The health-related quality of life of patients with a benign gynecological condition: a 2-year follow-up

A prospective observational HRQoL and cost study was conducted in the Department of Obstetrics and Gynecology in the hospitals of the Helsinki and Uusimaa Hospital District: the Helsinki University Hospital (comprising the Women’s Hospital, the Kätilöopisto Maternity Hospital and the Jorvi Hospital in the Helsinki metropolitan area) and four smaller community hospitals (Hyvinkää Hospital, Lohja Hospital, Porvoo Hospital and Raasepori Hospital [former Länsi-Uusimaa Hospital] outside of the Helsinki metropolitan area). The cost data will be reported separately. All women treated for a benign gynecological condition in the general gynecological outpatient department in these hospitals between 1 June 2012 and 31 August 2013 were invited to participate in the study. Patients with uterine fibroids or other benign uterine neoplasm, endometriosis, adenomyosis, a uterine prolapse, endometrial or cervical polyps, a gynecological bleeding disorder, dysmenorrhea or lower abdominal/pelvic pain, or some other benign uterine finding were included in the study. No other inclusion or exclusion criteria were used apart from the above-mentioned diagnosis groups. The ICD-10 classification codes were used to group the patients according to the clinician’s assessment. If a specific reason for the condition was found (for example a uterine fibroid or a uterine polyp causing abnormal uterine bleeding), this specific disease was the primary diagnosis and the patient fell into that patient group. If no apparent reason for the condition was found, the patient was categorized into the group reflecting the symptom (for example, idiopathic menorrhagia in the bleeding disorder group).

Patients were treated according to typical clinical practice. They filled in the 15D HRQoL questionnaire before treatment (before/when attending the first outpatient clinic appointment and baseline) and 6 months and 2 years after treatment initiation. If no answer to the follow-up survey was received in 3 weeks, one reminder was sent. The results were compared with the HRQoL of age-standardized general female population of the same geographical area (urban Southern Finland). The population data came from the Health 2011 Health Examination Survey which covers a representative sample of the general Finnish population [14].

The 15D is a standardized, generic and self-administered HRQoL instrument validated in the Finnish population that provides a HRQoL profile and a single index score. The patient is asked to evaluate its 15 dimensions (mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity) on a scale of 1–5 (1 = no problems and 5 = worst possible state). Population-based preference weights are used to calculate dimension level values and the single index score representing overall HRQoL (the 15D score) on a 0–1 scale (1 = full health and 0 = being dead). Thus, the higher the score is, the better the QoL of the patient is. Up to three missing answers can be imputed by predictions from linear regression analysis based on the other dimensions, with age and gender as independent variables [15,16]. The minimum clinically important change or difference in the 15D score has been established to be ± 0.015 [17].

Paired samples t-test was used to test the statistical significance of the change in HRQoL during follow-up. Statistical significance of the differences in means between groups was tested using Student’s t-test. A two-way p-value of <0.05 was considered statistically significant. All procedures performed in the study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Ethics Committee of the Helsinki University Central Hospital, registration number 538/E0/02) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed written consent was obtained from all individual study participants. This included consent to include material pertaining to themselves and an acknowledgement that patients cannot be identified via the published article.

Of the 1173 women who were invited to participate in the study, 543 women answered the baseline questionnaire. Of them 389 (71.6% of the women who decided to participate in the study) women fulfilling the inclusion criteria (concerning the reason of treatment and had answered at least 12 of the 15D dimensions in all three follow-up questionnaires) answered the 6-month follow-up and 311 (57.3%) women the 2-year follow-up. The mean age of the included patients at baseline was 49.6 years (standard deviation [SD] ± 12.8, range 19–98). Of them 178 (57.2%) were treated in a university hospital and 133 (42.8%) in a community hospital. Patients were treated due to bleeding disorders (n = 94), uterine fibroids (n = 79), polyps (n = 68), dysmenorrhea/pelvic pain (n = 24), endometriosis (n = 23), uterine prolapse (n = 7) or some other benign uterine disorder (n = 16). The mean long-term follow-up time was 24 months 11 days (SD ± 12 days).

Of all patients 167 (46.3%) were treated operatively: 44.4% (n = 79) of university hospital patients and 48.9% (n = 65) of community hospital patients. The percentage of patients operated on varied depending on the patient’s disorder (Figure 1). The only statistically significant difference in operative treatment between university hospitals and community hospitals was the higher frequency of polyp treatment in the surgical theatre in community hospitals (66.7 vs 36.8%, p < 0.05).

Even though the impact of benign gynecological conditions on the HRQoL of women is significant, relatively little has been published on HRQoL results of typical treatment protocols in an every-day clinical environment [1,3]. As a whole, our study revealed that the present clinical practice of treatment of benign uterine disorders yields mostly rather good HRQoL results. However, HRQoL remains inferior compared with the general female population and the degree of improvement after treatment varies from one condition to another.

As nearly 80% of women suffering from a benign gynecological disorder see a doctor annually [4] and up to two-thirds of patients may report moderate to severe impact on QoL [7], the HRQoL results in our study were surprisingly good already at baseline. However, the significance of these seemingly minor common disorders is evident also in our study as HRQoL of the women suffering from them does not reach the level of that of the general female population even after treatment. A wide spectrum of HRQoL dimensions is impaired but it is noteworthy that treatment allows women to regain sexual activity over time.

It has been reported previously that the impaired physical, sexual and also mental well-being in women with a benign gynecological condition improves after treatment [1,5–7,18–21]. Our study showed that the benefits of treatment appear fairly rapidly and were evident already at the short-term follow-up in the whole study group and in most of the specific diagnosis groups. The benefits were also relatively well sustained throughout the long-term follow-up. The physical QoL (dimensions of excretion, discomfort and symptoms, andvitality) and the mean 15D score improved statistically significantly from the baseline to the 6-month follow-up and remained at the improved level also at the 2-year follow-up. Sexual activity kept improving significantly throughout the study period, even from the 6-month follow-up to the 2-year follow-up.

Only a third of the bleeding disorder patients reported improved HRQoL during 6 months after treatment initiation. However, some of these patients benefited from treatment later on, as by the 2-year follow-up 43.6% of patients had improved HRQoL compared with baseline, quite well in line with the other diagnosis groups. The mean total HRQoL score did not improve and patients with bleeding disorders had more concerns in the different areas of QoL when compared with several other diagnosis groups. Thus, it seems that bleeding disorders affect the QoL of women suffering from them and treatment is not always easy. Hysterectomy has traditionally been thought to be the most effective treatment strategy of heavy menstrual bleeding [22–27]. However, literature has more recently also shown HRQoL results to be similar after less invasive treatments such as endometrial ablation and levonorgestrel-releasing intrauterine system (IUS) [23–27]. Furthermore, the IUS has been found to be the most cost-effective treatment [28,29] even though nearly 50% of patients initially treated with IUS may need to undergo hysterectomy later on [28]. Our study showed no difference in total HRQoL independent of whether bleeding disorder patients were treated conservatively or operatively. However, the 6-month results were not encouraging which could be due to conservative treatment failing in some patients. A larger proportion of patients had received symptom alleviation by the 2-year follow-up. In order to improve HRQoL of patients with bleeding disorders, a possibility for a second assessment of symptoms after 6 months of primary treatment should be maintained to be able to intervene if burdensome symptoms persist.

Like the systematic review of Jones et al., our study also found dysmenorrhea and pelvic pain patients to have impaired HRQoL. However, opposed to findings of the systematic review, virtually no improvement was seen in the HRQoL of our study patients during the 6-month or the 2-year follow-up [1]. Thus, our study suggests that the treatment conventions of pelvic pain and dysmenorrhea patients should be re-evaluated as healthcare resources are used for very little HRQoL benefit.

The QoL of endometriosis patients has been reported to affect all areas of QoL [30]. However, in our patient material, endometriosis patients were not significantly worse off at baseline than the other patient groups, but the patients with diagnosed endometriosis stood out from the other diagnostic groups with the biggest proportion of patients benefiting from treatment. Compared with treatment of other benign indications, hysterectomy has been found to be especially cost-effective in the treatment of endometriosis [2]. However, as a primary treatment of endometriosis drug treatment has been reported to be more cost-effective than surgery [31,32]. Even though laparoscopic excision of endometriosis has been shown to improve all domains (pain, control and powerlessness, emotional well-being, social support, and self-image) of QoL [33], our study patients with endometriosis had similar mean 15D scores irrespective of whether surgery or conservative treatment was used. This could, however, also be an indication of successful selection of the treatment modality for the patients at hand.

Treatment in the operation theatre is associated with high healthcare resource use and often places the patient under a higher complication risk. Thus, decisions for surgical treatment should always be justifiable. A study setting of comparison of the subjective patient outcome between operative and conservative treatment of a certain gynecological condition is rare. In our study, patients with uterine fibroids and prolapses benefited from operative treatment with better HRQoL results after surgery than after conservative treatment. Patients treated for polyps with an operational hysteroscopic polypectomy or in an outpatient setting did not differ regarding HRQoL results suggesting that outpatient hysteroscopic polypectomy should be preferred, as resource use in an outpatient setting tends to be smaller. Similar results concerning polypectomy have been reported earlier but the accessibility of outpatient polypectomies has been thought to be a restricting factor [34,35].

As a whole, the HRQoL of patients with benign gynecological disorders is good but still inferior to that of the general female population. The treatment improved especially the patients’ excretion functions, decreased discomfort and symptoms, and enhanced vitality and sexual activity. However, of these dimensions only sexual activity did not deviate statistically significantly from that in the general population at 2 years. Treatment of endometriosis, fibroids and polyps resulted in best HRQoL scores but the treatment protocols of unspecific pelvic pain and bleeding disorders need further evaluation. No differences in the HRQoL results were seen between smaller community hospitals and university hospitals.

Millions of women worldwide suffer from common gynecological conditions. These conditions have a marked effect on the HRQoL of the women affected by them. Thus, the impact of these seemingly minor disorders, without clear objective parameters to follow in healthcare, is vast on our population. In healthcare, more weight has generally started to be placed on subjective patient reported outcomes. In the future, especially in the field of common benign gynecological disorders, it is important to evaluate the outcome of treatment, the need for further treatment and the appropriate allocation of healthcare funds according to patient reported outcomes. Based on the research trend of recent years, we suspect that clinical practice could very well be evolving toward this direction in the upcoming years.

All the authors participated in planning the study. K Pynnä gathered the data. K Pynnä and H Sintonen were responsible for data analysis and K Pynnä for most of the interpretation of the data and for drafting the manuscript. P Räsänen, H Sintonen, RP Roine and P Vuorela acted as senior authors and consultants throughout the writing process and were responsible for revising the manuscript. All authors have approved the final version to be published.

R Kekkonen and R Hurskainen are thanked for helping to plan the study. Clinicians K Palva, H Hieta-Heikurainen, A Vallasto, P Härkki, M Pöyhönen-Alho, P Lehtovirta, O Kilpiö and J Tapper are gratefully acknowledged for enabling the study execution in the different hospitals. H Sarpila is warmly thanked for help in filing patient data.

H Sintonen is the developer of the 15D and receives royalties from its electronic versions. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

The study protocol was approved by the Ethics Committee of the Helsinki University Central Hospital (registration number 538/E0/02) and, thus, the study was performed in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed written consent was obtained from all individual study participants. This included consent to include material pertaining to themselves, an acknowledgement that patients cannot be identified via the paper and that full anonymization was performed.

The authors certify that this manuscript reports original clinical trial data. Individual, de-identified participant data that underlie the results reported in this article (text, tables, figures and appendices) are available from the corresponding author following publication if needed.