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Effectiveness of Laxatives in the Elderly - NIHR Health Technology ...

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16<br />

Methods<br />

and side-effects <strong>of</strong> laxatives as endpo<strong>in</strong>ts were<br />

<strong>in</strong>cluded, as were trials exam<strong>in</strong><strong>in</strong>g <strong>the</strong> use <strong>of</strong><br />

laxatives <strong>in</strong> <strong>the</strong> prevention <strong>of</strong> severe side-effects<br />

<strong>of</strong> constipation. Non-English language studies<br />

were translated and <strong>in</strong>cluded if <strong>the</strong>y met <strong>the</strong><br />

<strong>in</strong>clusion criteria.<br />

Studies <strong>of</strong> constipation <strong>in</strong> sp<strong>in</strong>al cord <strong>in</strong>jury<br />

and park<strong>in</strong>sonism were excluded. Trials <strong>of</strong><br />

enemas (e.g. soapsuds, Fleet ® ) and <strong>of</strong> bowel<br />

cleans<strong>in</strong>g programmes <strong>in</strong> preparation for<br />

surgery or colonoscopy were excluded.<br />

Study validity, data extraction<br />

and syn<strong>the</strong>sis<br />

If a trial met <strong>the</strong> <strong>in</strong>clusion criteria and had been<br />

<strong>in</strong>cluded <strong>in</strong> <strong>the</strong> review by Tramonte and colleagues<br />

(1997), <strong>the</strong> appropriate cl<strong>in</strong>ical data were <strong>in</strong>cluded.<br />

The data had been extracted <strong>in</strong>dependently by<br />

two reviewers. Data from any supplementary trials<br />

identified were extracted by one reviewer us<strong>in</strong>g<br />

<strong>the</strong> same data extraction form as <strong>the</strong> Cochrane<br />

reviewers. Authors were contacted for additional<br />

<strong>in</strong>formation if necessary and, when possible,<br />

p values and o<strong>the</strong>r statistics not presented <strong>in</strong><br />

orig<strong>in</strong>al papers were calculated. Quality <strong>of</strong> primary<br />

studies was summarised us<strong>in</strong>g <strong>the</strong> same scale used<br />

<strong>in</strong> <strong>the</strong> Cochrane review. This <strong>in</strong>volved methodological<br />

assessment us<strong>in</strong>g a 6-po<strong>in</strong>t scale cover<strong>in</strong>g<br />

report<strong>in</strong>g <strong>of</strong> <strong>in</strong>clusion and exclusion criteria,<br />

randomisation method, standardised assessment<br />

<strong>of</strong> adverse effects, double-bl<strong>in</strong>d design, description<br />

<strong>of</strong> withdrawals, and statistical analysis (Hedges<br />

& Olk<strong>in</strong>, 1985). Studies were grouped accord<strong>in</strong>g<br />

to class <strong>of</strong> laxative, if appropriate, and <strong>the</strong> data<br />

summarised us<strong>in</strong>g meta-analysis.

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