Type of HRQoL Measure
Advantages
Disadvantages
Generic measures
1. Generic measures cover important health-related quality of life domains. Outcomes can therefore be compared within and between conditions
1. Generic measures cover broad areas of health which may not be sensitive to specific symptoms. This may be because they are missing specific domains of health
2. As generic measures cover several health domains, they can help identify which are the key domains affected by different conditions and/or interventions
2. Generic measures may not be useful to clinicians who are treating specific symptoms and are interested in whether certain symptoms have changed
3. In some populations comorbidities are common and generic measures allow the assessment of the impact of more than one condition at a time
3. They may also not be acceptable to patients who may question the value of answering questions that are not related to their condition
4. When assessing new interventions, generic measures can capture other additional benefits or adverse effects, which can be important as differences in choice of interventions may be due to fewer adverse effects caused by a new intervention
4. There are many generic measures available each with different domains and different scoring systems that make it difficult to compare across them
Specific measures
1. Condition-specific measures have the advantage of being specific and more sensitive to conditions which makes them more acceptable to patients and clinicians
1. Specific measures increase the lack of comparability across measures
2. They are therefore useful in assessing the impact of a single condition or intervention(s) relating to that condition
2. They may exclude the impact of comorbidities and side effects
It’s also important to consider that populations exist where self-reporting may not be appropriate or applicable [49]. These include the pediatric population and the elderly where proxy reporting may be used. However, the appropriateness of parental or proxy reporting has been questioned. This is because many HRQoL instruments include questions about emotional status or functioning, and it is not possible to state that what is experienced or felt by the patient is the same as what is perceived by the adult or proxy. The proxy can only make a judgment, and this judgment may be influenced by how important they judge the item to be. Differences between self- and proxy-reporting of health are widely recognized, and measures specifically for proxy report (in contrast to measures developed for patients but completed by proxies on the patient’s behalf) have been developed [49–51].
Sometimes health professionals might be interested in developing a generic or specific HRQoL instrument once it has been determined that there is no available questionnaire for the evaluation purpose. Key considerations for developing a HRQL measure are:
- 1.
Literature review —Developers should always review the literature first to see whether a HRQoL questionnaire already exists in the area they are interested in and if not, whether similar instruments exist that they could learn from or take items from for consideration. Even if there are no questionnaires in their area of interest, they could still obtain valuable data by conducting a literature review; for example, there may be a study that investigated quality of life in their population of interest but was not turned into a questionnaire [52].
- 2.
Interviewing —Obtaining data directly from the population of interest is a valuable method of generating items for inclusion. The developer may wish to talk to patients, relatives, carers, doctors, nurses, or other health care professionals and could interview all of these, a mixture, or just one group. Once they have decided who to interview, they then need to decide how to interview. One-to-one interviews could be undertaken (e.g., face to face or over the telephone) or a focus group could be held: (1) one-to-one interviews can be useful in situations where the topic material might be more sensitive as patients are more likely to feel comfortable sharing experiences and views with one interviewer rather than in a larger group; (2) a focus group could contain a mixture of people, for example, patients, carers, and nurses, or just one group, for example, a group of patients. In a focus group, two researchers are generally needed to facilitate the group, with one taking responsibility for the discussions and one taking notes [52].
- 3.
Selecting a response scale —HRQoL measures can differ in their response scale options. They may be based upon severity (how “bad” something is), frequency (how often something happens), or the level of agreement with something (strongly agree, strongly disagree). Response choices for each item may be: yes/no responses; a scale/range of responses, for example, “all of the time,” “most of the time,” “some of the time,” “a little of the time,” “none of the time”; rating on a numerical scale, such as 0–100. Response scale options are often arbitrary and chosen for their simplicity. They should be as relevant and refined as possible. Some HRQL measures keep the same response scales for every item in the instrument, whereas others vary [1].
- 4.
Psychometric validation —A draft HRQoL measure can undergo preliminary testing to determine whether the items are relevant and whether any are redundant. This can be undertaken using a range of techniques including quantitative techniques such as factor analysis or perhaps further qualitative work with patients. Following this, it is important that the validity of the instrument is examined and its properties explored. This ensures that the measure assesses what it is intended to assess, and increases confidence in any results generated. This involves assessing the instrument for practicality, acceptability, reliability, and validity through a series of defined tests on the population group for whom the instrument is intended [1, 2, 27].
It is important to note that there is no gold standard methodology for the development of HRQoL questionnaires (although recently guidelines for the development and assessment of measures have been developed). There is also no gold standard for the psychometric testing of measures, either in terms of the tests used, or the measure or indicator that is used to assess other instruments against [1, 2, 27].
Another key issue is the translation and cultural adaptation of HRQoL instruments so that the measures can be used in cross-cultural settings [30]. It is important that the concept of each item is translated (rather than a direct linguistic translation), and both forward and backward translations are usually carried out by multiple translators. The translation is then assessed using a process known as “linguistic validation ” that assesses the validity and conceptual equivalence of the HRQoL questionnaire among the target population (including clinicians working in the area), and subsequently allows for changes to be made to the translation if necessary.
Robotic Surgery for Abdominal Wall Hernia Repair: Immediate Results on Quality of Life
Abdominal wall hernia repair (AHR ) is a common procedure, and it can be associated with significant complications, ranging from 10% to 60%, including surgical site infections, seromas, locoregional pain, bowel perforations, hernia recurrence, and some of them require reoperations [53–56]. These mediate and late complications may interfere with the quality of life of these patients [57].
Moreover, ventral hernia remains a wavering surgical problem from the defect severity and size, hernia type (primary vs. secondary), operative technical options (robotic, laparoscopy, open, reconstructive), mesh fixation methods (tacker, absorbable suture, fibrin sealant), mesh location (preperitoneal, interposition, onlay), and mesh type (lightweight vs. medium or heavy, biologic vs. synthetic) making investigations of general health-related quality of life measures difficult to assess and interpret across studies [54, 57–59]. For instance, some authors have found that in addition to an increased risk of seroma formation, longer operative time, and length of stay (LOS), patients with large hernia defects have more early postoperative pain and activity limitation than those with smaller hernia defects [60, 61].
The open AHR , with a simple suture closure, has been associated with a high rate of wound complications secondary to large flaps in the abdominal wall layers, as well as elevated recurrence rates between 25 and 63%. The open ventral hernia repair with mesh using a tension-free technique has decreased the recurrence rate from 40 to 10%, but it also increased the incidence of significant wound complications , including mesh infections [62]. Laparoscopic repair of abdominal hernia was introduced in 1992 by LeBlanc and Booth in order to improve recovery time, hospital stay, complication rates, and costs [61]. Published recurrence rates have been reduced from 9% to 0%. These recurrences have been attributed primarily to improper positioning of the mesh and to the use of tacking or stapling devices for fixation rather than abdominal wall suturing [60, 61].
The primary complications of laparoscopic ventral hernia repair, similarly to the open technique are seroma formation, wound infection, ileus, and hematoma. Although laparoscopic repair has been associated with faster recovery, fewer complications , and a lower recurrence rate compared to the open technique, there continues to be a significant incidence of postoperative pain associated with the transabdominal wall sutures or other fixative materials. Several authors have reported a 2% incidence of significant postoperative pain lasting more than 2–8 weeks after repair. Significant postoperative pain has also been described in association with helicoid staples tackers. Additionally, a randomized controlled study showed a significantly higher pain level with suture placement compared to tackers for mesh fixation [60–62].
The da Vinci robot (Intuitive Surgical, Sunnyvale, CA, USA) offers numerous advantages, including six degrees of motion, three-dimensional (3D) imaging, and superior ergonomics that enable easy and precise intracorporeal suturing. Previous reports have demonstrated the ease of intracorporeal suturing of the mesh to the abdominal wall. Possibly, patients with massive ventral hernia s who should have increased rates of surgical complexity, higher rates of perioperative complications and recurrence, and reduced QoL postoperatively, may be the ones who would benefit the most from robotic surgery [63–66].
Up to now, there has been no study regarding QoL utilizing questionnaires after robotic surgery for AHR . Immediate and delayed postoperative complications such as seroma formation, infection, fistula formation, small bowel obstruction, and pain remain the focus of surgical outcomes following hernia repair, and affect the general QoL [53, 56]. Although these parameters are relevant in defining successful outcomes in AHR, patient-reported outcome as well as length of hospital stay and length of the operative time are also becoming equally relevant. Consequently, patient interpretation of improved HRQoL processes is becoming increasingly important in defining successful outcomes. Increasing emphasis is being placed on patient-reported HRQoL outcomes in decision making, clinical research, clinical practice, and policy. A shift towards HRQoL measures in calculating cost-utility analysis and healthcare reimbursements has brought these measures to the forefront of medicine [57].
New data in AHR are emerging in the current literature related to surgical outcomes [67], using HRQoL measures such as: SF-36, SF-12, SF-8 forms, visual analogue score (VAS; another psychometric assessment scale that uses different subjective characteristics that can be measured directly), HerQLes, EuraHS-QoL, Inguinal Pain Questionnaire, Ventral Hernia Pain Questionnaire or Carolinas Comfort Scale (CCS) [58, 62, 68–73] (Table 2).
Table 2
Comparative review of generic and specific health-related quality of life (HRQoL) questionnaires for abdominal wall hernia repairs
Instrument | Location | Classification | Questions | Use |
---|---|---|---|---|
SF36 [35] | All types of hernias | Generic | 36-question | To assess the functional health states of large populations over time. Useful to compare outcomes across different populations and interventions, including cost-effectiveness studies |
HerQLes [70] | Ventral hernias | Specific | 12-question | To assess the impact of ventral hernia repair. Focus on abdominal wall function. |
EuraHS-QoL [71] | Inguinal hernias | Specific | 9-question | To assess patients before and after inguinal hernia repair. Needs further investigation as a tool in ventral or incisional hernia |
Carolina Confort Scale [58] | Ventral/inguinal hernias | Specific | 23-question | To evaluate QoL related to mesh after hernia repair. Cannot be administered preoperatively in the absence of mesh |
Inguinal pain questionnaire [72] | Inguinal hernias | Specific | 18-question | To evaluate pain and difficulties in performing activities after inguinal hernia repair |
Ventral hernia pain questionnaire [73] | Ventral hernias | Specific | 20-question | To evaluate QoL after ventral hernia repair |
The SF-36 survey is divided into eight measured scales that assess vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The short-form surveys are criticized for their purpose of assessing QoL in patients with chronic diseases rather than those afflicted with acute disease processes such as illnesses requiring surgical intervention. Particularly in ventral hernias, criticism of the SF-36 has resulted in the development of other QoL assessment tools tailored for abdominal disorders such as the Gastrointestinal Quality of Life Index and the CCS for patients with abdominal mesh [62, 74].
Given the increased focus on patient-measured satisfaction and QoL in health care and medical research, the CCS has been used to measure hernia-specific preoperative and postoperative QoL [69]. The CCS was first developed and validated in 2008 and has been shown to be superior to the short form 36 in measuring short- and long-term QoL. Since its inception, the CCS has been used in numerous peer-reviewed studies and is now the official metric for postoperative hernia QoL measurement by the governments of France and England. The CCS questionnaire is completed by patients before surgery to establish a baseline preoperative score and after surgery at 1-, 6-, 12-, and 24-month follow-up times to obtain short- and long-term QoL. The questionnaire addresses three primary areas of symptoms: pain, mesh sensation, and activity limitation. This is evaluated by answering seven questions about activities of daily living on a 6-point Likert scale. Zero corresponds to no symptoms and 5 to disabling symptoms. Scores of 0–1 (mild but not bothersome) are classified as asymptomatic, whereas 2 (mild and bothersome) to 5 are classified as symptomatic. In addition, the patient QoL questionnaires are answered outside the office without the presence of the physician or office staff and returned with guaranteed anonymity to prevent expectation bias and reporter bias. Along with QoL, the questionnaire asked for symptoms of recurrence [67, 75].
Colavita et al. [68] found that, on the whole, when comparing laparoscopic to open AHR, early QoL (at 1 month) was worse in the laparoscopic group. In the open AHR cohort massive status resulted in a worse early QoL at 1 month for postoperative pain and activity limitation. Measure of QoL at the extended time points in these domains was not different according to the size of the repair, and, indeed, they continued to decrease as the follow-up periods extended to 2 years. Mesh sensation in the open group was no different at any time during the follow-up despite the meshes averaging 340 cm2 larger in the massive hernia repair patients. Closure of the abdominal wall, which was achieved in 97.5% of open operations, may have impacted the patients’ perception of the mesh in their abdomens. On multivariate regression controlling for age, gender, country, BMI, smoking, recurrent hernia, and preoperative pain, QoL at the same follow-up periods for both the laparoscopic and open cohorts remained significant. When comparing the massive versus the regular-sized hernias within the laparoscopic cohort, repair of massive hernias was more likely to impact QoL negatively compared to the laparoscopic repair of regular-sized hernias; this was true for pain and activity limitations up to 1 year and mesh sensation for the full length of the study [68].
Generally, the width/length ratio did a poor job in predicting postoperative complications , likely because small ovoid hernias may present with few complications, and can have the same ratio as massive ovoid hernias with many complications. The ratio cut points, however, did discriminate in early postoperative QoL, in particular a width/length ratio of 5 or more in open AHR predicted early symptomatic postoperative pain, activity limitation, and mesh sensation. Greater than 15-cm hernia defect in both dimensions result in the worst early postoperative QoL whether VHR is performed laparoscopic or open. Indeed, a massively wide and long hernia defect repaired laparoscopically has a 100% chance of resulting in symptomatic postoperative pain and activity limitation at 1 month [55].
Although laparoscopic surgery has been advocated to decrease hospital stay, decrease postoperative pain, and reduce incision size, the gold standard for repairing a ventral hernia remains controversial [61, 63]. The efficiency and efficacy of robotic versus laparoscopic repair compared to the open technique is lacking [60, 61]. It is still unclear if one method of repair is superior to the other, and it is unknown if one repair method is more appropriate to certain types of hernia in comparison to the other, regarding QoL evaluation. The clinical guidelines of the Society for Surgery of The Alimentary Tract (SSAT 2005) showed that a hernia of less than 3 cm can be repaired primarily without the use of the prosthetic mesh, and any hernia where extensive tissue dissection is required such as in component separation technique is then qualified for open repair, yet any other hernia types that do not fall in the above category can be considered where possible for laparoscopic repair [69]. Hence, the success of the repair needs to address the guidelines, taking into consideration the individual circumstances of each hernia, and to plan in advance the best method of repair. Additionally, the current evidence available looks at the best method of repair with various outcomes including recurrence rate, the costs involved, postoperative complications, and long-term results [62, 69, 76].
Results showed less wound infection rate, less hemorrhage, and earlier return to work by almost 50%, but the laparoscopic repair carries a higher rate of bowel injury with 2.9% compared to only 0.9% in the open group [60, 61]. Therefore, the study concluded that laparoscopic repair is still as safe as the open conventional repair and open repair has rather significant advantages of less small bowel injury and seroma formation. Furthermore, recent researchers have shown that laparoscopic incisional hernia repair is far better than open hernia repair in the short-term outcomes such as blood loss, surgical site infection, and hospital stay, with earlier return to work [60, 61].