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The safety, efficacy and acceptability of task sharing tubal sterilization to midlevel providers: a systematic review

Open AccessPublished:January 23, 2014DOI:https://doi.org/10.1016/j.contraception.2014.01.008

      Abstract

      Background

      Task sharing is an important strategy for increasing access to modern, effective contraception for women and reducing unmet need for family planning.

      Objective

      The objective was to identify evidence for the safety, efficacy or acceptability of task sharing tubal sterilization to midlevel providers.

      Search strategy

      We searched PubMed, Cochrane and Popline for articles in all languages using the following key words: task sharing, tubal sterilization, midlevel providers, task shifting.

      Selection criteria

      All studies reporting on any measure of safety, efficacy or acceptability of tubal sterilization performed by any cadre of midlevel providers.

      Data collection and analysis

      Data were independently abstracted by two authors and graded using the United States Preventive Services Task Force rating for evidence quality. Heterogeneity of outcome measures precluded a meta-analysis.

      Main results

      Nine studies of fair to poor quality reported on safety and acceptability outcomes. Generalizability of findings is limited by inadequate sample size and lack of statistical comparisons. No study reported on long-term efficacy outcomes.

      Conclusions

      Well-designed clinical trials, of adequate sample size, are urgently needed to establish the safety, efficacy and acceptability of task sharing tubal sterilization to midlevel providers.

      Keywords

      1. Introduction

      Unintended pregnancy contributes significantly to maternal mortality and morbidity in developing nations [

      Trends in maternal mortality: 1990 to 2008. Geneva, Switzerland: World Health Organization, 2008 2010. Report No.

      ,
      ]. Globally, large disparities exist in access to the most effective forms of contraception. The latest estimates are that 222 million women have an unmet need for modern contraception; the need is greatest where the risks of maternal mortality are highest [
      • Darroch J.E.
      • Singh S.
      • Nadeau J.
      Contraception: an investment in lives, health and development.
      ,
      • Singh S.D.
      • JE
      Adding it up: the costs and benefits of investing in family planning and newborn and maternal health. Estimates for 2012.
      ]. In the least developed countries, 6 out of 10 women who do not want to get pregnant or who want to delay the next pregnancy are not using any method of contraception [
      • Singh S.D.
      • JE
      Adding it up: the costs and benefits of investing in family planning and newborn and maternal health. Estimates for 2012.
      ]. Unmet need for family planning is highest among the most vulnerable elements in society: adolescents, the poor, those living in rural areas and urban slums, people living with HIV and internally displaced people [
      • Dehlendorf C.
      • Rodriguez M.I.
      • Levy K.
      • Borrero S.
      • Steinauer J.
      Disparities in family planning.
      ,
      • Bakanda C.
      • Birungi J.
      • Mwesigwa R.
      • Zhang W.
      • Hagopian A.
      • Ford N.
      • et al.
      Density of healthcare providers and patient outcomes: evidence from a nationally representative multi-site HIV treatment program in Uganda.
      ].
      Multiple barriers to accessible, equitable and high-quality family planning care in developing nations exist; however, a critical barrier is a shortage of trained providers [
      ]. Human resource shortages in the health services are widely acknowledged as a threat to the attainment of the health-related Millennium Development Goals [
      ,

      Janowitz B, Stanback J, Boyer B. Task sharing in family planning. Stud Fam Plann. 43(1):57–62.

      ]. Task shifting, or task sharing, has been proposed as a strategy to optimize the available work force to deliver essential health services to those in need. Task shifting is defined as the delegation of specific tasks to less specialized health workers [
      ]. Task sharing refers to a partnership in which different levels of providers do similar work, rather than having less-credentialed providers take over provision completely [

      Janowitz B, Stanback J, Boyer B. Task sharing in family planning. Stud Fam Plann. 43(1):57–62.

      ]. While these terms are fairly new, the concept has existed and been utilized in a range of settings successfully. Task sharing or shifting can occur within clinics or across different supply outlets [
      ,

      Janowitz B, Stanback J, Boyer B. Task sharing in family planning. Stud Fam Plann. 43(1):57–62.

      ].
      Task sharing is a key strategy for reducing unmet need for family planning. While a wide range of modern, effective methods of contraception exist, inadequate numbers of providers to supply them exist, particularly in rural areas. The most effective forms of contraception, the long-acting and permanent methods [intrauterine device (IUD), implant, female or male sterilization] are particularly inaccessible due to the health worker shortage [
      ]. Multiple studies have examined the effectiveness and safety of task shifting delivery of injectable progestin or contraceptive pills, and provision of IUD by a range of midlevel providers [
      • Guilbert E.R.
      • Robitaille J.
      • Guilbert A.C.
      • Morin D.
      The Group of experts in Family Planning of the National Institute of Public Health of Q
      Challenges of implementing task-shifting in contraceptive care — an experience in Quebec, Canada.
      ,
      • Farr G.
      • Rivera R.
      • Amatya R.
      Non-physician insertion of IUDs: clinical outcomes among TCu380A insertions in three developing-country clinics.
      ,
      • Aziz F.A.
      • Osman A.A.
      Safety of intrauterine device insertion by trained nurse-midwives in the Sudan.
      ,
      • Lassner K.J.
      • Chen C.H.
      • Kropsch L.A.
      • Oberle M.W.
      • Lopes I.M.
      • Morris L.
      Comparative study of safety and efficacy of IUD insertions by physicians and nursing personnel in Brazil.
      ,
      • Eren N.
      • Ramos R.
      • Gray R.H.
      Physicians vs. auxiliary nurse-midwives as providers of IUD services: a study in Turkey and the Philippines.
      ,
      • Hoke T.H.
      • Wheeler S.B.
      • Lynd K.
      • Green M.S.
      • Razafindravony B.H.
      • Rasamihajamanana E.
      • et al.
      Community-based provision of injectable contraceptives in Madagascar: ‘task shifting’ to expand access to injectable contraceptives.
      ,
      • Stanback J.
      • Mbonye A.K.
      • Bekiita M.
      Contraceptive injections by community health workers in Uganda: a nonrandomized community trial.
      ]. The World Health Organization (WHO) recognizes task shifting as a key strategy to optimize reproductive health and has issued recommendations on which family planning services can be safely provided by different cadres of workers [
      ].
      Tubal ligation (TL) is a highly effective method of contraception, and a key barrier to its use is the lack of trained providers [

      Janowitz B, Stanback J, Boyer B. Task sharing in family planning. Stud Fam Plann. 43(1):57–62.

      ]. Several country programs have begun task sharing or shifting TL to midlevel providers to try and expand method choice for women [
      ,
      • Gordon-Maclean C.
      • Nantayi L.K.
      • Quinn H.
      • Ngo T.D.
      Safety and acceptability of tubal ligation procedures performed by trained clinical officers in rural Uganda.
      ]. A wide variation exists in the training and educational background of midlevel providers of contraceptive services.
      Prior to countries with human resources shortages of physicians deciding to scale up task sharing of TL, it is essential to confirm whether it is safe, effective and acceptable to women. TL is a major pelvic surgery and requires a provider who is capable of managing potentially life-threatening complications. While all contraceptive providers must be competent in counseling and informed consent, this is especially important, and challenging, with permanent methods of contraception. Qualitative research in Africa, Australia and Asia has indicated that health workers may be biased against permanent contraception and individuals' misunderstanding of the permanent nature of TL [
      • Okunlola M.A.
      • Oyugbo I.A.
      • Owonikoko K.M.
      Knowledge, attitude and concerns about voluntary surgical contraception [corrected] among healthcare workers in Ibadan, Nigeria.
      ,
      • Okunlola M.A.
      • Awoyinka S.B.
      • Owonikoko K.M.
      Awareness and practice of vasectomy among married male health workers at the University College Hospital, Ibadan, Nigeria.
      ,
      • Ngum Chi Watts M.C.
      • Liamputtong P.
      • Carolan M.
      Contraception knowledge and attitudes: truths and myths among African Australian teenage mothers in Greater Melbourne, Australia.
      ,
      • Hindin M.J.
      • McGough L.J.
      • Adanu R.M.
      Misperceptions, misinformation and myths about modern contraceptive use in Ghana.
      ,
      • Nishtar N.A.
      • Sami N.
      • Faruqi A.
      • Khowaja S.
      • Ul-Hasnain F.
      Myths and fallacies about male contraceptive methods: a qualitative study amongst married youth in slums of Karachi, Pakistan.
      ,
      • Gaym A.
      Current and future role of voluntary surgical contraception in increasing access to and utilization of family planning services in Africa.
      ].
      This review will identify the evidence base for the safety, efficacy and acceptability of task sharing TL to midlevel providers.

      2. Materials and methods

      We searched Pubmed, Cochrane and Popline databases for peer-reviewed articles concerning task sharing tubal sterilization with midlevel providers. We searched from database inception through January 2013. Search terms included the following:
      “Sterilization, Reproductive” [Mesh] OR “Sterilization, Tubal” [Mesh] OR “female sterilization” [TW] OR fimbriectomy [all fields] OR “tubal sterilization” [TW] OR “Pomeroy” [TW] OR “Parkland” [ all fields] OR “Reproductive Sterilization” [TW] OR “Tubal Sterilization” [all fields] OR “tubal sterilizations” OR “tubal sterilizations” [TW] OR Sterilization, Tubal/nursing* [TW] OR Sterilization, Tubal/methods [TW] AND “Allied Health Personnel*/organization and administration” [MAJR] OR “mid level provider” [TW] OR midlevel provider* [TW] OR “non-physician provider” [TW] OR “Mid-level health providers” [TW] OR “Physician Extenders” [all fields] OR “Feldsher” [all fields] OR “non-physician clinician” OR “Midwifery” [Mesh] OR “Nurse Midwives” [Mesh] OR “midwife” [TW] OR “nurse midwives” [TW] OR “Allied Health Occupations” [Mesh] OR “clinical officers” [TW] OR “assistant medical officers” [TW] OR “medical officers” [TW] OR “Staff Development” [Mesh] OR “employee cross-training” [all fields] OR “task-shifting” [TIAB] OR “task-sharing” [all fields] OR “Health Services Accessibility” [Mesh] OR Ambulatory Care/manpower* [Mesh]OR “Workload” [Mesh] OR “Personnel Turnover” [Mesh] OR “job substitution” [TW] OR “Clinical Competence” [Mesh] OR “Inservice Training” [Mesh] OR “Operating Room Nursing” [Mesh] OR “clinical competence” [TW] OR “operating room nursing” [TW] OR “Health Personnel” [Mesh] OR Nurse Midwives*/education [TW].
      The search strategy identified a total of 331 articles. Our inclusion criterion was any study design, in any language, reporting on outcomes of safety, efficacy or acceptability of task sharing TL with midlevel providers. All types of midlevel providers were included and were categorized according to WHO definitions of health worker cadres (Table 1). All measures of safety, efficacy (pregnancy rates) and acceptability were included. No date restrictions were applied. Both comparative and observational studies were included.
      Table 1WHO definitions of health worker cadres
      Optimizing health worker roles to improve access to key maternal and newborn health interventions through task shifting. Geneva: WHO, 2012.
      CategoryDefinitionAlternative names
      Advanced-level associate clinicianA professional clinician with advanced competencies to diagnose and manage the most common medical, maternal, child health and surgical conditions, including obstetric and gynaecological surgery (e.g., caesarean sections). Advanced-level associate clinicians are generally trained for 4 to 5 years post secondary education in established higher-education institutions and/or 3 years post initial associate clinician training. The clinicians are registered, and their practice is regulated by their national or subnational regulatory authority.Assistant medical officer, clinical officer (e.g., in Malawi), medical licentiate practitioner, health officer (e.g., Ethiopia), physician assistant, surgical technician, medical technician, nonphysician clinician
      Associate clinicianA professional clinician with basic competencies to diagnose and manage common medical, maternal, child health and surgical conditions. They may also perform minor surgery. The prerequisites and training can be different from country to country. However, associate clinicians are generally trained for 3 to 4 years post secondary education in established higher-education institutions. The clinicians are registered, and their practice is regulated by their national or subnational regulatory authority.Clinical officer (e.g., in Tanzania, Uganda, Kenya, Zambia), medical assistant, health officer, clinical associate, nonphysician clinician
      Auxiliary nurseHas some training in secondary school. A period of on-the-job training may be included and sometimes formalized in apprenticeships. An auxiliary nurse has basic nursing skills and no training in nursing decision making. The level of training varies between countries from a few months to 2–3 years.Auxiliary nurse, nurse assistant, enrolled nurses
      Auxiliary nurse midwifeHas some training in secondary school and typically a period of on-the-job training. Like an auxiliary nurse, an auxiliary nurse midwife has basic nursing skills and no training in nursing decision making. They possess some of the competencies in midwifery but are not fully qualified as midwives.Auxiliary midwife
      MidwifeA person who has been assessed and registered by a state midwifery regulatory authority or similar regulatory authority. Their education lasts 3, 4 or more years in nursing school and leads to a university or postgraduate university degree or the equivalent. A registered midwife has the full range of midwifery skills.Registered midwife, midwife, community midwife
      NurseA graduate who has been registered to practice after examination by a state board of nurse examiners or similar regulatory authority. Education includes 3, 4 or more years in nursing school and leads to a university or postgraduate university degree or the equivalent. A registered nurse has the full range of nursing skills.Registered nurse, nurse practicioner, clinical nurse specialist, advance practice nurse, licensed nurse, BS nurse, nurse clinician
      a Optimizing health worker roles to improve access to key maternal and newborn health interventions through task shifting. Geneva: WHO, 2012.
      Both authors participated in summarizing and systematically assessing the evidence through the use of standard data abstraction forms. The quality of each individual piece of evidence was assessed using the United States Preventive Services Task Force grading system [
      • Harris R.P.
      • Helfand M.
      • Woolf S.H.
      • Lohr K.N.
      • Mulrow C.D.
      • Teutsch S.M.
      • et al.
      Current methods of the US Preventive Services Task Force: a review of the process.
      ]. Each study was given a rating of Level 1, Level II-1, Level II-2, Level II-3 or Level III based on the study design (Table 2). Each study was also given a rating of poor, fair or good based on the criteria for grading the internal validity of a study (Table 3). A good study meets all criteria for that study design, a fair study does not meet all criteria but is judged to have no fatal flaw, and a poor study contains a fatal flaw. Also the type of evidence was identified as being either direct (the evidence was based on data directly addressing the question) or indirect (the evidence was extrapolated from other relevant data).
      Table 2Levels of evidence
      Levels of Evidence
      Level 1Evidence obtained from at least one properly designed randomized controlled trial.
      Level II-1Evidence obtained from well-designed controlled trials without randomization.
      Level II-2Evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group.
      Level II-3Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments could also be regarded as this type of evidence.
      Level IIIOpinions of respected authorities based on clinical experience, descriptive studies or reports of expert communities.
      U.S. Preventive Services Task Force. Guide to clinical preventive services, 2nd ed. Alexandria, Virginia: International Medical Publishing, 1996:862.
      Table 3Criteria for grading the internal validity of individual studies
      Study designCriteria
      Systematic reviews■ Comprehensiveness of sources/search strategy used
      ■ Standard appraisal of included studies
      ■ Validity of conclusions
      ■ Recency and relevance
      Case–control studies■ Accurate ascertainment of cases
      ■ Nonbiased selection of cases/controls with exclusion criteria applied equally to both
      ■ Response rate
      ■ Diagnostic testing procedures applied equally to each group
      ■ Appropriate attention to potential confounding variables
      Randomized controlled trials (RCTs) and cohort studies■ Initial assembly of comparable groups:
      ■ For RCTs: adequate randomization, including concealment and whether potential confounders were distributed equally among groups
      ■ For cohort studies: consideration of potential confounders with either restriction or measurement for adjustment in the analysis; consideration of inception cohorts
      ■ Maintenance of comparable groups (includes attrition, crossovers, adherence, contamination)
      ■ Important differential loss to follow-up or overall high loss to follow-up
      ■ Measurements: equal, reliable and valid (includes masking of outcome assessment)
      ■ Clear definition of interventions
      ■ All important outcomes considered
      ■ Analysis: adjustment for potential confounders for cohort studies or intention-to-treat analysis for RCTs
      Diagnostic accuracy studies■ Screening test relevant, available for primary care, adequately described
      ■ Study uses a credible reference standard, performed regardless of test results
      ■ Reference standard interpreted independently of screening test
      ■ Handles indeterminate results in a reasonable manner
      ■ Spectrum of patients included in study
      ■ Sample size
      ■ Administration of reliable screening test
      Harris et al. Current methods of the US Preventive Services Task Force: a review of the process. American Journal of Preventive Medicine. 20(3 Suppl):21–35, 2001 Apr.
      The presence of heterogeneity with respect to study designs, population characteristics, study population recruitment, extent of loss to follow-up and outcome measure definitions did not permit us to compute summary measures of association for outcomes of included studies.

      3. Results

      Nine studies met our inclusion criteria (Table 4) [
      • Chowdhury S.
      • Chowdhury Z.
      Tubectomy by paraprofessional surgeons in rural Bangladesh.
      ,
      • Wortman J.
      Training nonphysicians in family planning services and a directory of training programs.
      ,
      • Fongsri A.
      • McDaniel E.B.
      Use of nurse-midwives for minilap sterilization.
      ,
      • Ghorbani F.S.
      The use of paramedics in family planning services in Iran.
      ,
      • Dusitsin N.
      • Chalapati S.
      • Varakamin S.
      • Boonsiri B.
      • Ningsanon P.
      • Gray R.H.
      Post-partum tubal ligation by nurse-midwives and doctors in Thailand.
      ,
      • Koetsawang S.
      • Varakamin S.
      • Satayapan S.
      • Srisupandit S.
      • Apimas S.J.
      Postpartum sterilization by operating-room nurses in Thailand.
      ,
      • Satyapan S.
      • Varakamin S.
      • Suwannus P.
      • Chalapati S.
      • Onthuam Y.
      • Dusitsin N.
      Postpartum tubal ligation by nurse-midwives in Thailand: a field trial.
      ,
      • Vaz F.
      • Bergstrom S.
      • Vaz Mda L.
      • Langa J.
      • Bugalho A.
      Training medical assistants for surgery.
      ,
      • Chilopora G.
      • Pereira C.
      • Kamwendo F.
      • Chimbiri A.
      • Malunga E.
      • Bergstrom S.
      Postoperative outcome of caesarean sections and other major emergency obstetric surgery by clinical officers and medical officers in Malawi.
      ]. Types of midlevel providers included advanced-level associate clinicians (one study), associate clinicians (one study), auxiliary nurses (two studies), midwives (three studies) and nurses (one study). if a control group was used, it consisted of physicians (P).
      Table 4Evidence for safety, efficacy or client acceptability of tubal sterilization by nonphysician providers
      Author yearStudy site/time period/fundingStudy designPopulationResultsStrengthsWeaknessesGrade
      Chowdhury

      Trends in maternal mortality: 1990 to 2008. Geneva, Switzerland: World Health Organization, 2008 2010. Report No.

      1975
      BangladeshProviders: Paraprofessionals with 2 months of training Physicians Intervention: TL WHO HW Cadre:Auxiliary NurseNot specifiedProcedures (n): PP 366 P 254 Safety: Infection rate PP 5.5% P 6.4% Efficacy: Not reportedAcceptability: Not reportedComparativeNo description of population, limited information on intervention, no statistical comparisonsI–II, poor
      Wortman 1975
      ChinaAnecdotal descriptions of programs that have been successfulNot definedNot quantifiedHistorical interestNon comparative

      No description of population, limited information on intervention, no statistical comparisons
      III, poor
      Ghorbani
      • Darroch J.E.
      • Singh S.
      • Nadeau J.
      Contraception: an investment in lives, health and development.
      1979
      Iran 1968–1976Providers: 10 Paramedics with OR experienceIntervention:Postpartum TL by minilaparotomy, or interval TL by vaginal approach WHO HW Cadre: Auxiliary NurseWomen at a family planning clinic in a tertiary care university hospital

      Follow-up: Not defined
      Procedures (n): 24 TLSafety: “No complications recorded.” Efficacy:Not reported Acceptability:Not reportedNoncomparative, small sample size, limited morbidity outcomes, types of TL performed by paramedics not described, unclear follow-up for TLII-3, poor
      Fongsri
      • Singh S.D.
      • JE
      Adding it up: the costs and benefits of investing in family planning and newborn and maternal health. Estimates for 2012.
      1979
      Thailand 1976–1978Providers: 2 OR nurses1 physician Intervention:TL by minilaparotomyWHO HW Cadre: NurseFamily planning clinicProcedures (n): N 450 P 450 Safety: N 1 uterine perforation P 3 uterine perforation Efficacy:Not reported Acceptability:Not reportedComparative groupNon randomized, No power calculation Statistical testing performed on demographic variables, not outcomes, limited quantified outcomesII-2, poor
      Dusitsin
      • Dehlendorf C.
      • Rodriguez M.I.
      • Levy K.
      • Borrero S.
      • Steinauer J.
      Disparities in family planning.
      1980
      Thailand

      Not defined

      None listed
      Randomized, clinical trialProviders: 5 Nurse midwives (1 year following a 12-week training program) 3 PhysiciansIntervention: Postpartum TL by minilaparotomy (Pomeroy method) WHO HW Cadre: MidwivesWomen 24–48 h postpartum requesting TL with no prior abdominal surgeries or complications Follow-up 5 days 6 weeksProcedures (n): NM: 143 P: 149Safety: Operative difficultyNM 4.9% P 2.0% Postoperative comp: NM 7.0% P 6.0% Wound infection NM 1.4% P 0.7% Operating time: NM: 18.5 min P: 11.9 min p < .001 Efficacy: Not reported Acceptability: Not reportedRandomized

      Comparison group, Good description of NM training
      No description of randomization scheme

      No power calculation

      Statistical testing performed on demographic variables, not outcomes

      Patients in NM had a statistically significant increase in abdominal wall thickness, of .3 cm. This is unlikely to be clinically significant.
      I, poor
      Koetsawang 1981
      • Bakanda C.
      • Birungi J.
      • Mwesigwa R.
      • Zhang W.
      • Hagopian A.
      • Ford N.
      • et al.
      Density of healthcare providers and patient outcomes: evidence from a nationally representative multi-site HIV treatment program in Uganda.
      Thailand 1977–1978 None listedProspective cohort Providers:9 NM 9 Physicians Intervention:Postpartum TL by minilaparotomy (Pomeroy method) WHO HW Cadre: MidwivesWomen 24–48 h postpartum requesting TL with no prior abdominal surgeries or complications Follow-up 24 h 7 days 6 weeks 1 yearProcedures (n): NM: 1074 P: 302Safety: Transfusions NM 1 P 2 Wound complication NM 2.0% P 2.4% Readmission NM 0.5% P 1.3% Efficacy: “At 1 year a special follow-up evaluation was carried out on a random sample of each client group to determine contraceptive failure rate. No reported pregnancies for either group.” Acceptability:Well satisfied NM 95.9% P 95.6% Not satisfied NM 0.7% P 0.5%Comparison group, Good description of NM training, NM procedures performed under physician supervisionNo power calculation

      Statistical testing performed on demographic variables, not outcomes High loss to followup: 18% at 6 weeks.

      Unclear how they randomly sampled to look at efficacy, no description of numbers. Short time to follow-up in a postpartum patient for efficacy evaluation
      II-1, fair
      Satyapan
      1983
      Thailand

      12 months

      WHO, Dept Reproductive Health & Research
      Prospective cohort Providers:20 NM Intervention: Postpartum TL by minilaparotomy (Pomeroy method) WHO HW Cadre: MidwivesWomen 24–48 h Postpartum requesting TL with no prior abdominal surgeries or complications Follow-upProcedures: 3549 TL Safety:Operating difficulty requiring doctor

      0.5% Postop complications 11.3%

      Efficacy: Not reported Acceptability: At hospital discharge Fully satisfied, would recommend to friend: 97.4% Not fully satisfied, would not recommend: 2.4%

      Complete dissatisfaction: 0.1%
      Non comparative, no statistical testingII-1, fair
      Vaz

      Janowitz B, Stanback J, Boyer B. Task sharing in family planning. Stud Fam Plann. 43(1):57–62.

      1999
      Mozambique

      1 year

      None identified
      Prospective cohort Providers:14 surgical technicians WHO HW Cadre: Associate clinicianNot definedProcedures: 200 TL Safety:

      For all elective surgeries, total mortality rate of 0.1% Efficacy:

      Not reported Acceptability:

      Not reported
      Information about TL is poorly defined. Limited demographic data and outcome data reported.II-2, fair
      Chilopora 2007
      Malawi 38 health facilities over 3 months

      Colombia University
      Prospective cohort Providers:Clinical officers Physicians Intervention: TL with CDWHO HW Cadre: Advanced-level associate clinicianAll women undergoing CDProcedures: TL not specified

      Safety: Outcomes specific to TL not reported. No significant differences in maternal status post op between groups Efficacy: Not reported Acceptability: Not reported
      Comparative, statistical testingAll TL performed at time of CD, reduces generalizibility. No power calculation.II-2, poor
      NM = nurse midwife, P = physician, OR = operating room, PP = paraprofessional, N = nurse, CD = caesarean delivery.

      3.1 Safety

      Eight of the studies reported on at least one measure of safety of task sharing TL [
      • Chowdhury S.
      • Chowdhury Z.
      Tubectomy by paraprofessional surgeons in rural Bangladesh.
      ,
      • Fongsri A.
      • McDaniel E.B.
      Use of nurse-midwives for minilap sterilization.
      ,
      • Ghorbani F.S.
      The use of paramedics in family planning services in Iran.
      ,
      • Dusitsin N.
      • Chalapati S.
      • Varakamin S.
      • Boonsiri B.
      • Ningsanon P.
      • Gray R.H.
      Post-partum tubal ligation by nurse-midwives and doctors in Thailand.
      ,
      • Koetsawang S.
      • Varakamin S.
      • Satayapan S.
      • Srisupandit S.
      • Apimas S.J.
      Postpartum sterilization by operating-room nurses in Thailand.
      ,
      • Satyapan S.
      • Varakamin S.
      • Suwannus P.
      • Chalapati S.
      • Onthuam Y.
      • Dusitsin N.
      Postpartum tubal ligation by nurse-midwives in Thailand: a field trial.
      ,
      • Vaz F.
      • Bergstrom S.
      • Vaz Mda L.
      • Langa J.
      • Bugalho A.
      Training medical assistants for surgery.
      ,
      • Chilopora G.
      • Pereira C.
      • Kamwendo F.
      • Chimbiri A.
      • Malunga E.
      • Bergstrom S.
      Postoperative outcome of caesarean sections and other major emergency obstetric surgery by clinical officers and medical officers in Malawi.
      ]. Cadres of workers included advanced-level associate clinicians, associate clinicians, auxiliary nurses, midwives and nurses. Outcomes varied from minor to major morbidity. Among advanced-level associate clinicians, one study reported on outcomes of TL performed at cesarean delivery [
      • Chilopora G.
      • Pereira C.
      • Kamwendo F.
      • Chimbiri A.
      • Malunga E.
      • Bergstrom S.
      Postoperative outcome of caesarean sections and other major emergency obstetric surgery by clinical officers and medical officers in Malawi.
      ]. No significant difference in postoperative general maternal condition was noted by provider type. A study of associate clinicians does not provide safety outcomes specific to TL [
      • Chilopora G.
      • Pereira C.
      • Kamwendo F.
      • Chimbiri A.
      • Malunga E.
      • Bergstrom S.
      Postoperative outcome of caesarean sections and other major emergency obstetric surgery by clinical officers and medical officers in Malawi.
      ]. A total mortality rate of 0.1% is noted for all elective procedures performed by associate clinicians.
      Comparative data are available for two types of minor morbidity: wound infection and operative difficulty. Two studies reported on comparative rates of wound infection between auxiliary nurses or midwives and physicians [
      • Chowdhury S.
      • Chowdhury Z.
      Tubectomy by paraprofessional surgeons in rural Bangladesh.
      ,
      • Dusitsin N.
      • Chalapati S.
      • Varakamin S.
      • Boonsiri B.
      • Ningsanon P.
      • Gray R.H.
      Post-partum tubal ligation by nurse-midwives and doctors in Thailand.
      ]. Rates of wound infections were comparable in both studies; however, no statistical testing was performed (auxiliary nurses 5.5% vs. 6.4%, midwives 1.4% vs. 0.7%) [
      • Chowdhury S.
      • Chowdhury Z.
      Tubectomy by paraprofessional surgeons in rural Bangladesh.
      ,
      • Dusitsin N.
      • Chalapati S.
      • Varakamin S.
      • Boonsiri B.
      • Ningsanon P.
      • Gray R.H.
      Post-partum tubal ligation by nurse-midwives and doctors in Thailand.
      ]. A study of midwives showed that operating time was significantly longer with midwives than physicians: 18.5 compared with 11.9 min (p < .001) [
      • Satyapan S.
      • Varakamin S.
      • Suwannus P.
      • Chalapati S.
      • Onthuam Y.
      • Dusitsin N.
      Postpartum tubal ligation by nurse-midwives in Thailand: a field trial.
      ]. Two studies assessed “operative difficulty” by provider, with midwives and physicians reporting the surgeries as difficult 4.9% and 2.0% of the time, respectively [
      • Dusitsin N.
      • Chalapati S.
      • Varakamin S.
      • Boonsiri B.
      • Ningsanon P.
      • Gray R.H.
      Post-partum tubal ligation by nurse-midwives and doctors in Thailand.
      ,
      • Satyapan S.
      • Varakamin S.
      • Suwannus P.
      • Chalapati S.
      • Onthuam Y.
      • Dusitsin N.
      Postpartum tubal ligation by nurse-midwives in Thailand: a field trial.
      ]. Operative difficulty was not further clarified in the text. In a Thai study of 20 trained midwives performing 3549 TLs, a doctor's assistance was required 0.5% of the time due to technical difficulty. No fatalities or major morbidity, such as hysterectomy or massive hemorrhage, was reported in any of these studies.

      3.2 Efficacy

      None of the studies reported on long-term rates of efficacy TL as measured by pregnancy rates for any cadre of health worker. A Thai study of postpartum TL by nurses did report on short-term efficacy [
      • Koetsawang S.
      • Varakamin S.
      • Satayapan S.
      • Srisupandit S.
      • Apimas S.J.
      Postpartum sterilization by operating-room nurses in Thailand.
      ]. They reported: “At one year a special follow-up evaluation was carried out on a random sample of each client group to determine contraceptive failures. No reported pregnancies for either group.” Lactational status of parturients was not recorded, which would affect fertility and this measure.

      3.3 Acceptability

      Two studies evaluated client acceptability of task sharing TL to nurses and midwives [
      • Koetsawang S.
      • Varakamin S.
      • Satayapan S.
      • Srisupandit S.
      • Apimas S.J.
      Postpartum sterilization by operating-room nurses in Thailand.
      ,
      • Satyapan S.
      • Varakamin S.
      • Suwannus P.
      • Chalapati S.
      • Onthuam Y.
      • Dusitsin N.
      Postpartum tubal ligation by nurse-midwives in Thailand: a field trial.
      ]. Acceptability measures were not identified for other health worker cadres. At 7 days of follow-up, women were asked if they were well satisfied, unsatisfied or indifferent or had no response [
      • Koetsawang S.
      • Varakamin S.
      • Satayapan S.
      • Srisupandit S.
      • Apimas S.J.
      Postpartum sterilization by operating-room nurses in Thailand.
      ]. Satisfaction rates were high across both groups. Among women who had TL by a physician, 95.6% were well satisfied, 0.5% were not satisfied, 2.9% were indifferent, and 1% did not respond. This is similar to what was reported by the midwife group: 95.9% were well satisfied, 0.7% were not satisfied, 3.0% were indifferent, and 0.4% did not respond. Loss to follow-up at 7 days was not reported. No statistical comparison between groups on acceptability measures was performed. A second study measured acceptability at time of discharge from the hospital [
      • Satyapan S.
      • Varakamin S.
      • Suwannus P.
      • Chalapati S.
      • Onthuam Y.
      • Dusitsin N.
      Postpartum tubal ligation by nurse-midwives in Thailand: a field trial.
      ]. Women were asked if they were: fully satisfied and would recommend service to a friend (97.4%), not fully satisfied and would not recommend service to a friend (2.4%), or completely dissatisfied (0.1%). No control group was available for comparison.

      4. Discussion

      A limited body of poor evidence exists regarding the safety, efficacy and acceptability of task sharing TL with midlevel providers. With regards to safety, interpretation of the data is limited by scant data, different outcome measures and the absence of statistical comparisons in the majority of studies. Only one randomized trial has been reported in the literature [
      • Dusitsin N.
      • Chalapati S.
      • Varakamin S.
      • Boonsiri B.
      • Ningsanon P.
      • Gray R.H.
      Post-partum tubal ligation by nurse-midwives and doctors in Thailand.
      ]. However, the randomization schema and lack of statistical comparisons undermine the study's findings and reduce generalizability.
      No well-designed study has demonstrated equivalent efficacy of TL by midlevel providers. It is known that risk of pregnancy persists for 10 years following sterilization [
      • Peterson H.B.
      • Xia Z.
      • Hughes J.M.
      • Wilcox L.S.
      • Tylor L.R.
      • Trussell J.
      The risk of ectopic pregnancy after tubal sterilization. U.S. Collaborative Review of Sterilization Working Group.
      ,
      • DeStefano F.
      • Peterson H.B.
      • Layde P.M.
      • Rubin G.L.
      Risk of ectopic pregnancy following tubal sterilization.
      ]. A well-designed, randomized trial with minimal loss to follow-up that follows women for several years is needed to demonstrate equivalent efficacy.
      Two studies of fair to poor quality demonstrated high acceptance rates of TL, regardless of provider type. This evidence is limited by the use of different measures to evaluate client satisfaction and the absence of statistical comparison. Furthermore, these results are subject to reporting bias.
      A large shortage of trained health workers globally has impeded access towards achievement of the highest attainable standard of sexual and reproductive health for all individuals. Recognizing this need, recent recommendations from the WHO provide guidance on which key interventions in maternal and reproductive health can be safely delegated [
      ]. Contraceptive delivery, including TL and male sterilization, performed by a range of health workers is included in the guidance. These guidelines echo our findings: there is inadequate evidence to recommend performance of TL by auxiliary nurses or nurse midwives.
      Key differences exist between our review and that performed for the WHO guidance. The WHO recommendations assumed that TL was within the scope of competencies for advanced-level associate clinicians and associate clinicians; thus, no evidence was reviewed. Additionally, only randomized studies were considered in the WHO guidelines. This restriction resulted in only one study being identified and included [
      • Koetsawang S.
      • Varakamin S.
      • Satayapan S.
      • Srisupandit S.
      • Apimas S.J.
      Postpartum sterilization by operating-room nurses in Thailand.
      ]. Our review incorporates all available evidence, regardless of study design or cadre.
      It is not known why there is a lack of evidence for task sharing of TL. TL by advanced-level associate clinicians and associate clinicians is a relatively common practice [
      ]. Challenges in obtaining the necessary evidence for task sharing of family planning are multiple and include different types of health cadres with varied trainings in each country's health system, nonstandardized requirements for program reporting and limited resources for conducting research. Targeted monitoring and evaluation of task sharing programs can provide useful data on safety and efficacy, where programs are in place, and a large research trial deemed impossible.
      The difficulties in implementing task sharing and the need for close monitoring and evaluation are emphasized in a recent report from Canada [
      • Guilbert E.R.
      • Robitaille J.
      • Guilbert A.C.
      • Morin D.
      The Group of experts in Family Planning of the National Institute of Public Health of Q
      Challenges of implementing task-shifting in contraceptive care — an experience in Quebec, Canada.
      ]. The authors report on a policy change allowing trained nurses, in collaboration with pharmacists, to provide hormonal contraception (pills, ring, patch and injectable). This policy change involves a well-trained cadre of midlevel providers and a relatively low-risk intervention compared with provision of TL. Nonetheless, significant difficulties were encountered with implementation: resistance from physicians, translating teaching into actual practice and maintaining consistent quality standards [
      • Guilbert E.R.
      • Robitaille J.
      • Guilbert A.C.
      • Morin D.
      The Group of experts in Family Planning of the National Institute of Public Health of Q
      Challenges of implementing task-shifting in contraceptive care — an experience in Quebec, Canada.
      ].
      Several global initiatives have galvanized international support and funding to reduce unmet need for family planning and provide modern contraception to 120 million new users by the year 2020. This represents a critical opportunity to improve the lives and health of women and their families; however, the drive to rapidly scale up services must not compromise quality of care or a rights-based approach to service delivery. This is imperative for TL; programs must be cognizant and mindful of the history of coercive sterilization in multiple countries [
      • Mallet J.
      • Kalambi V.
      Coerced and forced sterilization of HIV-positive women in Namibia.
      ,
      • Cook R.J.
      • Dickens B.M.
      Voluntary and involuntary sterilization: denials and abuses of rights.
      ]. A commitment to rigorous monitoring and evaluation and monitoring of competencies in surgical skill and informed consent is essential to achieving this goal safely, effectively and equitably.
      Unintended pregnancy jeopardizes the lives and health of women and their families globally. Increasing access to skilled family planning providers through task sharing is used to expand access to the most effective methods of contraception [
      ,
      ,
      From Evidence to Policy: Expanding Access to Family Planning Optimizing the health workforce for effective family planning services.
      ]. Rigorous research and evaluation and monitoring of task sharing programs are essential to demonstrate that neither safety nor efficacy is compromised as access to care is expanded.

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