كتيب د الشريف

1HEALTH TECHNOLOGY ASSESSMENT (HTA)


in the USA, adoption and use of technology has been stimulated by patient and physician incentives to seek any potential health benefit with limited regard to cost, and by third-party payment, malpractice concerns, provider competition and effective marketing of technologies. In this era of increasing cost pressures, restructuring of health care delivery and payment, and continued inadequate access to care for millions in the developed countries and many more millions around the developing countries, HTA remains the substance of health care. Culprit or not, HTA can be managed in ways that improve people access to the health system and health outcomes with less cost, while continuing to encourage technology innovation. Now a day, the development, adoption, and diffusion of HTA is increasingly mediated by a widening group of policymakers in the health care sector and more specifically in developed countries. Government leaders and policy makers, Health product makers, hospital managers, clinicians, regulators, payers, and even the patients increasingly ask well-founded information to establish decisions about whether or how to develop technology, to allow it on the market, to use it, to acquire it, to pay for its use and more(1).

People in any community facing the challenge of health problems need to receive effective management and care to offer them the best possible chance of health. At the same time, there is a public health need to prevent illness wherever possible. However, available resources may be inadequate and must be allocated appropriately, depend on effectiveness and affordability (many treatments are not effective in all patients with a particular disease).

Decisions such as ‘Should every available treatment for ulcerative colitis be provided or should the resources be used to give home care to people with Alzheimer?’ and ‘Should everyone over 50 have their lipid tested or should the funds be used to provide vaccines against human papilloma virus which associated with cervical cancer, for teenage girls in Saudi Arabia?• Should treatment X be reimbursed in a healthcare system?• For which patients should it be provided?• For how long should patients receive the treatment?


Introduction to health technology assessment:

Technological innovation and growth in recent years in the world of medicines, diagnostic tools, telemedicine and surgical equipment has yielded truly remarkable advances in health care. In just the last several years, breakthroughs in such areas as antivirals, biotechnology, diagnostic imaging, molecular diagnostics, organ and tissue replacement, surgical techniques, wound care, and telemedicine have led remarkable improvements in health gains, quality of life and the organization and delivery of treatment(1).

In the United States of America, it is estimated that around 70% of the improvement in surviving post-myocardial infarction is a result of technological advances (2).Beside the benefits comes the challenge of investing in those health services that offer the best value for money. Health services have consumed progressively greater proportions of GDP since the 1970s, with spending on pharmaceuticals and health technologies being the main causes (37-). In the situation of lower economic growth, and increase ageing populations and the growth of health technologies, policy-maker face continuous challenge to make sure sustainable health care financing while also stimulating and supporting innovation of health technology which is imperative (89-) . Government must find a way to balance between providing high-quality, innovative care on the one hand and managing health care budgets and maintain the basic principles of health services such as equity and easy access.

Also, it is notice that there is a widespread variation in the utilization and diffusion of health technology within and between countries. This can be contributed to different health needs, economic conditions, unique health system features and different culture but it can also indicate suboptimal use of health technology and potential inequities in patient care and access which can bring unnecessary health budget and/or reduced health outcomes(1).

Certainly, few patients or clinicians are willing to forego access to state-of-the-art health care technology. In the wealthier countries, and particularly


HTA is a form of policy research that evaluates the short and long-term consequences of using a healthcare technology, thus seeks to consider the broader impacts of health technologies and to evaluate their clinical effectiveness, economical effectiveness and its appropriateness. So it helps to identify a particular technology optimal utilization, its appropriate placement in the spectrum of health care, and the patients who will benefit.

FUNDAMENTAL CONCEPTS

1. Health Technology: is a term used to cover any aspect of healthcare. It is the practical application of knowledge and there are three ways to describe health care technology: material nature, its purpose, and its stage of diffusion (1).

A. Material nature: The practical application of knowledge in health care is quite broad see box 3.

Box 2 : Definitions for HTA: 1- [HTA] is a multidisciplinary field of policy analysis. It studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology (10).2- Technology assessment is a form of policy research that examines short- and long-term social consequences (for example, societal, economic, ethical, and legal) of the application of technology. The goal of technology assessment is to provide policy-makers with information on policy alternatives (11).3- Health technology assessment considers the effectiveness, appropriateness and cost of technologies. It does this by asking four fundamental questions: Does the technology work, for whom, at what cost, and how does it compare with alternatives (12).


Are the sorts of challenges faced by policy makers? How they solve these challenges? (1).There is an international agreement that we are in need for more accountable, transparent and legitimate decision-making processes.Health service systems around the world have employed various methods to address these issues, mostly through regulation, financing schemes or information-sharing, such as global budgeting, provider capitation payment schemes, and concentration of specialized services that need expensive technology investment. Health technology assessment (HTA) has increasingly emerged as a method for informing more effective regulation of the utilization and diffusion of technologies. (1).

Definitions for HTA:

While there are various definitions, often relating to evidence-based medicine and comparative effectiveness research, HTA can be seen as “a multidisciplinary process of policy analysis that examines the medical, economic, social, and ethical implications of the incremental value, diffusion, and use of a medical technology in health care”. For more definitions see box2.

Box 1:Main factors that influence the development and demand for health technology-Advances in science and engineering-Elderly population-“Cascade” effects of unnecessary tests, unexpected results, or patient or physician anxiety- Emerging pathogens and new disease threats- Third-party payment( failure of third-party payers to limit coverage)- Economic incentives of technology companies, clinicians, and others- Physician specialty training at academic health centers- Malpractice prevention- Provider competition to offer state-of-the-art technology- Public demand driven by consumer awareness, mass media reports, and direct-to-consumer advertising.- Strong economies, high employment.


cholesterol testing)• Diagnosis: such as (ECG, serological test for hepatitis, x-ray for possible fracture)• Treatment: such as (antimalarial therapy, coronary artery bypass graft surgery, cognitive behavioral therapy, drugs for headache, appendectomy)• Rehabilitation: (e.g., assistive device for severe hearing impairment, incontinence aid, exercise program for post-stroke patients)

Not all technologies fall precisely into only one group. Technologies are used for diagnosis as well as treatment, e.g., coronary angiography. Furthermore, technology such as electronic patient record systems can support all of these technological purposes or applications (1).

C. Stage of Diffusion

Health technologies can be assessed at different levels of diffusion. Generally, health care technologies may be described as being: • Future: in a conceptual stage, anticipated, or in the earliest stages of development. • Experimental: undergoing laboratory testing (i.e., in animal). • Investigational: undergoing initial clinical (i.e., in humans) evaluation for a particular problem or special indication. • Established: believed as a standard approach to a particular condition or indication and diffused into general use. • Obsolete/outmoded/abandoned: superseded by other technologies or confirmed to be ineffective or unsafe. See box 3.

A technology that was once considered obsolete may come back to established use for, a better defined or completely different medical purpose. A well-known example is thalidomide, whose use as a sedative during pregnancy was halted more than 4 decay ago when it was found to induce severe fetal deformity, but which is now used to manage conditions such as leprosy, advanced multiple myeloma, and certain complications of HIV infection.(1)


Box 3: Example of the broad categories of health technology: Health technology ExampleOrganizational and managerial systems

prospective payment using diagnosis-relatedgroups, alternative health care delivery configurations, clinical pathways, total qualitymanagement programs

A device or piece of equipment

Titanium implants in facial reconstruction, endoscope, and laparoscope.

A drug Oral hypoglycemic, antibiotics, aspirin, beta-blockers, antilipidaemia such as statins

Prevention programmers provide vaccines against human papilloma virus which associated with cervical cancer

Biological vaccines, blood products, cellular and gene therapies

Devices, equipment and supplies

cardiac pacemakers, CT scanners, surgical gloves, diagnostic test kits

Medical and surgical procedures

psychotherapy, nutrition counseling, coronaryangiography, gall bladder removal

Support systems electronic patient record systems, telemedicine systems, drug formularies,blood banks, clinical laboratories

B. Technology purpose:

Health care technologies can also be grouped according to their health care purpose: Prevention, Screening, Diagnosis,Treatment, and Rehabilitation (1)

• Prevention such as (Childhood immunization, infection control program, dental caries prevention program)• Screening: such as (Mammography, Pap smear, tuberculin test, serum


HTA clearly contributes to the knowledge base for improving the quality of health care, by support development and updating of health care policies (standards, guidelines), For example:

1- The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Committee for Quality Assurance (NCQA) establish standards for measuring quality of care and services of hospitals, long-term care facilities, managed care organizations, primary care centers, and other health care institutions.

2- Standards-setting organizations (for manufacturers) such as the American National Standards Institute and the American Society for Testing and Materials develop of voluntary national consensus standards for the manufacture, use and reuse of health devices and their materials and components.

3- Health professional associations (e.g., American College of Cardiology, American College of Physicians, American College of Radiology, American Medical Association), National Institution of Clinical and Health Excellence (NICE) and special panels (e.g., the US Preventive Services Task Force of the Agency for Healthcare Research and Quality) coordinate develop clinical practice guidelines and other statements regarding the suitable use of health technologies.

Box 4 : Purposes of Health Technology Assessment(1)HTA can advise or inform technology-related policymaking. Among these are to advise or inform :

Health care networks, hospitals, group purchasing organizations, and other health care organizations about decisions concerning health technology purchase and management• Drug companies about product development and marketing and advertising decisions• Health professional associations about the role of a health technology in clinical guidelines.


2.Health Technology Assessment

A. Purposes of Health Technology Assessment

Health technology assessment is the systematic evaluation of properties, effects or other impacts of health technology. The major purpose of HTA is to inform decision-maker for technology in health care, where policymaking is used in the broad sense to consist of decisions made at, the individual level, the level of the health care system or institution, or at the regional, national and international levels.

HTA may concentrate on the direct and intended consequences of technologies as well as their indirect and unintended consequences. HTA is conducted by interdisciplinary groups using unambiguous analytical frameworks, drawing from a variety of methods. (1)

Box 4 : Purposes of Health Technology Assessment(1)HTA can advise or inform technology-related policymaking. Among these are to advise or inform :

• Government ministry of health, about undertaking community health programs such as: (screening, vaccination, and environmental protection programs)• Regulatory agencies such as the Saudi Food and Drug Administration (SFDA) about whether to authorize the commercial use of any technology• Political leaders about policies regarding technological innovation, development, regulation, payment, delivery of health care and research.• Health care providers, and employers about whether health technologies should be included in health benefits plans or illness management programs, addressing reimbursement (how much to pay) and coverage (whether or not to pay) • Patientsand physicians about the proper use of health care interventions for a particular patient’s clinical needs and situation.Standards-setting organizations for health technology and health care delivery regarding the produce, use, quality of health care, and other aspects of health technologies.


• Pneumococcal vaccine for high risk patients• Prenatal care• Smoking cessation interventions• Thrombolytic therapy for acute myocardial infarction• Thrombolytic therapy for ischemic stroke• Warfarin to prevent strokes due to atrial fibrillation

The reasons that worthy technologies are underused are diverse, and include the following.• Lack of awareness • Inadequate health technology dissemination• Limited coverage and reimbursement• Concerns about short-term cost without regard for cost-effectiveness in the long- and short-terms• Inappropriate concerns about improper use (e.g., pain therapy)• Insufficient donor or supply (e.g., organs for transplantation)• unbalanced concerns about adverse effects (e.g., warfarin to reduce risk of stroke)• Concerns about compliance (e.g., polypharmacy for HIV/AIDS)• Stigma (e.g., treatment of psychiatric diseases)

On the other hand, to regard the result of an early health technology assessment as definitive or absolute may be misleading. An assessed health technology may not yet be perfected; its users may not yet be skillful or proficient; its costs may not yet have stabilized; it may not have been tested in enough situations to identify its possible benefits; and its long-term outcomes may not yet be recognized (14). As one technology assessor concluded about the problems of when-to-assess: «It›s always too early until, unfortunately, it›s suddenly too late!” (15). Further, the «moving target problem» can complicate HTA (16). By the time a HTA is conducted, reviewed and disseminated, its conclusion may be outdated by new technology, in how it is used, or in its technological alternatives for a specified problem(1).


B. Timing of assessment:

The first question is when we should conduct the HTA?The correct answer is there is no single correct time to conduct an HTA. It is conducted to meet the needs of a range of policy-makers looking for assessment information during the lifecycles of health technologies.There is a clearly tradeoffs in the decisions concerning the timing for HTA. On one hand, the earlier a technology is assessed, the more likely its diffusion can be shortened if it is unsafe or ineffective (13).

Box 5 shows examples of underused health care technologies.

Box 5: Underused Health Care Technologies(1)• ACE inhibitors for treatment of heart failure• ACE inhibitors for prevention of renal deterioration in insulin-dependent diabetics• Ambulation aids (canes, crutches, walkers)• Antibiotics for gastrointestinal ulcers• Beta blockers for survivors of acute myocardial infarction• Cholesterol-lowering drugs for patients at risk of coronary artery disease• Cochlear implants for severe-to-profound deafness• Colorectal cancer screening• Corticosteroid inhalants for treating asthma• Corticosteroid therapy for fetuses at risk of preterm delivery• Depression diagnosis and treatment• Diabetic retinopathy screening• Hepatitis B virus vaccination of infants• Implantable cardioverter-defibrillators for survivors of cardiac arrest• Incontinence diagnosis and treatment• Intraocular pressure screening for glaucoma• Oral rehydration therapy for dehydrated children• Organ transplantation• Pain management• Polypharmacy (with protease inhibitors) for HIV/AIDS


- Microeconomic impact concerns include costs, charges, prices, and payment levels associated with individual health technologies.

- Macroeconomic impacts of technologies are the impact of new technologies on: public health care costs, resource allocation between different health service programs or between the budget Ministry of Health and other sectors, and shifts in the location of care, such as from outpatient settings to inpatient. Other macroeconomic issues that pertain to health technologies include regulation, third-party payment, and other policy changes on technological innovation, investment, technology disseminate.Other concerns include comparisons of resource requirements and outcomes (or benefits) of health technologies for particular applications, such as (cost effectiveness, cost utility, and cost benefit) (1).

D. Basic Steps of HTA

There is great variation in the conducting HTA, but most HTA activity involves some form of the following basic steps (1).1. Identify assessment topics2. Specify the assessment problem3. Determine location of assessment4. Search for the evidence5. Collect primary data (if appropriate)6. Critical appraisal for each evidence7. Integrate and synthesize evidence8. Write findings and recommendations9. Distribute findings and recommendations10. Observe impact

We should notes that, not all health technology assessment programs conduct all of these steps, and they are not necessarily conducted in a linear manner.Another framework for HTA is offered by the European Collaboration for Health Technology Assessment (17), as follows.

• Efficacy and/or effectiveness• Economic impacts


Box 6 shows examples of health care technologies found to be ineffective or harmful after being widely diffused.

C. What is assessed in HTA?

HTA may involve the assessment of one or more properties, impacts, or other attributes of health technologies. Which includes the following:• Technical properties• Social, legal, ethical and/or political impacts• Safety

Box 6. Examples of Health Care Technologies Found to be Ineffective or Harmful After Being Widely Diffused(1)•1Autologous bone marrow transplant with high-dose chemotherapy for advanced breast cancer•uColectomy to treat epilepsy•oDiethylstilbestrol (DES) to improve pregnancy outcomes•iElectronic fetal monitoring during labor without access to fetal scalp sampling•lEpisiotomy (routine or liberal) for birth•pExtracranial-intracranial bypass to reduce risk of ischemic stroke•xGastric bubble for morbid obesity•aGastric freezing for peptic ulcer disease•aHormone replacement therapy for healthy menopausal women•oHydralazine for chronic heart failure: Intermittent positive pressure breathing• Mammary artery ligation for coronary artery disease•aOptic nerve decompression surgery for nonarteritic anterior ischemic optic neuropathy•pQuinidine for suppressing recurrences of atrial fibrillationRadiation therapy for acne•aSleeping face down for healthy babies•lSupplemental oxygen for healthy premature babies•uThalidomide for sedation in pregnant women•hThymic irradiation in healthy children•hTriparanol (MER-29) for cholesterol reduction


Relationship of evidence-based medicine and Health technology assessment:

The EBM can be considered as part of HTA, EBM concentrated on individual level while HTA concentrated mainly on national or community level. Figure 1& 2

HEALTH TECHNOLOGY ASSESSMENT

HTA EBM

How should the technology be?Implemented in this setting?

Should the technology be?Implemented in this setting?

Can the technology work?In this setting?

Can the technology work?


A- Before conducting the assessment. - Submission of an assessment request/identification of an assessment need.

- Prioritization

- Commissioning.

B- Conducting the assessment.

- Definition of policy question(s)- Preparation of HTA protocol- Collecting background information/determination of the status of the technology- Asking the research questions- Determine the sources of data, appraisal of evidence, and synthesis of evidence for each of:- Safety- Efficacy/effectiveness- Psychological, social, ethical- Organizational, professional- Economic- Draft elaboration of discussion, conclusions, and recommendations- External review- Publishing of final HTA report and summary report

C-Dissemination

D- Use of HTA

E- Update of the HTA.


References:

1- HTA 101: Introduction to Health Technology Assessment by Clifford Goodman, United States National Library of Medicine, January 2004, http://www.nlm.nih.gov/nichsr/ta101/ta101.pdf2. Cutler D, McClellan M. Is technological change in medicine worth it? HealthAffairs, 2001, 20:11–29.3. Goldman DP et al. Consequences of health trends and medical innovationfor the future elderly. Health Affairs, 2005, 24(Suppl. 2):W5R5–17.4. Jones CI. Why have health expenditures as a share of GDP risen so much?SSRN, 2002 (http://ssrn.com/abstract=355400, accessed 7 April 2008).5. Fuchs V. Economics, values and health-care reform. American EconomicsReview, 1996, March:1–24.6. Newhouse JP. Medical care costs: how much welfare loss? Journal ofEconomic Perspectives, 1992, 6:3–21.7. OECD health data 2007. Paris, Organisation for Economic Co-operation andDevelopment, 2007.8. Hoffman B. Is there a technological imperative in health care? InternationalJournal of Technology Assessment in Health Care, 2002, 18:675–689.9. Rothman DJ. Beginnings count: the technological imperative in Americanhealth care. New York, Oxford University Press, 1997.10- International Network of Agencies for Health Technology Assessment (INAHTA). http://www.inahta.org. Accessed January 28, 2012.11- Banta HD, Luce BR. Health Care Technology and its Assessment: An International Perspective. New York: Oxford University Press; 1993.12- UK National Health Service R&D Health Technology Assessment Programme, 2003. http://www.hta.nhsweb.nhs.uk/abouthta.htm. Accessed January 28, 2012.13- McKinlay JB. From «promising report» to «standard procedure»: seven stages in the career of a medicalinnovation. Milbank Memorial Fund Quarterly. 1981;59(3):374- 411.14- Mowatt G, Bower DJ, Brebner JA, Cairns JA, Grant AM, McKee L. When and how to assess fastchanging technologies: a comparative study


Critical appraisal of HTA report:

There are many checklists for critical appraisal of HTA report but we choose the checklist for HTA report which recommended by INAHTA for more details you can visit the website www.inahta.org/HTA/Checklist for more explanation of this checklist (20).

Note: See appendix 1 for Useful resources for HTA.Note: See appendix 2 for example of critically appraised HTA report.


http://www.hqlo.com/home/4-Health Technology Assessment International (HTAi) www.htai.org/

5- International Network of Agencies for Health Technology Assessment (INAHTA)www.inahta.org

6- National Information Center on Health Services Research and Health Care Technology (NICHSR)http://www.nlm.nih.gov/nichsr/edu/healthecon/index.html

7- National Institute for Health and Clinical Excellencehttp://www.nice.org.uk

8- For a guide for patient and carer groups on how to get involved in a technology appraisal seehttp://www.nice.org.uk/aboutnice/howwework/devnicetech/technologyappraisalprocessguides/contributing_to_a_technology_appraisal_a_guide_for_patient_carer_gro ups_reference_n0516.jsp

9- Patient reported health instruments http://phi.uhce.ox.ac.uk/ (home)http://phi.uhce.ox.ac.uk/links.php(list of instruments for measuring quality of life)Scottish Medicines Consortium Guidance on Patient Group Submissionshttp://www.scottishmedicines.org/smc/files/PatientInterestGroupSubmissionTemplate.doc (template) and http://www.scottishmedicines.org/smc/files/Patient%20Interest%20Group%20Guidance..doc (guidance)

Appendix 2: critical appraisal for one HTA report:We will do critical appraisal for one HTA report with title of Laparoscopic adjustable gastric banding for weight loss in obese adults: clinical and economic review.

To view the full article you can click on the URL http: / /cadth.ca/en/products/heal th- technology-assessment/publication/739


of medical applications of four generic technologies. Health Technology Assessment.1997; 1(14).15- Buxton MJ. Problems in the economic appraisal of new health technology: the evaluation of heart transplants in the UK. In Economic Appraisal of Health Technology in the European Community. Drummond MF, ed. Oxford, England. Oxford Medical Publications, 1987.16- Goodman C. The moving target problem and other lessons from percutaneous transluminal coronary angioplasty. In: A Szczepura, Kankaanpää J. Assessment of Health Care Technologies: Case Studies, KeyConcepts and Strategic Issues. New York, NY: John Wiley & Sons; 1996:29- 65.17- Busse R, Orvain J, Velasco M, et al. Best practice in undertaking and reporting health technology assessments. Int J Technol Assess Health Care. 2002;18:361- 422.18- Eddy D. Health technology assessment and evidence-based medicine: what are we talking about? Value Health 2009;12(Suppl. 2):S67-19-Health technology assessment of medical devices: WHO Medical device technical series; 2011. ISBN 978 92 4 150136 120- A checklist for health technology assessment reports, International Network of Agencies for Health Technology Assessment (INAHTA), Stockholm, 2007. www.inahta.org/HTA/Checklist accessed 05.02.12

Appendixes

Appendix 1: Useful resources for HTA:

1- Health Technology Assessment on the Net: A Guide to Internet Sources of InformationThe latest version is available on the AHFMR website: http://www.ahfmr.ab.ca/publications/?search=Internet+sources+of+information&type=1

2- European network for Health Technology Assessment, EUnetHTAhttp://www.eunethta.net/

3- Health and Quality of Life Outcomes, online journal


This report funded by Health Canada and the governments of Alberta, Nova Scotia, Nunavut…..etc. But one of the reviewers received an unrestricted education grant from Ethicon Endosurgery Canada(Note)Who is Ethicon Endo-Surgery(EES)

«(EES) develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery.»

Which I think it a major flaw of this paper.

4. Is there a statement on whether the report has been externally reviewed? Partly The draft report was externally peer-reviewed by two or more peer reviewers. But it is not include names and affiliations of reviewers who have provided comment on the report.

5. Is there a short summary that can be understood by the non- technical reader? Yes Executive summary is written in clear simple language.B- Why the assessment has been undertaken

6. Is reference made to the policy question that is addressed? 7. Is reference made to the question that is addressed and the context of the assessment? Partly This report addresses why an assessment has been undertaken. But it not mentions who has request this work.

8. Is the scope of the assessment specified? Yes

9. Is there a description of the health technology that has been assessed? Partly The health technology was not clearly described.


Laparoscopic Adjustable Gastric Banding for Weight Loss in Obese Adults: Clinical and Economic Review

There are two main types of surgery available to reduce weight; 1-Malabsorptive procedure works by shortening the length of the digestive tract (GI) so that the amount of food absorbed by the body is reduced. This type of surgery involves creating a bypass by joining one part of the intestine to another. Example of this procedure is biliopancreatic diversion (BPD).

2-Restrictive surgery limits the size of the stomach so the person feels full after eating a small amount of food. This type of surgery can involve stapling parts of the stomach together or fitting a tight band to make a small pouch for food to enter.(NICE 2001) Example of this procedure is laparoscopic adjustable gastric banding (LAGB), open and laparoscopic gastric bypass (GB) which are the most common operations performed these days.(Colquitt 2005)

Assessment of the quality of the HTA report:The writer will depend mainly on INAHTA checklist for health technology assessment reports

A- Preliminary information

1. Are there appropriate contact details for provision of further information? Yes There are appropriate contact details 2. Are those who prepared the HTA report identified as authors or in the other ways? Partly • There is no clear indication of persons who were involved in preparing the report and their roles. • The research question and selection criteria were developed in consultation with the requestor.

3. Is there a statement regarding conflict of interest? No


scientific Quality of Research Overviews. The highest score of 7 means that the paper has a minimal flaw. Score 5 indicates minor flaws. Score 3 indicates major flaws. Score one indicate extensive flaws. But the quality of primary studies (RCT, cohorts, economic) and the assessment process was not clear (no valid instrument have been used).

Also there are no details of methods used and assumptions for economic analysis which is very important.

D-The results of the assessment

13. Are the results of the assessment clearly presented?

Study Quality score Comment

AETMIS(HTA)

2(major flaws) 1-No statistical pooling of out come2-Follow up period not reported3-generalizability and strength of the studies were limited 4- Result of sensitivity analysis not reported.5- it seemed to limit it analysis to medical cost and only direct medical cost (not clear)

AHFMR(HTA)

2(major flaws) 1-LAGB had higher rates of re-operations and long post-operative complications.2-the type of surgery perform not reported in the economic information report.

ICSI

(HTA)

1(extensive flaws) 1-LAGB resulted in significant morbidity

2- no economic information


C- How the assessment has been undertaken

10. What sources of information have been used? Not comprehensive Details of electronic database searches and other identification strategies are given. But no details of the search terms used, descriptions of hand-searching, attempts to identify unpublished material, contact with authors, industry, and research institutes not provided. No language restrictions.

Also filter was applied to limit the retrieval to systematic reviews, HTA and for the primary studies. Retrieval was limited from 20052007- for systematic reviews and HTAs and from 20042007- for the primary clinical and economic studies.

Important note; it is mention in page ii; (HTIS) responses are based on a limited literature search.

11.Is there information on the process for selecting material for assessment? No It was not clear in this report who has undertaken the selection and extraction of data or how this processing has been done. There are no designing data extraction forms. Also there is no clear instruction for data extraction process. Also there is no enough information about safety, equity, societal and ethical, organizational and technical issues. To be more specific there is no details of the basis for selection the clinical effectiveness study .it is clear there was no accuracy or consistency in data extraction. Are they used two independent reviewers for data extraction? No. Also there was no sufficient evidence to assess the long term effectiveness and safety.

12. Is there information on the basis for interpretation of selected data?

The quality of the included studies was assessed by two reviewers using a valid instrument which Oxman and Guyatt›s Index of the


For the primary study the quality score (weight) was not clear and not clearly presented. In the two randomized control trail (RCT) it was unclear whether the allocation concealment was adequate. Which is a major flaw. Is it intention to treat analysis or not, percentage of drop out, blinding (rarely reported), confounder, contamination and etc. so it was not clearly presented. The reviewers include information on study design, sample size in each study group, patient characteristics(% EWL or BMI), interventions, , outcome measures, follow-up, outcomes results and rarely side-effects (adverse events).but not include more details on settings and drop-out rate (withdrawals).For the economic information from primary study it was not clear presented e.g. relevant cost and consequences identified (carer benefits, social sector resources, patient and family resource and etc.). Rarely the author comment on indirect cost, differential timing consideration and sensitivity analysis)

14.Is there interpretation of the assessment results? Partly There is a tabular presentation but not comprehensive and not clear.

Also there is a selective interpretation and comment on their likely relevance to clinical practice and to health care system.

E- Implications of the assessmentresults and conclusions?

15.Are the findings of the assessment discussed? Yes 16. Are medico-legal implications considered? Not applicable 17. Are the conclusions from the assessment clearly stated? Partly 18.Are there suggestions for further action? Yes


Study Quality score Comment BCBS(SR)

4(between major and minor flaws)

1-Long term outcomes uncertain2-Long term complication not reported3-Over estimate of LAGB effectiveness 4- Selection bias. 5- no economic information

O›Brien et al(SR)

2 1- no follow up rates were reported2-selection bias3- no economic information

MAS(SR)

2 1-Due to lack of high quality studies regarded LAGB no conclusion were made for LAGB2- Economic information was not clear if it include LAGB?

Cochrane C.

(SR)

7(minimal flaws) 1- overall quality of the studies were poor2-LVBG resulted in more patients with excellent result and less late complication than LAGB 3- In general laparoscopic surgery took longer duration except in one

RCT


three years. Most of primary study shows that the LAGB is inferior of equal to other type of bariatric surgery.

Impact on co-morbid conditions LAGB, LRYGB and VBG were found to improve obesity related comorbidities, but the information was not clearly presented, reported rarely and inconsistently. And there is rarely direct comparison between different surgical procedures. Cochrane Collaboration SR concluded the following: GB resulted in more weight loss and better quality of life. And LVBG resulted in more patients with excellent result and less late complications than LAGB.Miller et al study shows that similar result in loss comorbidities between LAGB and VBG.Impact on mortalityIn general low mortality rate are associated with these type of surgery. AHFMR shows the mortality rates were similar across LRYGB, LVBG and LAGB.

Safety There were wide variations between different surgical techniques for short and long term complications. It is difficult to reach to a conclusion from this report. In general long term safety difficult to establish.Short term complication rate, hospital stay may be less in LAGB LAGB have more long term complication rate such as post-operative complications and re-operations than LRYGB and VBG. It should be noted that effectiveness and safety vary between different bariatric procedures. And in this report there were a rarely comparison between them.

Cost effectiveness Only one economic evaluation based upon UK costs was identified within this report (AETMIS, British study). Overall the bariatric surgery was cost effective to medical treatment. The British study resulted the cost per quality-adjusted life-year (QALY) gained to be £6,289 for gastric band mainly (RYGB), £10,237 for VBG and £8,527 for LAGB compared to £6964 for those receiving usual care. There were sensitivity analysis on different hospital length of stay and the result predicted for 20 years. The American study in AETMIS addressed different question.


In only one study there was similarity to the population in UK. The similarity in the following: Patients’ health care system, comparability of available alternatives, similar levels of resources, institutional arrangements comparable treatment – comparability with clinical management, Resource costs. But in other studies there was no similarity.

Clinical effectiveness Criteria for surgery The NICE guideline explains that Bariatric surgery is recommended as a treatment choice for adult with obesity if all of the following criteria are fulfilled 1-BMI of 40 kg/m2or more 2-between 35 kg/m2 and 40 kg/m2 and other comorbid conditions (i.e., type II diabetes or high blood pressure) that could be improved if they lost weight all appropriate.1- non-surgical actions have been tried but have failed to reach or maintain adequate, clinically beneficial weight loss for at least 6 months the person has2- Been getting or will get management in a specialist obesity service.3- Generally fit for surgery.4- Commits to the need for long-term follow-up. In addition.5- Bariatric surgery is recommended as first-line option for adult of BMI>50kg/m2 in whom surgical treatment is inappropriate.

Impact on weight loss

In this report the clinical effectiveness of bariatric surgery can be estimated by mainly %EWL( if it is more than 75% it considered excellent, if it is between 50%-75% good and fair if it is between 25%-50%) or by change in BMI from base line. also the improvement in obesity co-morbid condition is examined in some studies. Weight loss was more in RYGB and VBG than in LAGB (AETMIS,AHFMR,).But (ICSI) HTA report shows that RYGB superior to LAGB while LAGB superior to VBG.BCBS and Cochrane Collaboration Systematic review dos not answer the search question. It compare LAGB to open or laparoscopic GB (not LAGB to VBG OR RYGB). O›Brien et al SR shows significant weight loss in RYGB than LAGB but this significant difference disappeared after


of increase obesity with time it is expected that the number of operations will increase to 500 per year. (Clegg 2002).In AETMIS HTAs the British study shows the cost per quality adjusted life years (QALY) gained to be £8,527 for AGB (not clear is it open or laparoscopic), £6,289 for GB mainly RYGB and £10,237 for VBG. The sensitivity analysis were done but not reported? It was not clear whether they include the indirect cost or only the direct cost.

The report does not include studies which concern with different type of band or different type of surgical technique which very important for my decision. Is there a different in the cost of different band? Are there more complications with different type of surgical technique? Also the report does not include the studies which report the surgeons’ learning curve on patient›s outcome. As we know the adverse event and operating time will reduced with surgeon›s experience. Most of the studies done in different population accept one study (within AETMIS HTAs British study) which was in UK and the economy report was in pound. It is not simply to convert the cost from USA dollar or different currency to pound. Because it depends on many different circumstances such as organizational, different health systems between countries, physician fees and etc. All of these will affect the cost effectiveness and also the clinical effectiveness.

Figure 1

Obesity prevalence among adults: by sex, England


The Canadian study in AETMIS estimated the cost of LAGB to be $9,418 while the cost of LRYGB equal to $7,064 the currency unit was Canadian Dollar. Also Medical Services Advisory Committee in Australia concluded that the incremental annual budget impact would be $58 million for the estimated 3500 (AGB) operations, but 47.5 million if the procedure was (GB). LAGB costs a$ 4,912 more than RYGB. The LAGB costs are not offset by the shorter hospital stay and lower intensive care. AlsoCochrane Collaboration SR concluded that LAGB have less operative time, shorter hospital stays.Data from one primary studies showed that LAGB and VBG have an equal cost and QOL.An interesting data from primary study showed that the total cost of LAGB was 11,299 euro and 13,185 for VGB. The writer said this difference was not significant. The ICER for the cost 1% EWL equaling 103, 83 euro. The problem with this study is the small sample size and short follow up period. Also the quality of the study not clear.

Impact on quality of lifeThree studies found that LAGB patients have better quality of life after surgery. One study compares LAGB to non-surgical patients. One study found LAGB patients had significant higher result than VBG. Third study found LAGB equal to LRYGB. Applicability to UKObesity associated with increased risk of co-morbid disease and increases the rate of morbidity and mortality and decrease the quality of life. There is an insufficient evidence to support non-surgical approach to reduce and maintain weight reduction in morbid obesity. The prevalence of obesity in England has been increasing since 1994: To reach around 25% in 2003(figure1)Obesity has significant costs for society in UK. The direct cost of obesity to the NHS is £0.5bn while the indirect cost to the UK economy is at least £2bn. (Ioana 2003). Morbid obesity estimated 1.9% of women and 0.6% of men in England and Wales had a BMI more than 40 kg/m. This is equivalent to 124,000 men and 412,700 women. BMI of 35% and one or more comorbidities 600,000 the total around 1.2million from this number 2%-4% will be fit for surgery. The NHS estimated that only 200 operations are done every year. The average cost of surgical intervention is between 45005300-. But with these figures and the trend


(http://www.statistics.gov.uk/cci/nugget.asp?id=1329) From this HTA report it clear that the bariatric surgery is more clinical and cost effective than non-surgical approach. But as we see the report depends mainly on low quality HTA report and SR. It is true that the Cochrane SR have high quality score but the author mention it based on poor quality RCT and the conclusion was not conclusive in favor of LAGB. Most of the result for both clinical and economic studies based mainly on short term follow up not on long term follow up and safety was not clear. For this reason it is not possible to choose between surgical interventions on the basis of cost-effectiveness.I can’t recommend this technology to be funded out of the public purse. The generalizability of this report to UK may be limited based on the difference in health care policy and health care system.Instead I prefer to wait for further well design RCT to compare different surgical techniques with regard to clinical effectiveness, costs effectiveness and quality of life of patients in the short and more important long term follow up.

Reference for appendix

1. Boudreau R, Hodgson A. Laparoscopic adjustable gastric banding for weight loss in obese Adults: clinical and economic review [Technology report number 90]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2007.2. Clegg AJ, Colquitt J, Sidhu MK, Royle P, Loveman E, Walker A. (2002)The clinical effectiveness and cost-effectiveness of surgery for people with morbid obesity: a systematic review and economic evaluation. Health Technol Assess 2002; 6(12).3. http://64.233.183.104/search?q=cache:W26FzEXLQssJ:www.nice.org.uk/pdf/Fullguidance-PDF-morbid.pdf+cost+of+surgical+obesity+in+uk&hl=en&ct=clnk&cd=6&gl=uk4. Ioana V. 2003 «Obesity costs UK economy £2bn a year» BMJ 2003; 327:1308 (6 December), doi:10.1136/bmj.327.7427.1308-d<http://www.bmj.com/cgi/content/full/3271308-/7427/d>


Al-Shareef, Mohammed AbdullahConsultant Family MedicinePhysician, trainer and researcherCEO- of SFH-Makkah city

QUALIFICATIONMSc Evidence-Based Healthcare and Health Technology Assessment – Birmingham University, UK 2008 with merit degree.The following modules were covered1-Economic Evaluation of health care2-clinical trial3-evidence synthesis diagnosis and screening4-principle and practices of HTA5-Methadological basis of HTA6-epidemiology,statistics and health information7-conducting SR and meta-analysisSubspecialist in Diabetic Care Management: Warwick University, UK 2009Saudi board of family medicine (SSC-FM-2004) (with Honor degree) Arab Board of Medical Specialization in Family Medicine (ABFM) (2004)College of Medicine and Medical Sciences King Faisal University –DAMMAM (MBBS) (1 -8- 1995 )Internship Period (30 -9- 1996)).

MembershipMember of Global Scientific Family Medicine Alliance Advisory Board- 2013Member of Institutional review board at KAMC since May 2012Member of editorial board of journal of family and community medicine since 2011.

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