Research Article: Methodological considerations in clinical outcomes assessment of pharmacy-based minor ailments management: A systematic review

Date Published: October 4, 2018

Publisher: Public Library of Science

Author(s): Vibhu Paudyal, Scott Cunningham, Kathrine Gibson Smith, Katie MacLure, Cristin Ryan, Maria Cordina, Sherilyn Houle.

http://doi.org/10.1371/journal.pone.0205087

Abstract

The accessibility of services within community pharmacies provides an ideal opportunity to manage minor ailments, yet over £1.1 billion is spent by the National Health Service (NHS) in the United Kingdom (UK) in managing minor ailments in high cost settings. There is a need to review the evidence base around clinical effectiveness of pharmacy-based management of minor ailments since the absence of such may lead to under-utilisation of pharmacy services and non-implementation of available pharmacy service models. This study aimed to systematically review the methodological approaches used to assess clinical outcomes of pharmacy-based management of minor ailments in the research literature.

A systematic review was conducted to identify relevant literature using the following databases: Medline, EMBASE, CINAHL, IPA, CRD, CDSR, and Google Scholar from publication year 2000 onwards. Studies were included if they evaluated clinical outcomes of pharmacy-based management of any minor ailments, with or without a comparator setting such as Emergency Departments (EDs) or general practices. Screening and selection of titles, abstracts and full texts followed by data extraction and quality assessment (QA) was conducted. Paired researchers, from the team, reviewed papers using a protocol based on the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). QA was undertaken using the Critical Appraisal Skills Programme (CASP). Reporting was conducted in accordance with PRISMA checklist and statements.

A total of 19 studies were included. The majority of studies were observational, conducted in community pharmacies, and did not use a comparator participant group nor a comparator setting. Interventions included counselling, medicines supply and provision of advice on the management of minor ailments. One study used the randomised controlled trial (RCT) design with majority of the study utilising observational design. A range of clinical outcomes including symptom severity, pattern, resolution, and quality of life were reported. Methods used for the assessment of clinical outcomes were, overall, poorly reported. This included a lack of information on the development and validation of the data collection tools and the timing of baseline and follow-up data collection. Adverse clinical outcomes data were collected by only seven studies.

Currently, there are methodological limitations in the studies that have sought to assess clinical outcomes of pharmacy-based management of minor ailments. Such lack of high quality evidence may contribute to failings to shift care from high cost settings, such as EDs and general practices. Generation of high quality evidence is likely to influence public choices when seeking care for minor ailments. There is scope for development of a core outcomes set specific to minor ailments management and development of a validated methodology for measuring such outcomes in a research study.

Partial Text

Minor ailments are defined as ‘common or self-limiting or uncomplicated conditions which can be diagnosed and managed with minimum or no professional support’ [1]. For example, cough, cold, hay fever, red eye, minor sprains and pains. Despite the widely acknowledged expertise of community pharmacists, and pharmacy support staff, and their contribution to the management of minor ailments, internationally, there is an under-utilisation of pharmacy. For example, a recent analysis of routinely collected data in hospital emergency departments (ED) and in general practices in the United Kingdom (UK) demonstrated that between 5% and 13% of consultations respectively were for minor ailments equating to a cost of £1.1 billion [2]. Up to 20% of all general practitioner (GP) consultations are known to be for minor ailments consultations alone excluding the data where minor ailments forms a part of a consultation for a more serious condition [3]. The services of pharmacists in ED and general practices in managing minor ailments, inclusive of the recruitment of pharmacist independent prescribers, has recently been introduced in the UK [4].

A protocol was prepared using Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P, CRD42016050847) (S1 Appendix 1) [14]. An electronic search of MEDLINE, EMBASE, CINAHL, Centre for Review and Dissemination database (CRD), Cochrane Database of Systematic Reviews (CDSR), and Google Scholar were undertaken using Medical Subject Headings (MeSH) and natural language key words, Boolean and proximity (e.g. adj2] operators, truncations (*) and wild cards ($). The draft search strategy was utilised to perform a scoping search and moderated by the research team before a final version was agreed for each database. The reference lists of included studies were hand searched to identify any additional references for inclusion. Authors of conference abstracts were contacted to identify any related full text publications. Referencing software was used to manage included and excluded references and remove duplicate search results. An example search strategy is provided in S2 Appendix.

A total of 4798 unique titles were screened, of which 19 [1, 17–34] fulfilled eligibility criteria for inclusion in the review (Fig 1). All eligible papers were published in English language.

This study aimed to systematically review the methods and types of clinical outcomes in the evaluation of pharmacy-based management of minor ailments. The results have demonstrated a lack of high quality, adequately powered studies used in the evaluation of pharmacy-based minor ailments management. Amongst the studies included, only one study used an RCT design and there was a lack of adequately powered longitudinal follow-up studies. Within the included studies, explicit adherence to best practice guidelines [35–38] relating to study methodology was notably lacking. The Medical Research Council Framework signifies the importance of developing and validating the methodological tools used in the developing and evaluation of complex interventions [39].

Currently, there are methodological limitations in the studies that have sought to evaluate clinical outcomes of pharmacy-based management of minor ailments with regard to both type and method of assessing clinical outcomes. Future evaluations of pharmacy-based management of minor ailments should consider the use of high quality study designs, informed by best practice methodological guidelines, and validated methods of measuring clinical outcomes. There is scope for development of a core outcomes set specific to minor ailments management and development of a validated methodology for measuring such outcomes in a research study.

 

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http://doi.org/10.1371/journal.pone.0205087

 

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