Effectiveness of Laxatives in the Elderly - NIHR Health Technology ...
Effectiveness of Laxatives in the Elderly - NIHR Health Technology ...
Effectiveness of Laxatives in the Elderly - NIHR Health Technology ...
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Research questions for <strong>the</strong><br />
current review<br />
The current systematic review was carried out <strong>in</strong><br />
order to:<br />
(i) compare <strong>the</strong> effectiveness <strong>of</strong> pharmacological<br />
and non-pharmacological <strong>in</strong>terventions<br />
<strong>in</strong> <strong>the</strong> prevention and treatment <strong>of</strong> constipation<br />
<strong>in</strong> <strong>the</strong> elderly, <strong>in</strong>clud<strong>in</strong>g exam<strong>in</strong>ation<br />
<strong>of</strong> <strong>the</strong> effectiveness <strong>of</strong> <strong>the</strong> different classes<br />
<strong>of</strong> laxatives (bulk, osmotic, faecal s<strong>of</strong>teners<br />
and stimulants)<br />
(ii) establish, where possible, <strong>the</strong> costeffectiveness<br />
<strong>of</strong> pharmacological and<br />
non-pharmacological laxatives<br />
(iii) identify, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> systematic review,<br />
those areas where fur<strong>the</strong>r research should<br />
be undertaken.<br />
The review was carried out us<strong>in</strong>g structured<br />
guidel<strong>in</strong>es for systematic reviews (NHS Centre<br />
for Reviews and Dissem<strong>in</strong>ation, 1996). A range<br />
<strong>of</strong> sources were searched <strong>in</strong> order to identify<br />
trials <strong>of</strong> laxatives. Abstracts <strong>of</strong> experimental<br />
studies <strong>of</strong> <strong>the</strong> use <strong>of</strong> laxatives were retrieved<br />
and screened for <strong>in</strong>clusion by two reviewers.<br />
Data were extracted and are presented <strong>in</strong> tabular<br />
form. The sources, <strong>in</strong>clusion criteria and assessment<br />
<strong>of</strong> study validity are described below. In<br />
addition, a search was carried out to identify<br />
o<strong>the</strong>r systematic reviews and meta-analyses <strong>in</strong><br />
this area. Retrieved review articles were qualityassessed<br />
to determ<strong>in</strong>e whe<strong>the</strong>r <strong>the</strong>se could act<br />
as useful source documents for <strong>the</strong> review. A<br />
separate search concentrat<strong>in</strong>g specifically on<br />
cost-effectiveness data was also carried out with<br />
<strong>the</strong> aim <strong>of</strong> identify<strong>in</strong>g any primary studies and<br />
reviews <strong>of</strong> economic evaluation.<br />
Sources<br />
A recently published systematic review <strong>of</strong><br />
<strong>the</strong> treatment <strong>of</strong> constipation <strong>in</strong> adults carried<br />
out at <strong>the</strong> San Antonio Cochrane Center, USA,<br />
(Tramonte et al, 1997) was used as a ma<strong>in</strong> source<br />
<strong>of</strong> trials. The authors <strong>of</strong> this review had searched<br />
Medl<strong>in</strong>e (1966–95), Biological Abstracts (1990–95),<br />
Micromedex, bibliographies and textbooks, and<br />
Chapter 3<br />
Methods<br />
<strong>Health</strong> <strong>Technology</strong> Assessment 1997; Vol. 1: No. 13<br />
had contacted laxative manufacturers and<br />
experts. For <strong>the</strong> current review <strong>of</strong> laxatives <strong>in</strong><br />
elderly patients, a supplementary search <strong>of</strong><br />
databases not previously searched was undertaken.<br />
Sources for this search were computerised<br />
Embase (1982–December 1996), Psychlit (1974–<br />
December 1996), Medl<strong>in</strong>e (to December 1996),<br />
<strong>the</strong> Cochrane Library database, <strong>the</strong> nurs<strong>in</strong>g<br />
database CINAHL (Citation Index for Nurs<strong>in</strong>g<br />
and Allied <strong>Health</strong> Literature), International<br />
Pharmaceutical Abstracts (1985–July 1996) and<br />
<strong>the</strong> alternative <strong>the</strong>rapies database, AMED (see<br />
Appendix 2 for fur<strong>the</strong>r details). The core search<br />
strategy for trials is presented <strong>in</strong> Appendix 2. All<br />
UK laxative manufacturers were also contacted<br />
<strong>in</strong> an attempt to locate o<strong>the</strong>r published and<br />
unpublished studies.<br />
In addition, a database <strong>of</strong> trials that were<br />
excluded from <strong>the</strong> review by Tramonte and<br />
colleagues (1997) was obta<strong>in</strong>ed. This database<br />
was reviewed by two reviewers to determ<strong>in</strong>e<br />
whe<strong>the</strong>r any trials were eligible for <strong>in</strong>clusion<br />
<strong>in</strong> this review <strong>of</strong> laxatives <strong>in</strong> <strong>the</strong> elderly.<br />
Cost-effectiveness <strong>in</strong>formation was searched for<br />
<strong>in</strong> Current Contents/Cl<strong>in</strong>ical Medic<strong>in</strong>e, Medl<strong>in</strong>e<br />
and <strong>the</strong> NHS Economic Evaluation Database.<br />
The search covered reviews <strong>of</strong> economic evaluations,<br />
cost-effectiveness studies (<strong>in</strong>clud<strong>in</strong>g costm<strong>in</strong>imisation<br />
and cost–consequences analyses),<br />
cost–benefit analyses and cost<strong>in</strong>g studies.<br />
Inclusion/exclusion criteria<br />
The review <strong>in</strong>cluded RCTs <strong>of</strong> laxatives <strong>in</strong> <strong>the</strong><br />
treatment or prevention <strong>of</strong> constipation <strong>in</strong> <strong>the</strong><br />
elderly <strong>in</strong> any language. A trial was eligible for<br />
<strong>in</strong>clusion if all participants were aged 55 years or<br />
older and be<strong>in</strong>g treated for chronic constipation.<br />
Treatment <strong>of</strong> constipation as a side-effect <strong>of</strong><br />
<strong>the</strong>rapy and laxative treatments <strong>of</strong> <strong>the</strong> side-effects<br />
<strong>of</strong> constipation (e.g. faecal impaction) were<br />
eligible for <strong>in</strong>clusion.<br />
Treatments <strong>in</strong>cluded were bulk-form<strong>in</strong>g,<br />
stimulant, osmotic and faecal-s<strong>of</strong>ten<strong>in</strong>g laxatives.<br />
Trials which <strong>in</strong>cluded symptoms, quality <strong>of</strong> life<br />
15