Using medico-legal claims for quality improvement in maternity care: application and revision of an NHSLA coding taxonomy.

OBJECTIVE: To validate the NHSLA maternity claims taxonomy at the level of a single maternity service and assess its ability to direct quality improvement. DESIGN: Qualitative descriptive study. SETTING: Medico-legal claims between 1 January 2000 and 31 December 2016 from a maternity service in metropolitan Melbourne, Australia. POPULATION: All obstetric claims and incident notifications occurring within the date range were included for analysis. METHODS: De-identified claims and notifications data were derived from the files of the insurer of Victorian public health services. Data included claim date, incident date and summary, and claim cost. All reported issues were coded using the NHSLA taxonomy and the lead issue identified. MAIN OUTCOME MEASURES: Rate of claims and notifications, relative frequency of issues, a revised taxonomy. RESULTS: A combined total of 265 claims and incidents were reported during the 6 years. Of these 59 were excluded, leaving 198 medico-legal events for analysis (1.66 events/1000 births). The costs for all claims was $46.7 million. The most common claim issues were related to management of labour (n = 63, $17.7 million), cardiotocographic interpretation (n = 43, $24.4 million), and stillbirth (n = 35, $656,750). The original NHSLA classification was not sufficiently detailed to inform care improvement programmes. A revised taxonomy and coding flowchart is presented. CONCLUSIONS: Systematic analysis of obstetric medico-legal claims data can potentially be used to inform quality and safety improvement. TWEETABLE ABSTRACT: New taxonomy to target health improvement from maternity claims based on NHSLA Ten Years of Maternity Claims.

Wide variation in estimates of global prevalence and burden of chronic hepatitis B and C infection cited in published literature.

To evaluate the extent of heterogeneity in global estimates of chronic hepatitis B (HBV) and C (HCV) cited in the published literature, we undertook a systematic review of the published literature. We identified articles from 2010 to 2014 that had cited global estimates for at least one of ten indicators [prevalence and numbers infected with HBV, HCV, HIV-HBV or HIV-HCV co-infection, and mortality (number of deaths annually) for HBV and HCV]. Overall, 488 articles were retrieved: 239 articles cited a HBV-related global estimate [prevalence (n = 12), number infected (n = 193) and number of annual deaths (n = 82)]; 280 articles had HCV-related global estimates [prevalence (n = 86), number infected (n = 203) and number of annual deaths (n = 31)]; 31 had estimates on both HBV and HCV; 54 had HIV-HBV co-infection estimates [prevalence (n = 42) and number co-infected (n = 12)]; and 68 had estimates for HIV-HCV co-infection [prevalence (n = 40) and number co-infected (n = 28)]. There was considerable heterogeneity in the estimates cited and also a lack of consistency in the terminology used. Although 40% of 488 articles cited WHO as the source of the estimate, many of these were from outdated or secondary sources. Our findings highlight the importance of clear and consistent communication from WHO and other global health agencies on current consensus estimates of hepatitis B and C burden and prevalence, the need for standardisation in their citation, and for regular updates.

Immune Compromise in HIV-1/HTLV-1 Coinfection With Paradoxical Resolution of CD4 Lymphocytosis During Antiretroviral Therapy: A Case Report.

Human immunodeficiency virus type-1 (HIV-1) and human T lymphotropic virus type-1 (HTLV-1) infections have complex effects on adaptive immunity, with specific tropism for, but contrasting effects on, CD4 T lymphocytes: depletion with HIV-1, proliferation with HTLV-1. Impaired T lymphocyte function occurs early in HIV-1 infection but opportunistic infections (OIs) rarely occur in the absence of CD4 lymphopenia. In the unusual case where a HIV-1 infected individual with a high CD4 count presents with recurrent OIs, a clinician is faced with the possibility of a second underlying comorbidity. We present a case of pseudo-adult T cell leukemia/lymphoma (ATLL) in HIV-1/HTLV-1 coinfection where the individual fulfilled Shimoyama criteria for chronic ATLL and had pulmonary Mycobacterium kansasii, despite a high CD4 lymphocyte count. However, there was no evidence of clonal T-cell proliferation by T-cell receptor gene rearrangement studies nor of monoclonal HTLV-1 integration by high-throughput sequencing. Mutually beneficial interplay between HIV-1 and HTLV-1, maintaining high level HIV-1 and HTLV-1 viremia and proliferation of poorly functional CD4 cells despite chronicity of infection is a postulated mechanism. Despite good microbiological response to antimycobacterial therapy, the patient remained systemically unwell with refractory anemia. Subsequent initiation of combined antiretroviral therapy led to paradoxical resolution of CD4 T lymphocytosis as well as HIV-1 viral suppression and decreased HTLV-1 proviral load. This is proposed to be the result of attenuation of immune activation post-HIV virological control. This case illustrates the importance of screening for HTLV-1 in HIV-1 patients with appropriate clinical presentation and epidemiological risk factors and explores mechanisms for the complex interactions on HIV-1/HTLV-1 adaptive immunity.

A trial of daily vitamin supplementation as a means of reducing oral contraceptive side effects and discontinuation in Sri Lanka.

A 4-cell randomized, blind clinical trial was conducted at three sites in Sri Lanka to evaluate the impact of daily vitamin supplements in preventing oral contraceptive side effects and in improving continuation. No significant effects were found.

PIP: A 4-cell, randomized, blind clinical trial was conducted in the city of Colombo and in 2 rural areas of Sri Lanka between September 1978-December 1980 to test whether a daily vitamin supplement would prevent oral contraceptive (OC) side effects and lead to improved continuation. 668 women received Norinyl with a daily vitamin supplement; 677 received Norinyl with placebo; 620 received Brevicon, a lower dose OC, with vitamin supplement; and 686 received Brevicon with placebo. The vitamin supplement contained 1.4 mg Bl, 1.7 mg B2, 10 mg B6, 4 mcg B12, .8 mg folate, 60 mg C, and 16 mg niacin. Over 90% of rural acceptors and 75% of urban acceptors were followed up. No differences in continuation rates at 3, 6, 9, or 12 months at any site approached statistical significance. Continuation was slightly higher for the vitamin group in Colombo and 1 rural site, but slightly higher for the placebo group in the other rural area. 9-month gross rates of termination by reason, site, and treatment on the whole showed greater differences by site than within treatments. Rates of unplanned pregnancy did not differ noticeably by treatment in any site, and no significant difference was found between treatments for rates of termination for either menstrual side effects, "other medical reasons or side effects," or other reasons. For most symptoms, placebo users showed higher levels of side effects than vitamin users, but the differences were neither substantial nor, in the 1st follow-up visit, significant.

A comparison of Norinyl and Brevicon in three sites in Sri Lanka.

A set of 3 four-cell randomized, blind clinical trials was carried out in Sri Lanka to evaluate the impact of vitamin supplements and different oral contraceptive formulations. This paper concentrates on the comparisons of oral contraceptives. There seems to be no important difference between Norinyl, a standard-dose oral contraceptive, and Brevicon of a lower estrogen dosage--in either continuation or side effects. Continuation at one site was higher among Norinyl users, but several factors led us to the belief that this difference was due to differences in field worker performance rather than to the pharmacological properties of the drugs. Some differences in side effects were observable along predictable lines; breakthrough bleeding was more common among Brevicon users than Norinyl users, and most other side effects were more frequent among Norinyl users, although these latter differences were quite small, and there were several exceptions.

PIP: Between September 1978 and December 1980 a set of 3 4-cell randomized blind clinical trials were carried out in Sri Lanka to evaluate the impact of vitamin supplements and different oral contraceptive (OC) formulations. The 4 treatments of the study were: Norinyl, the standard OC used in Sri Lanka, with a daily multi-vitamin supplement; Norinyl with placebo; Brevicon, a lower dose OC, with a vitamin supplement; and Brevicon with placebo. Focus here is on the 3 2-cell comparisons of Norinyl versus Brevicon. 500 women recruited from low income areas of Colombo were assigned to the 4 treatments at random. 2 other trials were conducted according to a somewhat different design in rural areas of the Districts of Matara in the South and Puttalam in the North. The 4 treatment combinations used in the urban study were assigned on a sequential basis, after a random start, to acceptors on entry into the study. The 1st follow-up visit, conducted in the home by home visitors, was scheduled for 1 month after admission and succeeding visits were scheduled at 2-3 month intervals. In the urban study, recruitment was limited to low income areas with reasonable access to the clinic and to physically healthy women 18-40 years of age with no known or suspected contraindications to OCs and who had terminated their last pregnancy more than 3 months previously. Eligibility requirements for the rural study were the same as the urban study, except that women up to age 49 and those currently breastfeeding were included. The Colombo acceptors were younger than the Matara acceptors, were better educated, had fewer children, wanted fewer additional children, and were more likely to have previously used contraception. There were no striking or consistent differences in continuation. There were gross rates of termination by reason, site, and treatment. Differences by site were far more striking than differences by treatment within site. Of particular note were: the low proportion of dropouts due to menstrual side effects in Colombo; the predominance of "other medical" terminations in the rural areas; and the high urban lost to follow-up rate. Rates of unplanned pregnancy did not differ noticeably by treatment, in any site. Breakthrough bleeding was more common among Brevicon users than Norinyl users, and most other side effects were more frequent among Norinyl users, although these latter differences were quite small and there were several exceptions. In sum, there appears to be no important difference between Norinyl and Brevicon in either continuation or side effects.

Bleeding patterns and acceptability among Norplant users in two Asian countries.

Changes in menstrual bleeding patterns are the most frequent reason for discontinuing NORPLANT during the first year of use. Although NORPLANT is used by more women in Asia than in any other region, the changes that occur among these women are not well documented. In pre-introductory clinical trials of NORPLANT in the Philippines and Sri Lanka, 175 women were enrolled with greater than 95% continuing the method after one year. Daily menstrual bleeding calendars were kept by 94% of subjects for nine months and by 66% for one year. In contrast to findings in previous studies which showed that approximately 60% of NORPLANT users had bleeding disruptions in the first year of use, almost all of these women experienced bleeding disruptions. In a one-year study of menstrual pattern changes, increased bleeding was found to occur with the same frequency as reduced bleeding. However, the changes experienced by the Asian women tended to be decreases, rather than increases, in menstrual bleeding.

Contraceptives for lactating women: a comparative trial of a progesterone-releasing vaginal ring and the copper T 380A IUD.

From approximately one week before normal ovulation resumes, lactating women require protection against pregnancy by a contraceptive that is safe for both infant and mother in a multicenter one-year study, the natural hormone, progesterone, delivered vaginally by a sequence of four contraceptive rings designed for continuous use, was evaluated as a contraceptive for nursing mothers in comparison with the Copper T 380A IUD. Individual rings release in effective average dose of 10 mg day for a 3 month period. Evaluation included measures of lactational performance as well as of contraceptive efficacy and safety to mother and child. Nine participating clinics enrolled 802 ring users and 734 IUD acceptors between postpartum days 29 and 63. Life table analyses were performed with parallel decrements for ring and IUD subjects. Continuation in the study and analysis required that subjects not stop breastfeeding. The ring, with a one-year pregnancy rate of 1.5 per 100, did not differ significantly from the IUD with respect to contraceptive effectiveness (p > 0.05). More than half of the ring subjects were continuing at 6 months post admission and a quarter (23.5 per hundred) were still using the ring and breastfeeding one year after admission. Women with the IUD, however, had higher continuation rates (p < 0.001) at both time points. The largest single decrement for each method was that for weaning. Ring users had more complaints of vaginal problems but had fewer vaginal disorders on examination. At 12 months postpartum, 46 per 100 continuing ring users remained in amenorrhea. Lactation performance and the health and weight gain of the infants were similar among users of either regimen.

PIP: A multicenter trial conducted in nine clinics in Asia, Latin America, North Africa, and the US indicated the progesterone-releasing vaginal ring (PVR) is a safe, effective contraceptive method for lactating women. Study participants, enrolled 4-9 weeks postpartum, agreed to fully or nearly fully breast feed for at least 3 months after admission. The ring released an average of 10 mg of progesterone per day for a 3-month period. The Copper T 380A IUD served as the non-hormonal control. A total of 431 and 533 woman-years of observation were accumulated in the PVR and IUD groups, respectively. After 12 months of use, the cumulative pregnancy rate was 1.5 per 100 in the PVR group and 0.5 per 100 in the IUD group. In the year following admission, 3.4% of PVR acceptors complained of heavy and/or prolonged bleeding. At 12 months postpartum, 46.2% of ring users compared with only one-sixth of IUD users remained amenorrheic. Although PVR acceptors reported more vaginal problems (e.g., discharge or leukorrhea), pelvic examinations were more likely to detect abnormalities in IUD users. The 6- and 12-month continuation rates were 52.5% and 23.5%, respectively, in the PVR group and 74.8% and 34.5%, respectively, in the IUD group. The predominant reason for discontinuation was weaning. Breast feeding performance and infant growth were within normal limits for the PVR and IUD. Both methods are highly effective and appropriate for use by lactating women from the second postpartum month forward; the PVR has the additional advantage of being user-controlled.

The effect of oral contraceptive formulation and field-workers: a cautionary tale.

This paper examines oral contraceptive continuation rates and reported side effects in a large scale clinical research project conducted in Sri Lanka. The project evaluated standard- and low-dose pills used with and without vitamin supplements. Differences in continuation rates and perception of side effects are used to illustrate the impact that family planning field-workers can have on women's use of oral contraceptives.

PIP: The article reports the results of a large-scale clinical research project conducted in Sri Lanka in 1977-81 that was designed to address 3 issues: 1) whether oral contraceptives (OCs) with estrogen doses of 50 mcg and progestagen doses of 1 mg should be replaced by lower-dose preparations; 2) whether a multivitamin tablet taken in conjunction with OCs can reduce OC side effects and increase continuation rates; and 3) whether a recruitment and delivery system using young village women as house-to-house motivators and contraceptive suppliers can be a successful, cost-effective mechanism of family planning service delivery. Differences in continuation between OC types and in terms of vitamin supplementation versus nonsupplementation were generally inconsistent and nonsignificant. However, there were marked differences in continuation rates among the 3 study sites (Colombo, Matara, and Puttalam) which appeared to reflect the different attitudes and practices of fieldworkers in these areas. Fieldworkers in the urban area of Colombo, the study site with the highest continuation rate, were highly trained, well supervised, and did not have to travel as far as their counterparts in the other 2 study areas. 12-month termination rates in Colombo were significantly higher for low-dose compared to standard-dose OCs; again, this finding is considered to be more reflective of the greater skill and diligence of field workers assigned to follow up standard-dose clients than of properties of the 2 forms of OCs. In Matara, standard-dose only users had higher continuation and fewer side effects than study treatment acceptors in general or than standard dose placebo acceptors; in Puttalam, they had lower continuation and more side effects. The substantial differences in Puttalam are entirely explained as an artifact of the geographic assignment of fieldworkers: a home visiting team did not work in the standard-dose only area. These findings indicate that differences in the setting in which treatment is provided, especially in the quality of field personnel, are often far more important to treatment success than the contraceptive methods themselves.

Starting a programme in Sri Lanka.

PIP: A survey conducted by the Sri Lanka Family Planning Association (FPA) revealed a significant unmet need for reproduction health education among young people. The FPA presented the survey findings to policy makers and educational leaders at a national seminar. Emerging from this seminar were a pilot project in Sri Lanka schools, a program to train counselors in premarital at regular intervals. These interventions resulted in a substantial increase in the number of young people presenting to FPA clinics. Moreover, their success led the FPA to launch a national sexual education program in the schools, beginning in 1992. In preparation, a series of orientation seminars were held for Ministry of Education officials and school administrators. A team of teachers was recruited to participate in an intensive 2-month training program in sex education for youth over 15 years of age. At present, daily sex education classes are conducted in selected Sri Lankan schools and out-of-school youth are reached during holidays. The FPA has set a goal of reaching 100,000 young people with this program by the end of 1993. Program evaluation indicates that the proportion of young people who scored over 75% on a test of knowledge of human sexuality increased overall from 9% at pre-test to 67% at post-intervention testing. The FPA has received favorable feedback on this program from parents, educators, community leaders, and religious leaders, including some Buddhist priests.^ieng

Depo-Provera use in Sri Lanka: acceptor characteristics, continuation and side effects.

PIP: This study presents findings on the socio-demographic and health characteristics, continuation rates, menstrual disturbances, and changes in menstrual patterns as well as other side effects among a sample of 952 1st time acceptors of the injectable contraceptive Depo-Provera during 1978-1980 in Colombo, Sri Lanka. Those continuing to use the method were observed for 24 months. The reasons for discontinuation are discussed based on another study that focused on 321 discontinuers who received Depo-Provera from the same clinic. The overall continuation rates at 12 and 24 months were 58% and 29%, respectively. Relatively older and higher parity women had lower continuation rates than younger and lower parity women. The occurrence of amenorrhea rose sharply foloowing the 1st dose and stabilized such that about 1/3 of those continuing with Depo-Provera became amenorrheic. 1/4 of the women experienced menstrual disturbances such as spotting and irregular bleeding. Other side effects, including vomiting, headache, and dizziness, affected 6% of the women following the 1st dose, but declined gradually over time. Over the course of the observation, 41-66% of the women appeared to gain weight. The 2 primary reasons for discontinuing Depo-Provera were non-medical: 1) the desire to have another child and 2) the decision to be sterilized. The findings suggest that Depo-Provera has played a signinficant role in Sri Lanka in 2 ways: 1) its use has provided desired pregnancy spacing for those who wished to have another child and 2) it has assisted couples by providing them with time (without the fear of pregnancy) to decide to stop having children and then get sterilized.^ieng

Evaluation of safety, efficacy, and acceptability of NORPLANT implants in Sri Lanka.

This paper presents findings based on a one-year pre-introductory clinical investigation concerning safety, efficacy, and acceptability of the new contraceptive NORPLANT implants in Sri Lanka. The study is based on 400 acceptors of the implants at two clinics in Sri Lanka. Acceptors' mean age was 27 years, mean number of children was about two, and average educational attainment was eight years. Nearly half of the acceptors did not want to have another child. Follow-up was conducted at one, three, six, and twelve months. The one-year termination rate due to medical problems was very low, and the one-year life-table pregnancy rate was 0.5. Menstrual pattern disruption was the most frequently reported complaint with the implants. Amenorrhea increased in the first three months of use, and intermenstrual bleeding was common among those menstruating. In spite of these changes and some significant variations between the acceptors in the two study center, the overall degree of satisfaction with the implants was very high. The features most important to the acceptability of the implants were low risk of pregnancy, the long duration of action, and the convenience of use. The results of the study suggest that NORPLANT implants are safe, effective, and highly acceptable to Sri Lankan women.

PIP: This paper presents findings based on a 1 year pre-introductory clinical investigation concerning safety, efficacy, and acceptability of the new contraceptive Norplant implants in Sri Lanka. The study is based on 400 acceptors of the implants at 2 clinics in Sri Lanka. Acceptors' mean age was 27 years, mean number of children was about 2, and average educational attainment was 8 years. Nearly 1/2 of the acceptors did not want to have another child. Follow-up was conducted at 1,3,6, and 12 months. The 1 year termination rate due to medical problems was very low, and the 1 year life-table pregnancy rate was 0.5. Menstrual pattern disruption was the most frequently reported complaint with the implants. Amenorrhea increased in the 1st 3 months of use, and intermenstrual bleeding was common among those menstruating. In spite of these changes and some significant variations between the acceptors in the 2 study centers, the overall degree of satisfaction with the implants was very high. The features most important to the acceptability of the implants were low risk of pregnancy, the long duration of action, and the convenience of use. The results of the study suggest that Norplant implants are safe, effective, and highly acceptable to Sri Lankan women when administered by health personnel who are well trained in counseling women about the features of the method and in the proper insertion and removal techniques. Despite the overall high level of acceptability, some important variations were found with respect to the sociodemographic characteristics, effectiveness, satisafction, and adverse experiences between the 2 groups of acceptors in the study centers. This variation underscores the importance of conducting the study in more than 1 clinic within a country.

Early symptoms and discontinuation among users of oral contraceptives in Sri Lanka.

The relationship between symptoms reported during the first two cycles of oral contraceptive use and subsequent discontinuation was studied using data from a comparative clinical trial of two oral contraceptives (standard dose and low dose) in Sri Lanka. Among 24 symptoms considered, the most commonly reported were headache, nausea, irritability, dizziness, tiredness, intermenstrual spotting/bleeding, backache, abdominal pain, vomiting, and hair loss. Headache, nausea, vomiting, and dizziness were closely associated with each other and strongly predictive of discontinuation for both drugs. No other symptoms were consistently associated with each other or with subsequent discontinuation. Intermenstrual spotting/bleeding was associated with later discontinuation of the standard dose preparation, but not the lower dose preparation.