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Methodological Quality Assessment of Randomised Clinical Trials
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Systematic Reviews Methodological Quality Assessment of Randomised CI inicaI Tr iaIs
H C W d e Vet A G H Kessels P G Knipschild
A P Verhagen R A de Bie M Boers
University of Limburg, Maastricht, The Netherlands ~
~~~~~~
Objectives: To review t h e literature to summarise information from original research. The need for methodological quality assessment i n reviews of (randomised) clinical trials (RCTs) is well recognised. ‘Quality’ is not easy to define or measure. Recently quality, or ‘scientific quality’, has been defined as ‘the confidence that design, conduct, and analysis of a study h a s minimised or avoided biases i n its treatment comparisons’. But quality can refer to many decisions made in a trial. In addition to bias it may refer to relevance of study population, intervention and outcome measurement.
Physiotherapy and Genuine Urinary Stress Incontinence: A systematic review of randomised clinical trials H J M Hendriks S Van Den Heuvel National Institute for Research and Postgraduate Education for Allied Health Professions, Amersfoort, The Netherlands
B Berghmans Department of Urology, University Hospital, Maastricht, The Netherlands
Objective: To determine the effectiveness of physiotherapy of patients with genuine urinary stress incontinence (GUSI). Design: Computer-aided search of published papers (randomised clinical trials - RCTs) and a criteria-based systematic review of t h e methodological quality of t h e trials. Only RCTs were included because of their potential to provide a valid assessment of the effectiveness of a n intervention. Abstracts and unpublished studies were not included. Main outcome measurements: Score for quality of methods (based on t e n categories, eg homogeneous study population and prognostic characteristics,
Physiotherapy, July 1996, vol82, no 7
Assessing the quality of RCTs included in a review is important for two reasons: first because variation in quality can explain differences in t h e results, and secondly because when the methodology of the RCTs included in the review is weak, the conclusions of the review cannot be very strong. It is also necessary for experts to agree on the way literature will be summarised, especially where the quality of individual studies is assessed and incorporated i n systematic reviews and meta-analyses. We a i m to develop a universal criteria list as a minimum reference standard to be used for systematic reviews, a p a r t from every researcher’s own list.
Design: By means of the Delphi method we are trying to achieve international consensus on quality assessment in RCTs. Results and Conclusion: The procedure and the results will be presented. Conclusions and practical implications from this Delphi research will be presented at the Congress.
randomisation procedures, intervention and reference treatment, baseline and outcome measurements, data presentation and analysis); and main conclusion(s) of author(s) with regard to physiotherapy for patients with GUSI.
Results: Twenty-six RCTs were identified, of which 16 studied physiotherapy (exercise therapy and physiotherapeutic modalities) given to individual patients with GUSI. Fourteen studies scored more t h a n five points (maximum ten). These studies showed the positive pre- and post-test results of (standard) pelvic floor exercises (PFE) and four studies demonstrated an adequate support of biofeedback. Two studies reported t h e importance of a n intensive PFE programme (the degree and duration of treatment) and frequent and close supervision by the therapist. Prognostic characteristics of the outcome of physiotherapy intervention were deduced; positive effects were more likely in younger patients, those with milder degrees of GUSI, those who had no previous pelvic floor surgery, and those with a strong motivatiodperformance. Conclusion: PFE are effective in reducing GUSI. The use of some forms of biofeedback is recommended as a cost-effective method of treatment that can be added t o t h e standard PFE programme. These therapies may be useful before considering invasive treatment, but successful treatment is highly dependent on patient motivation and compliance.
Systematic Reviews Methodological Quality Assessment of Randomised CI inicaI Tr iaIs
H C W d e Vet A G H Kessels P G Knipschild
A P Verhagen R A de Bie M Boers
University of Limburg, Maastricht, The Netherlands ~
~~~~~~
Objectives: To review t h e literature to summarise information from original research. The need for methodological quality assessment i n reviews of (randomised) clinical trials (RCTs) is well recognised. ‘Quality’ is not easy to define or measure. Recently quality, or ‘scientific quality’, has been defined as ‘the confidence that design, conduct, and analysis of a study h a s minimised or avoided biases i n its treatment comparisons’. But quality can refer to many decisions made in a trial. In addition to bias it may refer to relevance of study population, intervention and outcome measurement.
Physiotherapy and Genuine Urinary Stress Incontinence: A systematic review of randomised clinical trials H J M Hendriks S Van Den Heuvel National Institute for Research and Postgraduate Education for Allied Health Professions, Amersfoort, The Netherlands
B Berghmans Department of Urology, University Hospital, Maastricht, The Netherlands
Objective: To determine the effectiveness of physiotherapy of patients with genuine urinary stress incontinence (GUSI). Design: Computer-aided search of published papers (randomised clinical trials - RCTs) and a criteria-based systematic review of t h e methodological quality of t h e trials. Only RCTs were included because of their potential to provide a valid assessment of the effectiveness of a n intervention. Abstracts and unpublished studies were not included. Main outcome measurements: Score for quality of methods (based on t e n categories, eg homogeneous study population and prognostic characteristics,
Physiotherapy, July 1996, vol82, no 7
Assessing the quality of RCTs included in a review is important for two reasons: first because variation in quality can explain differences in t h e results, and secondly because when the methodology of the RCTs included in the review is weak, the conclusions of the review cannot be very strong. It is also necessary for experts to agree on the way literature will be summarised, especially where the quality of individual studies is assessed and incorporated i n systematic reviews and meta-analyses. We a i m to develop a universal criteria list as a minimum reference standard to be used for systematic reviews, a p a r t from every researcher’s own list.
Design: By means of the Delphi method we are trying to achieve international consensus on quality assessment in RCTs. Results and Conclusion: The procedure and the results will be presented. Conclusions and practical implications from this Delphi research will be presented at the Congress.
randomisation procedures, intervention and reference treatment, baseline and outcome measurements, data presentation and analysis); and main conclusion(s) of author(s) with regard to physiotherapy for patients with GUSI.
Results: Twenty-six RCTs were identified, of which 16 studied physiotherapy (exercise therapy and physiotherapeutic modalities) given to individual patients with GUSI. Fourteen studies scored more t h a n five points (maximum ten). These studies showed the positive pre- and post-test results of (standard) pelvic floor exercises (PFE) and four studies demonstrated an adequate support of biofeedback. Two studies reported t h e importance of a n intensive PFE programme (the degree and duration of treatment) and frequent and close supervision by the therapist. Prognostic characteristics of the outcome of physiotherapy intervention were deduced; positive effects were more likely in younger patients, those with milder degrees of GUSI, those who had no previous pelvic floor surgery, and those with a strong motivatiodperformance. Conclusion: PFE are effective in reducing GUSI. The use of some forms of biofeedback is recommended as a cost-effective method of treatment that can be added t o t h e standard PFE programme. These therapies may be useful before considering invasive treatment, but successful treatment is highly dependent on patient motivation and compliance.