Measurement of patient-reported outcomes after laparoscopic cholecystectomy: a systematic review
- 74 Downloads
Patient-reported outcome (PRO) measures (PROMs) are increasingly used as endpoints in surgical trials. PROs need to be consistently measured and reported to accurately evaluate surgical care. Laparoscopic cholecystectomy (LC) is a commonly performed procedure which may be evaluated by PROs. We aimed to evaluate the frequency and consistency of PRO measurement and reporting after LC.
MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for prospective studies reporting PROs of LC, between 2013 and 2016. Data on the measurement and reporting of PROs were extracted.
A total of 281 studies were evaluated. Forty-five unique multi-item questionnaires were identified, most of which were used in single studies (n = 35). One hundred and ten unique rating scales were used to assess 358 PROs. The visual analogue scale was used to assess 24 different PROs, 17 of which were only reported in single studies. Details about the type of rating scale used were not given for 72 scales. Three hundred and twenty-three PROs were reported in 162 studies without details given about the scale or questionnaire used to evaluate them.
Considerable variation was identified in the choice of PROs reported after LC, and in how they were measured. PRO measurement for LC is focused on short-term outcomes, such as post-operative pain, rather than longer-term outcomes. Consideration should be given towards the development of a core outcome set for LC which incorporates PROs.
KeywordsLaparoscopic Cholecystectomy Outcome Surgery
This study was funded by the University of Auckland Honours Scholarship.
Compliance with ethical standards
Dr. Merry has financial relationships with SAFERsleep and is the Chair of the Board of the New Zealand Health Quality and Safety Commission. Mr. Alexander, Dr. Nguyen, Dr. Moore, Dr. Bartlett, Dr. Hannam, and Dr. Poole have no conflicts of interest or financial ties to disclose.
- 5.Comabella CCi, Gibbons E, Fitzpatrick R (2011) A structured review of patient-reported outcome measures for patients undergoing cholecystectomy. Patient-reported Outcome Measurement Group, Department of Public Health, University of Oxford, pp 1–40Google Scholar
- 17.Drossman DA (2006) Rome III: the new criteria. J Dig Dis 7:181–185Google Scholar
- 22.Prinsen CA, Vohra S, Rose MR, King-Jones S, Ishaque S, Bhaloo Z, Adams D, Terwee CB (2014) Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’. Trials 15:247CrossRefGoogle Scholar
- 24.Ware JE, Kosinski M, Dewey JE, Gandek B (2001) How to score and interpret single-item health status measures: a manual for users of the SF-8 health survey. Quality Metric Incorporated, LincolnGoogle Scholar
- 29.Alhashemi M, Almahroos M, Fiore JF, Kaneva P, Gutierrez JM, Neville A, Vassiliou MC, Fried GM, Feldman LS (2017) Impact of miniport laparoscopic cholecystectomy versus standard port laparoscopic cholecystectomy on recovery of physical activity: a randomized trial. Surg Endosc 31:2299–2309CrossRefGoogle Scholar
- 34.Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S (2010) The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. Clin Epidemiol 63:1179–1194CrossRefGoogle Scholar
- 38.van den Boezem PB, Velthuis S, Lourens HJ, Cuesta MA, Sietses C (2014) Single-incision and NOTES cholecystectomy, are there clinical or cosmetic advantages when compared to conventional laparoscopic cholecystectomy? A case–control study comparing single-incision, transvaginal, and conventional laparoscopic technique for cholecystectomy. World J Surg 38:25–32CrossRefGoogle Scholar
- 42.Marks J, Tacchino R, Roberts K, Onders R, Denoto G, Paraskeva P, Rivas H, Soper N, Rosemurgy A, Shah S (2011) Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data. Am J Surg 201:369–373CrossRefGoogle Scholar
- 44.Cleeland C, Ryan K (1994) Pain assessment: global use of the brief pain inventory. Ann Acad Med Singapore 23:129–138Google Scholar
- 45.Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A (2005) Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain 114:29–36CrossRefGoogle Scholar
- 50.Melzack R, Katz J (2007) McGill pain questionnaire. Encyclopedia of pain, Springer, pp 1102–1104Google Scholar
- 51.Crawford JR, Henry JD (2004) The Positive and Negative Affect Schedule (PANAS): construct validity, measurement properties and normative data in a large non-clinical sample. Br J Health Psychol 43:245–265Google Scholar
- 53.Spielberger CD, Gorsuch RL, Lushene RE (1970) STAI Manual for the Stait-Trait Anxiety Inventory (self-evaluation questionnaire). Consulting Psychologists, Palo AltoGoogle Scholar
- 59.Christoffersen MW, Brandt E, Oehlenschläger J, Rosenberg J, Helgstrand F, Jørgensen LN, Bardram L, Bisgaard T (2015) No difference in incidence of port-site hernia and chronic pain after single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy: a nationwide prospective, matched cohort study. Surg Endosc 29:3239–3245CrossRefGoogle Scholar
- 63.Marks JM, Phillips MS, Tacchino R, Roberts K, Onders R, DeNoto G, Gecelter G, Rubach E, Rivas H, Islam A (2013) Single-incision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of significantly higher hernia rates: 1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy. J Am Coll Surg 216:1037–1047CrossRefGoogle Scholar