Fecal Transplantation for C. Difficile-associated Disease
Fecal Transplantation for C. Difficile-associated Disease
A comprehensive search strategy was developed by a research librarian to identify any potentially relevant studies on FT for the treatment of CDAD. To keep findings contemporary, only studies published in the past 10 years (from January 2000 to October 2011) were included. Electronic databases searched included the Cochrane Library, PubMed, EMBASE, CINAHL, Biological Abstracts, BIOSIS Previews (ISI) and Web of Science (ISI). Websites of various health technology assessment agencies, regulatory agencies and guideline clearinghouses were also searched. The last search was run on 12 October 2011. The following Medical Subject Headings (MeSH) terms and keywords (including suffix variations of the root words) were used alone or in combination: Clostridium infections/Clostridium difficile/pseudomembranous/faeces/stool/rectal/colonflora/gastrointestinal/nasogastric tube/enema/donor/transplant/implant/infusion/transfusion/bacteriotherapy/human probiotic infusion. No limits were applied for study design.
The bibliographies of relevant articles were manually searched for additional references that may have been missed in the database searches. We also contacted several authors from Canada for missing information on their studies or information about ongoing clinical trials. Full details of the search strategy are available from the corresponding author upon request.
Title and abstracts were screened and eligibility of studies was determined by one reviewer (BG) using predefined inclusion and exclusion criteria. Systematic reviews, defined by the five criteria proposed by Cook and colleagues, that examined the safety and efficacy evidence from randomised or non-randomised comparative studies were included for analysis. Primary studies were included if they (1) included patients of any age with CDAD, (2) compared FT with standard care or reported safety and efficacy/effectiveness outcomes of FT in a series of patients without a control group, (3) were English full text studies published between 2000 and 2011. Studies were excluded if they (1) focused on the treatment using antibiotics or other probiotics, (2) included patients primarily with other gastrointestinal diseases, such as Crohn's disease or irritable bowel syndrome, or (3) were case reports.
Methodological quality of the included case series studies was assessed by one reviewer (BG). The five most important aspects of the Centre for Reviews and Dissemination (CRD) checklist for appraising the quality (including risk of bias and quality of reporting) of case series studies were used to examine each study. These included: (i) Were selection/eligibility criteria adequately reported? (ii) Were patients recruited consecutively? (iii) Were patients recruited prospectively? (iv) Was loss to follow-up reported or explained? (v) Were at least 90% of those included at baseline followed up? Results of quality assessment were not used to include or exclude studies.
Data from included studies were extracted by one reviewer (BG) using a predeveloped data extraction form, and cross-checked by a second reviewer (CH) for accuracy and consistency. When overlapping patient groups were reported, only the study quoting the most complete data set was used.
Information was extracted from each included study on (i) characteristics of patients (including age, gender, severity of disease and method of diagnosis); (ii) characteristics of intervention (including delivery method, dose and frequency); (iii) type of outcome measures. Safety outcomes included any adverse events associated with the FT procedure. Indicators of treatment efficacy/effectiveness included change in frequency and severity of symptoms, such as diarrhoea, testing for CD and its toxins, changes in colonoscopic or histological examinations, health-related quality of life measures, patients' acceptance of the procedure, prevention of more aggressive therapies (such as surgery), or reduction of emergency department visits.
Data extracted from each study and quality assessment results were synthesised using a narrative approach.
Methods
Search Strategy
A comprehensive search strategy was developed by a research librarian to identify any potentially relevant studies on FT for the treatment of CDAD. To keep findings contemporary, only studies published in the past 10 years (from January 2000 to October 2011) were included. Electronic databases searched included the Cochrane Library, PubMed, EMBASE, CINAHL, Biological Abstracts, BIOSIS Previews (ISI) and Web of Science (ISI). Websites of various health technology assessment agencies, regulatory agencies and guideline clearinghouses were also searched. The last search was run on 12 October 2011. The following Medical Subject Headings (MeSH) terms and keywords (including suffix variations of the root words) were used alone or in combination: Clostridium infections/Clostridium difficile/pseudomembranous/faeces/stool/rectal/colonflora/gastrointestinal/nasogastric tube/enema/donor/transplant/implant/infusion/transfusion/bacteriotherapy/human probiotic infusion. No limits were applied for study design.
The bibliographies of relevant articles were manually searched for additional references that may have been missed in the database searches. We also contacted several authors from Canada for missing information on their studies or information about ongoing clinical trials. Full details of the search strategy are available from the corresponding author upon request.
Study Selection
Title and abstracts were screened and eligibility of studies was determined by one reviewer (BG) using predefined inclusion and exclusion criteria. Systematic reviews, defined by the five criteria proposed by Cook and colleagues, that examined the safety and efficacy evidence from randomised or non-randomised comparative studies were included for analysis. Primary studies were included if they (1) included patients of any age with CDAD, (2) compared FT with standard care or reported safety and efficacy/effectiveness outcomes of FT in a series of patients without a control group, (3) were English full text studies published between 2000 and 2011. Studies were excluded if they (1) focused on the treatment using antibiotics or other probiotics, (2) included patients primarily with other gastrointestinal diseases, such as Crohn's disease or irritable bowel syndrome, or (3) were case reports.
Quality Assessment
Methodological quality of the included case series studies was assessed by one reviewer (BG). The five most important aspects of the Centre for Reviews and Dissemination (CRD) checklist for appraising the quality (including risk of bias and quality of reporting) of case series studies were used to examine each study. These included: (i) Were selection/eligibility criteria adequately reported? (ii) Were patients recruited consecutively? (iii) Were patients recruited prospectively? (iv) Was loss to follow-up reported or explained? (v) Were at least 90% of those included at baseline followed up? Results of quality assessment were not used to include or exclude studies.
Data Extraction and Synthesis
Data from included studies were extracted by one reviewer (BG) using a predeveloped data extraction form, and cross-checked by a second reviewer (CH) for accuracy and consistency. When overlapping patient groups were reported, only the study quoting the most complete data set was used.
Information was extracted from each included study on (i) characteristics of patients (including age, gender, severity of disease and method of diagnosis); (ii) characteristics of intervention (including delivery method, dose and frequency); (iii) type of outcome measures. Safety outcomes included any adverse events associated with the FT procedure. Indicators of treatment efficacy/effectiveness included change in frequency and severity of symptoms, such as diarrhoea, testing for CD and its toxins, changes in colonoscopic or histological examinations, health-related quality of life measures, patients' acceptance of the procedure, prevention of more aggressive therapies (such as surgery), or reduction of emergency department visits.
Data extracted from each study and quality assessment results were synthesised using a narrative approach.
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