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The PSRO hospital review system.

The 1972 Social Security amendments contained the landmark Professional Standards Review Organization (PSRO) provisions as well as several sections upgrading existing utilization review (UR) requirements under Medicare and Medicaid. With issuance of the PSRO Program Manual and the recent publication of the new UR regulations, HEW for the first time has brought Medicare and Medicaid hospital review requirements into conformity and made them compatible with and supportive of the PSRO program. This article defines the PSRO hospital review system, describes how the three major components-concurrent review, medical care evaluation studies, and profile analysis-interrelate and provides examples of each of these components. Under utilization review requirements or PSRO, hospitals will be required to implement an integrated system of review designed to assure appropriate utilization practices and improve the quality of care. These aims are to be accomplished through the application of concepts of peer review, the use of norms, criteria, and standards, the identification of deficiencies in the quality, administration, or appropriateness of health care services, and their correction through linkage with programs of continuing medical education. Although PSROs are initially responsible for review in hospitals, they will likely provide the locus for a community-wide system of peer review for all services provided under National Health Insurance.

Evaluation Studies as Topic↗

Comparative study of first-day postoperative cataract review methods.

PURPOSE: To assess whether telephone review on the first day after uneventful phacoemulsification is as effective as postoperative review in a hospital or the patients' home by nursing staff. SETTING: Sunderland Eye Infirmary, Sunderland, United Kingdom. METHOD: This prospective study comprised 3 arms, each of which consisted of 100 patients who had uneventful phacoemulsification with intraocular lens implantation. Patients received the same postoperative medications and were given a questionnaire regarding their opinions on the method of postoperative review. The method of review was different for each arm as follows: (1) home review by a nurse, (2) return to the hospital for review by a nurse, and (3) telephone review by a nurse. Statistical analysis of relative frequencies was done; exact testing was applied throughout to test for differences in proportions and, where applicable, to construct 95% confidence intervals. RESULTS: There were no significant differences between the 3 groups in the degree to which patients understood the instructions and questions. The telephone group was significantly less reassured than the home-visit group, but there was no significant difference in the degree of reassurance between the telephone and hospital-visit groups. Seventy percent of patients in the telephone group listed telephone review as their preferred method of postoperative review. CONCLUSION: In cases of uneventful phacoemulsification, telephone review is safe, effective, and acceptable and is a reasonable alternative to other first-day review methods.

House Calls↗

The sensitivity of rapid (partial) review of cervical smears.

Rapid review involves a daily rapid (e.g. 30 s) review of all smears not normally double-screened. It has been suggested that the method may increase the sensitivity of cervical cytology by identifying abnormalities not reported on initial screening, true false negatives (TFN). Rapid screening is reported to have high sensitivity for cervical neoplasia when used as a preview tool. To be effective, however, in a review mode it must be able to detect TFN. Several studies have found that many TFN result from factors such as low numbers of abnormal cells or subtle expression of diagnostic criteria. Studies on the sensitivity of rapid screening for detecting TFN would therefore provide a more reliable estimate of its value as a review tool. The sensitivity of rapid re-screening was evaluated using a test set of 200 cases. Each of 15 screeners rapidly reviewed (30 s partial screen) the set over a 2-week period. The set consisted of 129 normal, 28 low-grade squamous lesions (CIN I), 37 high-grade lesions (CIN II, III and adenocarcinoma in situ (AIS)) and six invasive carcinomas. The abnormals included 20 TFN cases. The median sensitivity for abnormalities was 62%. Rapid review was more sensitive for CIN II and CIN III (67%) and invasive carcinoma (66.7%) than for CIN I (53%). Great variation was apparent in the sensitivity for individual screeners, with a range of 41-86% for all abnormalities. The sensitivity for TFN cases varied even more (10-75%, median 35%) and for most screeners was significantly (P < 0.05) lower than for cases which were detected on initial screen (53-90%, median 70.6%). Following this trial rapid review was used routinely for a period of 3 months. In this time 11,413 cases were rapidly reviewed. This led to the full review of 415 slides (3.5%) and the identification of 16 cases of undetected CIN (12 CIN I, three CIN II, one CIN III). Based on current estimates of our laboratory false-negative rate this represents between a quarter and half of the TFN cases of CIN that probably occurred in this period. In conclusion, rapid screening is likely to be significantly less sensitive when used in a review rather than a preview mode. In routine practice the method requires a daily commitment of screener time, but does provide a higher yield of TFN smears than does random review, and allows amendment of these results prior to reporting.

Diagnostic Errors↗

Agreement between Cochrane Neonatal Group reviews and clinical guidelines for newborns at a Copenhagen University Hospital - a cross-sectional study.

AIM: To assess the agreement between Cochrane Neonatal Group reviews and clinical guidelines of a University Neonatology Department, to evaluate the reasons for potential disagreements and to ascertain whether Cochrane reviews were considered for the guidelines development. METHODS: The recommendations in the reviews and guidelines were compared and classified as being in 'agreement', 'partial agreement' or 'disagreement'. The guideline authors were interviewed for reasons about disagreement and whether Cochrane reviews were considered during the guideline development. RESULTS: Agreement between reviews and guidelines was found for 133 interventions (77%), partial agreement for 31 interventions (18%) and disagreement for nine interventions (5%). Six interventions were recommended in the guidelines, but not in the reviews. Three interventions were recommended in the reviews, but not in the guidelines. Use of consensus statements, evidence on surrogate markers, observational studies, basic immunology and pathophysiological knowledge, expert opinion, economical constraints, reservations about the external validity and unawareness of reviews were reasons for disagreement. Cochrane reviews were rarely (22%) used during the guideline development. CONCLUSION: We found agreement between more than three quarters of Cochrane reviews and neonatal guidelines. However, few important disagreements occurred. Reviews were only used for guideline development in about a fifth of cases.

Consensus↗

Influence of review design on percentages of missed interval breast cancers: retrospective study of interval cancers in a population-based screening program.

PURPOSE: To retrospectively investigate whether different review designs have an influence on the estimate of missed interval cancer in a population-based breast cancer screening program. MATERIALS AND METHODS: The Norwegian Breast Cancer Screening Program invites women aged 50-69 years to undergo biennial screening mammography. The current study was part of the evaluation and scientific aspects of the screening program and thus was covered by the general ethical approval of the screening program as a part of the Cancer Registry of Norway. All participants signed an informed consent that specified that data related to their screening visit could be used for evaluation and scientific purposes. Six radiologists (9-34 years of experience in mammography) reviewed previously obtained bilateral two-view screening and diagnostic mammograms of 231 interval cancers, 117 screening-detected cancers, and 373 normal cases. Four review designs were used: individual and paired blinded review and individual and consensus informed review. A five-point interpretation scale was used to reclassify the cancers into missed cancers, minimal signs, and true cancers. The number and proportion of subgroups were estimated with 95% confidence intervals. RESULTS: Of 231 interval cancers, 46 (19.9%) were reclassified as missed cancers with the mixed blinded individual review and 54 (23.4%) were classified as missed cancers with the mixed blinded paired review. Eighty-three cancers (35.9%) were classified as missed cancers with individual informed review, and 78 (33.8%) were classified as missed cancers with consensus informed review. Thirty-nine cancers (16.8%) were reclassified as missed when four or more radiologists assigned a score of 2 or more (probably benign or more suspicious); three cancers (1.3%) were reclassified as missed when a score of 4 or more (probably malignant or more suspicious) was assigned. CONCLUSION: The percentage of interval cancers classified as missed ranged from 1.3% to 35.9% according to review design. To encourage learning, a review protocol should include both blinded and informed designs.

Aged↗

Treatment delays for involuntary psychiatric patients associated with reviews of treatment capacity.

OBJECTIVE: To determine the duration of delays in treatment initiation when involuntary patients apply for a review of a finding of treatment incapacity and to estimate the cost of keeping patients hospitalized without treatment in these circumstances. METHOD: Using a computerized database and written records, we identified all patients at 2 psychiatric hospitals in Ontario who applied for a review of a finding of treatment incapacity during a 10-year period. We recorded clinical and demographic variables, dates of stopping and starting medication, and dates of review board hearings and outcomes. We also noted all cases in which a patient appealed a decision from the review board to the court. RESULTS: Two hundred and thirty-seven patients made 334 applications to the review board. The board overturned the physician's finding of incapacity in only 5 (1.5%) applications; 15 appealed the review board's finding to the courts. None of these appeals were successful. In the absence of an appeal to the courts, the average delay in initiating treatment was 25 days. For patients appealing to the court, the average delay was 253 days. The cost of hospitalizing untreated patients while their capacity was under legal review was estimated at $3,867,000, of which $1,333,000 could have been saved if treatment had started immediately after the review board confirmed incapacity. CONCLUSION: We have identified extensive delays in initiating psychiatric treatment for a number of patients. These delays are associated with legal review of treatment capacity. There are serious clinical risks and substantial costs associated with delay in treating patients with acute psychiatric illness. Where jurisdictions review treatment capacity, we recommend that treatment not be impeded once a review board has confirmed a clinical finding of incapacity.

Adolescent↗

Measuring the value of review of pathology material by a second pathologist.

In many departments, some cases are reviewed routinely by a second pathologist within the same department before sign out. The value of this practice is not known. We reviewed and compared the disagreement and amendment rates for cases reviewed by 1 or more pathologists based on the results of blinded review. A total of 8,363 cases underwent blinded review, and of these, 1,087 (13.0%) were reviewed by more than 1 pathologist before sign out. The disagreement rate for cases reviewed by more than 1 pathologist (4.8%) was significantly lower than for cases reviewed by only 1 pathologist (6.9%; P = .004). The amendment rate decreased to 0.0% from 0.5%, but this decrease was not statistically significant (P = .12). Review of material by a second pathologist before sign out is associated with a lower disagreement rate. These results suggest second review of surgical pathology is of value, but the best selection of cases to be reviewed remains to be defined.

Diagnostic Errors↗

MRI of meniscal lesions: soft-copy (PACS) and hard-copy evaluation versus reviewer experience.

OBJECTIVE: The purpose of our study was to compare diagnostic performance, reviewer confidence, and time requirements in the MRI diagnosis of meniscal tears for three types of reviewers and two types of image documentations (PACS vs hard copies). MATERIALS AND METHODS: An experienced musculoskeletal radiologist (reviewer 1), a fellow in musculoskeletal radiology (reviewer 2), and a junior staff member in orthopedic surgery (reviewer 3) evaluated MR images displayed on PACS monitors and hard copies independently and in a blinded fashion with regard to the presence or absence of meniscal tears. Seventy-one patients (mean age, 45.4 years; range, 16-80 years) were consecutively included if they had undergone both MRI of the knee and arthroscopy within 4 months. Arthroscopy was the standard of reference. Evaluation time and the reviewer's confidence in his or her diagnosis (Visual Analogue Scale, possible values of 0-100) were determined. RESULTS: Accuracies, sensitivities, and specificities in diagnosing meniscal tears were 80-87%, 63-85%, and 87-93% for soft copies and 82-85%, 64-76%, and 87-94.0%, respectively, for hard copies. Intrareviewer differences between PACS and hard copies were not significant for any of the three reviewers (McNemar tests). Reviewer 3 was less sensitive but more specific in the diagnosis of meniscal tears than reviewers 1 and 2. This difference was significant for both the PACS and hard copies. The reviewers' confidence in their diagnoses and evaluation times were not significantly different for PACS and hard copies (analysis of variance with Bonferroni post hoc analysis). CONCLUSION: Differences in the diagnostic performance of suspected meniscal tears depend on reviewer experience rather than on the type of documentation.

Adolescent↗

Evaluation of drug reviews.

Drug reviews appearing in Clinical Pharmacy, Drug Intelligence and Clinical Pharmacy (DICP), Drugs, and Pharmacotherapy from January 1982 through December 1984 were evaluated for number, duplication among journals, timeliness, scope, and format. The design of this study was primarily quantitative rather than qualitative. Pharmacotherapy published the most reviews (49), followed by Drugs (43), Clinical Pharmacy (37), and DICP (29). Drugs and Pharmacotherapy published the largest number of unique reviews (agents not reviewed by the other journals during the study period), while Pharmacotherapy and Clinical Pharmacy published the most reviews on newly marketed drugs. Reviews of four drugs (acyclovir, moxalactam, ranitidine, and trazodone) were compared in terms of major sections, terminology and format, bibliography, use of tables and figures, scope of evaluative comments, and review process. Reviews in Drugs consistently contained the most references and tables and provided the most detail. Information was most accessible in Drugs, followed by Pharmacotherapy. Drugs used the largest panel of reviewers. All of the journals provided evaluative comments, although the scope varied. Continuing-education credit is available for review articles in Clinical Pharmacy and DICP. In selecting one or more of these journals, individuals or institutions should compare their needs with regard to the timeliness, scope, and format of the review articles in each journal.

Evaluation Studies as Topic↗

Peer review of the biomedical literature.

Peer review is the assessment by experts of material submitted for publication. The peer reviewer serves the editor by substantiating the quality of the manuscript, and serves the author by giving constructive criticism. This system has benefits and drawbacks, including the tendency to select against novel work. Reviewers, whose work is generally unpaid, tend to be academicians who review for several journals and are authors and editors themselves. Editors often blind reviewers to authors to reduce bias, but reviewers frequently recognize the author anyhow. Blinding authors to reviewers may protect the reviewer. Manuscripts rejected by one journal because of peer review are usually published in another. Since peer review serves to validate the quality of the biomedical literature, the process should be valid itself.

Peer Review↗

A structured literature review to determine the use of the American Society for Therapeutic Radiology and Oncology consensus definition of biochemical failure.

OBJECTIVES: The American Society for Therapeutic Radiology and Oncology consensus definition (ACD) of biochemical failure after radiotherapy for prostate cancer requires three consecutive prostate-specific antigen increases from a nadir value. The members of the Consensus Panel recognized that the timing and frequency of prostate-specific antigen determinations could affect the comparability among different reports if this definition was used. For this reason, the Consensus Panel members recommended three guidelines for studies presented for publication (publication guidelines [PGs]). The present analysis examined the extent to which the ACD has been used in the peer-reviewed published literature and how frequently the PGs have been followed. METHODS: A structured literature review of 10 relevant journals was done. The inclusion criteria for the literature review required publication in calendar year 1999 or 2000; treatment with external beam radiotherapy and/or brachytherapy for previously untreated, nonmetastatic prostate cancer; and the use of a prostate-specific antigen-defined disease-free endpoint. A standardized checklist was created and completed by both of the authors. We independently reviewed each publication to determine whether the ACD of biochemical failure was used and whether the PGs were followed. Discrepancies between us were resolved by joint review of each publication in question to achieve a consensus. RESULTS: Fifty-seven articles met the inclusion criteria. The median number of patients in the articles reviewed was 302 (range 22 to 2222). The ACD was followed in 37 (64.9%) of 57 articles. None of the reviewed articles followed all three PGs. In five articles (8.7%), two of the three PGs were followed. The vast majority of the articles reviewed (52 of 57, 91.3%) followed one or none of the PGs recommended by the Consensus Panel. CONCLUSIONS: The ACD was used in two thirds of peer-reviewed published articles. The PGs were followed much less frequently. Consistent standards of reporting have not been uniformly applied to peer-reviewed manuscripts.

Brachytherapy↗

Risk, motives, and styles of utilization review: a cross-condition comparison.

In the United States various forms of managed care have been introduced to control the use of expensive medical services. One of the most prominent involves utilization review of hospital admissions. While reviewing the appropriateness of inpatient treatment is appealing in principle, its application is made difficult by clinical uncertainty. Managed care plans develop and implement review criteria often without the guidance of clear clinical norms of treatment. Under these conditions, we suggest that utilization review organizations (UROs) can be expected to develop "styles" of review that respond to clinical uncertainty, influenced by their experience, professional orientation, and financial incentives. Two review styles are explored in this paper: standardization, where the URO reduces the variance in clinical practices by eliminating those practices that deviate from professional norms and stringency, whereby the URO shifts the distribution of clinical practice as it tries to change the professional norms of practice. Data from a 1992-1993 national survey of utilization review organizations are used to test whether UROs have review styles that systematically respond to organizational attributes, economic pressures, and clinical uncertainty associated with three medical conditions: cardiac catheterization, low back pain, and adolescent depression. UROs were found to adopt more stringent review strategies for conditions with weaker norms of appropriate treatment. Financial incentives and organizational experience are positively related to greater stringency. Standardization responds to professional orientation and organizational experience. Variation in the review styles of UROs has implications for the resulting distribution of clinical practices as well as the equity of access to medical care.

Adolescent↗

Systematic reviews of nonrandomized clinical studies in the orthopaedic literature.

We systematically reviewed systematic reviews of surgical orthopaedic interventions published between 1996 and 2001 to document when and how nonrandomized studies were included. From more than 10,000 citations examined in various electronic databases, 58 orthopaedic systematic reviews were eligible for inclusion based on specific criteria. Thirty of these (52%) included nonrandomized studies, 15 of which found no randomized controlled trials. Systematic reviews were more likely to include randomized controlled trials if nondistinguishable operations were compared (if participants could be blinded). Only six of the systematic reviews that included nonrandomized studies (20%) assessed the quality of primary studies. Heterogeneity of studies was a major concern. In 21 of the systematic reviews that included nonrandomized studies (70%), data for groups treated similarly were pooled across studies, and outcomes for pooled groups were compared. The conclusions of systematic reviews that included nonrandomized studies are weakened by the limitations of nonrandomized study designs. The absence of established methods for including nonrandomized studies in systematic reviews, and consequently variability in the methods adopted, also limits the comparability of such reviews. Therefore the findings of systematic reviews that include nonrandomized studies should be interpreted with caution.

Clinical Trials as Topic↗

The science of systematic reviewing studies of diagnostic tests.

BACKGROUND: Systematic reviews have gradually replaced single studies as the highest level of documented effectiveness of health care interventions. Systematic reviewing is a new scientific method, concerned with the development and application of methods for identifying relevant literature, analysing the material while increasing validity and precision, and presenting and discussing the results in a way that does justice to the research question and to the available evidence. The objective of this study was to review the systematic reviews in laboratory medicine, to evaluate the methods applied in these reviews and the applicability of guidelines of the Cochrane Methods Working Group on Screening and Diagnostic Tests, and identify areas for future research. METHODS: All the systematic reviews in the field of clinical chemistry and laboratory haematology that could be identified in Medline, EMBASE and other literature databases up to December 1998, were evaluated. RESULTS: We studied 23 reviews of diagnostic trials. Although all reviews share the same basic methodology, there was a wide variation in the methods applied. There was no consensus on the quality criteria for inclusion of primary studies. The results of the primary studies were heterogeneous in most cases. This was partly due to design flaws in the primary studies, but was also inherent in the diverse study designs in diagnostic trials. We observed differences in the analysis of the factors that cause heterogeneity of the results, and in the summary statistics used to pool the data from the primary studies. The additional diagnostic value of a test, after other test results are taken into consideration, was only addressed in one study. CONCLUSION: This overview of 23 reviews of diagnostic trials identifies areas in the methods of systematic reviewing where consensus is lacking, such as quality rating of primary studies, analysis of heterogeneity between primary studies and pooling of data. Guidelines need to be improved on these points.

Clinical Chemistry Tests↗

The Uniform Clinical Data Set: an evaluation of the proposed national database for Medicare's quality review program.

The accuracy, reliability, and validity of the Medicare Peer Review Organization (PRO) review process have all been questioned. Evidence concerning the PRO program's effect on cost and quality of care remains lacking. The Health Care Financing Administration has thus committed itself to reform, and the Uniform Clinical Data Set (UCDS) has been proposed as the national database for Medicare's quality review program. The UCDS is an automated, computerized data set designed to standardize the evaluation of quality. It should allow an objective, consistent, and efficient process for peer review, based on explicit decision criteria and on aggregated information about patterns of care and quality. But is this truly so? We review the existing evidence on the UCDS and compare it with the current PRO reviews of quality, concluding that although the UCDS can potentially improve the accuracy and the reliability of data abstraction and the validity of reviews, this remains to be shown. Preliminary data on the UCDS suggest that work is needed before it can meet appropriate expectations for a national database for quality assessments. We also propose a model for reviews of quality in which we show that reviews of care done in the context of internal quality improvement programs will differ in goals and intensity from reviews of care done at the national level. We suggest that the UCDS has a unique, but limited role--that of national surveillance of practice patterns. Detailed assessments of quality are more appropriately done at local or institutional levels.

Data Collection↗

Health risk assessment of inorganic arsenic: an umbrella review.

Inorganic arsenic (iAs) is a toxic environmental pollutant linked to serious health risks, prompting global regulatory efforts. This study identifies major health conditions associated with iAs exposure using text network analysis, and assesses health risk assessments through an umbrella review and dose-response analysis. It synthesizes previous systematic reviews to offer a broader perspective on iAs-related health effects. An optimized text network analysis-based search strategy was applied across multiple databases to identify relevant systematic reviews. An umbrella review framework was employed to synthesize and reinterpret findings across systematic reviews. The methodological quality of included systematic reviews was assessed using the A MeaSurement Tool to Assess systematic Reviews 2 tool. Extracted data on study characteristics, exposure levels, and risk estimates were analyzed to evaluate the dose-response relationship between iAs exposure and health outcomes. From 922 systematic reviews, 36 were included and categorized into 10 health condition groups. For example, seven SRs found a significant dose-response relationship between iAs and bladder cancer, with one systematic review reporting relative risks of 2.70, 4.20, and 5.80 at 10, 50, and 150&#x202f;&#xb5;g/L, respectively. Individual study analysis further showed that each 10&#x202f;&#xb5;g/L increase in iAs raised bladder cancer risk by 3.11&#x202f;% (p=0.003). iAs exposure is associated with hypertension, diabetes, cardiovascular disease, and adverse fetal outcomes. Dose-dependent increases in bladder cancer, lung cancer, and hypertension risks were observed. These findings support more precise health risk assessments and regulatory strategies.

Humans↗

Conflicts of interest in medical science: peer usage, peer review and 'CoI consultancy'.

In recent years, the perception has grown that conflicts of interest are having a detrimental effect on medical science as it influences health policy and clinical practice, leading medical journals to enforce self-declaration of potential biases in the attempt to counteract or compensate for the problem. Conflict of interest (CoI) declarations have traditionally been considered inappropriate in pure science since its evaluation systems themselves constitute a mechanism for eliminating the effect of individual biases. Pure science is primarily evaluated by 'peer usage', in which scientific information is 'replicated' by being incorporated in the work of other scientists, and tested by further observation of the natural world. Over the long-term, the process works because significant biases impair the quality of science, and bad science tends to be neglected or refuted. However, scientific evaluation operates slowly over years and decades, and only a small proportion of published work is ever actually evaluated. But most of modern medical science no longer conforms to the model of pure science, and may instead be conceptualized as a system of 'applied' science having different aims and evaluation processes. The aim of applied medical science is to solve pre-specified problems, and to provide scientific information ready for implementation immediately following publication. The primary evaluation process of applied science is peer review, not peer usage. Peer review is much more rapid (with a timescale of weeks or months) and cheaper than peer usage and (consequently) has a much wider application: peer review is a prospective validation while peer usage is retrospective. Since applied science consists of incremental advances on existing knowledge achieved using established techniques, its results can usually be reliably evaluated by peer review. However, despite its considerable convenience, peer review has significant limitations related to its reliance on opinion. One major limitation of peer review has proved to be its inability to deal with conflicts of interest, especially in a 'big science' context when prestigious scientists may have similar biases, and conflicts of interest are widely shared among peer reviewers. When applied medical science has been later checked against the slower but more valid processes of peer usage, it seems that reliance on peer review may allow damaging distortions to become 'locked-in' to clinical practice and health policy for considerable periods. Scientific progress is generally underpinned by increasing specialization. Medical journals should specialize in the communication of scientific information, and they have neither the resources nor the motivation to investigate and measure conflicts of interest. Effectively dealing with the problem of conflicts of interest in applied medical science firstly requires a more explicit demarcation between the communications media of pure medical science and applied medical science. Greater specialization of these activities would then allow distinctive aims and evaluation systems to evolve with the expectation of improved performance in both pure and applied systems. In future, applied medical science should operate with an assumption of bias, with the onus of proof on applied medical scientists to facilitate the 'data transparency' necessary to validate their research. Journals of applied medical science will probably require more rigorous processes of peer review than at present, since their publications are intended to be ready for implementation. But since peer review does not adequately filter-out conflicts of interest in applied medical science, there is a need for the evolution of specialist post-publication institutional mechanisms. The suggested solution is to encourage the establishment of independent 'CoI consultancy' services, whose role would be to evaluate conflicts of interest and other biases in published applied medical science prior to their implementation. Such services would be paid-for by the groups who intend to implement applied medical research.

Conflict of Interest↗

Do themes in consumer medicines information literature reviews reflect those important to stakeholders?

OBJECTIVE: To compare the themes emerging from a stakeholder workshop on consumers' medicines information with themes in relevant published reviews. METHODS: A stakeholder workshop was held to permit consumer orientation of a systematic review of consumer medicines information. Analysis of the workshop outputs was compared to a content analysis of the identified published reviews. RESULTS: The workshop generated a range of responses inductively grouped into 12 over-arching themes. No reviews tackled all of these themes, nor addressed 'informed choice and autonomy'. More recent reviews reflected more workshop themes than older ones, suggesting a temporal trend towards a greater sensitivity to consumer issues. The most common workshop themes were covered by all reviews. Six themes in the reviews were related to traditional professional concerns including compliance, which did not arise in the workshop. CONCLUSION: The results highlight a mismatch between the themes in previous published reviews and the themes emerging from the workshop. The most commonly reflected themes in reviews conform to the 'patient education' model of discourse, while workshop themes less often echoed in reviews reflect the discourse of 'patient empowerment'. PRACTICE IMPLICATIONS: The findings suggest the importance of involving patients in the development of patient literature from the outset.

Aged↗