By Author
  By Title
  By Keywords

August 1995, Volume 45, Issue 8

Original Article

Audit Changes Clinical Practice! Impact on Rate of Justification of Hysterectomy Indication

Khalid S. Khan  ( Department of Obstetrics and Gynaecology, Aga Khan University Medical Centre, Karachi. )
Javaid H. Rizvi  ( Department of Obstetrics and Gynaecology, Aga Khan University Medical Centre, Karachi. )

Abstract

After performing a baseline audit in 1986-89, an ongoing quality assurance process was initiated in January, 1990 and all hysterectomies performed over the next 2 year period were analyzed. Hysterectomy indications were divided into two groups: one in which the uterine specimen was expected to show pathology and another in which no pathology was expected. The hysterectomy was considered justified in the former if the pathology report verified the indication or showed a significant alternate pathology. In the latter, validation criteria showing documentation of certain prerequisite diagnostic procedures performed before reverting to hysterectomy, were used to ascertain justification. The overall rate of justification in the ongoing audit was 96%, being 97% for the group where hysterectomy indication was potentially confirmable by pathologic study and 93% for the one where it was not. Comparison with baseline analysis showed that the justification rates were higher for all indications not potentially confirmable by pathologic study (93% vs 89%, p <0.05), for recurrent uterine bleeding (90% vs 83%, p <0.05) and for leiomyoma (97% vs 95%, p<0.05). The improvement was associated with less frequent use of multiple indications in the ongoing study (10% vs 16%, p <0.05). The justification rates for hysterectomy indication can be improved by prospective audit and by avoiding use of multiple indications (JPMA 45:208, 1995).

Introduction

Comparison of actual practice with that of an established ideal forms the conceptual basis of a clinical audit, but what is ideal treatment? There is support for clinical judgement as the final arbitrator of correct patient management, but some gynaccologists are known for acting liberally on the principle “Jf in doubt, cut it out" irrespective of the fact that the pathology might lie in the cerebrum rather than the pelvis1. So, is subjective opinion of one clinician adequate? One is faced with these kinds of questions when one attempts to review patient’s medical records for evaluation of appropriateness of hysterectomy. Such an audit becomes even more important when one realizes that hysterectomy is reported to be associated with 1-5/1000 mortality rate and 20- 50% morbid­ity rate2,3. This would be unwarranted if the hysterectomy was not originally indicated. Objective justification for main of the generally accepted indications for hysterectomy is provided by a few reliable studies. We recently reported a retrospective analysis on this subject4, showing that hysterectomies were justified in 92% cases. Deficiencies were highlighted by the frequent use of multiple indications and lower rates of justification for hysterectomy indications not confirmable by pathologic study. Similar studies have revealed 85-95% rate of justifica­tion5,6. The quality of care as judged by this comparison was adequate but there was room for improvement. As audit and quality assurance is being emphasized increasingly for purposes of improving patient care7,8, we introduced a criteria-based audit for justification of hysterec­tomy. The quality assurance process used for this audit requires selection of a primary preoperative diagnosis from a standard list, for which justification criteria were developed by consensus of the consultants working in the department. The impact on quality of care is studied by comparing the results of the first 2 year analysis with those of a baseline audit carried out at the same hospital.

Subjects and Methods

The Aga Khan University Medical Center is a private teaching hospital providing general and tertiary care to a largely self- referred population. The department of Obstetrics and Gynaecology is composed of 10 practicing specialists and there is an accredited residency training programme. The hospital has a staffed quality assurance committee that meets periodically to discuss hospital-wide quality issues. A focused audit on justification of hysterectomy indications was per­fonned 2 years after initiating a criteria-based quality assur­ance process to analyze its impact during the study period from January, 1990 to December 1991. The indications for hysterectomy, as described in our previous report4, were divided into two groups: A pre-opera­tive diagnosis in the first group had an anatomic or histologic basis and one in the second group was a description of a sign or symptoms which may or may not have associated his­topathologic abnormality as shown below:
1. Diagnosis potentially confirmable by pathologic examination e.g., leiomyoma, preinvasive and invasive gy­naecologic disease, endornetriosis, adnexal mass, pelvic infection, adenomyosis and others with potential of serious outcome.
2. Diagnosis not potentially confirmable by pathologic examination e.g., recurrent uterine bleeding, chronic pelvic pain, uterovaginal prolapse, pregnancy catastrophe and others with potential of serious outcome.
The decision to perform a hysterectomy was made by a consultant. A single preoperative diagnosis or a primary diagnosis in case of multiple reasons was indicated. If the preoperative note stated multiple indications without pointing, out the dominant diagnosis, the records were evaluated individually to choose the most appropriate single diagnosis based on the presenting signs, symptoms and preoperative investigations in each case. The operation was performed by a consultantor by a registrar/senior resident under a consultant’s supervision. The operative specimen was studied grossly and microscopically by a consultant pathologist. All data (preoperative note and histopathology report) were collected prospectively. In order for the hysterectomy to be considered justified in the first group, the pathologic examination of the hysterectomy specimen was required to reveal the same pathology as preoperatively indicated (verifi­cation of indication) or other significant pathology instead. For leiomyomato be considered justified it had to be at least 12 gestational weeks in size or symptomatic or distorting the uterine cavity. Adenomyosis was, defined histologically as invasion of more than one third of myometrial wall thickness. In the second group “Validation Criteria" (Table 1),

showing a documentation of certain pre-requisite diagnostic procedures performed before reverting to hysterectomy, were used to ascertain justification. Such validation criteria were the same as those for the baseline study4. The parameters studied were age, parity, multiplicity of indications, type of hysterectomy, conservation of ovaries and justification of indications. For the purpose of comparison data from a baseline analysis during 1986-894, were used as control. Chi-square test with Yates correction was used for analysis of difference between proportions. A p value of <0.05> was taken as significant.

Results



Table II shows the indications of hysterectomy and their justification during the period 1990-91. Of the 236 hysterecto­mies, 193 were performed for a diagnosis that potentially could be confirmed by pathological examination. The remain­ing 133 had a pre-operative diagnosis that was not confir­mable. A total of 312 (95.7%) indications were justified, 188 (97.4%) being justified in the group where pathology was expected and 124 (93.2%) in the group where pathology was not expected. The single most common indication was uterine leiomyoma stated in 112 patients. Of these, 24 cases showed no leiomyoma on pathological examination. In order for a leiomyoma to be considered significant, it had to be either at least 12 gestational weeks size or symptomatic or distorting the uterine cavity. Out of these 24 cases, 21 had significant alternate pathology e.g., adenomyosis, which had been confused for leiomyoma preoperatively. Taking these into account a total of 109(97.3%) hysterectomies were justified. Gynaecologic malignancy included 10 cases, six of which were for cervical cancer and four for endometrial cancer. All of these were verified. Gycaecological pre-malignant condi­tions included 5 cases, all involving the cervix. Thirty-two cases were operated on for adnexal masses and the indication was considered justified when an ovarian malignancy or a large leiomyoma orendometnosis was found. Hence, a total of 93.7% of hysterectomies in this Group were justified. Hyster­ectomies were performed for adenomyosis in 21(6.44%) cases. Post-operatively this diagnosis was verified in 18 cases (85.7%). Allowing for significant alternative pathology, the justification rate became 100%. The second most common indication was recurrent uterine bleeding for which 73 uteri were removed. In 66 of these cases, the indications were justified according to the criteria outlined in Table I. Out of these hysterectomies 49 were performed after a documented failed trial of hormones and dilatation and curettage. However considering other cntena outlined in table IV a total of 66 (90.4%) of cases were justified. On pathologic examination of these specimens, adenomyosis was present in 44 (62.27%) cases and uterine leiomyomas were seen in 16 (21.91%). The rest of the cases with significant pathology showed endometrial hyperplasia in 5 cases and endometrial cancer in one. Uterovaginal prolapse was noted in 48 cases, all of which were justified.

Table III shows the general characteristics of control and study groups. The control group was matched for all charac­teristics except use of multiple indications which was higher as compared to study group (16% v 10%, p <0.05).

Table IV shows the indications for hysterectomy in control and study groups. The control group was matched for all indications to study group. The impact of a prospective quality assurance process is shown in Table V.

The overall justification rates were improved in this study as compared to the baseline rates (96% vs 92%, p <0.05). The overall high rate of accompanied by significantly better rates for all indications not potentially confirmable by pathologic study (93% vs 89%, p <0.05), for recurrent uterine bleeding (90% vs 83%, p <0.05) and for leiomyoma (97% vs 95%, p <0.05).

Discussion

Hysterectomy is one of the most common orrative procedure performed in women of reproductive age 9,10. The medical, emotional, sexual and economic consideration re­ lated to removal of the uterus are complicated by religious, cultural and financial pressure on patients and their families. When performed appropriately, hysterectomy leads to pa­tient’s satisfaction and praise, but this is not always the case. Several questions about the indications, probable overuse and justification of hysterectomy have been raised6,11,12. Quality assurance programmes have been shown to have a healthy impact on quality of patient care by decreasing the frec1uency of hysterectomy and increasing its confirmation rate13,14. . Evaluation of appropriateness of hysterectomy should be an integral part of an audit. Appropriateness can be defined as the degree of correlation between a condition and the action taken to improve it. Justification of hysterectomy indication thus becomes its valid measure7. The indications for hysterectomy, however, vary from benign conditions like uterovaginal prolapse to pre- malignant and malignant condi­tions like those of the cervix, to life threatening situations like uterine rupture11,12. Lack of an acceptable list of indications may lead to overuse of the procedure13. In many cases the accuracy of preoperative diagnosis cannot be established5. The problem of defining a hysterec­tomy indication is not only complicated by the numerous lists documented in literature, but also by the use of combinations of several indications, any one of which alone would be insufficient for justification of the procedure11. The use of multiple indications has been associated with lower justifica­tion rates15 . Hence, in this study the surgeon was required to clearly indicate a primary diagnosis in the preoperative note which could later be verified or validated, Efforts to validate the preoperative indications ‘for hysterectomy are further complicated by the general lack of agreement over the definition of "necessary" This is because quality of life considerations including a negative effect on daily routines, fear of unintended pregnancy, stress of dys­menorrhea etc. have an important contribution in the decision to remove a uterus, and all uteri removed are not expected to show an abnormality detectable by presently available his­topathologic techniques. For such indications there was lack of suitable validation criteria in the past12. We resolved these issues by developing a system of reviewing two relatively brief documents i.e., surgeons preoperative note and histopathology report, to monitor the appropriateness of hysterectomy - when pathologic tissue was expected in the surgical specimens, the indication could be verified by the pathology report and when no pathologic tissue was expected the indication could be validated if certain criteria (Table I) had been satisfied in the preoperative note. This system resulted in improved justification rates for hysterectomy indications as shown in Table V. This change could be attributed to the differences in type of patients admitted and the attending surgeons during the two periods that were analyzed. The former is unlikely because there were similarities of age, parity, predominance of abdominal type hysterectomy, trend of ovarian conservation and most com­mon indications in the control and study groups (Tables Ill and IV) For the latter, there was no change in the two studies. The lower use of multiple indications in the study group (Table Ill) may have been a result of the increased awareness of its deficiencies highlighted by the baseline study at the same hospital4 before initiation of the audit. Hence, the improve­ment can be attributed to reduction in use of multiple indications, use of feedback and increased awareness on the part of surgeons participating in the study. Medical audit should ideally be based on randomized clinical trials. In the absence of such data other methods like obtaining consensus opinion16 may be applied. We resorted to use of present criteria to judge the appropriateness of treatment in relation to signs. symptoms and investigations as described in “methods”. One could argue that such guidelines developed by an expert panel depend entirely on the panel members. So, such a consensus view cannot reflect the views of other experts, but is universally essential in this matter? The art of providing appropriate medical care could become extremely difficult if one attempted to achieve worldwide agreement. We believe that audit 1ratings of justification of hysterectomy indication based on consensus criteria are preferable to an audit in which the only arbitrator of correct management is clinical judgement of one individual, The system of reviewing two sample records i.e.. preoperative note and histopathology report provides an efficient means of ongoing quality assurance and the justifica­tion rates can be improved by a prospective audit in which use of multiple indications is avoided. It is possible to educate clinicians to be more critical in their decision-making and to change their clinical practice.

Acknowledgements

The authors are grateful to Mr. Javed I. Qureshi for preparation of the manuscript: to Professor S.C. Robinson for its critical review; and to all the consultants and staff for their untiring efforts during the period of this study.

References

1. Jones, U. L. Abnonnal uterine bleeding. In: Jones, D. L., ed. Fundamentals of Obstetrics and Gynaecology, Volume 2, 45th Ed. London, Faber and Faber,   1988, pp. 63-70.
2. Dicker, R. C., Greenspan, J. R., Strauss, L. 1. et al. Complications of abdominal and vaginal hysterectomy among women of reproductive age in the United States. Am. J. Obstet. Gynaecol., 1982;144:841-48.
3, Loft, A., Anderson, T. F., Bronnum, H. H. et al. Early post- operative mortality following hysterectomy. Br. J. Obstet. Gynaecol., 1991 ;98 :147-54.
4. Rizvi, 3. H., Aizal, W., Ali, A. et al. Was that hysterectomy really necessary? Aust. N. Z. J. Obstet. Gynaecol., 1991 ;31 :80- 83.
5. Lees N. C., Dicker, R. C., Rubin, G. L. et al. Confirmation of the pre-operative diagnosis for hysterectomy. Am. 3. Obstet. Gynaecol., 1984;150:283-87.
6. Gainbone, J. C., Lench, 3. B., Slenski, M J. et aL Validation of hysterectomy indications andthequality assurance process, Obstet. Gynaecol., 1989;73:1045-49.
7. Task force on quality assurance. Administrative organization of quality assurance activities. In: Quality Assurance in Obstetrics and Gynaecology. Washington D. C., American College ofObstetricians and Gynaecologists, 1989. pp. 45-53.
8. Hamilton-Fairly, D. Audit in obstetrics and gynaecology. Report of a RCOG meeting. Br. 3. Obstet. Gynaecol., 1993;101:81-84.
9. Selwood, T. and Wood, C. Incidence ofhysterectomy in Australia. Med. J. Aust.. 1978;2:201-204.
10. Vessey, M. P., Villard-Mackintosh, L., McPherson, K. et al. The epidemiology of hysterectomy: Findings in a large cohort study. Br. J. Obstet. Gynaecol., 1992,99:402-407.
11. Thompson, J. D. and Birch, H. W. Indications for hysterectomy. Clin. Obstet Gynaecol., 1981 ;24:1248-58.
12. Esterday, C. L., Grimes, D. A. and Riggs, J. A. Hysterectomy in the United States, Obstet. Gynaecol., 1983 ;62 :203-212.
13. Dyck, F. J., Murphy, F. A., Murphy, J. K. et al. EtTect of surveillance on the number of hysterectomies in the province of Saskatchewan. N. EngI. J.Med., 1977;296: 1326-28.
14. Gambone, J. C., Reiter, R. C., Lench, J.B. et al. The impact of a quality assurance process on the frequency and confirmation rate of hysterectomy. Am. J. Obstet. Gynaecol., 1990; 163:545-50.
15. Reiter, R. C., Gambone, J. C. and Lench, 3. B. Appropriateness of hysterectomies performed for multiple pre-operative indications. Obstet. Gynaecol., 1992;80:902-90_.
16. Fink, A., Kosekoff, J., Chassin, M. et al. Consensus methods: Characteristics and guidelincs for use. Am. 3. Public Health, 1984;74:979-83.

Journal of the Pakistan Medical Association has agreed to receive and publish manuscripts in accordance with the principles of the following committees: