Ranking of patient and surgeons' perspectives for endpoints in randomized controlled trials—lessons learned from the POVATI trial [ISRCTN 60734227]

Fischer, Lars; Deckert, Andreas; Zimmermann, Johannes B.; Büchler, Markus W.; Seiler, Christoph M.

doi:10.1007/s00423-011-0798-3

Cited by 7 publications

(6 citation statements)

References 18 publications

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“…Most studies ( n = 19) included patients only, including preferences of pregnant women and parents of children (as proxies) . Five studies compared preferences of patients with those of healthcare professionals . One study compared preferences of primary stakeholders as patients, family members or mental healthcare providers with preferences of policymakers in schizophrenia .…”

Section: Resultsmentioning

confidence: 99%

“…Twenty‐eight studies compared preferences of different participant groups, mostly patients vs. health care professionals. Among the 22 studies evaluating preferences of patients and health care providers, only one stated that the preferences assessed were identical, and four found at least some agreement concerning the most valued outcomes . The remaining 17 studies showed differences between the groups studied, either in differing hierarchies or in strength of preferences.…”

Section: Resultsmentioning

confidence: 99%

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A descriptive review on methods to prioritize outcomes in a health care context

Janssen

Gerhardus

Schröer-Günther

et al. 2014

Health Expectations

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

A descriptive review on methods to prioritize outcomes in a health care context

Janssen

Gerhardus

Schröer-Günther

et al. 2014

Health Expectations

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“…To avoid any potential of predicting group allocation for patients, the block length is fixed in a separate document that is withheld from the study site. As performed in previous studies, sealed and opaque envelopes are produced and labeled with the randomization number containing a data sheet that states the group allocation for the patient with the respective randomization number [17-19]. Randomization envelopes will be used in consecutive order.…”

Section: Methods and Designmentioning

confidence: 99%

Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583]

Rahbari

Knebel

Kieser

et al. 2012

Trials

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BackgroundThe optimal strategy for abdominal wall closure has been an issue of ongoing debate. Available studies do not specifically enroll patients who undergo emergency laparotomy and thus do not consider the distinct biological characteristics of these patients. The present randomized controlled trial evaluates the efficacy and safety of two commonly applied abdominal wall closure strategies in patients undergoing primary emergency midline laparotomy.Methods/designThe CONTINT trial is a multicenter, open label, randomized controlled trial with a two-group parallel design. Patients undergoing a primary emergency midline laparotomy are enrolled in the trial. The two most commonly applied strategies of abdominal wall closure after midline laparotomy are compared: the continuous, all-layer suture technique using slowly absorbable monofilament material (two Monoplus® loops) and the interrupted suture technique using rapidly absorbable braided material (Vicryl® sutures). The primary endpoint within the CONTINT trial is an incisional hernia within 12 months or a burst abdomen within 30 days after surgery. As reliable data on this primary endpoint is not available for patients undergoing emergency surgery, an adaptive interim analysis will be conducted after the inclusion of 80 patients, allowing early termination of the trial if necessary or modification of design characteristics such as recalculation of sample size.DiscussionThis is a randomized controlled multicenter trial with a two-group parallel design to assess the efficacy and safety of two commonly applied abdominal wall closure strategies in patients undergoing primary emergency midline laparotomy.Trial registrationNCT00544583

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“…Since patients do not recall the smaller incision, we should ask ourselves whether surgeons and industry care more than do the patients to whom we offer SILS [71]. This observation is supported by a large RCT [72] where both surgeons and patients were preoperatively and postoperatively asked to rank predetermined, outcome variables hierarchically according to their importance. It was found "Cosmetic result" was the only variable being significantly more important from the surgeon's perspective than from the patient's perspective.…”

Section: Methodological Righteousness Sans Honestymentioning

confidence: 99%

Innovations in Endosurgery—Journey into the Past of the Future

Agarwal¹,

Chintamani

Ali³

et al. 2012

Indian J Surg

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Progress in surgical practice has paralleled the civilizational evolution. Surgery has progressed from being the last resort in saving life to being form and function preserver. Post-renaissance Industrial age gave an impetus to this march of surgery. The currently on going digital technological revolution has further catalysed this march. Having achieved the stabilized and acceptable clinical outcomes, the surgeon has embarked on a journey of improving patient reported outcomes (PRO). Improvement in PROs with the advent of laparoscopic surgery with the attendant emphasis on minimising invasion has led to debates about invasion being just parietal or holistic in physiological sense. There is a concern that parietal invasiveness shouldn't be a trade-off for compromised clinical outcomes. Single Incision Laparoscopic Surgery (SILS) in its current avatar with current instrumentation seems to be an enthusiastic bandwagon rolling on with the cosmetic benefits acting as veil to hide the potential clinical concerns. History of surgical innovations is riddled with tales of vindictiveness and vicissitude. Lest the same fate befalls SILS we would do better to examine the SILS bandwagon in its current form till the emerging technologies address the current concerns.

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Ranking of patient and surgeons' perspectives for endpoints in randomized controlled trials—lessons learned from the POVATI trial [ISRCTN 60734227]

Cited by 7 publications

References 18 publications

A descriptive review on methods to prioritize outcomes in a health care context

A descriptive review on methods to prioritize outcomes in a health care context

Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583]

Innovations in Endosurgery—Journey into the Past of the Future

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