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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Effects of lower limb prosthesis on activity, participation, and quality of life: a systematic review

KA Samuelsson, O Toytari, AL Salminen, and A Brandt.

Review published: 2012.

Link to full article: [Journal publisher]

CRD summary

The review found that available evidence on the effectiveness of different lower limb prostheses for adults was inconsistent and study quality was variable, highlighting the need for high quality research in this area. Given the suboptimal study quality and the variation between the studies, these cautious findings appear reliable.

Authors' objectives

To evaluate the effects of lower limb prostheses for adults on activity, participation and quality of life.

Searching

Fourteen databases (including DARE, MEDLINE and EMBASE) were searched with no language restrictions. Search dates encompassed 1998 to June 2009. Search terms were reported. The proceedings of two conferences, a journal on assistive technology, and the reference lists of relevant studies and reviews were also checked.

Study selection

Controlled and before-and-after studies that compared the use of a lower limb prosthesis versus a different prosthesis or no prosthesis in adults (older than 18 years) were eligible for inclusion. Review primary outcomes were activity, participation and/or quality of life; secondary outcomes were user satisfaction, use/non-use and cost-related outcomes. Studies were required to be conducted in a real-life context and to report at least one of the primary outcomes. Eligible types of prosthesis were listed in the review. Studies that were conducted in a laboratory setting or that included a control population who had not undergone amputation were excluded.

The mean age of participants in the included studies was 48.5 years (range 18 to 83); the proportion of men ranged from 9% to 88% (where reported). All patients had undergone transtibial or transfemoral amputation. Most patients were recruited via health care providers (where reported). Most studies compared a new prosthesis versus the participants' previous prosthesis. Half the studies compared a microprocessor-controlled versus a non-microprocessor controlled knee. Interventions used in other studies varied widely. Fourteen different outcome measures were used, most focusing on activity or quality of life.

Two reviewers independently selected studies for inclusion. Disagreements were resolved by discussion or by consulting two other reviewers.

Assessment of study quality

Internal study validity was assessed using an adaptation of published criteria to allot from 1 to 10 points. Items assessed were: reporting of participant selection methods, inclusion criteria, drop-outs and psychometric properties of measurement tools; suitability of outcomes; sample size (over 10 patient-years); duration of follow-up (over four months); drop-out rates (under 20%); data presentation; and adjustment for confounders. External validity was assessed by allotting up to 4 points for the adequacy of reporting of study characteristics, use of clinically relevant outcomes, and whether the effect size was clinically important (at least 10% improvement). For randomised controlled trials (RCTs), methods of randomisation and allocation concealment, avoidance of confounding, compliance and use of intention-to-treat analysis were also assessed.

All four reviewers assessed study quality.

Data extraction

Descriptive data were extracted for comparisons between the two groups in each study. P values were reported for some comparisons.

Methods of synthesis

Studies were combined in a narrative synthesis, organised by type of outcome. Findings were presented using a vote-counting approach, with details of studies that reported statistically significant findings for specific outcome measures and those that did not.

Results of the review

Eight studies were included in the review, with 219 participants (range 10 to 100). According to the table of study designs (Table 1), there were two RCTs, one case-control study, three before-and-after studies, and two observational cross-over studies. Scores for internal validity ranged from 5 to 8 points. Seven of eight studies scored 3 or 4 points for external validity. Only two studies scored highly for both internal and external validity. Follow-up was under four months in all except one study (range four weeks to two years, where reported).

Five of seven studies that reported activity or participation found a significant difference between the groups for at least one measure. Two of three relevant studies reported benefit from a microprocessor-controlled (compared with a non-microprocessor-controlled) knee; the third study found no significant difference between them. Single studies reported benefits from a neoprene-suspension sleeve (compared to an elastomeric-suspension liner), a silicon (compared with non-silicon) cover prosthesis, and an osseo-integrated transfemoral amputation prosthesis (compared with a conventional prosthesis). One study found no significant difference between a shock-absorbing versus a rigid-pylon prosthesis.

Four of five studies reported that there was a significant difference between the groups in quality of life for at least one measure. Interventions associated with benefits (relative to their comparator) were the osseo-integrated transfemoral amputation prosthesis (one study) and the microprocessor-controlled knee (three studies). No significant difference was found between a silicon and non-silicon cover prosthesis for quality of life outcomes.

Findings for secondary outcomes were also reported in the review.

Cost information

Cost outcomes were reported in two studies. One study found that a microprocessor-controlled knee (compared with a non-microprocessor-controlled knee) was associated with a cost-utility gain of 0.09 quality-adjusted life-year (QALY) at a cost of 35.971 Euros per QALY using a five-year healthcare system perspective; from a societal perspective, there was no significant difference in cost. The other study reported that a total surface-bearing socket was associated with higher material costs, shorter manufacturing time and fewer visits than a conventional patellar tendon-bearing socket.

Authors' conclusions

Available evidence on the effectiveness of different lower limb prostheses for adults was inconsistent and study quality was variable, highlighting the need for high quality research in this area.

CRD commentary

The objectives and inclusion criteria of the review were clear. Relevant sources were searched for published and unpublished studies in any language. Steps were taken to minimise the risk of reviewer bias and error at each stage of the review process.

Appropriate methods were used to assess study quality. The characteristics of the included studies were described in some detail (although funding sources were not reported), but there was some discrepancy between text and tables for study design. As the authors acknowledged, there were few studies, study quality was variable and studies differed widely in their interventions and outcome measures. Findings were inconsistent across different measures, and it was difficult to determine the clinical relevance of statistically significant results.

Given the suboptimal study quality and heterogeneity between the studies, the authors' cautious findings appear reliable.

Implications of the review for practice and research

Practice: The authors stated that the interventions described in the review could not be recommended on available evidence.

Research: The authors stated that high priority should be given to research on key factors influencing the effectiveness of prosthetic interventions in everyday life.

Funding

Supported in part by the Nordic Welfare Centre (formerly Nordic Development Centre for Rehabilitation Technology).

Bibliographic details

Samuelsson KA, Toytari O, Salminen AL, Brandt A. Effects of lower limb prosthesis on activity, participation, and quality of life: a systematic review. Prosthetics and Orthotics International 2012; 36(2): 145-158. [PubMed: 22307861]

Indexing Status

Subject indexing assigned by NLM

MeSH

Adult; Artificial Limbs /psychology; Cost-Benefit Analysis; Follow-Up Studies; Humans; Microcomputers /economics; Motor Activity /physiology; Patient Participation /psychology; Patient Satisfaction; Quality of Life /psychology; Social Participation /psychology

AccessionNumber

12012038100

Database entry date

08/04/2013

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 22307861