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PubMed2006

Study protocol: delayed intervention randomised controlled trial within the Medical Research Council (MRC) Framework to assess the effectiveness of a new palliative care service.

BACKGROUND: Palliative care has been proposed to help meet the needs of patients who suffer progressive non-cancer conditions but there have been few evaluations of service development initiatives. We report here a novel protocol for the evaluation of a new palliative care service in this context. METHODS/DESIGN: Using the MRC Framework for the Evaluation of Complex Interventions we modelled a new palliative care and neurology service for patients severely affected by Multiple Sclerosis (MS). We conducted qualitative interviews with patients, families and staff, plus a literature review to model and pilot the service. Then we designed a delayed intervention randomised controlled trial to test its effectiveness as part of phase II of the MRC framework. Inclusion criteria for the trial were patients identified by referring clinicians as having unresolved symptoms or psychological concerns. Referrers were advised to use a score of greater than 8 on the Expanded Disability Scale was a benchmark. Consenting patients newly referred to the new service were randomised to either receive the palliative care service immediately (fast-track) or after a 12-week wait (standard best practice). Face to face interviews were conducted at baseline (before intervention), and at 4-6, 10-12 (before intervention for the standard-practice group), 16-18 and 22-24 weeks with patients and their carers using standard questionnaires to assess symptoms, palliative care outcomes, function, service use and open comments. Ethics committee approval was granted separately for the qualitative phase and then for the trial. DISCUSSION: We publish the protocol trial here, to allow methods to be reviewed in advance of publication of the results. The MRC Framework for the Evaluation of Complex Interventions was helpful in both the design of the service, methods for evaluation in convincing staff and the ethics committee to accept the trial. The research will provide valuable information on the effects of palliative care among non-cancer patients and a method to evaluate palliative care in this context.

Journal Article↗

PubMed2006

Pelvic floor muscle training is not effective in women with UI in pregnancy: a randomised controlled trial.

The objective of this study was to test the short- and long-term effects of pelvic floor muscle training (PFMT) during pregnancy in women at risk, i.e. women who were already affected by urinary incontinence (UI) during pregnancy. The intervention consisted of three sessions of PFMT between week 23 and 30 during pregnancy and one session 6 weeks after delivery, combined with written information. The research design was a randomised, controlled trial with four follow-ups up to 1 year after delivery. Participants in the study were 264 otherwise healthy women with UI during pregnancy, allocated at random to the intervention (112) or usual care (152) group. The main outcome measure was a UI severity scale and a 7-day bladder diary. No effect of pelvic floor muscle training was shown in this study at (half) a year after pregnancy. UI decreased strongly after pregnancy, irrespective of usual care or PMFT during pregnancy. For most women, usual care appears to be sufficient. The results support a 'wait and see' policy: wait for the urinary incontinence to take its natural course and see if, for women still incontinent half a year after pregnancy, pelvic floor muscle training is effective.

Adult↗

PubMed2006

Advances in the management of sepsis: the randomised controlled trials behind the Surviving Sepsis Campaign recommendations.

The Surviving Sepsis Campaign is the first international, multiorganisation, multidisciplinary attempt to reduce the appalling morbidity and mortality related to sepsis. Under the auspices of the campaign, guidelines have been published that cover more than 50 aspects of care of the septic patient. Campaign guidelines on antimicrobial therapy cover very general aspects of antibiotic policy and are mostly supported by expert opinion rather than randomised controlled trials. However, these 'common sense' recommendations on antibiotic therapy have been included in this review. The core areas of the Surviving Sepsis Campaign guidelines have been crystallised into resuscitation and management 'bundles'. This review focuses on the most important clinical trials that form the basis of these core guidelines.

Anti-Bacterial Agents↗

PubMed1997

Randomised controlled trial of aspirin and aspirin plus heparin in pregnant women with recurrent miscarriage associated with phospholipid antibodies (or antiphospholipid antibodies)

OBJECTIVE: To determine whether treatment with low dose aspirin and heparin leads to a higher rate of live births than that achieved with low dose aspirin alone in women with a history of recurrent miscarriage associated with phospholipid antibodies (or antiphospholipid antibodies), lupus anticoagulant, and cardiolipin antibodies (or anticardiolipin antibodies). DESIGN: Randomised controlled trial. SETTING: Specialist clinic for recurrent miscarriages. SUBJECTS: 90 women (median age 33 (range 22-43)) with a history of recurrent miscarriage (median number 4 (range 3-15)) and persistently positive results for phospholipid antibodies. INTERVENTION: Either low dose aspirin (75 mg daily) or low dose aspirin and 5000 U of unfractionated heparin subcutaneously 12 hourly. All women started treatment with low dose aspirin when they had a positive urine pregnancy test. Women were randomly allocated an intervention when fetal heart activity was seen on ultrasonography. Treatment was stopped at the time of miscarriage or at 34 weeks' gestation. MAIN OUTCOME MEASURES: Rate of live births with the two treatments. RESULTS: There was no significant difference in the two groups in age or the number and gestation of previous miscarriages. The rate of live births with low dose aspirin and heparin was 71% (32/45 pregnancies) and 42% (19/45 pregnancies) with low dose aspirin alone (odds ratio 3.37 (95% confidence interval 1.40 to 8.10)). More than 90% of miscarriages occurred in the first trimester. There was no difference in outcome between the two treatments in pregnancies that advanced beyond 13 weeks' gestation. Twelve of the 51 successful pregnancies (24%) were delivered before 37 weeks' gestation. Women randomly allocated aspirin and heparin had a median decrease in lumbar spine bone density of 5.4% (range -8.6% to 1.7%). CONCLUSION: Treatment with aspirin and heparin leads to a significantly higher rate of live births in women with a history of recurrent miscarriage associated with phospholipid antibodies than that achieved with aspirin alone.

Abortion, Habitual↗

PubMed2005

The Coping with Asthma Study: a randomised controlled trial of a home based, nurse led psychoeducational intervention for adults at risk of adverse asthma outcomes.

BACKGROUND: Morbidity and mortality associated with severe asthma might be reduced by interventions that address psychosocial factors contributing to adverse outcomes. A study was undertaken to assess the effectiveness of a 6 month home based psychoeducational intervention delivered by a respiratory nurse specialist for adults at risk of adverse asthma outcomes. METHODS: A pragmatic randomised controlled trial was performed in 92 adults registered with hospital or primary care asthma clinics. All had previous hospital admissions and/or were on British Thoracic Society step 4-5 treatment and had failed to attend clinic appointments or were considered to have poor adherence to other aspects of their agreed management. Patients were visited in their homes for assessment and, where appropriate, intervention. The main outcomes measured were symptom control, asthma specific quality of life, and generic health status. RESULTS: At the 6 month primary time point there were no significant differences between usual care and intervention groups in mean symptom control, physical functioning, or mental health scores (differences (with 95% CI) -0.35 (-1.83 to 1.13), 3.10 (-11.42 to 17.63), 0.42 (-10.22 to 11.07), respectively). Small effects on asthma specific quality of life up to 12 months (e.g. adjusted difference at 12 months 0.13 (95% CI 0.02 to 0.25)) and short term effects on generic health status, which mirrored improvements in aspects of self-care observed at the end of the intensive phase of the intervention, were apparent only from fully adjusted analyses. CONCLUSIONS: A home based intervention provided by a nurse receiving psychological supervision may have effects on quality of life but is overall of limited long term benefit to adults at risk of adverse asthma outcomes.

Adaptation, Psychological↗

PubMed2005

Lay health worker intervention with choice of DOT superior to standard TB care for farm dwellers in South Africa: a cluster randomised control trial.

SETTING: Farms in the Boland health district, Western Cape Province, South Africa. OBJECTIVE: To evaluate the effect of lay health workers (LHWs) on tuberculosis (TB) control among permanent farm workers and farm dwellers in an area with particularly high TB prevalence. DESIGN: Pragmatic, unblinded cluster randomised control trial. METHODS: This trial measured successful treatment completion rates among new smear-positive (NSP) adult TB patients on 106 intervention farms, and compared them with outcomes in patients on 105 control farms. Farms were the unit of randomisation, and analysis was by intention to treat. RESULTS: A total of 164 adult TB patients were recruited into the study, 89 of whom were NSP. The successful treatment completion rate in NSP adult TB patients was 18.7% higher (P = 0.042, 95%CI 0.9-36.4) on farms in the intervention group than on farms in the control group. Case finding for adult NSP TB cases was 8% higher (P = 0.2671) on farms in the intervention group compared to the control group. CONCLUSION: Trained LHWs were able to improve the successful TB treatment rate among adult NSP TB patients in a well-established health service, despite reduction of services.

Adolescent↗

PubMed2006

Effective improvement of doctor-patient communication: a randomised controlled trial.

BACKGROUND: Doctor-patient communication is an essential component of general practice. Improvement of GPs' communication patterns is an important target of training programmes. Available studies have so far failed to provide conclusive evidence of the effectiveness of educational interventions to improve doctor-patient communication. AIM: To examine the effectiveness of a learner-centred approach that focuses on actual needs, to improve GPs' communication with patients. DESIGN OF STUDY: Randomised controlled trial. SETTING: One hundred volunteer GPs in the Netherlands. METHOD: The intervention identified individual GPs' deficiencies in communication skills by observing authentic consultations in their own surgery. This performance assessment was followed by structured activities in small group meetings, aimed at remedying the identified shortcomings. Outcomes were measured using videotaped consultations in the GPs' own surgery before and after the intervention. Communication skills were rated using the MAAS-Global, a validated checklist. RESULTS: The scores in the intervention group demonstrated a significant improvement compared with those of the control group (95% confidence interval = 0.04 to 0.75). The effect size was moderate to large (d-value = 0.66). The level of participation significantly contributed to the effectiveness. Largest improvement was found on patient-centred communication skills. CONCLUSION: The approach of structured individual improvement activities based on performance assessment is more effective in improving communication skills than current educational activities.

Communication↗

PubMed2004

Randomised control trial of a smoking cessation intervention directed at men whose partners are pregnant.

BACKGROUND: Although smoking cessation programs significantly reduce smoking rates in the general population, some sectors are poorly motivated by them, especially healthy men from lower socioeconomic classes. METHODS: By using a significant life event (approaching birth of a child) we exploited a time of increased receptiveness to smoking cessation influences. A multicomponent intervention was conducted and evaluated using a stratified, randomised control trial, with an intention to treat analysis. RESULTS: Five hundred and sixty-one men were enrolled and 505 (90%) followed to the end of their partners' pregnancy. At 6-month follow-up 16.5% of 291 smokers of the intervention group and 9.3% of 270 in the control group reported they had stopped smoking (P=0.011, OR=0.52, 95% CI 0.31 - 0.86). The strongest predictors of smoking cessation were being in a skilled occupation, having a higher number of quit attempts in the previous year and having the first cigarette of the day relatively later. CONCLUSIONS: The number of smoking men who had to be treated to achieve one stopping smoking (NNT) during their partner's pregnancy was 13 to 14. Innovative antismoking population health measures for the partners of antenatal patients are effective and perhaps should be more widely adopted.

Australia↗

PubMed1990

Meta-analysis of randomised controlled trials in patients with primary IgA nephropathy (Berger's disease).

An overview of the papers published in the last 10 years was performed to evaluate whether treatment with currently available drugs was beneficial in patients with primary IgA nephropathy (IgAN). Eight selected papers involving 196 IgAN patients with moderate or heavy proteinuria, associated in some cases with the nephrotic syndrome, were analysed. The criteria for inclusion were strict, because meta-analysis requires randomised controlled trials with full descriptions. Furthermore, papers were selected in which treatment was performed on IgAN patients with proteinuria, since prognosis is poor in the presence of this sign. The results of statistical analysis show that IgAN patients with heavy proteinuria, whether or not associated with the nephrotic syndrome, benefit from the administration of corticosteroids and/or cytotoxic drugs, as 66.7% of patients had complete or partial remission both in controlled trials and in retrospective studies; renal function also improved in treated patients. In contrast, no beneficial effect was observed in IgAN patients with moderate proteinuria. These results suggest that it is advisable to administer corticosteroids and/or cytotoxic drugs to IgAN patients with heavy proteinuria, irrespective of the association of this condition with the nephrotic syndrome in individual patients.

Adrenal Cortex Hormones↗

PubMed2003

Promotion of health and physical activity improves the mental health of elderly immigrants: results of a group randomised controlled trial among Turkish immigrants in the Netherlands aged 45 and over.

OBJECTIVES: Older immigrants from non-industrialised countries are a growing group, they have comparatively many health problems and are often hard to reach through health promotion and other preventive services. The aim of this study was to assess the effect of a short health education and physical exercise programme on the health and the physical activity of Turkish first generation elderly immigrants. DESIGN: Randomised controlled trial. SETTING: Welfare services in six Dutch cities. PARTICIPANTS: 126 people born in Turkey and aged 45 years and over, of whom 92 completed the trial. INTERVENTION: Eight, two hour sessions consisting of health education and exercises. Topics in health education focused on means to maintain a good health. Education was adapted to the culture and knowledge of older Turks and offered by a Turkish peer educator, in Turkish. MAIN OUTCOME MEASURES: Physical and mental wellbeing, and mental health based on the SF-12/36; knowledge on health and disease; physical activity. RESULTS: Participants were highly disadvantaged; 52% had not completed primary school and 49% had considerable problems in speaking Dutch. Participants in the intervention group showed an improvement in mental health (effect size: 0.38 SD (95% confidence intervals 0.03 to 0.73), p=0.03); the oldest subgroup also in mental wellbeing (effect size 0.75 SD (0.22 to 1.28), p=0.01). No improvements were seen in physical wellbeing and activity, nor in knowledge. CONCLUSIONS: Health education and physical exercise improve the mental state of deprived immigrants. Painstaking cultural adaptations to contents and method of delivery are essential to reach this effect.

Emigration and Immigration↗

PubMed2003

Cognitive-behavioural therapy and motivational intervention for schizophrenia and substance misuse. 18-month outcomes of a randomised controlled trial.

BACKGROUND: Comorbid substance misuse in people with schizophrenia is associated with poor clinical and social outcomes. There are few studies of psychological treatments for this population and little long-term follow-up of their benefits. AIMS: To investigate symptom, substance use, functioning and health economy outcomes for patients with schizophrenia and their carers 18 months after a cognitive-behavioural treatment (CBT) programme. METHOD: Patients with dual diagnosis from a randomised controlled trial of motivational intervention, individual CBT and family intervention were assessed on multiple outcomes at 18-month follow-up. Carers were assessed on symptom, functioning and needs over 12 months. Health economy data were collected over 18 months. RESULTS: There were significant improvements in patient functioning compared with routine care over 18 months. No significant differences between treatment groups were found in carer or cost outcomes. CONCLUSIONS: The treatment programme was superior to routine care on outcomes relating to illness and service use, and the cost was comparable to the control treatment.

Caregivers↗

PubMed1993

Randomised controlled trial of nasal ventilation in acute ventilatory failure due to chronic obstructive airways disease.

Acute exacerbations of chronic obstructive airways disease (COAD) are a common cause of admission to hospital, and have a high mortality. Nasal intermittent positive pressure ventilation (NIPPV) has been used successfully in patients with respiratory failure due to neuromuscular and skeletal disorders, but the outcome of treatment in patients with COAD is less well known. We carried out a prospective randomised controlled trial of conventional treatment versus conventional treatment plus NIPPV, in 60 patients with acute ventilatory failure due to exacerbations of COAD. For the NIPPV group there was a rise in pH, compared with a fall in the controls (mean difference of change between the groups 0.046 [95% CI 0.06-0.02, p < 0.001]), and a larger fall in PaCO2 (mean difference in change between the groups 1.2 kPa [95% CI 0.45 to 2.03, p < 0.01]). Median visual analogue scores over the first 3 days of admission showed less breathlessness in the NIPPV group (2.3 cm [range 0.1-5.5]) than in the control group (4.5 cm [range 0.9-8.8]) (p < 0.025). Survival rates at 30 days were compared for intention-to-treat and efficacy populations. In the efficacy mortality comparison, mortality in the NIPPV group was reduced: 1/26 vs 9/30 (relative risk = 0.13, CI = 0.02-0.95, p = 0.014). This effect was less in the intention-to-treat analysis: 3/30 vs 9/30 (relative risk = 0.33, CI = 0.10-1.11, p = 0.106). In patients with acute ventilatory failure due to COAD who received NIPPV there was a significant rise in pH, a reduction in PaCO2 and breathlessness, and reduced mortality.

Adrenal Cortex Hormones↗

PubMed2000

Comparison of wet combing with malathion for treatment of head lice in the UK: a pragmatic randomised controlled trial.

BACKGROUND: Concern about the effectiveness and toxicity of insecticide lotions has led to promotion of mechanical methods to remove head lice. We compared the effectiveness of "bug-busting" (wet combing with a fine-toothed comb) and malathion lotion. METHODS: We screened 4037 schoolchildren in two counties in Wales, UK (intermediate resistance to malathion). Of 167 found to have head lice, 81 (aged 3-14 years) were eligible to participate in a randomised controlled trial that compared mechanical removal of lice by a commercial kit every 3-4 days for 2 weeks with two applications of 0.5% malathion lotion 7 days apart; parents carried out both treatments. The outcome measure was the presence of live lice 7 days after the end of treatment. Analyses were by intention to treat. FINDINGS: 74 children completed the study and 72 were included in the analysis. The cure rate was 38% (12 of 32) for bug-busting and 78% (31 of 40) for malathion. Children assigned bug-busting were 2.8 (95% CI 1.5-5.2) times more likely than those assigned malathion to have lice at the end of treatment (p=0.0006). INTERPRETATION: Malathion lotion was twice as effective as bug-busting, even in an area with intermediate resistance. Policies advocating bug-busting as first-line treatment for head lice in the general population are inappropriate. Assessment of the outcome of treatment 1-2 weeks after completion is essential for successful management. Only about 50% of participants complied fully with treatment, so future trials should be pragmatic in design, avoid false incentives, and study representative samples of children.

Adolescent↗

PubMed2005

A two year randomised controlled trial of intramuscular depot steroids in patients with established rheumatoid arthritis who have shown an incomplete response to disease modifying antirheumatic drugs.

BACKGROUND: In rheumatoid arthritis (RA), intramuscular (IM) pulsed depomedrone expedites an immediate response to disease modifying antirheumatic drugs (DMARDs). Although IM depomedrone is also widely used to treat disease flares in patients treated with DMARDs, its effect on radiological progression has not been assessed. OBJECTIVE: To evaluate the benefits of 120 mg IM depomedrone versus placebo in patients with established RA whose disease was inadequately controlled by existing DMARDs. METHODS: In a 2 year prospective randomised controlled trial patients were assessed using the ILAR/WHO core dataset, disease activity score (DAS28), x ray examination of hands and feet scored by Larsen's method, and bone densitometry. RESULTS: 291 patients with RA were screened, 166 were eligible, and 91 consented and were randomised. Disease activity improved more rapidly in the steroid treated patients than with placebo, but after 6 months no difference remained. A small but significant reduction in erosive damage in the steroid group compared with placebo was also found. More adverse reactions occurred in the steroid treated group than in the placebo patients (55 v 42), especially those reactions traditionally related to steroids (16 v 2), including vertebral fracture, diabetes, and myocardial infarction. Hip bone density fell significantly in steroid treated but not placebo patients. CONCLUSIONS: IM depomedrone improved disease activity in the short term and produced a small reduction in bone erosion at the cost of a significant increase in adverse events. Despite the initial benefit of IM depomedrone, when patients respond suboptimally to a DMARD they should not be given long term additional steroids but should be treated with alternative or additional DMARDs.

Adult↗

PubMed2006

A pragmatic, unblinded randomised controlled trial comparing an occupational therapy-led lifestyle approach and routine GP care for panic disorder treatment in primary care.

BACKGROUND: Treated anxiety increased in the UK by over 30% since 1994. Medication and psychological treatment is most common, but outcomes are sometimes poor, with high relapse rates. Lifestyle has a potential role in treatment, but is not considered in clinical guidelines. Panic disorder is potentially influenced by lifestyle factors. METHODS: 16 week unblinded pragmatic randomised controlled trial in 15 East of England primary care practices (2 Primary Care Trusts). Participants met DSM-IV criteria for panic disorder with/without agoraphobia. Follow-up at 20 weeks and 10 months. Control arm, unrestricted routine GP care. Trial Arm, Occupational therapy-led lifestyle treatment comprising: lifestyle review of fluid intake, diet pattern, exercise, caffeine, alcohol and nicotine; negotiation of positive lifestyle changes; monitoring and review of impact of changes. PRIMARY OUTCOME MEASURE: Beck Anxiety Inventory. DATA ANALYSIS: Intention-to-treat analysis provided between-group comparisons using analysis of co-variance. Bonferroni method to adjust p-values. RESULTS: From 199 referrals, 36 GP care and 31 lifestyle arm patients completed to final follow-up. Significantly lower lifestyle arm BAI scores at 20 weeks (p<0.001), non-significant (p=0.167) at 10 months after Bonferroni correction. 63.6% lifestyle arm, and 40% GP arm patients (p=0.045) panic-free at 20 weeks; 67.7% and 48.5% (p=0.123) respectively at 10 months. LIMITATIONS: Final study size/power calls for caution in interpreting findings. CONCLUSIONS: A lifestyle approach may provide a clinically effective intervention at least as effective as routine GP care, with significant improvements in anxiety compared with routine GP care at the end of treatment. Further study is required before suggesting practice changes.

Adolescent↗

PubMed2003

Randomised controlled trial of a shared care programme for newly referred cancer patients: bridging the gap between general practice and hospital.

OBJECTIVE: To determine the effect of a shared care programme on the attitudes of newly referred cancer patients towards the healthcare system and their health related quality of life and performance status, and to assess patients' reports on contacts with their general practitioner (GP). SETTING: Department of Oncology at Aarhus University Hospital and general practices. DESIGN: Randomised controlled trial in which patients completed questionnaires at three time points. The shared care programme included transfer of knowledge from the oncologist to the GP, improved communication between the parties, and active patient involvement. PARTICIPANTS: 248 consecutive cancer patients recently referred to the department. MAIN OUTCOME MEASURES: Patients' attitudes towards the healthcare services, their health related quality of life, performance status, and reports on contacts with their GPs. RESULTS: The shared care programme had a positive effect on patient evaluation of cooperation between the primary and secondary healthcare sectors. The effect was particularly significant in men and in younger patients (18-49 years) who felt they received more care from the GP and were left less in limbo. Young patients in the intervention group rated the GP's knowledge of disease and treatment significantly higher than young patients in the control group. The number of contacts with the GP was significantly higher in the intervention group. The EORTC quality of life questionnaire and performance status showed no significant differences between the two groups. CONCLUSIONS: An intersectoral shared care programme in which GPs and patients are actively involved has a positive influence on patients' attitudes towards the healthcare system. Young patients and men particularly benefit from the programme.

Adolescent↗

PubMed2006

Telemedicine in dermatology: a randomised controlled trial.

OBJECTIVES: To compare the clinical equivalence, patient and clinician opinion of store-and-forward (SF) teledermatology with conventional face-to-face consultation in setting a management plan for new, adult outpatient referrals. To assess the equivalence of digital photography and dermoscopy with conventional face-to-face consultation in the management of suspected cases of malignant melanoma or squamous cell carcinoma. DESIGN: For the SF teledermatology aspect of the study, a prospective randomised controlled trial was carried out. SETTING: Eight general practices and a hospital dermatology department in Sheffield, England. PARTICIPANTS: For the SF teledermatology part of the study, adults (aged 16 years and over) requiring a new (not seen by a hospital dermatologist within the past year) consultant opinion. For the digital photography element of the study, adults (aged 16 years and over) requiring a consultant opinion due to suspicion of malignant melanoma or squamous cell carcinoma. INTERVENTIONS: Patients in the telemedicine intervention group were referred to the consultant, and managed as far as possible using one or more digital still images and a structured, electronic referral and reply. The control group was managed by conventional hospital outpatient consultation. Patients referred to the 2-week wait clinic were invited to have a series of digital photographs, with and without dermoscopy, immediately before their face-to-face consultation. A second consultant viewed these and outlined a diagnosis and management plan which was compared with the actual management. Both were compared with the definitive diagnosis (either the final clinical or histological diagnosis, where undertaken). MAIN OUTCOME MEASURE: The concordance between the consultant who had managed the case and an independent consultant who gave a second face-to-face opinion. RESULTS: A total of 208 patients were recruited. There was also a greater loss of control cases (26%) than intervention cases (17%). A statistically significant difference in ages between the two groups completing the study (mean age of intervention group 43.6 years, control group 49.7 years, p = 0.039) indicates that this may have introduced a bias between the two groups. A further possible source of bias is the delay (mean difference of 54 days, p = 0.0001) between the SF opinion and the second opinion in the SF group, whereas control patients usually received their second opinion on the same day as their outpatient appointment. In 55% (51/92) of telemedicine cases and 78% (57/73) of control cases, the diagnosis concurred, with the second opinion. In 55% (51/92) of telemedicine cases and 84% (61/73) of control cases, the management plan concurred with the second opinion. Of the 92 telemedicine cases, 53 were judged also to require a face-to-face consultation, mainly to establish a diagnosis and treatment plan. With the digital photography for suspected skin cancer aspect of the study, it was found that an unexpectedly high proportion (33%, 85/256) of referrals proved to have a malignancy or a severely dysplastic lesion, with almost 22% having a malignant melanoma or squamous cell carcinoma, possibly reflecting the rise in incidence of skin cancers reported elsewhere. When both standard and dermoscopic images were employed, diagnostic concordance was modest (68%). The approach was highly sensitive (98%, 95% CI: 92 to 99%), at the expense of specificity (43%, 95% CI: 36 to 51%). Overall, 30% of cases would not have needed to be seen face-to-face, though two squamous cell carcinomas would have been missed (a number-needed-to-harm of 153). If the highest level of clinician confidence had been applied, no cancers would have been missed, but only 20% of patients would have avoided an outpatient appointment. CONCLUSIONS: In view of the difficulties in recruitment and the potential biases introduced by selective loss of patients and the delay in obtaining a valid second opinion in the study group, no valid conclusions can be drawn regarding the clinical performance of this model of SF telemedicine. With regard to digital photography in suspected skin cancer, it is unlikely that this approach can dramatically reduce the need for conventional clinical consultations, whilst still maintaining clinical safety. Additional research on the assessment of diagnostic and management agreement between clinicians would be valuable in this and other fields of research.

Adolescent↗

PubMed2000

Antenatal home blood pressure monitoring: a pilot randomised controlled trial.

OBJECTIVE: To measure recruitment to, compliance with, and the acceptability of a trial designed to test whether a reduced schedule of antenatal visits combined with training in self-measurement of blood pressure at home may improve hypertension screening and save money. To test the specific hypothesis that even after taking into account extra unscheduled visits, the reduced schedule with ambulatory monitoring reduces total visits. DESIGN: A pilot randomised controlled trial. SETTING: Four urban and four rural general practices in Yorkshire and Lancashire. POPULATION: One hundred and five low risk women in the third trimester of pregnancy. Eighty women participated. INTERVENTION: Women were invited to participate at 24-28 weeks. Those who accepted were allocated either to a standard nine subsequent visit schedule (30, 32, 34, 36, 37, 38, 39, 40, 41 weeks) or to a reduced schedule (34, 38, 41 weeks). Those in the latter group measured their blood pressure weekly using a portable sphygmomanometer at home. MAIN OUTCOME MEASURES: Recruitment, total number of clinic visits, frequency of blood pressure measurement, schedule preference, and anxiety. RESULTS: Although there were more unscheduled visits in the home monitoring group, this did not outweigh the reduction in scheduled visits, (total visits reduced from 7 x 4 to 4 x 5, P < 0 x 001), and blood pressure was measured during more weeks (9 vs 7 weeks, P < 0 x 001) in the experimental group. Most women expressed a preference for the reduced schedule both when the idea was first suggested, and after they had experienced it, and there were no significant differences in anxiety. CONCLUSION: Replacement of antenatal screening visits with home blood pressure monitoring is acceptable to women. The reduction in clinic visits is not compensated by an increase in visits for other reasons and overall blood pressure measurement is omitted less often. Whether it reduces adverse outcomes or has any rare side effects will require a larger trial, but this pilot study indicates that it is likely to be safe, and that such a large trial would be feasible.

Adult↗