There was weak evidence for  custom orthoses reducing pain and forefoot plantar pressures .
Evidence was inconclusive for foot function , walking speed , gait parameters , and reducing hallux abductovalgus angle progression .
CONCLUSION Custom orthoses may be beneficial in reducing pain and elevated forefoot plantar pressures in the rheumatoid foot and ankle .
OBJECTIVE To identify and critically appraise the evidence for the effectiveness of custom orthoses for the foot and ankle in rheumatoid arthritis .
Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity
Background Controlled clinical trials of health care interventions are either explanatory or pragmatic . Explanatory trials test whether an intervention is efficacious ; that is , whether it can have a beneficial effect in an ideal situation . Pragmatic trials measure effectiveness ; they measure the degree of beneficial effect in real clinical practice . In pragmatic trials , a balance between external validity ( generalizability of the results ) and internal validity ( reliability or accuracy of the results ) needs to be achieved . The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention . The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized . However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability . We are conducting two pragmatic r and omized controlled trials on interventions in the management of hypertension in primary care . We describe the design of the trials and the steps taken to deal with the competing dem and s of external and internal validity . Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions . Internal validity is maximized by decreasing contamination bias through cluster r and omization , and decreasing observer and assessment bias , in these non-blinded trials , through baseline data collection prior to r and omization , automating the outcomes assessment with 24 hour ambulatory blood pressure monitors , and blinding the data analysis . Summary Clinical trials conducted in community practice s present investigators with difficult method ological choices related to maintaining a balance between internal validity ( reliability of the results ) and external validity ( generalizability ) . The attempt to achieve method ological purity can result in clinical ly meaningless results , while attempting to achieve full generalizability can result in invalid and unreliable results . Achieving a creative tension between the two is crucial
There was weak evidence for  custom orthoses reducing pain and forefoot plantar pressures .
Evidence was inconclusive for foot function , walking speed , gait parameters , and reducing hallux abductovalgus angle progression .
CONCLUSION Custom orthoses may be beneficial in reducing pain and elevated forefoot plantar pressures in the rheumatoid foot and ankle .
OBJECTIVE To identify and critically appraise the evidence for the effectiveness of custom orthoses for the foot and ankle in rheumatoid arthritis .