Patient-reported outcome instruments used to assess pain  and functioning in studies of bisphosphonate treatment  for bone metastases.
OBJECTIVE
When treating metastatic bone disease, relief of bone pain is often a key outcome. Because pain cannot be quantified with objective clinical measures, patient-reported outcome (PRO) measures are required to assess patients' subjective experience. The goal of the current review was to examine measures used to assess pain, as well as the impact of pain on functional status and health-related quality of life (HRQL), in trials of bisphosphonates for the treatment of bone metastases.


METHODS
A literature search focused on articles published from January 1999 to April 2009.


RESULTS
A total of 49 articles were located that used PROs to assess pain-related outcomes of bisphosphonate treatment for bone metastases. The Brief Pain Inventory was the most commonly used multi-item instrument. However, the most common approach for assessing pain was to administer a single-item scale such as a visual analog scale, numerical rating scale, or verbal rating scale. Of the 49 studies, 19 included a PRO assessing functional status or HRQL.


CONCLUSIONS
Although pain is an important outcome of trials examining treatment for bone metastases, the current review suggests that there is little consistency in PRO measurement across studies. Furthermore, presentation of measures often lacked clear description, information on measurement properties, citations, clarity regarding method of administration, and consistent instrument names. Recommendations are provided for instrument validation within the target population, assessment of content validity, use of PRO instruments recently developed for patients with bone metastases, clear description of instruments, and implementation of measures consistent with recommendations from instrument developers.
United BioSource Corporation, 7101 Wisconsin Ave, Suite 600, Bethesda, MD 20814, USA. louis.matza@unitedbiosource.com
Louis S
LS
Matza
Lesley J
LJ
Fallowfield
Karen C
KC
Chung
Brooke M
BM
Currie
Kate
K
Van Brunt
Donald L
DL
Patrick
D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D003625:Data Collection / Q000379:methods; D004164:Diphosphonates / Q000627:therapeutic use*; D006801:Humans; D017063:Outcome Assessment, Health Care; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement / Q000379:methods; D011788:Quality of Life; D012107:Research Design
D050071:Bone Density Conservation Agents; D004164:Diphosphonates