Methodological challenges of multiple-component intervention: lessons learned from a randomized controlled trial of functional recovery after hip fracture.

Methodological challenges of multiple-component intervention: lessons learned from a randomized controlled trial of functional recovery after hip fracture. Allegrante, J. P, Peterson, M. G E, Cornell, C. N, MacKenzie, C R., Robbins, L., Horton, R., Ganz, S. B, Ruchlin, H. S, Russo, P. W., Paget, S. A, & Charlson, M. E HSS journal : the musculoskeletal journal of Hospital for Special Surgery, 3(1):63-70, 2, 2007. 4782JID: 101273938; OID: NLM: PMC2504100; ppublish;Intervenció/placebo
$Methodological challenges of multiple-component intervention: lessons learned from a randomized controlled trial of functional recovery after hip fracture. [link]$ Paper doi abstract bibtex

We conducted a randomized controlled trial to assess the efficacy and safety of a multiple-component intervention designed to improve functional recovery after hip fracture. One hundred seventy-six patients who underwent surgery for a primary unilateral hip fracture were assigned randomly to receive usual care (control arm, n = 86) or a brief motivational videotape, supportive peer counseling, and high-intensity muscle-strength training (intervention arm, n = 90). Between-group differences on the physical functioning, role-physical, and social functioning domains of the SF-36 were assessed postoperatively at 6 months. At the end of the trial, 32 intervention and 27 control patients (34%) completed the 6-month outcome assessment. Although patient compliance with all three components of the intervention was uneven, over 90% of intervention patients were exposed to the motivational videotape. Intervention patients experienced a significant (P = 0.03) improvement in the role-physical domain (mean change, -11 +/- 33) compared to control patients (mean change, -37 +/- 41). Change in general health (P = 0.2) and mental health (P = 0.1) domain scores was also directionally consistent with the study hypothesis. Although our findings are consistent with previous reports of comprehensive rehabilitation efforts for hip fracture patients, the trial was undermined by high attrition and the possibility of self-selection bias at 6-month follow-up. We discuss the methodological challenges and lessons learned in conducting a randomized controlled trial that sought to implement and assess the impact of a complex intervention in a population that proved difficult to follow up once they had returned to the community.

@article{Allegrante2007,
  abstract = {We conducted a randomized controlled trial to assess the efficacy and safety of a multiple-component intervention designed to improve functional recovery after hip fracture. One hundred seventy-six patients who underwent surgery for a primary unilateral hip fracture were assigned randomly to receive usual care (control arm, n = 86) or a brief motivational videotape, supportive peer counseling, and high-intensity muscle-strength training (intervention arm, n = 90). Between-group differences on the physical functioning, role-physical, and social functioning domains of the SF-36 were assessed postoperatively at 6 months. At the end of the trial, 32 intervention and 27 control patients (34%) completed the 6-month outcome assessment. Although patient compliance with all three components of the intervention was uneven, over 90% of intervention patients were exposed to the motivational videotape. Intervention patients experienced a significant (P = 0.03) improvement in the role-physical domain (mean change, -11 +/- 33) compared to control patients (mean change, -37 +/- 41). Change in general health (P = 0.2) and mental health (P = 0.1) domain scores was also directionally consistent with the study hypothesis. Although our findings are consistent with previous reports of comprehensive rehabilitation efforts for hip fracture patients, the trial was undermined by high attrition and the possibility of self-selection bias at 6-month follow-up. We discuss the methodological challenges and lessons learned in conducting a randomized controlled trial that sought to implement and assess the impact of a complex intervention in a population that proved difficult to follow up once they had returned to the community.},
  added-at = {2023-02-03T11:44:35.000+0100},
  author = {Allegrante, John P and Peterson, Margaret G E and Cornell, Charles N and MacKenzie, C Ronald and Robbins, Laura and Horton, Roberta and Ganz, Sandy B and Ruchlin, Hirsch S and Russo, Pamela Williams and Paget, Stephen A and Charlson, Mary E},
  biburl = {https://www.bibsonomy.org/bibtex/262f9d124ab56881a82e0711fe83ab605/jepcastel},
  city = {Department of Health and Behavior Studies, Teachers College, Columbia University, 525 West 120th Street, New York, NY, 10027, USA, jpa1@columbia.edu.},
  doi = {10.1007/s11420-006-9036-x},
  interhash = {000744c4c9eee18dd7f89d4979530def},
  intrahash = {62f9d124ab56881a82e0711fe83ab605},
  isbn = {1556-3316},
  issn = {1556-3316},
  journal = {HSS journal : the musculoskeletal journal of Hospital for Special Surgery},
  keywords = {imported},
  month = {2},
  note = {4782<m:linebreak></m:linebreak>JID: 101273938; OID: NLM: PMC2504100; ppublish;<m:linebreak></m:linebreak>Intervenció/placebo},
  number = 1,
  pages = {63-70},
  pmid = {18751772},
  timestamp = {2023-02-03T11:44:35.000+0100},
  title = {Methodological challenges of multiple-component intervention: lessons learned from a randomized controlled trial of functional recovery after hip fracture.},
  url = {http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2504100&tool=pmcentrez&rendertype=abstract},
  volume = 3,
  year = 2007
}

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