Latin American Journal of Pharmacy (formerly Acta Farmacéutica Bonaerense) Lat. Am. J. Pharm. 36 (7): 1322-7 (2017)
Received: March 1, 2017 Revised version: April 4, 2017 Accepted: April 6, 2017
Magnitude of Applicability of Clinical Practice Guidelines for Diagnosis, Prevention and Treatment of Osteoporosis in Pharmacy Practice Sheikh A. KHALIQ1,2,*, Syed B.S. NAQVI1,2, Anab FATIMA3 & Bilqees FATIMA2 Faculty of Pharmacy, University of Karachi, Karachi, Pakistan Faculty of Pharmacy, Hamdard University, Karachi, Pakistan 3 Faculty of Pharmacy, Dow University of Health Sciences, Karachi, Pakistan 1
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SUMMARY. The objective of this cross sectional study is to evaluate the applicability magnitude of International Osteoporosis Foundation guidelines in Pakistani population by pharmacy practitioners. The study was conducted from December 2015 to January 2017. Data collected from 50 pharmacists working in hospitals and community sites. Six domains of guideline are evaluated; scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability, editorial independence and additionally overall quality. SPSS 20 software was used to analyze the data. Magnitudes of domains are scope and purpose 66%, stakeholder involvement 68%, rigour of development 89%, clarity of presentation 91%, applicability 87%, and editorial independence 81% (t= -4.43, p < 0.007 at 95% CI, SD: 10.875, SE: 4.43). 72% (36) pharmacists are interested to recommend guideline without any changes, 28% (14) need some modifications. Pharmacists of Pakistan believe that IOF guidelines recommended for Asian countries can be implemented successfully in Pakistani population for the diagnosis, prevention and treatment of osteoporosis. RESUMEN. El objetivo de este estudio transversal es evaluar la magnitud de aplicabilidad de las directrices de la Fundación Internacional de Osteoporosis en la población paquistaní por parte de los profesionales de farmacia. El estudio se llevó a cabo de diciembre de 2015 a enero de 2017. Los datos corrsponden a 50 farmacéuticos que trabajan en hospitales y sitios de la comunidad. Se evalúan seis dominios: el alcance y el propósito, la participación de las partes interesadas, el rigor del desarrollo, la claridad de la presentación, la aplicabilidad, la independencia editorial y, además, la calidad general. Se utilizó el software SPSS 20 para analizar los datos. Las magnitudes de los dominios son alcance y propósito 66%, participación de las partes interesadas 68%, rigor del desarrollo 89%, claridad de presentación 91%, aplicabilidad 87% e independencia editorial 81% (t = -4,43, p < SD: 10.875, SE: 4.43). El 72% (36) de los farmacéuticos están interesados en recomendar la guía sin ningún cambio, el 28% (14) cree que necesita algunas modificaciones. Los farmacéuticos de Pakistán creen que las directrices de IOF recomendadas para los países asiáticos pueden aplicarse con éxito en la población paquistaní para el diagnóstico, la prevención y el tratamiento de la osteoporosis.
INTRODUCTION Clinical practice guidelines are systematically developed statements, which helps healthcare provider to make a clinical decision in specific clinical circumstances. Guidelines can also help for choosing effective strategies, reduce unnecessary costs and avoid inaccuracies in clinical decision making. High variability is possible in the quality of clinical practice guidelines. For this reason it is important that healthcare professionals should understand to assess the quality of this resource.
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Pharmacists should play highly active role in practicing evidence based management. Pharmacist’s unique background, training and skills for evidence based practice, improves the quality of pharmaceutical care. In specific clinical circumstances, pharmacist or medical practitioners take decision about patient, based upon systematically developed clinical practice guidelines 1. Sometimes, management of hospital formulary or national formulary is assisted by clinical practice guidelines. Formation of health policy is also governed by guidelines 2,3. The development process
KEY WORDS: applicability, domains, guidelines, magnitude, osteoporosis.
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ISSN 0326 2383 (printed ed.) ISSN 2362-3853 (on line ed.)
Latin American Journal of Pharmacy - 36 (7): 1322-1327 (2017)
of guidelines must ensure rigorous strategies and appropriate methodologies, so that recommendations can be implemented successfully 4-6. It has been noted that some guidelines does not contain basic standardization and 7 thus show variability in quality 8-10. In order to determine the variability in quality of guideline, Appraisal of Guidelines for Research & Evaluation (AGREE–II) Instrument 11 was developed. This instrument evaluates the methodologies and transparencies for the development of guidelines. Population of Pakistan is growing rapidly, therefore elderly population is increasing and osteoporosis is becoming a big threat. The prevalence of osteopenia and osteoporosis was found to be 16 and 34%, respectively by using ultrasound technique of 45-70 years aged women 12. Study of North West Frontier Province which is now Khyber Pukhtoon Khua have prevalence of 29 and 42%, respectively 13. Most of the guidelines like National Osteoporosis Foundation (NOF), American Academy of Orthopedics (AAO), North American Guidelines of Osteoporosis, World Health Organization (WHO), International Osteoporosis Foundation (IOF) are made, evaluated and appraised for the patients of western world. Ideally Pakistan should have local guidelines; however scarcity of resources is a major reason for non-availability. It is therefore necessary to evaluate the application of above mentioned guidelines by using AGREE-II instrument in Pakistani population.
MATERIALS AND METHODS A prospective, descriptive cross sectional research was conducted in Karachi and other cities of Pakistan from December 2015 to January 2017. The data were collected from validated and reliable questionnaire 14,15 after detailed discussion of IOF (International Osteoporosis Foundation) guidelines recommended for Asian countries 16 to diagnose, prevent and treat osteoporosis to pharmacists (Clinical and Hospital Pharmacists). A minimum sample size of 46 pharmacists was determined by power analysis technique, where effect size was moderate (0.35), level of significance (α = 0.05), power of study (β = 0.80) 17; however, 50 pharmacists were included in the study. The questionnaire focused on six main domains (scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability and editorial independence) (BOX). The appraisal of guidelines for research and evaluation (AGREE-II) Instrument 18 was used to address the issue of variability in guideline quality. Pharmacists are also asked to rate the overall quality of guideline for its applicability in pharmacy practice system of Pakistan. The questionnaire included data in ordinal scale which is evaluated by calculating domain scores by formula in AGREE-II instrument 14,15. Mathematical computation of domains score are made according to the following method:
Statistical Analysis SPSS 20 version software was used to evaluate descriptive, inferential statistics at 95% confidence interval (Independent sample t-test) and mathematical evaluation was done on Microsoft Office Excel. Verbal inform consent was taken by the pharmacists and
approved by the University of Karachi.
Maximum possible score = strongly agree (7) X questions/items (3) X # of pharmacists (50) = a Minimum possible score = strongly disagree (1) X questions/items (3) X # of pharmacists (50) = b Scaled domain score = (obtained score – minimum possible score) / (maximum possible score – minimum possible score) = c X 100 = Z%
Domains (Type)
Scope & Purpose
RESULTS Evaluation of 23 questions/items explained the magnitude of applicability for six key domains of International Osteoporosis Foundation guidelines for Asia (Table 1).
Questionnaire of Agree – II Instrument 18
Questions/Items
Q1. The overall objective/s of the guideline is/are specifically described . Q2. Specific description is available in guideline pertaining to health question Q3. Specific description is available in guidelines for population e.g. public, patient, to whom guidelines is applicable
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KHALIQ S.A., NAQVI S.B.S., FATIMA A. & FATIMA B.
Stakeholder Involvement
Q4. Professional groups from relevant specialty were part of IOF guideline development group Q5. Population which is targeted in this guideline, their preferences & views have been taken Q6. The target users of the guideline are clearly defined Q7. Systematic methods were used to search for evidence Q8. The criteria for selecting the evidence are clearly described Q9. Comprehensive detail is available for strength & limitation of body of evidence
Rigour of Development
Clarity of Presentation
Q10. Clear detail are available for formulating the recommendations and their methodology
Q11. The health benefits, side effects, and risks have been considered in formulating the recommendations Q12. There is an explicit link between the recommendations and the supporting evidence Q13. The guideline has been externally reviewed by experts prior to its publication Q14. A procedure for updating the guideline is provided Q15. The recommendations are specific and unambiguous Q16. It is clearly mentioned that what are different options available for the management of osteoporosis Q17. Key recommendations are easily identifiable Q18. The guideline describes facilitators and barriers to its application Q19. The guideline provides advice and/or tools on how the recommendations can be put into practice
Applicability
Q20. The potential resource implications of applying the recommendations have been considered Q21. Auditing/monitoring criteria for IOF guide for Asia is mentioned
Editorial Independence
Q22. Recommendations and details of guidelines are not influenced by any funding body
Q23. Members of guideline development group have competing interests (if any), that was appropriately addressed after recording Table1. Domains and Items of Questionnaire.
Score of these domains were scope and purpose (66%), stakeholder involvement (68%), rigour of development (89%), clarity of presentation ((91%), applicability (87%), and editorial indepenDomain (Items)
1 (Q1 - Q3) 2 (Q4 - Q6)
3 (Q7 - Q14)
4 (Q15 - Q17) 5 (Q18 - Q21) 6 (Q22 - Q23) Q 24
dence (81%) (t= -4.43, p < 0.007 at 95% CI, SD: 10.875, SE: 4.43), whereas response of last question/item regarding overall quality of guideline was 90.67% (Table 2).
Domain Description
Magnitude*
Stakeholder Involvement
68.00%
Scope & Purpose
Rigour of Development Clarity of Presentation Applicability
Editorial Independence
Overall Quality of Guideline
66.00% 89.00% 91.00% 87.00%
Significance
t= -4.43 p < 0.007 95% CI
81.00% 90.67%
Table 2. Evaluation of 23 questions/items for six key domains of International Osteoporosis Foundation guidelines for Asia.
* Calculated by mathematical valid & reliable formula 14,15 provided by AGREE-II instrument 18
Out of total, pharmacists working in hospital, primary care centers and clinics are 80% (N 1324
= 40), 10% (N = 5) and 10% (N = 5), respectively ( Fig. 1 ).
Latin American Journal of Pharmacy - 36 (7): 1322-1327 (2017)
Pharmacist’s response for the item of rate of overall all quality of guideline from 1 = fully disagree to 7 = fully agree, 56% responded quality score 7 as fully agree with best quality, 32% rated quality score 6, 12% rated quality score 5. None of the pharmacists reported that quality score is 1, 2, 3, as well as 4. After comprehension of guidelines, 72% pharmacists agree that they will recommend guidelines without any amendments; however, 28% need some modification before recommendation, none of pharmacists is in disagreement that guidelines should not be followed ( Table 3 ).
Figure 1. Clinical setting of pharmacists.
In the similar way, distribution patterns of pharmacists working in government and private sector are 70% (N = 35) and 30% (N = 15) respectively (Fig. 2).
Figure 2. Pharmacists distribution.
1 (Fully Disagree) 0.00%
Yes
72.00%
2
0.00%
Overall quality of guideline rating (Item 24)
3
4
0.00%
0.00%
5
12.00%
6
32.00%
IOF guideline for Asia recommended by Pharmacists (Item 25) Yes with modification 28.00%
7 (Fully Agree) 56.00%
No
0.00%
Table 3. Pharmacist’s response for the item of rate of overall all quality of guideline.
DISCUSSION The main objective of current study was to evaluate the applicability magnitude of six main domains of IOF (International Osteoporosis Foundation) guideline recommended for Asian countries by profession of Pharmacy Practice in Pakistan. Unfortunately, guideline which is recommended for Asian countries by IOF comprises the data of population from Hong Kong and China 16. South Asian populations living in SAARC (South Asian Association for Regional Cooperation) countries like Pakistan, India, Bangladesh, Sri Lanka, Bhutan, Nepal, Maldives, and Afghanistan are having different pharmaco-genetic characteristics in many clinical situations, it is therefore appropriate to have data from local population in order to make appropriate clinical decisions regarding osteoporosis. Pharmacists in Pakistan are working either in government or private sector hospitals, primary care centers or community set ups believe that magnitude of applicability of scope and purpose of guidelines is 66%. Probable reason behind this result is that despite clear objective of IOF guide for Asia, local population, patients and public is not considered and most
of the epidemiological extrapolations are from Chinese and Hong Kong data. Every society has their own norms and values, similarly guidelines development members have their own societal norms and values that may affect the choice, interpretation of evidence as well as their recommendations for disease state management 19-25. When guidelines are developed, views of the main stakeholders must be considered. Stakeholders usually comprises of physicians of different specialties, pharmacists, nurses and other allied health professional. Moreover stakeholder also means that these individuals have comprehension about population for whom guideline is meant. Pharmacists of Pakistan believe that applicability magnitude of this domain is 68% and probably views of target patients and population of Pakistan have not been sought as an important stakeholder. Many authors believe that patient should be part of the team to develop the guideline, which is not found in many currently available standards 26,27. Applicability magnitude score of rigour of development is 89%, rigour of development relates to the process used to gather and synthesized the evidence, 1325
KHALIQ S.A., NAQVI S.B.S., FATIMA A. & FATIMA B.
the methods to formulate the recommendations, and to update them. Pharmacists in Pakistan are partially agree that during search and synthesis of evidence systematic methods were applied, nevertheless, it is clearly described that how selection of evidence was done, consideration was done for strength and limitations of evidences, appropriate methodology was followed for formulating the recommendations, consideration was employed for side effects, risks, health benefits when formulating the recommendation, sound evidences are supporting almost all the recommendations, review of guideline was done before publication and perpetual update criteria is mentioned. Another imperative domain clarity of presentation deals with language, structure and format of the guideline. This domain has highest applicability magnitude i.e. 91%, which represents that pharmacists in Pakistan are convinced that recommendations of IOF for Asia provides concrete and precise description of different options in particular situation of patient. There is no ambiguity in recommendations, and key recommendations are clearly presented after consideration of all health issues in population of Asia. As far as concerned with applicability, more than 50% pharmacists are completely agree that guidelines provided the facilitators and barriers of application and guidelines can be practiced despite certain financial barriers and limitation of resources, however, pharmacists are partly agree that criteria for audit and monitoring of guideline is clearly presented, that is why magnitude of applicability is 87%. Domain of editorial independence is concerned with the competing interest of all the members contributed in the development of guideline. Pharmaceutical companies, government or charity organizations, professional associations sometimes provide funds for the development of guidelines. This funding may be financial contribution as whole or may just part like printing of guideline. Decisions in any healthcare system may influenced by conflict of interest 28, 29, it can also influence the development of guidelines 30-32. Magnitude of applicability of this domain was 81%. Pharmacists are near to full agreement that development and recommendation of guideline is not influenced by funding bodies, but competing interests of guideline development group members have not been addressed appropriately. It is interesting that all domain scores are significantly (p < 0.007) lower than 1326
maximum possible score of 100% by independent sample t-test. This indicates that average magnitudes of applicability of all domains of guideline are significantly lower than ideal score. Pharmacists were also asked to rate overall quality of IOF guidelines. Magnitude of overall quality of guideline is 90.67% that is why 72% pharmacists are ready to recommend or use this guideline in their pharmacy practice without any modifications, however, 28% pharmacists mentioned that they would use IOF guideline in their pharmacy practice but with some modifications as per requirements of Pakistani patients. Interestingly, none of the pharmacist mentioned that he/she would not recommend guideline. CONCLUSION Score regarding quality of scope and purpose was found to be lowest and highest for clarity of presentation. In some domains, lower score is largely reflecting the lack of inclusion of patient views and not piloting the guidelines in Pakistani population. Majority of pharmacist did not reject the IOF guideline recommended for Asian countries. Acknowledgement
Authors acknowledge the contribution of chief pharmacists of state owned and private hospitals to allow presentation of IOF guidelines and filling questionnaire. Contribution of authors
Sheikh Abdul Khaliq designed and conducted the study; Syed Baqir Shyum Naqvi supervised the whole study while Anab Fatima searched the evidences and analyzed the data by validated and reliable mathematical formula. REFERENCES
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