Outcome studies following sex modification

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"Gender Bender",  The Age Newspaper,  9 October 1999
 Of the 350 operations performed by the team in 25 years, bowers says, 'we were wrong in three cases'. Three women came back after the operation wanting to be men again.
"Surgical gender reassignment for male to female transsexual people",  National Health Service UK,  September 1998
 The published studies cannot be relied upon to provide valid estimates of benefit and harm.
 There is a need for high quality controlled trials to determine the risks and benefits of gender reassignment surgery. Potential patients should be identified using standardised selection criteria.
 Current evidence consists of one prospective controlled study, numerous case series, and one cross-sectional study. Most studies about the effectiveness of surgical gender reassignment have not collected data prospectively and are hampered by losses to follow up and lack of validated outcome measures.
 All of the non-controlled studies have serious methodological limitations. Common weaknesses include:

Recruitment procedures and selection criteria are often inadequately described; Use of non-validated assessment instruments - we cannot be certain the measures reported would be important to individuals with gender dysphoria; Assessments are rarely confirmed with other sources such as relatives and independent psychological opinion; Large losses to follow up raise the strong possibility of response bias - patients who have dropped out may differ from those who have chosen to continue;

Heterogeneity in diagnosis, with some studies giving no description of diagnostic criteria;

Little description of adjunctive therapies, which may have been used as part of multidisciplinary gender reassignment package (e.g. counselling, psychotherapy).

In light of the above criticisms the results from these studies should be interpreted with extreme caution.

 Mate-Kole (1990)4 presents a prospective controlled study (n=40) in which subjects receiving early surgery were compared with those on the waiting list. Changes in social, sexual and work activity were assessed, although baseline scores are not presented. Instruments were administered to measure psychoneurotic symptoms and personality characteristics.

After 2 years, significant differences were noted in some social activities between the operated group compared with the waiting list group... The operated group had significantly reduced scores on the psychoneurotic index, although the clinical significance of this result is not reported. Scores on the personality characteristics scale were not significantly different.

These results should be viewed with caution as treatment allocation was not randomised, and assessors were not blinded to treatment group. Adverse effects were not reported in this study, and there were no opportunities for subjects to express regrets following surgery. It is important to note that many of the outcomes tested were not significantly different between the operated and waiting list groups. The choice of outcome measures has not been justified in this study, and we cannot be sure that the measures above are important in people with gender dysphoria.

 In summary the evidence surrounding male-to-female gender reassignment surgery is poor. The study methods have allowed opportunity for selection bias (as a result of biased sampling and losses to follow up), recall bias (through retrospective data collection), and response bias (as assessors have not been blinded to operative status). Measurement tools have not been validated and many of these lack face validity to measure changes in gender dysphoria e.g. by focusing questions of cosmetics and sexual functioning rather than global measures of well being. The high rates of improvement, of over 80% in many series, should be interpreted in light of these methodological limitations.
Friedemann Pfafflin,  "Regrets After Sex Reassignment Surgery",  J of Psychology & Human Sexuality,  5:4 1992
 Using data drawn from the follow-up literature covering the last 30 years, and the author's clinical data on 295 men and women after SRS, an estimation of the number of patients who regretted the operations is made.
 Among female to male transsexuals after SRS no regrets were reported in the author's sample and in the literature they amount to less than 1%.
 Among male to female transsexuals after SRS, regrets are reported in 1 - 1.5%.
 Regret, in this study, is defined as gender dysphoria in the new gender role and after SRS which is expressed in behavior, i.e. attempts at re-reorientation of gender role behavior and/or re-adoption of the former sex/gender role behavior and/or applications for legal name/gender change and/or attempts to have SRS reversed.
 Poor differential diagnosis, failure to carry out the real life test, and poor surgical results seem to be the main reasons behind the regrets reported in the literature. According to three cases observed by the author in addition to personality traits the lack of proper care in treating the patients played a major role.
Peggy Cohen-Kettenis, Bram Kuiper,  "Sex Reassignment Surgery: A study of 141 Dutch Transsexuals",  Archives of Sexual Behavior,  17:5 1988, p. 439
 None of the persons in our study regretted the decision to undergo SRS
 Although the degree of gender dysphoria that existed prior to therapy is unknown, we assume that these findings indicate diminished gender dysphoria, for the feeling reported at the follow-up would not as such constitute an indication for SRS. Prior to therapy, however, the situation was such as to prompt the decision to seek SRS.
 Taking into account that the evaluation has been marginal and does not warrant far-reaching conclusions, we assume that the research findings do not indicate that the reported subjective well-being should be regarded as unreliable or misleading.
 The expectation that the treatment would abolish the previously experienced gender dysphoria and thus lead to happiness may have positively colored the answers.
 According to data supplied by the NGCF, three MFs and not a single FM have committed suicide after starting therapy in the past 10 years.
 It is characteristic of ex post facto research that the independent variables cannot be verified and consequently no definite conclusions can be formulated between the dependent variable (gender dysphoria) and the independent variables (eg. Hormonal therapy, surgical interventions).
 A total of 141 persons entered the study: 36 FMs and 105 MFs. In all, 3 FMs and 4 MFs refused to cooperate for various reasons, 6 FMs and 33MFs did not respond, and 9FMs and 33 MFs could not be traced.
 The findings obtained in the FMs compare favourably with those obtained in the MFs
 Allowing for the restrictive methodology of the (ex post facto) study, it is concluded that there is no reason to doubt the therapeutic effect of sex reassignment surgery.
 One has to bear in mind that in general the FMs-ti and the MFs-ti are happy in the knowledge that they operations will be performed within a reasonable time. They are taking a loan on the future.
 No specific differences were found between those who were still in medical treatment and those who had completed treatment.
 The self-reported happiness may have been distorted by wishful thinking.
 Not infrequently significant others are lost, social isolation ensues and a sense of existential loneliness is experienced. Such life situations appear to be the most important factor in the majority of cases of attempted suicide. The fact that 1 in 7 MFs and 1 in 36 FMs tried to commit suicide after treatment started is considered a critical signal.
 Those who reported being unhappy or very unhappy might have experienced gender dysphoria without being able or willing to report this. They might have ascribed the feelings of dysphoria to causes other than gender problems while being unaware of a continuing gender conflict.
 SRS is no panacea. Alleviation of the gender problems does not automatically lead to a happy and light-hearted life. On the contrary, SRS can lead to new problems.
 It is possible that now that SRS has started or even been completed, there is cognitive dissonance reduction in the sense that the persons simply cannot accept the notion that all has been in vain.
 Although a fair number of persons attribute their feelings of happiness to SRS, there appears to be no direct relation between the subjective well-being and the phase of therapy. Those who have completed SRS are not happier or less happy than those who are still in the initial phase of therapy. In other words, a person's positive evaluation of his/her life-in-its-totality is not directly related to his/her progress in physical adjustment to the opposite sex.
 The evaluation was made on the basis of subjective data only, that is on what the persons themselves reported on their gender identity, gender role, and physical condition.
Johannes Kemper, Dorette Polland, Kathrin Schiatterer, Gunter Stalla, Klaus Von Werder, Alexander Yassouridis,  "A follow-up study for estimating the effectiveness of a cross-gender hormone substitution therapy on transsexual patients",  Archives of Sexual Behavior,  27:5 October 1988, p. 475(18)
 Long term follow up studies have to be carried out to evaluate further risks of cross-gender hormone replacement therapy like the possible development of neoplasia or long-term effects leading to cardiovascular diseases. Cases of ischemic cerebrovascular diseases accompanying infertility therapy or cross-gender hormone replacement therapy, as performed in transsexual patients, have been reported.
Anne Bolin,  "In Search of Eve: Transsexual Rites of Passage",  Bergin & Garvey,  January 1988 pp2-3
pp2-3: Although much of the information about transsexuals is collected by gender clinics that provide programs for psychological evaluation, therapy, hormonal management and even surgery, many transsexuals who are under the care of medical and mental health professionals in private practice are lost forever to scientific scrutiny, unless the caretaker is undertaking his or her own investigation.
E Fahrner, G Kockott,  "Transsexuals Who Have Not Undergone Surgery: A Follow-Up Study",  Archives of Sexual Behavior,  16:6 1987, p. 511
 Significant changes were seen only in transsexuals who had surgery.
 Slight improvements were seen in patients with an unaltered wish for surgery.
 Transsexuals who relinquished their wish for surgery did not differ substantially from transsexuals with an unaltered wish for surgery.
 Transsexuals who have not had surgery and have no present wish for it are in the minority.
 All transsexuals who had not undergone surgery indicated that they were experiencing the same degree of difficulty with respect to social adjustment as at the time of diagnosis.
Dag Korlin, Gunnar Lindemalm, Nils Uddenberg,  "Long-Term Follow-Up of "Sex Change" in 13 male-to-female Transsexuals",  Archives of Sexual Behavior,  15:3 1986, p. 187
 For a total of four individuals (30%), sex reassignment was considered retrospectively to be a mistake.
 Repentance was chosen as the most crucial single outcome variable. One patient had officially requested reversal of sex change and another three were judged as repenting surgery in more indirect ways.
 Psychosocial adjustment showed a slight improvement after surgery. However, the majority of patients (eight) were judged to be unchanged.
 One striking finding is that overall sexual adjustment is often unchanged by genital surgery.
 Thirteen male to female transsexuals were investigated in an intensive interview study. The follow-up period varied between 6 and 25 years, with an average of 12 years. Surgical outcome was disappointing, and only one-third of the patients where a vaginal construction was carried out had a functioning vagina.
Michael Ross, William Walters,  "Transsexualism and Sex Reassignment",  Oxford University Press,  1986 p151
p151: it would also appear that continuation of supportive psychotherapy after surgery, perhaps for the first year, is mandatory to ensure the best adjustment of patients to their new role in society.
L. Lothstein, Howard Roback,  "Black Female Transsexuals and Schizophrenia: A Seredipitous Finding?",  Archives of Sexual Behavior,  13:4 1984, p. 371
 Unfortunately, record keeping of female patients is quite poor, and investigators rarely report their statistics according to such basic parameters as ages, SRS, educational background, race or religious preference.
Daryl Costos, Michael Fleming, Brad MacGowan,  "Ego Deveopment in Female to Male Transsexual Couples",  Archives of Sexual Behavior,  13:6 1984, p. 581
 While the number of subjects is to small to make any meaningful inferences, one could argue as do Meyer and Reter (1979) that this is confirmation that full sexual reassignment surgery really does not grant any increase in adaptation or that those who choose to go on for complete genital reconstruction are people who see the events of their lives in a most simplistic manner.
Edward Blanchard, Betty Steiner,  "Gender Reorintation, Psychological Adjustment, and Involvement with Female Partners in Female to Male transsexuals",  Archives of Sexual Behavior,  12:2 1983, p. 149
 Surgery may exert its major therapeutic effect on the patient before it is performed, by virtue of the patient's anticipation of it.
 The present findings support the notion that gender reorientation is accompanied by improved psychological and social adjustment.
Laura Roberto,  "Issues in Diagnosis and Treatment of Transsexualism",  Archives of Sexual Behavior,  12:5 1983, p. 445
 Outcome data suggest that sex reassignment surgery is variably effective and potentially deleterious
L. Lothstein,  "Sex Reassignment Surgery: Historical, Bioethical and Theoretical Issues",  Am J Psychiatry,  139:4  April 1982, p. 417
 In order to apply the results of these follow-up studies to the wider group of post surgical transsexuals, we must determine whether those who have been studied represent an adequate cross-section of all sex reassignment surgery patients. If not, this sampling bias is a primary methodological problem inherent in all of the published studies on sex reassignment surgery.

A review of those studies reveals other serious methodological problems, including a lack of universally accepted criteria for diagnosing gender dysphoria and determining suitable candidates for sex reassignment surgery; lack of an adequate control group; considerable variability among programs in gender identity clinics as well as in the quality, training and experience of clinical staff; failure to include basic data on patients race and age; frequent use of nonoperationalized criteria for improvement, such as patients' subjective feelings of happiness; use of college grade level systems for evaluating outcome; failure to provide data on the length of time between evaluation, surgery and follow-up; failure to use inform diagnostic labels; failure to use standardized clinical instruments to assess patients, even within a single study; limitation of clinica investigation to gross, social-psychological analysis; use of hypothetical post hoc analyses to provide missing presurgical data; and use of biased evaluators to interpret outcome data. This list is by no means exhaustive.

John Hampson, Daniel Hunt,  "Follow-Up of 17 Biologic Male Transsexuals After Sex-Reassignment Surgery",  Am J Psychiatry,  137:4 April 1980
 For whatever reasons, the number of followed up cases in the literature reflects only an insignificant fraction of the actual number of treated transsexuals.
 The committee screened over 250 applicants who requested sex-reassignment surgery. Of these 250, 17 biologic males were diagnosed and treated for transsexualism.
 None of the 17 transsexuals had doubts about having had the surgery.
 The authors followed up 17 biologic male transsexuals who had received sex-reassignment surgery an average of 8.2 years previously.
 No changes in levels of psychopathology and only modest gains overall in economic functioning and interpersonal relationships were found.
 Larger gains were made in sexual satisfaction and being accepted as family members.
 For a select group surgery is still the best means of coping with transsexualism.
 An individuals adjustment before surgery is one of the best indictors of success in coping with the stress of surgery.
 These outcome measures are based largely on the accepted premise that surgery is palliative treatment aimed at promoting better adjustment rather than correcting basic psychological problems. Thus, more emphasis is placed on such factors as socio-economic functioning, interpersonal relationships, family acceptance, and other factors measuring changes in ability to fit into society.
Jon Meyer, Donna Reter,  "Sex Reassignment Follow-up",  Archives of General Psychiatry,   August 1979 P1015
P1015: Sex reassignment surgery confers no objective advantage in terms of social rehabilitation, although it remains subjectively satisfying to those who have rigorously pursued a trial period and who have undergone it.
J Calnan, B. Hore, F Nicolle,  "Male Transsexualism in England: Sixteen Cases with Surgical Intervention",  Archives of Sexual Behavior,  4:1 1975
 Sixteen patients have been followed up for periods of 6 months to 18 months. Only two patients have undergone successful surgery have been dissatisfied. 11 patients appear to have benefited objectively and subjectively. Three patients were dissatisfied with complications arising from surgery. Two patients who have had successful surgery have been dissatisfied in that, although living as females, they do not regard themselves as "fully female". One patient, however, feels more content then before. The second patient has a fear of leaving the house during the day because he thinks he will be recognized by the public as a transsexual. He is almost totally housebound during the day but will leave the house at night when the streets are deserted. These symptoms were present prior to surgery, but surgical reassignment has not produced any improvement.
Lionel Oversey, Ethel Person,  "The Transsexual Syndrome in Males II. Secondary Transsexualism",  American Journal of Psychotherapy,  1974
 Follow-up studies, in general, are inadequate.
J Hoenig, J. Kenna,  "Social and Economic Aspects of Transsexualism",  Brit. J. Psychiat.,  117  1970, pp. 163-172
P172: Assessment of therapeutic results must be in terms of comparisons with the pre-treatment situation, and this must be kept in mind particularly in relation to the high incidence of promiscuity and prostitution in that type of patient.