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☆
66
endometriosis is more
effective than placebo at
reducing pain and
improving quality of life
QOL was noted after
surgery without
differences between short
and long term
dysmenorrhoea and
quality of life as well as
patient satisfaction were
comparable in the medium
term
signicant improvement
on condition-specic
quality of life outcomes at
6 weeks and 6 months
signicant difference for
mid-term functional
A. A. Samara
digestive and urinary
outcomes in patients with
large involvement of the
rectum
Number of
patients QoL instrument Follow up Conclusion regarding QoL
39 EQ-5D and SF-12 12 months Laparoscopic excision of
Laparoscopic excision of
endometriosis vs.
endometriosis
placebo
52 SF-36 51 months Persistent improvement in
laparoscopically assisted
to open colorectal
resection
colorectal
endometriosis
2014 Surgical excision of
62 SF-36 12 months Improvement in
Laparoscopic
hysterectomy vs.
laparoscopic
dysmenorrhea
73 SF-12 6 months Both groups reported
supracervical
hysterectomy
Robotic vs. laparoscopic
60 GIQLI, SF-36 24 months There is no statistically
surgery for endometriosis
endometriosis
Conservative surgery vs.
radical rectal surgery for
deeply invasive
deep rectal
endometriosis
endometriosis involving
the rectum
Table 5.4 RCTs in gynecological surgery
Author Year Operation Comparison
Abbott etal. [67] 2004 Surgical excision of
Touboul etal.
[68]
Berner etal. [69] 2015 Surgical treatment of
Soto etal. [70] 2017 Surgical excision of
Roman etal. [71] 2018 Surgical excision of
5 Quality ofLife asEndpoint inSurgical Randomised Controlled Trials
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
higher and disease-free
survival is lower for
minimally invasive radical
hysterectomy than for
open surgery, and
postoperative quality of
life is similar between the
treatment groups
baseline during early and
later phases of recovery,
and the adverse event
prole, favour TLH
compared with TAH for
treatment of stage I
endometrial cancer
6 months Recurrence rates are
EuroQoL-5D,
MDASI
67
631 SF-12, FACT-Cx,
Μinimally invasive vs.
open radical
hysterectomy for cervical
cancer
cancer
2020 Surgery for cervical
361 FACT-G 6 months QoL improvements from
Total laparoscopic
hysterectomy (TLH) vs.
total abdominal
hysterectomy (TAH)
endometrial cancer
Frumovitz etal.
[72]
Janda etal. [73] 2010 Surgery for stage I
EQ-5D European Quality of Life–5 Dimensions instrument, SF-12 Short-Form 12, SF-36 Short-Form 36, GIQLI Gastrointestinal Quality of Life Index, FACT-Cx Functional
Assessment of Cancer Therapy-Cervical, MDASI MD Anderson Symptom Inventory, FACT-G Functional Assessment of Cancer Therapy-General
68
A. A. Samara
Discussion
Traditionally, morbidity and mortality following an operation have been the parameters applied to assess clinical outcomes of different surgical interventions. Moreover, economic outcomes including hospital charges and length of stay have also been used [74]. A primary reason for patients to seek surgical advice and care is an impaired quality of life [75]. Following the devel­opment of patients’ rights movements, quality of life became a principal endpoint in health care research [76]. From the negative health measures like the “ve D’s” (death, disease, disability, dis­comfort, and dissatisfaction), research interest has shifted towards the assessment of more posi­tive dimensions with the purpose of evaluating health and not disease [76]. Data regarding Health-related Quality of Life (HR-QoL) can be used to adapt treatments and improve clinical outcomes by detecting physical or psychological disabilities in patients that may otherwise be overlooked [74].
Several tools have been used to calculate QoL in both a generic or specic manner. In general, QoL measures are based on questionnaires that must be short and easy to answer [76]. HR-QoL instruments must satisfy 3 critical measurement properties: reliability, validity and responsive­ness [75]. The Short Form-36 (SF-36) and EORTC (European Organization for Research and Treatment of Cancer) QLQ-C30 are exam­ples of widely used and validated generic QoL instruments. QLQ-C30 is the most widely used disease-specic instrument for the assessment of QOL in cancer patients worldwide [74].
While in the last decade indicate that the Royal College of Surgeons supports and encour­ages RCT use for evaluating surgical interven­tions, until recently only a few surgical trials were identied in the worldwide literature [77]. ProtecT [78] (Prostate testing for cancer and Treatment) and ROSSINI [79] (Reduction of Surgical Site Infection using a Novel Intervention) are excellent examples demonstrating how RCTs in surgery can be successfully conducted and overcome the specic difculties associated with surgical RCTs such as randomisation between
surgical and non-surgical interventions, recruit­ing patients on an emergency basis, and collect­ing data from multiple centres [77].
During the past two decades as reported in our results, several studies were published with HR-QoL as an endpoint comparing operative versus non-operative management, or comparing different surgical approaches and techniques. Randomised controlled trials have been con­ducted in almost every surgical specialty— including trials for coronary revascularization surgery, colorectal and gastrointestinal surgery and gynecology surgery—to compare and exam­ine surgical techniques while questioning the value of surgical intervention. However, the total number of RCTs in surgery remains minimal, with recruitment tending to be lower compared with medical RCTs [77].
Randomization minimizes differences between treatment groups during recruitment for the trial, however it cannot prevent differential treatment between groups later in the trial or dif­ferential assessment of outcomes which result in systematic bias [80]. Blinding as many individu­als as possible in a trial is the optimal strategy to minimize the likelihood of differential treatment or assessments of outcomes [80]. Applying blinding techniques to randomised controlled trials of surgical interventions is more challeng­ing than medical RCTs where placebos are typi­cally used. Although surgeons can rarely be blinded, it may be possible for researchers to blind other treatment team members and thus limit the potential for differential treatment. A novel blinding technique must include three qualities: it must successfully conceal the group allocation; it must not impair the ability to accu­rately assess outcomes; and it must be accept­able to individuals that will be assessing outcomes [80, 81]. In a systematic review of all trials in orthopedic trauma over 10 years, researchers determined that over 85% of trials could have blinded at least some of the individu­als assessing outcomes [82].
A well-designed RCT has high internal valid­ity and acceptable external validity (generaliz­ability). Findings from small, underpowered and poorly designed surgical RCTs may be overval-
5 Quality ofLife asEndpoint inSurgical Randomised Controlled Trials
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
69
ued because their design provides them with unwarranted credibility [17]. In reality, RCTs and observational studies contribute complemen­tary evidence. Although non-RCTs or observa­tional designs lack the validity of randomisation to control for selection bias, other principles of high-quality methodology such as blinding, intention-to-treat analysis, and complete follow­ up applied for the design of an RCT should be adopted to improve the quality of observational studies [83]. Solomon etal. performed a system­atic review of treatment evaluation questions and concluded that only 40% of treatment questions involving surgical procedures could have been evaluated by an RCT [84].
RCTs in surgery typically have lower internal validity compared to medical RCTs, as they are dependent on the abilities of participating sur­geons [83]. Both training and experience are required to develop expertise in a surgical proce­dure, and learning curves exist even for fully trained surgeons [85]. Failure to control for the learning curve in a trial may underestimate the novel intervention’s treatment effect [86]. Approaches to minimize the effect of the learning curve include: a prespecied number of cases during the surgeon’s life-time; the number of cases in the year preceding the trial; general training in the area; and outcomes consistent with good clinical practice [85].
In a systematic review for comparative clini­cal trials investigating the effectiveness of a sur­gical or minimally invasive procedure, Wenner etal., reported that a very low proportion of stud­ies (7.6%) met the minimal design attributes of inclusion criteria [86]. This may indicate the many barriers to conducting well-designed com­parative trials of surgical procedures, such as the relatively high cost associated and correspond­ingly limited funding for non-device surgical tri­als, or difculties recruiting patients to randomised trials of operations [86]. On the con­trary, a systematic review by Walter et al. con­cluded that there was no difference regarding the reported quality of surgical trials compared to non-surgical trials; however, approximately half or fewer of all the trials had adequate methodol­ogy [87].
There is a pressing need to standardize end­points in perioperative clinical trials and to agree on a core data set that is common to all trials. Standardizing endpoints are necessary compo­nents of evidence-based practice that will improve the validity of pooled analysis of clinical trials [88]. Comparison between studies is made easier, and other investigators will have a stron­ger foundation on which to design future, deni­tive trials [88, 89]. Primary endpoints in clinical trials must be clinically relevant, sensitive to treatment effect, measurable and interpretable, while secondary endpoints could provide a more global view of the benet of the treatment [90]. Regarding quality-of-life research, RCT’s focused on HRQL as their primary outcome were more likely to be of better quality than other stud­ies, which provide their HRQL ndings along­side the main clinical outcomes [91, 92].
In recently published studies, preoperative HR-QoL has been associated with the presence of postoperative complications and even with cancer stage in the time of diagnosis [93–96]. Based on these ndings, assessment of preopera­tive HR-QoL can guide decision making regard­ing the optimal therapeutic option and minimalizing the possibility of complications for every patient.
Conclusion (Fig.5.2)
During the two last decades, randomized con­trolled trials have been conducted in almost every surgical specialty—including trials for coronary revascularization surgery, colorectal and gastro­intestinal surgery and gynecology surgery—to compare and examine surgical techniques while questioning the value of surgical intervention. RCT’s focused on HRQL as their primary out­come were more likely to be of better quality than studies providing HRQL ndings alongside the main clinical outcomes. Conducting a well­designed, high-quality RCT can be a challenge which may be the primary reason for the low number of RCTs in surgery. Future research and clinical trials in surgery should routinely include analysis of QoL as an outcome measure.
70
Following the development of patients’ rights movements, quality of life became a principal endpoint in health care research
RCTs have been conducted in almost every surgical specialty - including trials for coronary revascularization surgery, colorectal and gastrointestinal surgery and gynecology surgery — to compare and examine surgical techniques while questioning the value of surgical intervention.
RCTs in surgery have lower internal validity compared to medical RCTs, as they are dependent on the abilities of participating surgeons.
Conducting a well-designed, high-quality RCT can be a challenge which may be the primary reason for the low number of RCTs in surgery
RCT’s focused on HRQL as their primary outcome were more likely to be of better quality than studies providing HRQL findings alongside the main clinical outcomes
Future research and clinical trials in surgery should routinely include analysis of QoL as an outcome measure.
A. A. Samara
Fig. 5.2 Highlighted conclusions. Abbreviations: RCTs Randomized-Controlled Trials
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