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

ABSTRACT: BACKGROUND: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. METHODS: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. RESULTS: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. CONCLUSIONS: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.

SUBMITTER: Paudyal V

PROVIDER: S-EPMC6171901 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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

Paudyal Vibhu V Cunningham Scott S Gibson Smith Kathrine K MacLure Katie K Ryan Cristin C Cordina Maria M

PloS one 20181004 10

<h4>Background</h4>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 o ...[more]

PMID: 30286166

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Project description:Community pharmacy professionals are being widely accepted as sources of treatment and advice for managing minor ailments, largely owing to their location at the heart of the community. The aim of the present study was, therefore, to document the involvement of community pharmacy professionals in the management of minor ailments and perceived barriers that limit their provision of such services. Simulated patient (SP) visits combined with a qualitative study using in-depth interviews was conducted among community pharmacy professionals in Gondar town, Northwest Ethiopia. Scenarios of three different minor ailments (uncomplicated upper respiratory tract infection, back pain and acute diarrhea) were selected and results were reported as percentages. Pharmacy professionals were also interviewed about the barriers in the management of minor ailments. Out of 66 simulated visits, 61 cases (92.4%) provided one or more medications to the SPs. Pharmacy professionals in 16 visits asked SPs information on details of symptoms and past medical and medication history. Ibuprofen alone or in combination with paracetamol was the most commonly dispensed analgesics for back pain. Oral rehydration fluid (ORS) with zinc was the most frequently dispensed medication (33.3%) for the management of acute diarrhea followed by mebendazole (23.9%). Moreover, amoxicillin-clavulanic acid capsule (35%) followed by Amoxicillin (25%) were the most commonly dispensed antibiotics for uncomplicated upper respiratory tract infection. Lack of clinical training and poor community awareness towards the role of community pharmacists in the management of minor ailments were the main barriers for the provision of minor ailment management by community pharmacy professionals. Overall, community pharmacists provided inadequate therapy for the simulated minor ailments. Lack of access to clinical training and poor community awareness were the most commonly cited barriers for providing such services. So as to improve community pharmacists' involvement in managing minor ailments and optimize the contribution of pharmacists, interventions should focus on overcoming the identified barriers.

Project description:BackgroundThe importance of access to medicines in promoting global health cannot be overstated, particularly as an estimated 2 billion people lack access to basic medicines, particularly in developing nations. While over-the-counter (OTC) medications are relatively safe and cost-effective, there is a risk of misuse due to factors such as inaccurate self-diagnosis, inadequate dosing, addiction, adverse drug reactions, and drug interactions. To ensure proper use and prevent irrational self-medication, pharmacists can play a crucial role in guiding patients. However, the legislation in Costa Rica only covers OTC and prescription drugs, and health authorities are proposing a new decree to include a list of drugs that can be recommended by pharmacists without a prescription to treat minor ailments, which would be classified as behind-the-counter (BTC).ObjectiveCharacterize the pharmaceutical consultation, compare the medications recommended by pharmacy professionals for minor ailments with the legislation in force in Costa Rica, and determine whether the current OTC medications are sufficient to treat minor ailments.Material and methodsThis study is a descriptive, observational, cross-sectional study that focuses on a sample of the Costa Rican population that comes to consult with a pharmacist in one of the four pharmacies of the Hospital Clínica Bíblica (HCB) in San José, Costa Rica. Consultations included users over 18 years of age or caregivers of underage patients seeking advice or assistance from publicly accessible pharmacies, excluding consultations that involved information related to other hospital departments. This study aims to analyze the pharmaceutical consultation for minor ailments and compare the medications recommended by pharmacists with the list of medications allowed in Costa Rica. The study also aims to determine if the current OTC medications are adequate for treating minor ailments.ResultsA total of 1537 consultations were gathered, which were divided into four categories: pharmaceutical recommendation (48%), medication information (31%), other consultations (18%), and referrals to another health professional (3%). Among the consultations classified as pharmaceutical recommendations, 90% were related to minor ailments. Prescription drugs accounted for 75.3% of the medications recommended and consulted. However, when the BTC category was included, the percentage of recommended prescription drugs decreased to 29.6%, while BTC drugs constituted 45.7%. Finally, the chi-square test rejected the null hypothesis that there was no association between the availability of OTC drugs and the minor ailments for which patients sought consultation.ConclusionsMost cases of pharmacy consultations involve minor illnesses such as digestive symptoms, joint pain, and respiratory issues. The proposed decree by health authorities in Costa Rica is noteworthy as it establishes standardized protocols for the prescription of BTC medications to ensure the safety of patients.

Project description:Objective: This study aims to systematically review the content and potential effects of clinical pharmacy services in tuberculosis (TB) care management. Methods: Searches were performed in PubMed, Embase, Cochrane, Scopus, and Web of Science databases following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Study characteristics and outcomes were extracted, and clinical pharmacy service components were characterized using the Descriptive Elements of Pharmacist Intervention Characterization Tool. Results: Twenty articles were included for full-text assessment, of which 10 fulfilled inclusion criteria, comprising 1,168 patients (N = 39 to 258 per study). These articles included five prospective cohort studies, two case-control studies, two quasi-experimental studies, and one cross-sectional study. Intervention foci within clinical pharmacy services were medication adherence (50%), medication safety (40%), education to patients/caregivers regarding needs/beliefs (30%), optimizing medication/therapy effectiveness (30%), emphasizing HRQoL (10%), and drug selections (10%). The three most frequently applied interventions were drug information/patient counseling (80%), adverse drug reaction monitoring (50%), and drug use evaluation (20%). Based on the World Health Organization (WHO) outcome classification, treatment success ranged from 72% to 93%, with higher cure outcomes (53%-86%) than treatment completion (7%-19%). Other outcomes, including isoniazid metabolites, medication counts, sputum conversion, adherence/compliance, knowledge, and quality of life, were better in the intervention group than those in comparator groups, and/or they improved over time. Risk of bias analysis indicated that the included studies were not comparable to a randomized clinical trial. Conclusion: Clinical pharmacy services as single or composite interventions potentially improve TB outcomes, but its evidence is still inconsistent and limited due to the lack of randomized controlled studies using the WHO outcome classification. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=199028, identifier CRD42020199028.

Project description:Studies focused on comprehensive assessment of self-perceived competency of community pharmacists to manage minor ailments are scanty despite that self-perceived competency is a valid determinant of task performance. The objectives of the study were to assess community pharmacists' self-perceived competency to manage fourteen common minor ailments in Qatar, and identify its significant predictors. A cross-sectional assessment of 307 community pharmacists was conducted with a pre-tested 20-item questionnaire. Self-perceived competency was assessed with nine elements on a scale of 1-10 (Maximum obtainable score: Each minor ailment = 90; each element = 140). Mann-Whitney U and bivariate logistic regression were used for data analyses. The response rate was 91.9% (282/307). The majority of the respondents were males (68.1%; 192/282), within the age range of 31-40 years (55.3%; 156/282). The minor ailments with the highest median competency score were constipation (76), and cold/catarrh (75) while travel sickness (69), and ringworm (69) had the lowest. The two condition-specific competency elements with the highest median score were recommendation of over-the-counter (OTC) medicines (115), and provision of instructions to guide its use (115). Ability to differentiate minor ailments from other medical conditions had the lowest median competency score (109). The significant predictors self-perceived competency were female gender (OR = 2.39, 95%CI: 1.34-4.25, p = 0.003), and working for chain pharmacies (OR = 2.54, 95%CI: 1.30-4.96, p = 0.006). Overall, Community pharmacists' self-perceived competency was adequate for majority of the common minor ailments, and it was highest for constipation and cold/catarrh, and specifically for the recommendation of OTC medicines and provision of instructions to guide its use. However, diagnostic ability to differentiate minor ailments from other medical conditions with similar features had the lowest median competency score. Female gender and working in chain pharmacies were the significant predictors of self-perceived competency to manage minor ailments.

Project description:BACKGROUND:Ecological momentary assessment (EMA) is a method of collecting real-time data based on repeated measures and observations that take place in participant's daily environment. EMA has many advantages over more traditional, retrospective questionnaires. However, EMA faces some challenges to reach its full potential. The aims of this systematic review are to (1) investigate whether and how content validity of the items (i.e. the specific questions that are part of a larger EMA questionnaire) used in EMA studies on physical activity and sedentary behaviour was assessed, and (2) provide an overview of important methodological considerations of EMA in measuring physical activity and sedentary behaviour. METHODS:Thirty papers (twenty unique studies) were systematically reviewed and variables were coded and analysed within the following 4 domains: (1) Content validity, (2) Sampling approach, (3) Data input modalities and (4) Degree of EMA completion. RESULTS:Only about half of the studies reported the specific items (n = 12) and the source of the items (n = 11). None of the studies specifically assessed the content validity of the items used. Only a minority (n = 5) of the studies reported any training, and one tested the comprehensibility of the EMA items. A wide variability was found in the design and methodology of the EMA. A minority of the studies (n = 7) reported a rationale for the used prompt frequency, time selection, and monitoring period. Retrospective assessment periods varied from 'now' to 'in the last 3.5 hours'. In some studies there was a possibility to delay (n = 6) or deactivate (n = 10) the prompt, and some provided reminders after the first prompt (n = 9). CONCLUSIONS:Almost no EMA studies reported the content validation of the items used. We recommend using the COSMIN checklist (COnsensus-based Standards for the selection of health Measurement INstruments) to report on the content validity of EMA items. Furthermore, as often no rationale was provided for several methodological decisions, the following three recommendations are made. First, provide a rationale for choosing the sampling modalities. Second, to ensure assessment 'in the moment', think carefully about the retrospective assessment period, reminders, and deactivation of the prompt. Third, as high completion rates are important for representativeness of the data and generalizability of the findings, report completion rates. TRIAL REGISTRATION:This review is registered in PROSPERO, the International prospective register of systematic reviews (registration number: CRD42017077996).

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

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

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