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Background Postpartum contraceptive counseling and access are challenging in Nepal’s remote, hilly areas, driving a disproportionately high unmet need for contraception. Community health workers (CHWs) play an important role in delivering healthcare in difficult to reach places, but there is limited evidence from professionalized CHW models and their impact over time in Nepal. We implemented a pilot program in two rural districts in Nepal where full-time, salaried, and supervised CHWs delivered a bundled reproductive, maternal, newborn, and child health (RMNCH) intervention. This included contraceptive counseling adapted from the Balanced Counseling Strategy . Here we describe postpartum contraceptive outcomes associated with the integrated RMNCH intervention over a five-year period. Methods Applying a type 2 hybrid effectiveness-implementation approach, we conducted a non-randomized pre-post study with repeated measurements and nested qualitative data collection to study the intervention’s reach, effectiveness, adoption, implementation, and maintenance. Results Compared to the pre-intervention period, we observed higher ward-level post-intervention postpartum contraceptive prevalence, stratified by early postpartum (RR: 2.20; 95% CI: 1.96, 2.48) and late postpartum (RR: 1.70; 95% CI: 1.50, 1.93), after adjusting for district and intervention site. Lactational amenorrhea method (LAM) was the most common method during early postpartum in most intervention sites. The proportion of women who switched to other effective methods after LAM was relatively low. Qualitative data indicated that CHWs’ longitudinal engagement with participants helped facilitate contraceptive counseling and uptake despite challenges such as participants’ fear of side effects, limited autonomy for women, and peer influence. Conclusions Our findings suggest the integrated RMNCH intervention’s potential to increase modern contraceptive uptake in low-resource community settings and underscore CHWs’ ability to help drive longer-term change in their communities, especially around sensitive topics. This study contributes to the implementation research literature on community-based interventions to improve postpartum contraception use and may inform other CHW programs in similar contexts. Trial registration ClinicalTrials.gov Identifier: NCT03371186, registered 04 December 2017, retrospectively registered. Plain English Summary Women in Nepal’s remote, hilly areas often lack access to contraceptive counseling despite not wanting another pregnancy soon after giving birth. Community health workers (CHWs) play a key role in delivering healthcare in difficult to reach places. We tested out a program in two rural districts in Nepal where CHWs visited women in their homes to offer reproductive, maternal, newborn, and child health (RMNCH) care. The program included counseling individuals on contraception based on their family planning needs and values. We studied how modern contraception use changed in the area after this RMNCH program was introduced, compared to before. We found that, on average, the proportion of women who used a modern method of contraception increased in the local areas where CHWs visited women to provide RMNCH care. We also learned through conversations with CHWs, others involved in the program, and those who received care from CHWs, that CHWs’ regular visits helped them build relationships within their community, which likely helped women feel more comfortable being counseled and choose contraceptive methods. Women in the community hesitated to use modern contraceptives because they were afraid of side effects, were often unable to make decisions for themselves without their partners or families’ approval, or because the contraceptives they wanted were not available. We found that CHWs can help drive longer-term change in their communities, especially around sensitive topics like contraception.

Background Timely tracking of health outcomes is difficult in low- and middle-income countries without comprehensive vital registration systems. Community health workers (CHWs) are increasingly collecting vital events data while delivering routine care in low-resource settings. It is necessary, however, to assess whether routine programmatic data collected by CHWs are sufficiently reliable for timely monitoring and evaluation of health interventions. To study this, we assessed the consistency of vital events data recorded by CHWs using two methodologies—routine data collected while delivering an integrated maternal and child health intervention, and data from a birth history census approach at the same site in rural Nepal. Methods We linked individual records from routine programmatic data from June 2017 to May 2018 with those from census data, both collected by CHWs at the same site using a mobile platform. We categorized each vital event over a one-year period as ‘recorded by both methods,’ ‘census alone,’ or ‘programmatic alone.’ We further assessed whether vital events data recorded by both methods were classified consistently. Results From June 2017 to May 2018, we identified a total of 713 unique births collectively from the census (birth history) and programmatic maternal ‘post-delivery’ data. Three-fourths of these births ( n  = 526) were identified by both. There was high consistency in birth location classification among the 526 births identified by both methods. Upon including additional programmatic ‘child registry’ data, we identified 746 total births, of which 572 births were identified by both census and programmatic methods. Programmatic data (maternal ‘post-delivery’ and ‘child registry’ combined) captured more births than census data (723 vs. 595). Both methods consistently classified most infants as ‘living,’ while infant deaths and stillbirths were largely classified inconsistently or recorded by only one method. Programmatic data identified five infant deaths and five stillbirths not recorded in census data. Conclusions Our findings suggest that data collected by CHWs from routinely tracking pregnancies, births, and deaths are promising for timely program monitoring and evaluation. Despite some limitations, programmatic data may be more sensitive in detecting vital events than cross-sectional census surveys asking women to recall these events.

Hospitalisation and a seven-day injectable antibiotics course are recommended by the World Health Organization (WHO) to treat suspected clinical neonatal sepsis / possible serious bacterial infection (PSBI). Some infants presenting with PSBI signs associated with a moderate risk of mortality may only need a two-day hospitalisation followed by outpatient care treatment with oral antibiotics to complete seven days of antibiotics. A multi-centre, individually randomised, open-label trial will be conducted in seven sites in six countries: Bangladesh, Ethiopia, India (two sites), Nigeria, Pakistan and Tanzania. A common protocol will be used with the same study design, including the participants, intervention, comparison, outcomes, quality control, and analysis procedures. 0-59 days old infants presenting with moderate-mortality risk signs (low body temperature (<35.5°C), movement only when stimulated, stopped feeding well) or two or more signs of clinical severe infection (CSI) will be assessed and pre-enrolled. After 48 hours of hospital stay, clinically stable infants with a negative C-reactive protein test will be randomised either to hospital discharge on oral amoxicillin (intervention) or continued hospitalisation (control) arm. The intervention arm will receive oral amoxicillin for five days, whereas the control arm will receive injection gentamicin plus injection ampicillin for five more days plus supportive therapy if needed. We plan to enrol 5250 eligible young infants, 2625 infants in each of the two study arms. An experienced, well-trained independent outcome assessor will visit all enrolled cases on days 4, 8 and 15 after the initiation of treatment to assess the study outcomes in both intervention and control arms. The primary outcome of poor clinical outcome defined as death between randomisation and day 15 of initiation of treatment, deterioration during the 7-day treatment period, or persistence of the presenting sign of CSI at the end of the 7-day treatment period will be compared to assess if an early discharge and outpatient treatment leads to superior or at least non-inferior clinical outcome than continued inpatient treatment. The harmonisation of activities, including methods and processes, will be carried out diligently. Central training will be conducted by the WHO coordinating team, a central data coordination centre to collate all data, standardisation exercises for all clinical signs and internal and external monitoring. All the selected sites have extensive research experience. Through regular online and physical meetings, data-based monitoring, and physical site visits by WHO monitors, quality assurance and harmonisation will be ensured. This trial has been approved by the WHO and local site institutional ethics committees. If the results show that young infants with moderate-mortality risk PSBI signs can be safely and effectively treated on an outpatient basis after a shorter hospital stay, it will reduce the burden on the hospitals, potentially reduce nosocomial hospital infections and increase access to treatment for families with poor access to health facilities. It may also reduce the health system costs (human and materials) and allow the overburdened hospitals to pay more attention to critically ill young infants. In addition, this evidence will contribute to making a case for reviewing the WHO PSBI guideline. International Standard Randomised Controlled Trial Number, ISRCTN16872570.

World Health Organization (WHO) recommends hospitalisation and injectable antibiotics for clinical sepsis / possible serious bacterial infection (PSBI) in young infants up to two months of age. However, some young infants with low-mortality risk signs of PSBI may not require hospitalisation, for which evidence needs to be generated. This is a protocol for a multicentre, individually randomised, open-label trial that will be conducted in seven sites in six countries Bangladesh, Ethiopia, India (two sites), Nigeria, Pakistan and Tanzania. All sites will use this common protocol with the same study design, inclusion of participants, intervention, comparison, and outcomes, as well as quality control and analysis procedures to contribute to the overall sample size. All young infants (age <60 days) presenting at study hospitals with any single low-mortality risk sign (high body temperature ≥38°C, severe chest indrawing, or fast breathing of ≥60 breaths per minute in <7 days old infants) will be randomised to either outpatient care with injectable gentamicin for two days and oral amoxicillin for seven days (intervention) or inpatient care with injection gentamicin plus injection ampicillin along with supportive treatment, where needed, for seven days (control). We plan to enrol 7000 eligible young infants, 3500 infants in each of the two study arms. A trained and standardised independent outcome assessor will visit all enrolled cases on days two, four, eight and 15 post-randomisation to assess the study outcomes in both intervention and control groups. The primary outcome of poor clinical outcome, defined as death within two weeks of initiation of treatment, deterioration during the 7-day treatment period, or persistence of the presenting sign at the end of the 7-day treatment period, will be compared to assess if the outpatient treatment leads to superior or at least non-inferior clinical outcome than inpatient treatment. The selected sites have extensive research experience. The methods and all study procedures will be harmonised through central training of research staff by WHO, standardisation exercises for clinical signs, central data coordination centre and internal and external monitoring. Continuous evaluation of the enrolment by the sites will be carried out through regular calls, databased monitoring, and site visits by WHO monitors. This trial has received ethical approvals from the WHO and local site institutional ethics committees. If the results show that young infants with any single low-mortality risk PSBI sign can be effectively and safely treated on an outpatient basis, it may substantially increase access to treatment for infants and families with poor access to health facilities. It may also reduce the human, financial and material costs to the health system and allow the currently overloaded health facilities to focus on more critically ill infants. This evidence will contribute toward making a case for reviewing the current WHO PSBI management guideline. International Standard Randomised Controlled Trial Number ISRCTN44033252.

In contrast to drug trials, the surgical RCT, which compares a \"novel\" to the \"usual\" intervention, has to deal with the learning curve. The learning curve usually refers to the accumulated experience on a new procedure that allows continuous refinement of patient selection, operative technique, adjunctive medication and postprocedural care. Although some investigators suggested that surgical RCTs should start with the first patient,11,12 most investigators disagree. Most believe that it is inappropriate to compare a familiar with an unfamiliar surgical intervention, as mistakes and adverse outcomes are more likely to occur with the unaccustomed procedure, which will bias the results against the novel intervention.13-15 The authors of the appraised RCT inform us that neither the patient nor the research assistant who assessed the outcomes was aware of the type of prosthesis that had been inserted. Whether this materialized or not, we just don't know. Physiotherapists doing assessments in hospitals do have access to patients' charts. Conscious or unconscious perusal of the operative record could have revealed the type of implant used. We don't know to what extent the investigators concealed this information on patients' charts. The Evidence-Based Surgery Working Group members include: Stuart Archibald, MD;*[dagger][dagger] Mohit Bhandari, MD;[dagger] Charles H. Goldsmith, PhD;[dagger] Dennis Hong, MD;[dagger] John D. Miller, MD;*[dagger][double dagger] Marko Simunovic, MD, MPH;[dagger][double dagger] Ved Tandan, MD, MSc;*[dagger][double dagger] Achilleas Thoma, MD;[dagger][double dagger] John Urschel, MD;[dagger][double dagger] Sylvie Cornacchl, MSc[dagger][double dagger]

The Evidence-based Surgery Working Group members include Stuart Archibald, MD;*[dagger][double dagger] Frank Baillie, MD;[dagger][double dagger]¶ Mohit Bhandari, MD;[dagger][double dagger]¶ Margherita Cadeddu, MD;*[dagger][double dagger] [Claudio S. Cin]à, MD;[dagger][double dagger]§¶ Sylvie Cornacchi, MSc;[dagger][double dagger] Forough Farrokhyar, PhD;[dagger][double dagger]§ Anna Garnett, BA;[dagger][double dagger] Charles H. Goldsmith, PhD;[dagger][double dagger]§ Ted Haines, MD;[double dagger]§ Robert Hansebout, MD;*[dagger][double dagger] Carolyn Levis, MD;*[dagger][double dagger] Marko Simunovic, MD, MPH;[dagger][double dagger]§¶ [Ved R. Tandan], MD;*[dagger][double dagger]§ [Achilleas Thoma], MD*[dagger][double dagger]§

Readers are able to utilize several types of summarized information from expert opinion and textbook reviews to systematic reviews. Traditional, or narrative, reviews, by definition, do not use a systematic approach to identifying information on a particular topic. Moreover, narrative reviews often pose background-type questions and provide a general overview of a topic such as those found in book chapters and instructional course lectures. A background question is, for example, \"What is the epidemiology, clinical presentation, treatment options and prognosis following femoral shaft fractures in adults?\" We use the term systematic review for any summary of the medical literature that attempts to address a focused clinical question with explicit strategies for the identification and appraisal of the available literature (Table 1 and Table 2); meta-analysis is a term used for systematic reviews that use quantitative methods (i.e., statistical techniques) to summarize the results. Systematic reviews typically pose a foreground-type question. Foreground questions are more specific and provide insight into a particular aspect of management. For instance, investigators may provide a systematic review of plating versus nailing of humeral shaft fractures on nonunion rates (foreground question) rather than a general review of how bone heals after all treatments of humeral shaft fractures (background question). You quickly determine from talking with your colleagues and your fellowship supervisor that there have been a number of randomized trials comparing operative and nonoperative treatment of acute ruptures of the Achilles tendon. Realizing that your 1-week deadline will not be sufficient to summarize all of the articles, you decide to focus your literature search to identify any recent reviews of this topic. Being relatively proficient on the Internet, you select your favourite search site, National Library of Medicine's PubMed at www.pubmed.gov. You select the \"Clinical Queries\" section and choose a search for systematic reviews. You type in the words \"Achilles tendon.\" This identifies 12 documents. You review the titles of the 12 potentially relevant studies and are happy to find a systematic review and meta-analysis of operative versus nonoperative treatment for acute ruptures of the Achilles tendon.3 You retrieve this article for further review. The meta-analysis of operative versus nonoperative treatment of Achilles tendon ruptures meets most of the criteria for study validity, including explicit eligibility criteria, a comprehensive search strategy, and assessment and reproducibility of study validity.2 The authors found a very large benefit of operative repair on rerupture rates at the cost of greater infection risk. Furthermore, pooling of study results seems justified by the nonsignificant tests of heterogeneity, reasonable similarity of results (point estimates) and widely overlapping CIs around those point estimates. On the other hand, the quality of studies was relatively poor, including a failure to conceal randomization in all studies. Our interpretation is that the magnitude of the effect is sufficiently large that, despite the limitations in study quality, the inference that operative repair provides substantially lower repeat rupture rates in patients with Achilles tendon ruptures is secure. Thus, surgeons who manage patients with Achilles tendon ruptures similar to those presented in this meta-analysis (younger, athletic, acute ruptures) can reassure them that current evidence favours operative treatment. When patients seem different from diose included in a meta-analysis, clinicians should consider whether they are really so different that the results cannot be applied to their patients.

The RCPSC requires that the participating surgeon formally document the self-audit process. The required documentation includes an audit proposal; appropriate data-collection forms; dates of initiation and completion; data interpretation; anticipated outcomes for the surgeon's practice; and summaries of the findings and actual participation of the surgeon in the self-audit. The college does not require the participating surgeon to keep raw data from the audit. Although Schedule B provides protection for surgeons functioning on designated hospital quality-of-care committees, it is unlikely to provide the same degree of protection to a surgeon performing an independent self-audit.\" Therefore, a surgeon who plans to complete a self-audit and keep the data and data summary should be made aware that this information may be legally discoverable, if a civil action is made against the surgeon and relevant data from a self-audit are requested. The surgeon who discards raw data after a self-audit would not be considered to have acted improperly.19 Preserving the remaining documentation of the self-audit will fulfil RCPSC requirements for documentation. In a self-audit, a surgeon asks himself a challenging, introspective question related to his current surgical practice. As the question is being considered, proposed and resolved by the surgeon the educational process of self-audit and self-directed learning is taking place.\" Participation by governing societies and specialty groups may further contribute to learning and could play an important role in stimulating the individual surgeon to conduct a self-audit. Discussion at meetings and conferences may then confirm or validate findings and facilitate the difficult process of changing practice. A database of templates for self-audit could be further developed and maintained by specialty groups to facilitate the process for individual surgeons and provide needed incentive and structure. Ideally, this will lead to an improved overall acceptance of this challenging but rewarding process.

Ability of environmental stressors to induce transgenerational diseases has been experimentally demonstrated in plants, worms, fish, and mammals, indicating that exposures affect not only human health but also fish and ecosystem health. Small aquarium fish have been reliable model to study genetic and epigenetic basis of development and disease. Additionally, fish can also provide better, economic opportunity to study transgenerational inheritance of adverse health and epigenetic mechanisms. Molecular mechanisms underlying germ cell development in fish are comparable to those in mammals and humans. This review will provide a short overview of long-term effects of environmental chemical contaminant exposure in various models, associated epigenetic mechanisms, and a perspective on fish as model to study environmentally induced transgenerational inheritance of altered phenotypes.

Background: Although hypertension guidelines have utility in treating uncomplicated hypertension, they often overlook the pathophysiologic basis and heterogeneity of hypertension. This may explain the relatively poor hypertension control rates. A proposed approach is to guide addition and subtraction of medications using ambulatory plasma renin activity (PRA) values. To evaluate the heterogeneity of hypertension and the medication burden associated with it, we investigated medication usage in relation to PRA among hypertensive patients within a large ethnically diverse organization. Methods: A cross sectional data analysis was performed of hypertensive subjects with PRA measurements in the Kaiser Permanente Southern California database between 1 January 1998 and 31 October 2009. Results: Among 7,887 such patients 0, 1, 2, ≥3 medication usage was 16%, 20%, 24%, 40% respectively. PRA levels ranged 1000-fold. Across PRA quartiles (Q1 to Q4) ≥3 meds were prescribed to 50%, 40%, 34%, 37%. From low to high PRA quartiles there was no usage trend for angiotensin converting enzyme inhibitors (ACEIs)/ angiotensin receptor blockers (ARBs) (71%), but diuretics increased (52%, 53%, 57%, 68%), calcium channel blocker's (CCB) fell (56%, 53%, 51%, 42%), and β-blockers fell (77%, 61%, 49%, 41%). Moreover, systolic BP fell (146, 142, 140, 135 mm Hg), blood urea nitrogen (BUN) rose (16, 17, 18, 20 mg/dl), serum uric acid rose (6.1, 6.3, 6.5, 6.9 mg/dl), and chronic kidney disease rose (22%, 22%, 23%, 27%). Conclusions: Polytherapy was the norm for treating hypertension. Lower PRAs were associated with higher blood pressures and more medications. Higher PRAs were associated with lower pressures and fewer medications. The results indicate that opportunities exist to simplify antihypertensive therapy by using current ambulatory PRA levels to guide drug selections and subtractions.