Dataset Information

Randomised controlled factorial trial of dietary advice for patients with a single high blood pressure reading in primary care.

ABSTRACT:

Objective

To assess the effect of brief interventions during the "watchful waiting" period for hypertension.

Design

Factorial trial.

Setting

General practice.

Methods

296 patients with blood pressure > 160/90 mm Hg were randomised to eight groups defined by three factors: an information booklet; low sodium, high potassium salt; prompt sheets for high fruit, vegetable, fibre; and low fat.

Main outcome measures

Blood pressure (primary outcome); secondary outcomes of diet, weight, and dietary biomarkers (urinary sodium:potassium (Na:K) ratio; carotenoid concentrations).

Results

Blood pressure was not affected by the booklet (mean difference (diastolic blood pressure) at one month 0.2, 95% confidence interval 1.6 to 2.0), salt (0.13; 1.7 to 2.0), or prompts (0.52; 1.3 to 2.4). The salt decreased Na:K ratio (difference 0.32; 0.08 to 0.56, P = 0.01), and the prompts helped control weight (difference 0.39 (0.85 to 0.05) kg at one month, P = 0.085; 1.2 (0.1 to 2.25) kg at six months, P = 0.03). Among those with lower fruit and vegetable consumption (< 300 g per day), prompts increased fruit and vegetable consumption and also carotenoid concentrations (difference 143 (16 to 269) mmol/l, P < 0.03) but did not decrease blood pressure.

Conclusion

During watchful waiting, over and above the effect of brief advice and monitoring, an information booklet, lifestyle prompts, and low sodium salt do not reduce blood pressure. Secondary analysis suggests that brief interventions-particularly lifestyle prompts-can make useful changes in diet and help control weight, which previous research indicates are likely to reduce the long term risk of stroke.

SUBMITTER: Little P

PROVIDER: S-EPMC403849 | biostudies-literature | 2004 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised controlled factorial trial of dietary advice for patients with a single high blood pressure reading in primary care.

Little Paul P Kelly Jo J Barnett Jane J Dorward Martina M Margetts Barrie B Warm Daniel D

BMJ (Clinical research ed.) 20040413 7447

<h4>Objective</h4>To assess the effect of brief interventions during the "watchful waiting" period for hypertension.<h4>Design</h4>Factorial trial.<h4>Setting</h4>General practice.<h4>Methods</h4>296 patients with blood pressure > 160/90 mm Hg were randomised to eight groups defined by three factors: an information booklet; low sodium, high potassium salt; prompt sheets for high fruit, vegetable, fibre; and low fat.<h4>Main outcome measures</h4>Blood pressure (primary outcome); secondary outcome ...[more]

PMID: 15082472

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Project description:ObjectiveTo determine the effectiveness of intensive structured care to optimise blood pressure control based on individual absolute risk targets in primary care.DesignPragmatic multicentre randomised controlled trial.SettingGeneral practices throughout Australia, except Northern Territory, 2009-11.ParticipantsOf 2185 patients from 119 general practices who were eligible for drug treatment for hypertension according to national guidelines 416 (19.0%) achieved their individual blood pressure target during a 28 day run-in period of monotherapy. After exclusions, 1562 participants not at target blood pressure (systolic 150 (SD 17) mm Hg, diastolic 88 (SD 11) mm Hg) were randomised (1:2 ratio) to usual care (n=524) or the intervention (n=1038).InterventionComputer assisted clinical profiling and risk target setting (all participants) with intensified follow-up and stepwise drug titration (initial angiotensin receptor blocker monotherapy or two forms of combination therapy using angiotensin receptor blockers) for those randomised to the intervention. The control group received usual care.Main outcome measuresThe primary outcome was individual blood pressure target achieved at 26 weeks. Secondary outcomes were change in mean sitting systolic and diastolic blood pressure, absolute risk for cardiovascular disease within five years based on the Framingham risk score, and proportion and rate of adverse events.ResultsOn an intention to treat basis, there was an 8.8% absolute difference in individual blood pressure target achieved at 26 weeks in favour of the intervention group compared with usual care group (358/988 (36.2%) v 138/504 (27.4%)): adjusted relative risk 1.28 (95% confidence interval 1.10 to 1.49, P=0.0013). There was also a 9.5% absolute difference in favour of the intervention group for achieving the classic blood pressure target of ≤ 140/90 mm Hg (627/988 (63.5%) v 272/504 (54.0%)): adjusted relative risk 1.18 (1.07 to 1.29, P<0.001). The intervention group achieved a mean adjusted reduction in systolic blood pressure of 13.2 mm Hg (95% confidence interval -12.3 to -14.2 mm Hg) and diastolic blood pressure of 7.7 mm Hg (-7.1 to -8.3 mm Hg) v 10.1 mm Hg (-8.8 to 11.3 mm Hg) and 5.5 mm Hg (-4.7 to -6.2 mm Hg) in the usual care group (P<0.001). Among 1141 participants in whom five year absolute cardiovascular risk scores were calculated from baseline to the 26 week follow-up, the reduction in risk scores was greater in the intervention group than usual care group (14.7% (SD 9.3%) to 10.9% (SD 8.0%); difference -3.7% (SD 4.5%) and 15.0% (SD 10.1%) to 12.4% (SD 9.4%); -2.6% (SD 4.5%): adjusted mean difference -1.13% (95% confidence interval -0.69% to -1.63%; P<0.001). Owing to adverse events 82 (7.9%) participants in the intervention group and 10 (1.9%) in the usual care group had their drug treatment modified.ConclusionsIn a primary care setting intensive structured care resulted in higher levels of blood pressure control, with clinically lower blood pressure and absolute risk of future cardiovascular events overall and with more people achieving their target blood pressure. An important gap in treatment remains though and applying intensive management and achieving currently advocated risk based blood pressure targets is challenging.

Project description:ObjectiveTo estimate the effectiveness of different strategies involving delayed antibiotic prescription for acute respiratory tract infections.DesignOpen, pragmatic, parallel group, factorial, randomised controlled trial.SettingPrimary care in the United Kingdom.Patients889 patients aged 3 years and over with acute respiratory tract infection, recruited between 3 March 2010 and 28 March 2012 by 53 health professionals in 25 practices.InterventionsPatients judged not to need immediate antibiotics were randomised to undergo four strategies of delayed prescription: recontact for a prescription, post-dated prescription, collection of the prescription, and be given the prescription (patient led). During the trial, a strategy of no antibiotic prescription was added as another randomised comparison. Analysis was intention to treat.Main outcome measuresMean symptom severity (0-6 scale) at days 2-4 (primary outcome), antibiotic use, and patients' beliefs in the effectiveness of antibiotic use. Secondary analysis included comparison with immediate use of antibiotics.ResultsMean symptom severity had minimal differences between the strategies involving no prescription and delayed prescription (recontact, post-date, collection, patient led; 1.62, 1.60, 1.82, 1.68, 1.75, respectively; likelihood ratio test χ(2) 2.61, P=0.625). Duration of symptoms rated moderately bad or worse also did not differ between no prescription and delayed prescription strategies combined (median 3 days v 4 days; 4.29, P=0.368). There were modest and non-significant differences in patients very satisfied with the consultation between the randomised groups (79%, 74%, 80%, 88%, 89%, respectively; likelihood ratio test χ(2) 2.38, P=0.667), belief in antibiotics (71%, 74%, 73%, 72%, 66%; 1.62, P=0.805), or antibiotic use (26%, 37%, 37%, 33%, 39%; 4.96, P=0.292). By contrast, most patients given immediate antibiotics used antibiotics (97%) and strongly believed in them (93%), but with no benefit for symptom severity (score 1.76) or duration (median 4 days).ConclusionStrategies of no prescription or delayed antibiotic prescription result in fewer than 40% of patients using antibiotics, and are associated with less strong beliefs in antibiotics, and similar symptomatic outcomes to immediate prescription. If clear advice is given to patients, there is probably little to choose between the different strategies of delayed prescription.Trial registrationISRCTN38551726.

Project description:ObjectiveTo compare the quality and accuracy of manual office blood pressure and automated office blood pressure using the awake ambulatory blood pressure as a gold standard.DesignMulti-site cluster randomised controlled trial.SettingPrimary care practices in five cities in eastern Canada.Participants555 patients with systolic hypertension and no serious comorbidities under the care of 88 primary care physicians in 67 practices in the community.InterventionsPractices were randomly allocated to either ongoing use of manual office blood pressure (control group) or automated office blood pressure (intervention group) using the BpTRU device. The last routine manual office blood pressure (mm Hg) was obtained from each patient's medical record before enrollment. Office blood pressure readings were compared before and after enrollment in the intervention and control groups; all readings were also compared with the awake ambulatory blood pressure.Main outcome measureDifference in systolic blood pressure between awake ambulatory blood pressure minus automated office blood pressure and awake ambulatory blood pressure minus manual office blood pressure.ResultsCluster randomisation allocated 31 practices (252 patients) to manual office blood pressure and 36 practices (303 patients) to automated office blood pressure measurement. The most recent routine manual office blood pressure (149.5 (SD 10.8)/81.4 (8.3)) was higher than automated office blood pressure (135.6 (17.3)/77.7 (10.9)) (P < 0.001). In the control group, routine manual office blood pressure before enrollment (149.9 (10.7)/81.8 (8.5)) was reduced to 141.4 (14.6)/80.2 (9.5) after enrollment (P < 0.001/P = 0.01), but the reduction in the intervention group from manual office to automated office blood pressure was significantly greater (P < 0.001/P = 0.02). On the first study visit after enrollment, the estimated mean difference for the intervention group between the awake ambulatory systolic/diastolic blood pressure and automated office blood pressure (-2.3 (95% confidence interval -0.31 to -4.3)/-3.3 (-2.7 to -4.4)) was less (P = 0.006/P = 0.26) than the difference in the control group between the awake ambulatory blood pressure and the manual office blood pressure (-6.5 (-4.3 to -8.6)/-4.3 (-2.9 to -5.8)). Systolic/diastolic automated office blood pressure showed a stronger (P < 0.001) within group correlation (r = 0.34/r = 0.56) with awake ambulatory blood pressure after enrollment compared with manual office blood pressure versus awake ambulatory blood pressure before enrollment (r = 0.10/r = 0.40); the mean difference in r was 0.24 (0.12 to 0.36)/0.16 (0.07 to 0.25)). The between group correlation comparing diastolic automated office blood pressure and awake ambulatory blood pressure (r = 0.56) was stronger (P < 0.001) than that for manual office blood pressure versus awake ambulatory blood pressure (r = 0.30); the mean difference in r was 0.26 (0.09 to 0.41). Digit preference with readings ending in zero was substantially reduced by use of automated office blood pressure.ConclusionIn compliant, otherwise healthy, primary care patients with systolic hypertension, introduction of automated office blood pressure into routine primary care significantly reduced the white coat response compared with the ongoing use of manual office blood pressure measurement. The quality and accuracy of automated office blood pressure in relation to the awake ambulatory blood pressure was also significantly better when compared with manual office blood pressure. Trial registration Clinical trials NCT 00214053.

Project description:ObjectiveTo assess strategies for advice on analgesia and steam inhalation for respiratory tract infections.DesignOpen pragmatic parallel group factorial randomised controlled trial.SettingPrimary care in United Kingdom.ParticipantsPatients aged ≥ 3 with acute respiratory tract infections.Intervention889 patients were randomised with computer generated random numbers in pre-prepared sealed numbered envelopes to components of advice or comparator advice: advice on analgesia (take paracetamol, ibuprofen, or both), dosing of analgesia (take as required v regularly), and steam inhalation (no inhalation v steam inhalation).OutcomesPrimary: mean symptom severity on days 2-4; symptoms rated 0 (no problem) to 7 (as bad as it can be). Secondary: temperature, antibiotic use, reconsultations.ResultsNeither advice on dosing nor on steam inhalation was significantly associated with changes in outcomes. Compared with paracetamol, symptom severity was little different with ibuprofen (adjusted difference 0.04, 95% confidence interval -0.11 to 0.19) or the combination of ibuprofen and paracetamol (0.11, -0.04 to 0.26). There was no evidence for selective benefit with ibuprofen among most subgroups defined before analysis (presence of otalgia; previous duration of symptoms; temperature >37.5 °C; severe symptoms), but there was evidence of reduced symptoms severity benefit in the subgroup with chest infections (ibuprofen -0.40, -0.78 to -0.01; combination -0.47; -0.84 to -0.10), equivalent to almost one in two symptoms rated as a slight rather than a moderately bad problem. Children might also benefit from treatment with ibuprofen (ibuprofen: -0.47, -0.76 to -0.18; combination: -0.04, -0.31 to 0.23). Reconsultations with new/unresolved symptoms or complications were documented in 12% of those advised to take paracetamol, 20% of those advised to take ibuprofen (adjusted risk ratio 1.67, 1.12 to 2.38), and 17% of those advised to take the combination (1.49, 0.98 to 2.18). Mild thermal injury with steam was documented for four patients (2%) who returned full diaries, but no reconsultations with scalding were documented.ConclusionOverall advice to use steam inhalation, or ibuprofen rather than paracetamol, does not help control symptoms in patients with acute respiratory tract infections and must be balanced against the possible progression of symptoms during the next month for a minority of patients. Advice to use ibuprofen might help short term control of symptoms in those with chest infections and in children.Trial registrationISRCTN 38551726.

Project description:Pre-operative weight loss has been consistently associated with increased post-operative morbidity. The study aims to determine if pre-operative oral nutritional supplements (ONSs) with dietary advice reduce post-operative complications.Single-blinded randomized controlled trial. People with colorectal cancer scheduled for surgery with pre-operative weight loss >1?kg/3-6?months were randomized by using stratified blocks (1:1 ratio) in six hospitals (1 November 2013-28 February 2015). Intervention group was given 250?mL/day ONS (10.1?KJ and 0.096?g protein per mL) and dietary advice. Control group received dietary advice alone. Oral nutritional supplements were administered from diagnosis to the day preceding surgery. Research team was masked to group allocation. Primary outcome was patients with one or more surgical site infection (SSI) or chest infection; secondary outcomes included percentage weight loss, total complications, and body composition measurements. Intention-to-treat analysis was performed with both unadjusted and adjusted analyses. A sample size of 88 was required.Of 101 participants, (55 ONS, 46 controls) 97 had surgery. In intention-to-treat analysis, there were 21/45 (47%) patients with an infection-either an SSI or chest infection in the control group vs. 17/55 (30%) in the ONS group. The odds ratio of a patient incurring either an SSI or chest infection was 0.532 (P?=?0.135 confidence interval 0.232 to 1.218) in the unadjusted analysis and when adjusted for random differences at baseline (age, gender, percentage weight loss, and cancer staging) was 0.341 (P?=?0.031, confidence interval 0.128 to 0.909). Pre-operative percentage weight loss at the first time point after randomization was 4.1% [interquartile range (IQR) 1.7-7.0] in ONS group vs. 6.7% (IQR 2.6-10.8) in controls (Mann-Whitney U P?=?0.021) and post-operatively was 7.4% (IQR 4.3-10.0) in ONS group vs. 10.2% (IQR 5.1-18.5) in controls (P?=?0.016).Compared with dietary advice alone, ONS resulted in patients having fewer infections and less weight loss following surgery for colorectal cancer. We have demonstrated that pre-operative oral nutritional supplementation can improve clinical outcome in weight losing patients with colorectal cancer.

Dataset Information

Randomised controlled factorial trial of dietary advice for patients with a single high blood pressure reading in primary care.

Objective

Design

Setting

Methods

Main outcome measures

Results

Conclusion

Publications

Randomised controlled factorial trial of dietary advice for patients with a single high blood pressure reading in primary care.

Similar Datasets

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