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Helicobacter pylori test-and-treat intervention compared to usual care in primary care patients with suspected peptic ulcer disease in the United States |
Ladabaum U, Fendrick A M, Glidden D, Scheiman J M |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology A "test and treat" intervention (TTI) for the management of patients with suspected peptic ulcer disease (PUD) was examined. Educational sessions were provided to general medicine practitioners to increase the use of TTI in primary care. These educational sessions were combined with the establishment of office-based, whole blood Helicobacter pylori (H. pylori) serological testing.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients with suspected PUD. Possible symptoms of PUD were gnawing or burning epigastric pain, pain relieved with food or anti-acids, and pain that occurred when the stomach was empty or that awakened the patient at night.
Setting The setting was primary care. The economic study was conducted in the USA.
Dates to which data relate The effectiveness and resource use data were gathered from November 1996 to April 1998. No price year was reported.
Source of effectiveness data The effectiveness evidence was derived from a single study.
Link between effectiveness and cost data The costing was conducted prospectively on a sub-sample of patients who were involved in the effectiveness study.
Study sample The use of power calculations was not reported. Eligible patients were identified by general medicine practitioners at the time of the patient visit, and were then contacted by study investigators (by telephone) for participation in the study. Of the 68 eligible patients identified at three TTI centres, 54 (79%) agreed to participate. Of the 47 eligible patients identified at three control centres, 39 (85%) accepted to participate. The mean age was 40 (+/- 13) years in the TTI group and 43 (+/- 15) years in the control group. The TTI group comprised 61% females and the control group comprised 64% females.
Study design This was a prospective, randomised clinical trial that was conducted in six centres. The method of randomisation was not reported, but the unit of randomisation was the centre (all patients in three centres received TTI, while all patients in three other centres received usual care). The participants were contacted after one year for the outcome assessment. The health care providers were aware that the study involved patients with suspected PUD, but were unaware of the specific hypothesis, the details of the study, or the outcome of interest. Similarly, at the 1-year assessment, the patients were contacted by phone and the interviewers were unaware of which primary care centre the patient had visited (and, therefore, which type of treatment they had received). No patient was lost to follow-up. However, the rate of response to the questionnaire was 89% in the TTI patients and 97% in the control patients.
Analysis of effectiveness The analysis of the clinical study appears to have been conducted on an intention to treat basis, as all the patients included in the initial study sample were generally accounted for in the effectiveness analysis. The exception was the assessment of the questionnaire responses. The outcome measures used in the analysis were:
the management of H. pylori (e.g. proportion of patients tested and positive, proportion of patients treated and positive, and H. pylori therapies in positive patients);
the use of antisecretory medications;
physician visits;
endoscopies, upper gastrointestinal contrast radiography, or other diagnostic procedures; and
a questionnaire on symptom progression, frequency of symptoms, use of prescribed and over-the-counter medications, absence from work, and assessment of medical care for symptom management.
The study groups were comparable at baseline in terms of age, gender and symptoms at presentation.
Effectiveness results In terms of the management of H. pylori:
81% of patients in the TTI group were tested versus 49% in the control group, (p=0.004);
43% of the patients in the TTI group were H. pylori positive versus 58% in the control group, (p=0.26);
90% of the patients in the TTI group who were treated for H. pylori were positive versus 91% in the control group; and
overall, H. pylori therapies in positive patients were comparable, (p=0.08).
In terms of antisecretory medications, statistically significant differences were observed only with respect to the following:
proton-pump inhibitor (PPI) prescriptions (48% for TTI versus 69% for control group; relative risk, RR=0.70, 95% confidence interval, CI: 0.49 - 0.98; p=0.04),
histamine-2 receptor antagonist (H2RA) prescriptions (13% versus 33%; RR 0.39, 95% CI: 0.17 - 0.88; p=0.02), and
repeat H2RA or PPI prescriptions (35% versus 66%; RR 0.53, 95% CI: 0.35 - 0.81; p=0.003).
No statistically significant differences were found between the groups for physician visits, endoscopies, upper gastrointestinal contrast radiography, or other diagnostic procedures.
The diagnostic findings were comparable.
Similar results were also observed with the questionnaire when some categories of questions were grouped. For example, improvement of symptoms ("better or "much better") was reported by 79% of patients in the TTI group versus 71% of patients in the control group, (p=0.40). Frequent symptoms were reported by 31% (TTI group) versus 47% (control group) of patients, respectively, (p=0.13).
Clinical conclusions The effectiveness analysis showed that, compared with providers who only received passive dissemination, the use of educational sessions aimed to improve TTI strategies in primary care increased the proportion of patients tested. Fewer prescriptions for PPI, H2RA, and PPI or repeat H2RA, were observed. However, physician visits and diagnostic procedures were comparable, as were patient perceptions of symptoms, appropriateness of therapy, and absences from work.
Measure of benefits used in the economic analysis The health outcomes were left disaggregated and no summary benefit measure was used in the economic analysis. In effect, a cost-consequences analysis was conducted.
Direct costs Discounting was not relevant since the costs were incurred during less than 2 years. The unit costs were not presented separately from the quantities of resources used. The costs were not broken down, but the analysis considered medical services and medications. The perspective appears to have been that of the health maintenance organisation. The costs were derived from the financial database of the health maintenance organisation. Resource use came from a sub-sample of 38 TTI patients and 16 control patients, which represented 70% and 41%, respectively, of the two groups of patients included in the effectiveness study. The price year was not reported.
Statistical analysis of costs The costs were presented as median values with interquartile ranges (IQRs). Standard statistical tests were conducted to test the statistical significance of differences in the estimated costs.
Indirect Costs The indirect costs were not considered.
Sensitivity analysis Sensitivity analyses were not conducted.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The median total disease-related expenses per patient were $454 (IQR: 162 - 932) for TTI patients and $576 (IQR: 327 - 1,435) for control patients, (p=0.17).
The mean endoscopy-related costs for those who underwent endoscopy was $703 (+/- 328) for TTI patients and $649 (+/- 410) for control patients.
Synthesis of costs and benefits A synthesis of costs and benefits was not relevant since, in effect, a cost-consequences analysis was conducted.
Authors' conclusions Compared with passive dissemination, the combination of an educational session led by gastroenterology sub-specialists and the availability of office-based serological testing for Helicobacter pylori (H. pylori) led to an increase in the use of test-and-treat intervention (TTI) strategies in primary care. However, the increased use of the TTI did not result in significantly lower referral rates, diagnostic procedures or disease-related costs. Nor did it result in improvements in the patients' self-assessed clinical status, satisfaction with care, and medication use at one year.
CRD COMMENTARY - Selection of comparators The rationale for the choice of the comparator was clear. It reflected standard care and it was described. You should decide whether it represents a valid comparator in your own setting.
Validity of estimate of measure of effectiveness The analysis of effectiveness was based on a randomised trial, which was appropriate for the study question. The method of randomisation was unclear, and one of the centres included in the intervention group had already developed the TTI strategy. The unit of randomisation was the centre rather than the patient. The length of follow-up and the methods used to assess the outcomes were reported. The study interviewers and providers were partially blinded to the study objective. The study groups were comparable at baseline. The providers did not practice at different sites, which minimised the potential for contamination and bias. The main limitation to the validity of the study was the lack of power calculations, and also the fact that no explicit justification was provided for the sample size chosen. A larger sample size would be needed to identify statistically significant differences in effectiveness outcomes.
The answers to the questionnaire were obtained via telephone interviews, thus self-reported information was used. Most of the main outcome measures referred to treatment patterns rather than to health measures. The authors noted that, owing to the study design, it was not possible to determine how much the impact of the combined intervention could be attributed to the on-site test or to the outreach session. It was also not possible to assess the impact of passive guideline dissemination alone compared with no intervention. The authors also noted that not all patients in the intervention group underwent the TTI strategy, while a large number of control patients did. This could have reduced the differences between the groups. Finally, formal tests to assess H. pylori initial status and potential eradication were not conducted.
Validity of estimate of measure of benefit No summary benefit measure was used in the analysis because, in effect, a cost-consequences analysis was conducted.
Validity of estimate of costs The perspective of the payer appears to have been adopted, although this was not stated clearly. A breakdown of the costs was not provided, but all costs covered by the health care payer were considered. The source of the data was reported. Resource use was estimated from the sample of patients included in the clinical trial, but only patients with complete paid claims were considered. Statistical analyses were conducted on the costs, but no sensitivity analyses were conducted. Therefore, the cost estimates were specific to the study setting. The price year was not reported, which makes reflation exercises difficult. The authors referred to a published study (Ladabaum et al., see Other Publications of Related Interest) for the approach used to estimate the costs.
Other issues The authors reported that their results were comparable with those from other published studies. However, the issue of the generalisability of the study results to other settings was not addressed and sensitivity analyses were not conducted. Thus, the external validity of the analysis was low. The study referred to patients with suspected PUD and this was reflected in the authors' conclusions.
Implications of the study The authors stated that further studies should investigate several aspects associated with TTI strategies in primary care, as the impact on the benefits and costs was unclear.
Source of funding Supported by an American Digestive Health Foundation/TAP Pharmaceuticals Outcomes Research Pilot Program Award; an unrestricted research grant from Astra Merck to the University of Michigan Gastroenterology Division; and the National Institutes of Health (grant M01-RR00079).
Bibliographic details Ladabaum U, Fendrick A M, Glidden D, Scheiman J M. Helicobacter pylori test-and-treat intervention compared to usual care in primary care patients with suspected peptic ulcer disease in the United States. American Journal of Gastroenterology 2002; 97(12): 3007-3014 Other publications of related interest Lassen AT, Pedersen FM, Bytzer P, et al. Helicobacter pylori test-and-eradicate versus prompt endoscopy for management of dyspeptic patients: a randomised trial. Lancet 2000;356:455-60.
Ladabaum U, Fendrick AM, Scheiman JM, et al. Outcomes of initial non-invasive Helicobacter pylori testing in US primary care patients with uninvestigated dyspepsia. American Journal of Gastoenterology 2001;96:2051-7.
Indexing Status Subject indexing assigned by NLM MeSH Adult; Diagnostic Tests, Routine; Education, Medical, Continuing; Female; Health Care Costs; Helicobacter Infections /complications /diagnosis /drug therapy /economics; Helicobacter pylori; Humans; Male; Medical Records; Middle Aged; Patients; Peptic Ulcer /economics /microbiology; Physicians' Offices; Physicians, Family /education; Primary Health Care; Prospective Studies; Surveys and Questionnaires; Treatment Outcome AccessionNumber 22003000076 Date bibliographic record published 31/01/2005 Date abstract record published 31/01/2005 |
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