The value of demonstration projects for new interventions: The case of human papillomavirus vaccine introduction in low- and middle-income countries.

Demonstration projects or pilots of new public health interventions aim to build learning and capacity to inform country-wide implementation. Authors examined the value of HPV vaccination demonstration projects and initial national programmes in low-income and lower-middle-income countries, including potential drawbacks and how value for national scale-up might be increased. Data from a systematic review and key informant interviews, analyzed thematically, included 55 demonstration projects and 8 national programmes implemented between 2007-2015 (89 years' experience). Initial demonstration projects quickly provided consistent lessons. Value would increase if projects were designed to inform sustainable national scale-up. Well-designed projects can test multiple delivery strategies, implementation for challenging areas and populations, and integration with national systems. Introduction of vaccines or other health interventions, particularly those involving new target groups or delivery strategies, needs flexible funding approaches to address specific questions of scalability and sustainability, including learning lessons through phased national expansion.

New vaccine adoption: qualitative study of national decision-making processes in seven low- and middle-income countries.

As more new and improved vaccines become available, decisions on which to adopt into routine programmes become more frequent and complex. This qualitative study aimed to explore processes of national decision-making around new vaccine adoption and to understand the factors affecting these decisions. Ninety-five key informant interviews were conducted in seven low- and middle-income countries: Bangladesh, Cameroon, Ethiopia, Guatemala, Kenya, Mali and South Africa. Framework analysis was used to explore issues both within and between countries. The underlying driver for adoption decisions in GAVI-eligible countries was the desire to seize GAVI windows of opportunity for funding. By contrast, in South Africa and Guatemala, non-GAVI-eligible countries, the decision-making process was more rooted in internal and political dynamics. Decisions to adopt new vaccines are, by nature, political. The main drivers influencing decisions were the availability of funding, political prioritization of vaccination or the vaccine-preventable disease and the burden of disease. Other factors, such as financial sustainability and feasibility of introduction, were not as influential. Although GAVI procedures have established more formality in decision-making, they did not always result in consideration of all relevant factors. As familiarity with GAVI procedures increased, questioning by decision-makers about whether a country should apply for funding appeared to have diminished. This is one of the first studies to empirically investigate national processes of new vaccine adoption decision-making using rigorous methods. Our findings show that previous decision-making frameworks (developed to guide or study national decision-making) bore little resemblance to real-life decisions, which were dominated by domestic politics. Understanding the realities of vaccine policy decision-making is critical for developing strategies to encourage improved evidence-informed decision-making about new vaccine adoptions. The potential for international initiatives to encourage evidence-informed decision-making should be realised, not assumed.

National decision-making on adopting new vaccines: a systematic review.

In recent years numerous new vaccines have been developed, offering potential reductions in the morbidity and mortality caused by a range of diseases. This has led to increased interest in decision-making about the adoption of new vaccines into national immunization programmes. This paper aims to systematically review the literature on national decision-making around the adoption of new vaccines. A thematic framework was developed inductively through analysis of the vaccine adoption decision-making frameworks included in the review. This thematic framework was then applied to the remaining studies included in the review. In total, 85 articles were included in the review: 39 articles describing examples of vaccine adoption decision-making, 26 presenting vaccine decision-making frameworks, 21 empirical articles of decision-making relating to vaccine adoption and 19 theoretical essays. An analysis of vaccine adoption decision-making frameworks identified nine broad categories of criteria: the importance of the health problem; vaccine characteristics; immunization programme considerations; acceptability; accessibility, equity and ethics; financial/economic issues; impact; alternative interventions and the decision-making process. The quality of the empirical studies was varied. Although some of the issues included in the frameworks were similar to those considered in the studies, there were also some notable differences. On the whole, the frameworks were more comprehensive than the studies, including a greater range of criteria. The existing literature provides a good foundation for further research into vaccine adoption decision-making. The current review, in pulling together what is already known and by identifying strengths, weaknesses and gaps in the existing evidence base, aims to encourage a more focused and rigorous approach to the topic in future. This could help to identify the most appropriate ways to develop vaccine adoption decision-making, so as to improve decisions and, ultimately, health outcomes.

Nonoperative management of stomal stenosis after gastroplasty for morbid obesity.

Over a period of six years, 33 of 172 (19 per cent) patients who had gastric partitioning had stomal stenosis develop which was defined as an inability to drink fluids or swallow saliva, or both. All were managed conservatively in the hospital or on an outpatient basis. This consisted of total parenteral nutrition and endoscopy to evaluate the stoma with or without dilation; Eder-Puestow dilaters and long term jejunostomy feeding were used. Thirteen of these patients were dilated a total of 36 times. Three required three to six dilations each, up to the maximum size (45F). There were no complications. Twenty-nine required repletion by combined parenteral and enteral nutrition. Three required jejunostomy insertion as a separate procedure. Patients were observed for six to 60 months. Thirty-two did well. Gastrogastrostomy was required in one patient with a stenosis after the second gastroplasty. Three patients who were dilated regained over 20 per cent of their ideal weight.

Vertical banded gastroplasty: assessment of efficacy.

We previously demonstrated unacceptably high failure rates with horizontal gastroplasty. Shortly thereafter, vertical banded gastroplasty was introduced. Since April 1982 we have operated on 56 patients who were carefully selected and closely followed. There were 10 men and 46 women, aged 15 to 54 years (mean age 36 years) with preoperative weights of 93.5 to 198.6 kg (mean 125.9 kg). The mean weight loss at 6 to 12 months was 36 +/- 10 kg, or 30% of body weight. At 18 months, data were available for 48 of the 56 patients. Their weight losses were 44 +/- 11 kg, or 35% of body weight. Eight patients were lost to follow-up. The weight of nine additional patients plateaued before they lost 30% of their starting weights and another eight patients have started to regain weight after achieving satisfactory weight loss. Included are two patients with severe stenoses who regained all weight lost.

Failure rate with gastric partitioning for morbid obesity.

One hundred twenty-two morbidly obese patients were selected for gastric partitioning from a multidisciplinary obesity clinic over a 4 year period. Initial early success was not a guarantee against cessation of weight loss or the regaining of lost weight. By emphasizing criteria for success and failure, both from our series and the literature, we showed an alarming increase in the failure rates for this procedure which is predicated on the fact that those lost to follow-up were probably failure patients. Numerous articles in the literature contain inadequate data because they refer to pounds rather than percentage of weight loss, they fail to consider revisions as failures, they do not provide 24 month follow-up data, and they do not take into account the possibility that those lost to follow-up are failure patients. The operation carries mortality and serious morbidity rates of 0 to 3 percent and 4 to 10 percent, respectively, with an average 28 percent weight loss at 24 months and a minimal failure rate of 50 percent. The alarming increase in the number of these procedures being carried out across the continent makes it mandatory for surgeons to accurately collect and register their data until the long-term effects and results are known. Gastric partitioning, although probably not experimental, is still developmental. The widespread use and possibly abuse of these operations may result in discreditation of the surgical approach to morbid obesity which would be unfortunate since it is the only practical method at this time for dealing with the problem.