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The Quince...

Issue 102
Prognosis in stable angina
Determinants of primary medical care quality
Sham device vs inert pill as placebos

Prognosis in stable angina

This study was set up to investigate the prognosis associated with stable angina in a contemporary population as seen in clinical practice, to identify the key prognostic features, and from this to construct a simple score to help with risk prediction. It was a prospective observational cohort study, using a Pan-European survey in 156 outpatient cardiology clinics. 3031 patients were included on the basis of a new clinical diagnosis by a cardiologist of stable angina with follow-up at one year. The main outcome measure was death or non-fatal myocardial infarction.

The study showed that the rate of death and non-fatal myocardial infarction in the first year was 2.3 per 100 patient years; the rate was 3.9 per 100 patient years in the subgroup (n = 994) with angiographic confirmation of coronary disease.

The clinical and investigative factors most predictive of adverse outcome were comorbidity, diabetes, relatively short duration of symptoms, increasing severity of symptoms, abnormal ventricular function, resting electrocardiogaphic changes, or not having any stress test done.

The results of non-invasive stress tests did not significantly predict outcome in the population who had tests done. A score was constructed using the parameters predictive of outcome to estimate the probability of death or myocardial infarction within one year of presentation with stable angina.

The conclusion of the paper was that it was shown to be possible to construct a score based on the presence of simple, objective clinical and investigative variables.

This could be used to discriminate effectively between very low risk and very high risk patients and to estimate the probability of death or non-fatal myocardial infarction over one year.

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Determinants of primary medical care quality

This study was set up to identify factors associated with the quality of  primary medical care under the new UK general medical services contract.

It was a  cross sectional study set in the  NHS in Ayrshire and Arran area, Scotland. It included 60 general practices as participants.

The main outcome measures were quality scores reflecting the total points achieved on the 10 clinical domains and holistic care.

Univariate and multivariate regression analyses were used to relate the quality scores to measures of population characteristics, urban-rural location, general practitioner characteristics, clinical team size and composition, practice characteristics, and income from other sources.

The results of the study showed that deprivation in the practice population was associated with higher scores. Quality scores also increased with the size of the clinical team. Practices with higher income from other sources had lower quality scores. Practices that were accredited, had training status, or contained younger general practitioners had higher quality scores, but these effects were explained by other associated factors. 53% of the variation in quality scores was explained by a multivariate model, which included measures of deprivation, clinical team size and composition, and financial incentives.

Overall the study showed that the population characteristics had little association with the quality of primary medical care incentivised under the UK general medical services contract.

Larger clinical teams delivered higher quality clinical care, but the nurse-doctor composition of the clinical team did not influence quality. 

Practices that were more likely to respond to financial incentives because of previous behaviour or lower income from other sources recorded higher quality. If generalisable, the results suggest that initiatives to improve primary medical care quality should focus on the structure and resourcing of providers.

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Sham device v inert pill as placebos

This study was set up to investigate the placebo effect in patients whether a sham device (a validated sham acupuncture needle) had a greater placebo effect than an inert pill in patients with persistent arm pain.

This was a single blind randomised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls. Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study.

The study was made of 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored over 3 on a 10 point pain scale.

The interventions compared were  acupuncture with a sham device twice a week for six weeks or a placebo pill once a day for eight weeks.

The results were based on arm pain measured on a 10 point pain scale. Secondary outcomes were symptoms measured by the Levine symptom severity scale, function measured by Pransky's upper extremity function scale, and grip strength.

The study showed that pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups, but changes were not different between the groups.

Changes in severity scores for arm symptoms and grip strength were similar between groups, but arm function improved more in the placebo pill group (2.0, 0.06 to 3.92, P = 0.04). Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point  arm pain scale and on the symptom severity scale in those using the  sham device than those on the placebo pill .

Differences were not significant, however, on the function scale or for grip strength. Reported adverse effects were different in the two groups.

It is concluded that the sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in.

Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals.

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Last updated:

Copyright 2006 | Norman Vetter


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