiveness. The first sample consisted of 180 patients participating in a randomized clinical trial. The second was recruited from members of the National Association for Colitis and Crohns Disease. Reliability of the subscales and the summary score of the UK IBDQ is demonstrated by Cronbach's alpha and item-total correlations. Their validity is demonstrated by their correlations with SF-36 subscales and an empirical index of disease activity. Good intraclass correlations and responsiveness ratios show their reproducibility and responsiveness. The findings support the reliability, validity, reproducibility, and responsiveness of the UK IBDQ and its acceptability to patients in UK.

Emotions↗

Open access follow up for inflammatory bowel disease: pragmatic randomised trial and cost effectiveness study.

OBJECTIVE: To evaluate whether follow up of patients with inflammatory bowel disease is better through open access than by routine booked appointments. DESIGN: Pragmatic randomised controlled trial. SETTING: Two district general hospitals in Swansea and Neath, Wales. PARTICIPANTS: 180 adults (78 with Crohn's disease, 77 ulcerative or indeterminate colitis, 25 ulcerative or idiopathic proctitis) recruited from outpatient clinics during October 1995 to November 1996. INTERVENTION: Open access follow up according to patient need. MAIN OUTCOME MEASURES: Generic (SF-36) and disease specific (UK inflammatory bowel disease questionnaire UKIBDQ) quality of life, number of primary and secondary care contacts, total resource use, and views of patients and general practitioners. RESULTS: There were no differences in generic or disease specific quality of life. Open access patients had fewer day visits (0.21 v 0. 42, P<0.05) and fewer outpatient visits ( 4.12 v 4.64, P<0.01), but some patients had difficulty obtaining an urgent appointment. There were no significant differences in specific investigations undertaken, inpatient days, general practitioner surgery or home visits, drugs prescribed, or total patient borne costs. Mean total cost in secondary care was lower for open access patients (P<0.05), but when primary care and patient borne costs were added there were no significant differences in total costs to the NHS or to society. General practitioners and patients preferred open access. CONCLUSIONS: Open access follow up delivers the same quality of care as routine outpatient care and is preferred by patients and general practitioners. It uses fewer resources in secondary care but total resource use is similar. Better methods of ensuring urgent access to outpatient clinics are needed.

Adult↗

Assessment of the learning curve in health technologies. A systematic review.

OBJECTIVE: We reviewed and appraised the methods by which the issue of the learning curve has been addressed during health technology assessment in the past. METHOD: We performed a systematic review of papers in clinical databases (BIOSIS, CINAHL, Cochrane Library, EMBASE, HealthSTAR, MEDLINE, Science Citation Index, and Social Science Citation Index) using the search term "learning curve." RESULTS: The clinical search retrieved 4,571 abstracts for assessment, of which 559 (12%) published articles were eligible for review. Of these, 272 were judged to have formally assessed a learning curve. The procedures assessed were minimal access (51%), other surgical (41%), and diagnostic (8%). The majority of the studies were case series (95%). Some 47% of studies addressed only individual operator performance and 52% addressed institutional performance. The data were collected prospectively in 40%, retrospectively in 26%, and the method was unclear for 31%. The statistical methods used were simple graphs (44%), splitting the data chronologically and performing a t test or chi-squared test (60%), curve fitting (12%), and other model fitting (5%). CONCLUSIONS: Learning curves are rarely considered formally in health technology assessment. Where they are, the reporting of the studies and the statistical methods used are weak. As a minimum, reporting of learning should include the number and experience of the operators and a detailed description of data collection. Improved statistical methods would enhance the assessment of health technologies that require learning.

Biomedical Technology↗

A systematic review of comparisons of effect sizes derived from randomised and non-randomised studies.

BACKGROUND: There is controversy about the value of evidence about the effectiveness of healthcare interventions from non-randomised study designs. Advocates for quasi-experimental and observational (QEO) studies argue that evidence from randomised controlled trials (RCTs) is often difficult or impossible to obtain, or is inadequate to answer the question of interest. Advocates for RCTs point out that QEO studies are more susceptible to bias and refer to published comparisons that suggest QEO estimates tend to find a greater benefit than RCT estimates. However, comparisons from the literature are often cited selectively, may be unsystematic and may have failed to distinguish between different explanations for any discrepancies observed. OBJECTIVES: The aim was to investigate the association between methodological quality and the magnitude of estimates of effectiveness by comparing systematically estimates of effectiveness derived from RCTs and QEO studies. Quantifying any such association should help healthcare decision-makers to judge the strength of evidence from non-randomised studies. Two strategies were used to minimise the influence of differences in external validity between RCTs and QEO studies: a comparison of the RCT and QEO study estimates of effectiveness of any intervention, where both estimates were reported in a single paper a comparison of the RCT and QEO study estimates of effectiveness for specified interventions, where the estimates were reported in different papers. The authors also sought to identify study designs that have been proposed to address one or more of the problems often found with conventional RCTs. METHODS DATA SOURCES: Relevant literature was identified from: The Cochrane Library, MEDLINE, EMBASE, DARE, and the Science Citation Index. References of relevant papers already identified experts. Electronic searches were very difficult to design and yielded few papers for the first strategy and when identifying study designs. CHOICE OF INTERVENTIONS TO REVIEW FOR STRATEGIES 1 AND 2: For strategy 1, any intervention was eligible. For strategy 2, interventions for which the population, intervention and outcome investigated were anticipated to be homogeneous across studies were selected for review: Mammographic screening (MSBC) of women to reduce mortality from breast cancer. Folic acid supplementation (FAS) to prevent neural tube defects in women trying to conceive. DATA EXTRACTION AND QUALITY ASSESSMENT: Data were extracted by the first author and checked by the second author. Disagreements were negotiated with reference to the paper concerned. For strategy 1, study quality was scored using a checklist to assess whether the RCT and QEO study estimates were derived from the same populations, whether the assessment of outcomes was 'blinded', and the extent to which the QEO study estimate took account of possible confounding. For strategy 2, a more detailed instrument was used to assess study quality on four dimensions: the quality of reporting, the generalisability of the results, and the extent to which estimates of effectiveness may have been subject to bias or confounding. All quality assessments were carried out by three people. DATA SYNTHESIS AND ANALYSIS: For strategy 1, pairs of comparisons between RCT and QEO study estimates were classified as high or low quality. Seven indices of the size of discrepancies between estimates of effect size and outcome frequency were calculated, where possible, for each comparison. Distributions of the size and direction of discrepancies were compared for high- and low-quality comparisons. FOR STRATEGY 2, THREE ANALYSES WERE CARRIED OUT: Attributes of the instrument were described by k statistics, percentage agreement, and Cronbach's a values. Regression analyses were used to investigate -variations in study quality. (ABSTRACT TRUNCATED)

Breast Neoplasms↗

Patient centred assessment of quality of life for patients with four common conditions.

OBJECTIVES: To assess the reliability, validity, and responsiveness of a new quality of life measure, the patient generated index (PGI) of quality of life, in patients with four common clinical conditions. DESIGN: Prospective one year follow up study. SETTING: Outpatient departments and four general practices in Grampian, Scotland. SUBJECTS: 1746 patients consulting a general practitioner in one of four practices, or referred to outpatients from all Grampian practices over a four month period, with low back pain, menorrhagia, suspected peptic ulcer, and varicose veins. MAIN OUTCOME MEASURES: Postal questionnaire including the PGI, SF-36 health survey, and clinically derived condition specific measures of disease severity. RESULTS: Test-retest reliability was satisfactory for group comparisons (intraclass correlation coefficient 0.65). Validity was confirmed by the observed association of the PGI with the SF-36, condition specific instruments, and sociodemographic variables. For low back pain, the PGI and the SF-36 pain scale were found to be most responsive to clinical change. For patients with menorrhagia and suspected peptic ulcer, only the condition specific instruments detected larger changes than the PGI. CONCLUSIONS: It is possible to develop a patient generated index of quality of life that not only assesses the extent to which patients' expectations are matched by reality but also satisfies criteria of reliability and responsiveness to change. Further work is required to make the PGI more acceptable and meaningful to patients, but it is believed that it offers an exciting new approach to the evaluation of medical care.

Family Practice↗

Randomised comparison of percutaneous angioplasty vs continued medical therapy for hypertensive patients with atheromatous renal artery stenosis. Scottish and Newcastle Renal Artery Stenosis Collaborative Group.

BACKGROUND: Data from randomised studies are lacking on the value of interventional procedures in the management of atheromatous renal artery stenosis. This randomised prospective trial compared the effects on blood pressure (BP) and renal function of percutaneous transluminal angioplasty vs medical therapy in hypertensive patients with both unilateral and bilateral disease. METHODS: A total of 135 eligible patients were identified, of whom 55 (44%) were randomised. Eligible patients had sustained hypertension, with a minimum diastolic BP of 95 mm Hg on at least two anti-hypertensive drugs. Renal artery stenosis was defined by renal angiography as at least 50% stenosis in the affected vessel. All patients were observed during an initial 4-week run-in period on a fixed drug regimen and subsequent changes measured from this 4-week baseline. RESULTS: Blood pressure fell during the run-in period in all groups. In patients with bilateral renal artery stenosis randomised to angioplasty, a statistically significant (P<0.05) fall in BP was observed at latest follow-up (range 3-54 months). The mean fall in BP at latest follow-up in the angioplasty group, corrected for the medical group response, was 26/10 mm Hg. In patients with unilateral renal artery stenosis, no statistically significant or clinically important differences in outcome were observed between the two groups. No significant differences or trends in serum creatinine were observed between or within any group during follow-up. Major outcome events (death, myocardial infarction, heart failure, stroke, dialysis) were similar in the angioplasty and medical groups during follow-up. In the 40/135 patients undergoing angioplasty, serious or potentially serious complications attributable to the procedure were observed in 11 patients, bleeding at the arterial site (8 patients) being the most frequent. CONCLUSIONS: In hypertensive patients with atheromatous renal artery stenosis, percutaneous renal angioplasty results in a modest improvement in systolic BP compared with medical therapy alone. This benefit was confined to patients with bilateral disease. No patient was 'cured', renal function did not improve, and intervention was accompanied by a significant complication rate.

Adult↗

Signal versus noise in the evidence base for medicine: an alternative to hierarchies of evidence?

Clinical practice frequently generates questions that are not easily answered by randomized trials. On conventional hierarchies of evidence, 'weaker' study designs are often more feasible. Also, much research is not well designed. Yet we still need to make best use of the available evidence. Systematic reviews must therefore address the danger of underestimating the evidence from relevant literature if it includes only that of a certain methodological quality. This would run the risk of missing or distorting the true message that the review is trying to identify. We propose a classification of research which does not reject studies on the basis of design alone, but recognizes the importance of assessing the message or 'signal' within each piece of research. It explicitly introduces judgement into the appraisal and synthesis of evidence, and affords more flexibility in attaching weight to evidence that might otherwise be lost. It includes an assessment of methodological quality, balancing this against the weight of its message, rather than rejecting studies which are below a certain threshold for quality. Fundamentally flawed research will still be rejected, but more commonly papers can still be used, tempering the importance that we attach to their signal by the amount of 'noise' around that signal. The balance of these two elements may be termed the 'signal to noise ratio'.

Evidence-Based Medicine↗

Medical abortion or vacuum aspiration? Two year follow up of a patient preference trial.

OBJECTIVE: To describe and compare health outcomes two years after medical abortion or vacuum aspiration in women recruited into a patient preference trial during 1990 to 1991. DESIGN: Women recruited to the original, partially randomised study were contacted for assessment using a structured interview. SETTING: Grampian region of Scotland, UK. PARTICIPANTS: One hundred and forty women who had participated in a partially randomised study of first trimester abortion two years previously. INTERVENTION: Vacuum aspiration or medical abortion using mifepristone and gemeprost. MAIN OUTCOME MEASURES: Long-term general, reproductive and psychological health; acceptability of procedure; perceived value of choice of method of termination. RESULTS: There were no significant differences between women who had undergone medical abortion or vacuum aspiration two years previously in general, reproductive or psychological health. Almost all women placed a high value on the provision of choice of method of termination. There was a significant difference in perception of long term procedure acceptability among women who had been randomised to a method of termination. CONCLUSIONS: Women should have the opportunity to choose the method of termination. This opportunity will result in high levels of acceptability, particularly at gestations under 50 days of amenorrhoea.

Abortifacient Agents, Nonsteroidal↗