Ureteric injuries during hysterectomy-A Norwegian retrospective study of occurrence and claims for compensation over an 11-year period.

INTRODUCTION: Ureteric injury is a rare but serious, iatrogenic complication of hysterectomy. The risk depends on indication for surgery, predisposing risk factors, and peroperative conditions. Our aims were to evaluate and learn from compensation claims to The Norwegian System of Patient Injury Compensation (NPE) for ureteric injury occurring during hysterectomies to predict risk factors, time of identification, symptoms, and consequences, and to relate these cases to injuries registered in The Norwegian Patient Registry. MATERIAL AND METHODS: A retrospective study of ureteric injuries occurring during hysterectomies, reported to NPE and the Norwegian Patient Registry from 2009 through 2019. RESULTS: During the study period, 53 096 hysterectomies were registered in The Norwegian Patient Registry, of which ureteric injury was documented in 643 (1.2%). More ureteric injuries were registered in large hospital trusts than in small trusts (1.3% vs. 0.7%, p < 0.05). NPE received 69 claims due to ureteric injury occurring during hysterectomy, comprising 11% of all injuries in the study period. Compensation was approved for 15%. Women who claimed compensation were younger (48.1 ± 8.9 years vs. 55.1 ± 13.6 years, p < 0.01), more likely to have had a benign diagnosis (89.9% vs. 52.1%, p < 0.01), and more likely to have had the ureteric injury recognized after discharge (58.0% vs. 33.0%, p < 0.001) compared with non-complainants. Identification of the ureters during the hysterectomy was documented in 30% of the NPE patient files. Additional information for the NPE cases included the following. The most common symptoms of unidentified injury were pain (77%), fever (12%), urinary leakage (13%), and anuria (8%). Re-operation was necessary in 77% of the cases, and 10% of the women lost one kidney. Long-term consequences after repair, such as loss of a kidney or persistent pain, were seen in 17%. No women died because of the injury. CONCLUSIONS: The incidence of ureteric injury occurring during hysterectomy in Norway was 1.2%; 11% involved a claim for compensation, and 15% of these had their case approved. Most ureteric injuries were not recognized during the hysterectomy. Documentation of peroperative identification of the ureters during hysterectomy was often missing. Vigilance to pain as a postoperative symptom of peroperative unrecognized ureteric injury may result in earlier diagnosis and treatment.

Claims for compensation from women with cervical cancer in Norway-A retrospective, descriptive study of a 12-year period.

INTRODUCTION: In Norway, all patient-reported claims for compensation are evaluated by The Norwegian System of Patient Injury Compensation (NPE). The number of claims from women with cervical cancer is rising, and the approval rate is high. Our aim was to study claims for compensation from women with cervical cancer to identify the type of failures, when, during the time-course of treatment, the medical failures occurred, and the consequences of the failures. MATERIAL AND METHODS: A retrospective, descriptive study of claims for compensation to NPE from cervical cancer patients during a 12-year period, from 2007 through 2018. We used anonymized medical expert statements and summaries of NPE cases. RESULTS: In all, 161 women claimed compensation for alleged medical failure related to cervical cancer. Compensation was approved for 100 (62%) women. Mean age at the time of alleged failure was 37.5 years (SD ±9.9). The main reasons why women sought medical attention were routine cervical screening (56%), or vaginal bleeding or discharge (30%). In approved cases, incorrect evaluation of cytology and histology was the cause of most failures (72%). Mean delay of cervical cancer diagnosis for approved cases was 28 months (SD ±22). Treatment not in accordance with guidelines was the cause of failure in 2% of the cases, and failure during follow up was the cause of failure in 12%. Consequences of the failures were as follows: worsening of cancer prognosis (89%), treatment-induced adverse effects, such as loss of fertility (43%) and/or loss of ovarian function in premenopausal women (50%), and permanent injury after chemo-radiation (27%). Seven women (7%) died, most probably as a consequence of the failure. CONCLUSIONS: The main cause of medical failure in women with cervical cancer was incorrect pathological diagnosis. The main consequences of failures were worsening of cancer prognosis and treatment-induced adverse effects. Increased focus on the quality of pathological examinations, and better routines in all parts of the cervical examinations might improve patient safety for women in risk of cervical cancer.

Approved claims for compensation from gynecological patients in Norway-What characterizes the cases? A 14-year nationwide study.

INTRODUCTION: The Norwegian System of Patient Injury Compensation (NPE) evaluates all patient-reported claims in Norway. Our aim was to study the cases from gynecological patients approved by NPE in order to identify the main reasons for the injuries, the consequences of the treatment failure for the women, and the time course when the treatment failure occurred. MATERIAL AND METHODS: A retrospective, descriptive study of approved gynecological compensation claims during a 14-year period, based on patient files from NPE. RESULTS: In all, 1454 women claimed compensation for injury related to gynecological treatment in Norway from 2000 to 2013. Compensation was approved for 438 (30.1%) women. Eleven women declined participation in the study and 16 cases were excluded, leaving 411 cases for further analyses. Consent to participate was given by 211 (51.3%) women, who gave full access to all their NPE files. Anonymized resumes and expert statements were used for the 138 (33.6%) women who did not respond and the 62 (15.1%) women who were deceased. Guidelines or good clinical practice were not followed in 40.5% of the cases. The most common reasons for injury were surgical complications (67.6%), delayed (22.4%) and incorrect (17.0%) diagnoses, and failure of communication (11.7%). The main consequences of injuries were need for extensive treatment (64.2%), permanent injury (55.2%) and impaired physical ability (41.9%). Worsening of cancer prognosis occurred in 58 women (14.1%) and death due to treatment failure in 29 (7.1%) women. Most failures occurred during the treatment period (75.2%). CONCLUSIONS: We found that the main reason for injuries in gynecological patients was non-adherence to guidelines or good clinical practice. Surgery-related injuries were most common. Increased focus on adherence to guidelines and surgical skills might improve patient safety for gynecological patients in Norway.

Can a midwife-led continuity model improve maternal services in a low-resource setting? A non-randomised cluster intervention study in Palestine.

OBJECTIVES: To improve maternal health services in rural areas, the Palestinian Ministry of Health launched a midwife-led continuity model in the West Bank in 2013. Midwives were deployed weekly from governmental hospitals to provide antenatal and postnatal care in rural clinics. We studied the intervention's impact on use and quality indicators of maternal services after 2 years' experience. DESIGN: A non-randomised intervention design was chosen. The study was based on registry data only available at cluster level, 2 years before (2011and2012) and 2 years after (2014and2015) the intervention. SETTING: All 53 primary healthcare clinics in Nablus and Jericho regions were stratified for inclusion. PRIMARY AND SECONDARY OUTCOMES: Primary outcome was number of antenatal visits. Important secondary outcomes were number of referrals to specialist care and number of postnatal home visits. Differences in changes within the two groups before and after the intervention were compared by using mixed effect models. RESULTS: 14 intervention clinics and 25 control clinics were included. Number of antenatal visits increased by 1.16 per woman in the intervention clinics, while declined by 0.39 in the control clinics, giving a statistically significant difference in change of 1.55 visits (95% CI 0.90 to 2.21). A statistically significant difference in number of referrals was observed between the groups, giving a ratio of rate ratios of 3.65 (2.78-4.78) as number of referrals increased by a rate ratio of 3.87 in the intervention group, while in the control the rate ratio was only 1.06.Home visits increased substantially in the intervention group but decreased in the control group, giving a ratio of RR 97.65 (45.20 - 210.96) CONCLUSION: The Palestinian midwife-led continuity model improved use and some quality indicators of maternal services. More research should be done to investigate if the model influenced individual health outcomes and satisfaction with care. TRIAL REGISTRATION NUMBER: NCT03145571; Results.

Assessment of Surgical Competence: Development and Validation of Rating Scales Used for Laparoscopic Supracervical Hysterectomy.

OBJECTIVE: To develop a procedure-specific rating scale for laparoscopic supracervical hysterectomy (LSH), and to compare the construct validity and reliability with a general rating scale in laparoscopic surgery, global operative assessment of laparoscopic skills (GOALS). DESIGN: Prospective interobserver study. In collaboration with an expert group, we developed the procedure-specific rating scale, competence assessment tool for laparoscopic supracervical hysterectomy (CAT-LSH). LSH was performed by gynecologists with different levels of surgical competence levels (13 procedures were performed by inexperienced trainees, 13 by intermediate experienced, and 15 by laparoscopic experts). All procedures were video-recorded. Surgical performance was evaluated in all procedures using both CAT-LSH and GOALS by the surgical assistant, as well as by 2 blinded observers evaluating the video recordings. SETTING: University teaching hospital. PARTICIPANTS: Laparoscopic experts, consultants and gynecological registrars from the Department of Gynecology. RESULTS: There were significant differences between the 3 proficiency groups in both the rating scales. Mean GOALS score evaluated by the operating assistant and the 2 observers were for inexperienced surgeons 16.4 vs. 13.6 (p < 0.01), for surgeons with intermediate experienced 22.6 vs. 19.5 (p < 0.05) and for expert surgeons 26.1 vs. 22.4 (p < 0.01), respectively. Corresponding results for the CAT-LSH scores were 41.0/34.6 (p < 0.01), 49.2/43.1 (p < 0.01), and 58.7/51.1 (p < 0.01), respectively. The interrater reliability measured by the interclass correlation coefficient between the surgical assistant and the 2 blinded observers for GOALS and CAT-LSH were 0.71 and 0.75, respectively. CONCLUSIONS: The GOALS and CAT-LSH appear to have construct validity and high interrater reliability. Assessment of surgical competence during LSH is feasible in daily practice with objective rating scales like CAT-LSH and GOALS.

Assessment of periodic blood loss: interindividual and intraindividual variations of pictorial blood loss assessment chart registrations.

STUDY OBJECTIVE: To explore the interindividual and intraindividual variation of Pictorial Blood Loss Assessment Chart (PBAC) registrations of subjective perception of minimal, normal, and heavy menstrual bleeding in women using their usual sanitary protection. DESIGN: Retrospective study (Canadian Task Force classification II-3). SETTING: University tertiary hospital. PATIENTS: Women who had participated in 4 previously published prospective studies using PBAC as the outcome measure. INTERVENTIONS: Patients underwent hysteroscopic removal of polyps, laparoscopic occlusion of uterine vessels, or uterine artery embolization, and control subjects received no treatment. MEASUREMENTS AND MAIN RESULTS: PBAC scores, hemoglobin concentration, and subjective assessment of periodic blood loss were recorded in 429 women during 1049 menstrual cycles. The median PBAC values in groups of women who assessed their bleeding as light, normal, and heavy were 45.0, 116.0, and 254.5, respectively (p < .001). Sensitivity and specificity for specific PBAC cutoff points were calculated using a receiver operating characteristic curve. The maximum sensitivity for assessment of heavy periodic blood loss (78.5) was reached at a PBAC score of 160. The corresponding specificity was 75.8. At PBAC values below 130, 90% of the women reported normal blood loss, and 91% had hemoglobin values >12.0 g/dL. The reliability of repeated PBAC scores for individual measures was assessed via calculation of the intraclass correlation coefficient, which for repeated PBAC measurements was 0.86 (95% confidence interval, 0.80-0.90) for average measures. CONCLUSION: The interindividual variation was high, and the intraindividual variation was low. A low PBAC score may be used to define treatment end points for clinical use or in trials.