Renal Disease: Scope of Literature

Summary

In most cases, studies excluded patients with physical or cognitive disability, life-threatening illnesses and/or moderate to severe complications. Pregnancy or planned pregnancy was another common disqualifying factor.

The most notable of the few exceptions to the exclusion of patient with co-morbidities are the VA-CCHT programs, many of which targeted veterans with complex medical conditions or at an increased risk for high health care service use. The most common co-morbidities in 1 study included congestive heart failure, peripheral vascular disease, and chronic pulmonary disease (Barnett et al., 2007). Other studies including patients with co-morbidities, and the conditions most frequently reported, can be seen in Table 8.1.3: Population Characteristics – Clinical Characteristics I and Table 8.1.3: Population Characteristics – Clinical Characteristics II, below. The most common co-morbidities were hypertension, obesity, hyperlipidemia/dyslipidemia, and cardiovascular disease.

Details

Number and Location

A search of literature published from 2005-2010 located 2 studies of home telehealth for management of renal disease (Gallar et al., 2007; Michael et al., 2009). Note that telehealth interventions in which the presence of a visiting home nurse was required did not meet our definition of home telehealth and were excluded.

Gallar et al. (2007) took place in Spain. Michael et al. (2009) do not report location; however, it appears to be U.S.-based.

A final search for material published from 2011-2012 found 1 additional study that met our inclusion criteria and filled gaps left by the first round of searching (An, 2011). This study was analyzed in a slightly different way than the studies retrieved in our original search, and its findings were incorporated into this review in a limited fashion. For more details, please see Methods.

Study Design

The Oxford 2011 Levels of Evidence were used to assess the strength of the evidence base.[1] Studies were placed on a scale running from Level 1,[2] considered the highest level of evidence, through to Level 5.[3] Levels are based primarily on study design. Studies were also assigned scores for quality of execution and reporting. Low execution/reporting scores resulted in downgrading.

The Oxford 2011 Levels of Evidence are intended to provide guidance rather than absolute judgments, and do not obviate the need for careful appraisal of local needs and context. The quality of studies within a given level can vary, as can their applicability to select populations. Furthermore, this system is not suitable for all forms of assessment. In the text that follows, the Oxford 2011 Levels of Evidence are used only when discussing clinical outcomes.

The evidence base for home telehealth in the management of renal disease was extremely weak. The 2 studies retrieved were initially classed as Level 3 and Level 4 evidence, but were downgraded for low execution/reporting scores: Gallar et al. (2007) to Level 4 evidence, and Michael et al. (2009) to Level 5.

Gallar et al. (2007) used concurrent comparison groups and prospective measurement of exposure and outcomes. However, allocation was not fully randomized; subjects who refused the intervention were placed in the comparison group, where they made up almost one-third of participants. Michael et al. (2009) used a non-controlled case series design. The number of patients enrolled was 35, of which 27 completed the study and were used in the analysis. Both study publications give authorship and/or funding credits to industry members, raising the possibility of bias.

The intervention period in Michael et al. (2009) was 3 months. Length of participation ranged from 3 to 24 months in Gallar et al. (2007), with the mean being approximately 8 months.