Introduction
QoL instruments and measures for endometriosis
Methods
Search strategy
Selection criteria
Results
First author and study period | Type of study | Sample size | Range of age | Type of medical treatment | Type of endometriosis treated | Results | Instruments |
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Ács et al. 2015 [50] | Multicenter randomized controlled study | 180 n = 45 Oral elagolix 150 mg once daily n = 45 Elagolix 250 mg n = 45 placebo n = 45 LA 1-month depot 3.75 mg intramuscularly | 18-45 | GnRH antagonist: Elagolix vs leuprorelin acetate (LA) and placebo | Not specified | There were improvements from baseline to week 12 in all 5 dimensions of the EHP-5 in all treatment groups. The differences between elagolix 150 mg, elagolix 250 mg vs. LA were statistically significant (p = 0.006 and p = 0.0204, respectively), which indicated a higher efficacy of LA in the pain dimension of EHP-5. | EHP-5 |
Agarwal et al. 2015 [47] | Randomized, multicenter, open-label clinical trial | 20 n = 5 D + E2 transdermal n = 7 D + E2 nasal n = 8 D + E2 + T nasal | 25-45 | Gonadotropin-releasing hormone agonist (GnRHa) deslorelin (D) with low-dose estradiol ± testosterone (E2 ± T) add-back | Not specified | There were statistically significant improvements relative to baseline for five of the ten quality of life domains: physical functioning, role physical, bodily pain, social functioning, and vitality; those that were unaffected by treatment were already within normative ranges for women of similar age at baseline. Quality of life issues with everyday problems was significantly improved with treatment. | SF-36 |
Caruso et al. 2015 [51] | Prospective study | 92 | 18-37 | Dienogest | Not specified | At 3 months follow-up, women reported QoL improvement in physical function, physical role, body pain, general health, social function and emotional role categories (p < 0.05); at 6 months follow-up, they reported improvement in all categories (p < 0.001). | SF-36 |
Caruso et al. 2015 [63] | Prospective study | 56 | 18-31 | Palmitoylethanolamine and α-lipocic acid | Not specified | No changes were observed in QoL at the 3rd month follow-up. By the 6th and 9th month all categories of the QoL (P < 0.001) improved. | SF-36 |
Caruso et al. 2016 [57] | Comparative, open-label prospective study | 96 n = 63 Study group (continuous regimen) n = 33 Control group (21/7 regimen) | 18-35 | 2 mg dienogest/30 μg ethinyl estradiol continuous vs 21/7 regimen oral contraceptive | Not specified | At 3 and 6 months, the Study group reported QoL improvements in all categories (p < 0.001). The Control group reported QoL improvements in all categories at the second follow-up (p < 0.05). The QoL of the Control group improved slightly at the second follow-up. The intergroup statistical comparison analysis between each follow-up showed a better efficacy of the continuous regimen than the 21/7 conventional regimen in all the QoL aspects. | SF-36 |
Carvalho et al. 2018 [62] | Randomized clinical trial | 103 n = 52 ENG implant n = 51 LNG-IUS | 18-35 | Etonogestrel-releasing contraceptive implant vs 52 mg levonorgestrel-releasing intrauterine system | Not specified | Health-related quality of life improved significantly in all domains of the core and modular segments of the Endometriosis Health Profile-30 questionnaire, with no difference between both treatment groups. | EHP-30 |
Granese et al. 2015 [49] | Multi-center randomized trial | 78 n = 39 Dienogest + E2V n = 39 GnRH-a | 18-45 | Gonadotrophin-releasing hormone analog vs dienogest plus estradiol valerate after laparoscopic surgery for endometriosis | Not specified | At the 9-month follow up, the questionnaire results showed a considerable increase of scores for all women compared with before surgery, demonstrating an improvement in the QoL and an equal health-related satisfaction with both treatments | EHP-5 |
Lee et al. 2016 [48] | Prospective, comparative study | 64 n = 28 GnRHa + add back group n = 36 Dienogest group | 18-45 | GnRHa plus add back therapy vs dienogest in the treatment of pain recurrences after laparoscopic surgery for endometriosis | Not specified | In this study, there are no differences in QOL according to treatment option. | WHOQOL-BREF |
Leonardo-Pinto et al. 2017 [55] | Prospective cohort study | 30 | 18-45 | Dienogest | DIE (intestinal and posterior fornix) | Treatment with dienogest for 12 months positively affected several domains of QoL, with significant improvement in the physical, psychological, as well as a self-assessment of QoL and health. | WHOQOL-BREF |
Luisi et al. 2015 [52] | Prospective observational multicenter cohort study | 142 | Dienogest | Not specified | Quality-of-life assessments in the present study showed improvements in both physical and mental indices within 12 weeks, also confirming the decrease of endometriosis-associated pain. | SF-12 | |
Morotti et al. 2014 [58] | Prospective patient preference trial | 144 n = 82 COC group n = 62 Desogestrel group | COCs vs POPs in patients with migraine without aura | Symptomatic rectovaginal endometriosis and migraine without aura | Regarding the quality of life, the baseline values of physical component summary (PCS) and mental component summary (MCS) were similar for both groups while after 6 months of treatment a statistical improvement was observed in both components in group POP (p < 0.001 for both PCS and MCS) compared to group COC (p = 0.154 and p = 0.640 for PCS and MCS respectively) | SF-36 | |
Sansone et al. 2018 [61] | Multicenter prospective observational study | 25 | 18-45 | Etonogestrel implant | Ovarian endometrioma | After 12 months, the bodily pain, general health, vitality, social functioning, and mental health domains of the QoL score were significantly improved. | SF-36 |
Seo Jong-Wook 2019 [56] | Prospective cohort study | 52 women n = 20 GnRHA+ COC n = 32 Dienogest (28.1 5.9) | Combined oral contraceptive (COC) after gonadotropin-releasing hormone (GnRH) agonist plus add-back therapy vs dienogest (DNG) treatment as medical treatments after surgery | Ovarian endometrioma | Physical, psychological, social, and environmental components of QOL were not significantly different across treatment options. | WHOQOL-BREF | |
Strowitzki et al. 2010 [53] | Randomized, double-blind, placebo-controlled study | 188 n = 90 Placebo n = 98 Dienogest | 18-45 | Dienogest at a dose of 2 mg daily for 12 weeks | Not specified | Quality-of-life analyses indicated greater improvements in the dienogest group for two of eight SF-36 categories: bodily pain and role emotional Mental sum scale and physical sum scale scores showed similar improvements in both groups. | SF-36 |
Strowitzki et al. 2010 [54] | Randomized, multicenter, open-label trial | 186 n = 90 DNG group n = 96 LA group | 18-45 | Dienogest vs leuprolide acetate for 24 weeks | Not specified | Compared with LA, DNG was associated with pronounced improvements in specific quality-of-life measures. In particular, DNG produced greater improvements in the categories “physical functioning,” “vitality,” and “social functioning.” | SF-36 |
Tanmahasamut et al. 2012 [59] | Double-blind randomized controlled trial | 54 n = 28 Levonorgestrel-releasing intrauterine system n = 26 Control group | Postoperative Levonorgestrel-releasing intrauterine system | Not specified | The Short Form-36 scores improved in the levonorgestrel-releasing intrauterine system group but did not change in the expectant management group | SF-36 | |
Yucel et al. 2018 [60] | Prospective, cross-sectional and non-comparative study | 42 | 18-50 | Levonorgestrel-releasing intrauterine system | Not specified | Regarding the SF-36 health questionnaire, the calculated physical health scores and the mental health scores increased by the end of 12 months. | SF-36 |
Zhao et al. 2012 [46] | Controlled, randomized, open-label study | 100 n = 50 GnRHa +PMR n = 50 Control group: only GnRHa therapy | 18-48 | Progressive muscle relaxation training on patients under GnRHa | Not specified | After 12 weeks of therapy with gonadotrophin-releasing hormone agonists (GnRHa), women with endometriosis experienced improvement in almost all QoL parameter. Between-group comparisons of the improvement in scores after intervention showed that the PMR group had significantly better improvement in the scores of anxiety, depression and overall/domain QOL than the control group (P < 0.05) | SF-36 |
First author and study period | Type of study | Sample size | Range of age | Type of surgical intervention performed | Type of endometriosis treated | Results | Instruments |
---|---|---|---|---|---|---|---|
Angioni et al. 2015 [78] | Randomized clinical trial | 159 | Laparoscopic en-block resection of DIE vs. incomplete surgical treatment with or without GnRHa administration after surgery | Deep infiltrating endometriosis of the cul-de-sac and of the rectovaginal septum | At 1-year follow-up patients treated with en-block resection showed significant improvement in physical function (p < 0.01), general health (p < 0.01) and vitality (p < 0.01) in comparison to baseline and to 12 months follow-up of the patients who underwent an incomplete surgical treatment. GnRHa administration is followed by a temporary improvement of pain in patients with incomplete surgical treatment. | SF-36 | |
Bassi et al. 2011 [68] | Prospective study | 151 | Laparoscopic segmental rectosigmoid resection | Deep infiltrating endometriosis with bowel involvement | One year after the bowel resection, there was a significant increase (p < 001) in scores in all SF-36 domains, as well as in the sum of the components comprising both physical health and mental health recorded before and after the surgical procedure. | SF-36 | |
Byrne et al. 2018 [71] | Multicenter prospective cohort study | 4721 | 25.9-44.8 | Laparoscopic surgical excision of rectovaginal endometriosis requiring dissection of the pararectal space. | Rectovaginal endometriosis | Global quality of life significantly improved at 6 months. There was a significant improvement in quality of life in all measured domains and in quality-adjusted life years. These improvements were sustained at 2 years. | EQ-5D |
Comptour et al. 2019 [65] | Prospective and multicenter cohort study | 981 | 15-50 | Laparoscopic treatment | Not specified | Improvement was observed for all the SF-36 dimensions at 6 months after surgery, and this improvement remained stable over several years. | SF-36 |
Daraï et al. 2010 [75] | Randomized trial | 52 n = 26 laparoscopically assisted n = 26 open surgery group | 25-44 | Laparoscopically assisted vs open colorectal resection | Colorectal endometriosis | The median follow-up was 19 months. Except for physical functioning, all the items of the SF-36 questionnaires were improved after surgery for the whole population. An improvement in PCS (P = 0.0001) and MCS (P < 0.0001) scores of the SF-36 questionnaire was noted after surgery. No difference in delta of PCS and MCS scores of the SF-36 questionnaire was observed between the groups. | SF-36 |
Deguara et al. 2013 [64] | Prospective study | 21 | 18-50 | Laparoscopic surgery | Not specified | Therapeutic laparoscopic surgery shows benefits in the symptoms and psyche of patients with endometriosis. | SF-36; SF-12 |
Kent et al. 2016 [77] | Prospective Cohort Study | 137 patients had surgery, of which 100 completed follow-up | Laparoscopic surgery: 2-stage procedure with interval downregulation using GnRH analogs. | Severe rectovaginal endometriosis compromising the bowel | Surgery by an experienced multidisciplinary team results in significant improvement in pain, sexual function, and quality of life up to 1 year postoperatively. Pelvic clearance improves outcome. | EHP-30; EQ-5D | |
Mabrouk et al. 2011 [67] | Prospective cohort study | 100 | 23-39 | Laparoscopic surgery | DIE | Six months postoperatively all the women had a significant improvement in every scale of the SF-36 (p < 0.0005). | SF-36 |
Meuleman et al. 2014 [79] | Prospective Cohort study | 203 n = 76 Study group: patients with DIE receiving bowel resection n = 127 Control group: subgroup with or without DIE not receiving bowel resection | 20-47 | CO2 laser ablative surgery with bowel resection and without bowel resection | Extensive DIE with colorectal extension | In both groups, EHP30 scores improved significantly and remained stable for 24 months after surgery. No differences were observed between study and control groups. | EHP-30 |
Misra et al. 2020 [80] | Parallel-group randomized controlled trial. | 192 patients n = 96 Diathermy n = 96 Helium | 16-50 | Laparoscopic ablation or excision with helium thermal coagulator vs hook electrodiathermy | Not specified | Small but statistically significant differences in some quality-of-life measures (pain, emotional wellbeing and self-image) also favored the use of electrodiatherm. | EHP-30 |
Pontis et al. 2016 [82] | Prospective observational study | 16 | Combined transurethral and laparoscopic approach | Symptomatic bladder endometriosis | At one year follow up, patients showed significant improvement in physical function (p < 0.01), in general health (p < 0.00021), in physical (p < 0.0003) and emotional roles (p < 0.03), in mental health (p < 0.004), and vitality (p < 0.0013), in comparison to baseline (pre-surgery) | SF-36; | |
Ribeiro et al. 2014 [74] | Prospective observational cohort study | 45 | Laparoscopic colorectal segment resection | Intestinal deep endometriosis | At 6 months post-operatively and 1 year post-operatively significant improvements were observed in all domains of the SF-36 (p < 0.05). Physical health-related QOL domains showed greater improvement than mental health domains. | SF-36 | |
Riiskjær 2018 [70] | Prospective observational study | 175 | Laparoscopic bowel resection | Rectosigmoid endometriosis | A total of 97.1% of the women completed the 1-year follow up (170). A significant improvement on all quality-of-life scores was observed (p = 0.0001). | SF-36 | |
Roman et al. 2018 [72] | 2-arm randomized controlled trial | 60 n = 27 Conservative surgery n = 33 Segmental resection | 27-36 | Conservative surgery, by shaving or disk excision, vs radical rectal surgery, by segmental resection | Deep endometriosis infiltrating the rectum | The intention-to-treat comparison of the overall scores on SF36 did not reveal significant differences between the two arms 2 years postoperatively. | SF-36 |
Roman et al. 2019 [73] | 2-arm randomized controlled trial | 60 n = 27 Conservative surgery n = 33 Segmental resection | 27-36 | Conservative surgery, by shaving or disk excision, or radical rectal surgery, by segmental resection | Deep endometriosis infiltrating the rectum | There is an overall improvement in pelvic pain and quality of life after surgery, which is comparable between the two arms and remains constant during the 5 years of follow-up. | SF-36 |
Silveira da Cunha Araùjo et al. 2014 [69] | Observational prospective cohort study | 36 | Laparoscopic treatment for deep infiltrative endometriosis with colorectal resection | Bowel endometriosis | Analysis of each domain revealed improved quality of life when comparing the period before surgery with 12 and 48 months after surgery. There was a significant increase (p < 0.001) in the scores in all of the SF-36 domains when comparing T0 vs T12 and T0 vs T48, with higher average scores at T48 corresponding to the domains of physical functioning, role physical, and social functioning | SF-36 | |
Soto et al. 2017 [81] | Multicenter randomized controlled trial | 73 n=38 Laparoscopic group n=35 Robotic group | Laparoscopic versus robotic surgery | Not specified | EHP-30: all parameters improved compared with baseline at 6 weeks and 6 months. No statistical differences were found between groups when each parameter was compared at baseline, 6 weeks, or 6 months on univariate analysis. The physical and mental health component of the SF-12 did not change significantly compared with baseline. When compared across all time points using a linear mixed model, there were no differences between groups | SF-12; EHP-30 | |
Touboul et al. 2015 [76] | Randomized controlled trial | 40 n = 20 laparoscopically assisted group n = 20 open surgery group | 25-44 | Laparoscopically assisted vs open colorectal resection | Colorectal endometriosis | QOL was significantly improved after surgery and remained stable over 4 years All dimensions of the SF-36 were increased postoperatively and remained steady over 4 years except for physical functioning (PF) which increased without reaching statistical significance No difference in QOL was observed between the groups | SF-36 |
Valentin et al. 2017 [66] | Prospective and multicenter observational study | 161 | 15-50 | Laparoscopic procedure | Minimal endometriosis (rAFS score < 6) | The study shows 86% of failure of surgery to improve QOL. Surgery is seldom a good option to increase QOL for patients with minimal endometriosis. | SF-36 |