The Geras virtual frailty rehabilitation program to build resilience in older adults with frailty during COVID-19: a randomized feasibility trial.

BACKGROUND: The Coronavirus (COVID-19) pandemic has exacerbated the risk for poor physical and mental health outcomes among vulnerable older adults. Multicomponent interventions could potentially prevent or reduce the risk of becoming frail; however, there is limited evidence about utilizing alternative modes of delivery where access to in-person care may be challenging. This randomized feasibility trial aimed to understand how a multicomponent rehabilitation program can be delivered remotely to vulnerable older adults with frailty during the pandemic. METHODS: Participants were randomized to either a multimodal or socialization arm. Over a 12-week intervention period, the multimodal group received virtual care at home, which included twice-weekly exercise in small group physiotherapy-led live-streamed sessions, nutrition counselling and protein supplementation, medication consultation via a videoconference app, and once-weekly phone calls from student volunteers, while the socialization group received only once-weekly phone calls from the volunteers. The RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework was used to evaluate the feasibility of the program. The main clinical outcomes were change in the 5-times sit-to-stand test (5 × STS) and Depression, Anxiety and Stress Scale (DASS-21) scores. The feasibility outcomes were analyzed using descriptive statistics and expressed as frequencies and mean percent with corresponding confidence intervals (CI). Analysis of covariance (ANCOVA) was used for the effectiveness component. RESULTS: The program enrolled 33% (n = 72) of referrals to the study (n = 220), of whom 70 were randomized. Adoption rates from different referral sources were community self-referrals (60%), community organizations (33%), and healthcare providers (25%). At the provider level, implementation rates varied from 75 to 100% for different aspects of program delivery. Participant's adherence levels included virtual exercise sessions 81% (95% CI: 75-88%), home-based exercise 50% (95% CI: 38-62%), protein supplements consumption 68% (95% CI: 55-80%), and medication optimization 38% (95% CI: 21-59%). Most participants (85%) were satisfied with the program. There were no significant changes in clinical outcomes between the two arms. CONCLUSION: The GERAS virtual frailty rehabilitation study for community-dwelling older adults living with frailty was feasible in terms of reach of participants, adoption across referral settings, adherence to implementation, and participant's intention to maintain the program. This program could be feasibly delivered to improve access to socially isolated older adults where barriers to in-person participation exist. However, trials with larger samples and longer follow-up are required to demonstrate effectiveness and sustained behavior change. TRIAL REGISTRATION: ClinicalTrials.gov NCT04500366. Registered August 5, 2020, https://clinicaltrials.gov/ct2/show/NCT04500366.

Deprescribing for older people living in residential aged care facilities: Pharmacist recommendations, doctor acceptance and implementation.

BACKGROUND: Deprescribing is an intervention to address the high prevalence of inappropriate polypharmacy in older people living in residential aged care facilities (RACFs). Many deprescribing interventions are complex and involve several stages including initial pharmacist recommendation, subsequent acceptance of the recommendations by a prescriber and the patient, and then actual implementation. OBJECTIVES: This study aimed to investigate pharmacist deprescribing recommendations for residents within RACFs, general practitioner (GP) acceptance, and the actual implementation of the accepted recommendations at 12-month. METHODS: The intervention occurred as part of a randomised controlled trial and comprised a pharmacist-led medication review using an evidence-based algorithm, with the focus on identifying medications to potentially deprescribe. Consent to participate was obtained from residents (or surrogate decision-makers), RACF nursing staff and the resident's GP. Deprescribing recommendations were reviewed by GPs before implementation as part of the intervention and control arms of the trial, although control group participants continued to receive their usual medications in a blinded manner. RESULTS: There were 303 participants enrolled in the study, and 77% (941/1222) of deprescribing recommendations suggested by the pharmacists were accepted by GPs. Of the recommendations accepted by GPs, 74% (692/ 941) were successfully implemented at the end of the follow-up visit at 12 months. The most common reason for deprescribing was because medications were no longer needed (42%, 513/ 1231). CONCLUSION: Pharmacist-led deprescribing recommendations arising from an algorithm-based medication review are acceptable to doctors and can have a significant impact on reducing the number of inappropriate medications consumed by older people in RACFs. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613001204730.

Interventions to address polypharmacy in older adults living with multimorbidity: Review of reviews.

OBJECTIVE: To summarize evidence from published systematic reviews evaluating the effect of polypharmacy interventions on clinical and intermediate outcomes. It also summarizes the adverse events that may occur as a result of these interventions. DATA SOURCES: A literature search was conducted using the electronic databases MEDLINE, Embase, CINAHL, Cochrane Central, and Cochrane Database of Systematic Reviews (PROSPERO registration number: CRD42018085767). STUDY SELECTION: The search yielded a total of 21,329 citations, of which 619 were reviewed as full text and 5 met the selection criteria. SYNTHESIS: The polypharmacy interventions were found to produce statistically significant reductions in potentially inappropriate prescribing and improved medication adherence; however, the observed effects on clinical and intermediate outcomes were inconsistent. None of the included reviews reported any significant benefit of polypharmacy interventions for quality-of-life outcomes. Specific to health care utilization and cost, polypharmacy interventions reduced health care resource usage and expenditure. The reviews reported no differences in adverse drug events between polypharmacy interventions and usual care groups. The overall certainty of evidence was reported as low to very low across included reviews. CONCLUSION: Polypharmacy interventions are associated with reductions in potentially inappropriate prescribing and improvements in medication adherence. However, there is limited evidence of their effectiveness for clinical and intermediate outcomes.

Recommendations for outcome measurement for deprescribing intervention studies.

Interpreting results from deprescribing interventions to generate actionable evidence is challenging owing to inconsistent and heterogeneous outcome definitions between studies. We sought to characterize deprescribing intervention outcomes and recommend approaches to measure outcomes for future studies. A scoping literature review focused on deprescribing interventions for polypharmacy and informed a series of expert panel discussions and recommendations. Twelve experts in deprescribing research, policy, and clinical practice interventions participating in the Measures Workgroup of the US Deprescribing Research Network sought to characterize deprescribing outcomes and recommend approaches to measure outcomes for future studies. The scoping review identified 125 papers reflecting 107 deprescribing studies. Common outcomes included medication discontinuation, medication appropriateness, and a broad range of clinical outcomes potentially resulting from medication reduction. Panel recommendations included clearly defining clinically meaningful medication outcomes (e.g., number of chronic medications, dose reductions), ensuring adequate sample size and follow-up time to capture clinical outcomes resulting from medication discontinuation (e.g., quality of life [QOL]), and selecting appropriate and feasible data sources. A new conceptual model illustrates how downstream clinical outcomes (e.g., reduction in falls) should be interpreted in the context of initial changes in medication measures (e.g., reduction in mean total medications). Areas needing further development include implementation outcomes specific to deprescribing interventions and measures of adverse drug withdrawal events. Generating evidence to guide deprescribing is essential to address patient, caregiver, and clinician concerns about the benefits and harms of medication discontinuation. This article provides recommendations and an initial conceptual framework for selecting and applying appropriate intervention outcomes to support deprescribing research.

Cost-Utility Analysis of Discontinuing Antidepressants in England Primary Care Patients Compared with Long-Term Maintenance: The ANTLER Study.

BACKGROUND: Depression is a common mental health condition with considerable negative impact on health and well-being. Although antidepressants are recommended as first-line treatment, there is limited evidence regarding the cost effectiveness of long-term maintenance antidepressants for preventing relapse. OBJECTIVES: Our objective was to calculate the mean incremental costs and quality-adjusted life-years (QALYs) over 12 months of discontinuing long-term antidepressant medication in well patients compared with maintenance, using patient-level trial data. METHODS: We conducted a cost-utility analysis of 478 participants from 150 UK general practices recruited to a randomised, double-blind trial (ANTLER). QALYs were calculated from EQ-5D-5L and 12-Item Short Form survey (SF-12) results, with primary analysis using the EQ-5D-5L value set for England. Resource use was collected from primary care patient electronic medical records and self-completed questionnaires capturing mental-health-related resource use. Costs were calculated by applying standard UK unit costs to resource use. Adjustments were made for baseline variables. RESULTS: Participants randomised to discontinuation had significantly worse utility scores at 3 months (- 0.032; 95% confidence interval [CI] - 0.053 to - 0.011) but no significant difference in QALYs (- 0.011; 95% CI - 0.026 to 0.003) or costs (£3.11; 95% CI - 41.28 to 47.50) at 12 months. The probability that discontinuation was cost effective compared with maintenance was 12.9% at a threshold of £20,000 per QALY gained. CONCLUSIONS: Discontinuation of antidepressants was unlikely to be cost effective compared with maintenance for currently well patients on long-term antidepressants. However, this analysis provides no information on the wider impact of antidepressants. Our findings provide information on the potential impact of discontinuing long-term maintenance antidepressants and facilitate improving guidance for shared patient-clinician decision making. TRIAL REGISTRATION: EudraCT number 2015-004210-26; ISRCTN number ISRCTN15969819.

Polypharmacy and mobility outcomes.

Polypharmacy is known to be associated with negative consequences of mobility related conditions such as falls, functional decline and disability. This systematic review highlights the effectiveness of deprescribing interventions on mobility related conditions in older adults in the community dwelling reported taking five or more medications daily.

Examining Interprofessional teams structures and processes in the implementation of a primary care intervention (Health TAPESTRY) for older adults using normalization process theory.

BACKGROUND: Many countries are engaged in primary care reforms to support older adults who are living longer in the community. Health Teams Advancing Patient Experience: Strengthening Quality [Health TAPESTRY] is a primary care intervention aimed at supporting older adults that involves trained volunteers, interprofessional teams, technology, and system navigation. This paper examines implementation of Health TAPESTRY in relation to interprofessional teamwork including volunteers. METHODS: This study applied Normalization Process Theory (NPT) and used a descriptive qualitative approach [1] embedded in a mixed-methods, pragmatic randomized controlled trial. It was situated in two primary care practice sites in a large urban setting in Ontario, Canada. Focus groups and interviews were conducted with primary care providers, clinical managers, administrative assistants, volunteers, and a volunteer coordinator. Data was collected at 4 months (June-July 2015) and 12 months (February-March 2016) after intervention start-up. Patients were interviewed at the end of the six-month intervention. Field notes were taken at weekly huddle meetings. RESULTS: Overall, 84 participants were included in 17 focus groups and 13 interviews; 24 field notes were collected. Themes were organized under four NPT constructs of implementation: 1) Coherence- (making sense/understanding of the program's purpose/value) generating comprehensive assessments of older adults; strengthening health promotion, disease prevention, and self-management; enhancing patient-focused care; strengthening interprofessional care delivery; improving coordination of health and community services. 2) Cognitive Participation- (enrolment/buy-in) tackling new ways of working; attaining role clarity. 3) Collective Action- (enactment/operationalizing) changing team processes; reconfiguring resources. 4) Reflective Monitoring- (appraisal) improving teamwork and collaboration; reconfiguring roles and processes. CONCLUSIONS: This study contributes key strategies for effective implementation of interventions involving interprofessional primary care teams. Findings indicate that regular communication among all team members, the development of procedures and/or protocols to support team processes, and ongoing review and feedback are critical to implementation of innovations involving primary care teams. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT02283723 November 5, 2014. Prospectively registered.

Disconnected relationships between primary care and community-based health and social services and system navigation for older adults: a qualitative descriptive study.

BACKGROUND: There are gaps in knowledge and understanding about the relationships between primary care and community-based health and social services in the context of healthy aging at home and system navigation. This study examined provider perspectives on: a) older adults' health and social needs; b) barriers to accessing services; c) the nature of relationships between primary care and health and social services; and d) ways to facilitate primary care and health and social services navigation to optimize older adults' health. METHODS: Four focus groups were conducted involving providers (n = 21) in: urban primary care clinics and health and social services organizations serving older adults in Hamilton, Ontario, Canada. Purposive sampling was employed to recruit community health and social services managers, directors or supervisors and primary health care providers in a Family Health Team via email. RESULTS: Health and social services needs were exacerbated for community-dwelling older adults with multiple chronic conditions. Strong family/caregiver social support and advocacy was often lacking. Access barriers for older adults included: financial challenges; lack of accessible transportation; wait times and eligibility criteria; and lack of programs to address older adults' needs. Having multiple providers meant that assessments among providers and older adults resulted in contradictory care pathways. Primary care and health and social services linkages were deficient and complicated by poor communication with patients and health literacy barriers. Primary care had stronger links with other health services than with community-based health and social services; primary care providers were frustrated by the complex nature of health and social services navigation; and care coordination was problematic. Health and social services referred older adults to primary care for medical needs and gathered patient information to gauge program eligibility, but not without challenges. CONCLUSIONS: Results point to strategies to strengthen primary care and health and social services system navigation for older adults including: using a person-focused approach; employing effective primary care and health and social services communication strategies; applying effective system navigation; building trust between primary care and health and social services providers; advocating for improved program access; and adapting services/programs to address access barriers and meet older adults' needs.

GeriMedRisk, a telemedicine geriatric pharmacology consultation service to address adverse drug events in long-term care: a stepped-wedge cluster randomized feasibility trial protocol (ISRCTN17219647).

BACKGROUND: Multimorbidity, polypharmacy, and older age predispose seniors to adverse drug events (ADE). Seniors with an ADE experience greater morbidity, mortality, and health care utilization compared to their younger counterparts. To mitigate and manage ADEs among this vulnerable population, we designed a geriatric pharmacology consultation service connecting clinicians with specialist physicians and pharmacists and will investigate the feasibility and acceptability of this complex intervention in the long-term care setting, prior to conducting a larger efficacy trial. METHODS/DESIGN: We will conduct a cluster randomized feasibility trial and qualitative analysis of GeriMedRisk among four long-term care homes in the Waterloo-Wellington region from May 1 to December 31, 2017. The primary outcome is the feasibility and acceptability of GeriMedRisk and the stepped-wedge cluster randomized controlled trial design. We hypothesize that GeriMedRisk is a feasible intervention and its potential to decrease falls and drug-related hospital visits can be evaluated with a stepped-wedge cluster randomized controlled trial design. DISCUSSION: This mixed methods study will inform a larger efficacy trial of GeriMedRisk's ability to decrease adverse drug events among seniors in the long-term care setting. ETHICS AND DISSEMINATION: The Hamilton Integrated Research Ethics Board granted the approval for this study protocol 2812. We plan to disseminate the results of this study in peer-reviewed journals and also to our partners and stakeholders. TRIAL REGISTRATION: ISRCTN clinical trials registry, ISRCTN17219647 (March 27, 2017).

Enduring sexual dysfunction after treatment with antidepressants, 5α-reductase inhibitors and isotretinoin: 300 cases.

OBJECTIVE: To investigate clinical reports of post-SSRI sexual dysfunction (PSSD), post-finasteride syndrome (PFS) and enduring sexual dysfunction following isotretinoin. METHODS: Data from RxISK.org, a global adverse event reporting website, have been used to establish the clinical features, demographic details and clinical trajectories of syndromes of persistent sexual difficulties following three superficially different treatment modalities.RESULTSWe report on 300 cases of enduring sexual dysfunction from 37 countries following 14 different drugs comprised of serotonin reuptake inhibiting antidepressants, 5α-reductase inhibitors and isotretinoin. While reports of certain issues were unique to the antidepressants, such as the onset of premature ejaculation and persistent genital arousal disorder (PGAD), there was also a significant overlap in symptom profile between the drug groups, with common features including genital anaesthesia, pleasureless or weak orgasm, loss of libido and impotence. Secondary consequences included relationship breakdown and impaired quality of life.CONCLUSIONSThese data point to a legacy syndrome or syndromes comprising a range of disturbances to sexual function. More detailed studies will require developments in coding systems that recognise the condition(s). Further exploration of these tardive sexual syndromes may yield greater understanding of tardive syndromes in general.

Manifesto de Curitiba: pela Prevenção Quaternária e por uma Medicina sem conflitos de interesse / The Curitiba Manifesto: for the Quaternary Prevention and for a Medical Practice without confl icts of interest

Nós, médicos de família e comunidade reunidos no I Seminário Brasileiro de Prevenção Quaternária, trazemos o seguinte manifesto em prol de uma Medicina isenta de conflitos de interesses e imbuída de profissionalismo no seu sentido mais pleno. Estamos baseados nos seguintes pressupostos: Código de Ética Médica1 II - O alvo de toda a atenção do médico é a saúde do ser humano, em benefício da qual deverá agir com o máximo de zelo e o melhor de sua capacidade profissional; IV - Ao médico cabe zelar e trabalhar pelo perfeito desempenho ético da Medicina, bem como pelo prestígio e bom conceito da profissão; V - Compete ao médico aprimorar continuamente seus conhecimentos e usar o melhor do progresso científico em benefício do paciente; IX - A Medicina não pode, em nenhuma circunstância ou forma, ser exercida como comércio; XIV - O médico empenhar-se-á em melhorar os padrões dos serviços médicos e em assumir sua responsabilidade em relação à saúde pública, à educação sanitária e à legislação referente à saúde; XXIII - Quando envolvido na produção de conhecimento científico, o médico agirá com isenção e independência, visando ao maior benefício para os pacientes e a sociedade; ... É vedado ao médico: Art. 68. Exercer a profissão com interação ou dependência de farmácia, indústria farmacêutica, ótica ou qualquer organização destinada à fabricação, manipulação, promoção ou comercialização de produtos de prescrição médica, qualquer que seja sua natureza. ... É vedado ao médico: Art. 104. Deixar de manter independência profissional e científica em relação a financiadores de pesquisa médica, satisfazendo interesse comercial ou obtendo vantagens pessoais. Conceito de profissão enquanto compromisso com valores profissionais Uma profissão é: 1. livre da influência do comércio e do Estado e 2. responsável pela sua própria educação e estrutura de conhecimento2 E conceito de Prevenção Quaternária3 "Ação feita para identificar pacientes em risco de sobremedicalização, para os proteger de mais intervenções em saúde e para lhes sugerir intervenções eticamente aceitáveis" (Adaptado de Jamoulle e Roland, 1995) Portanto, nós, médicos defensores da prevenção quaternária em qualquer nível de atenção à saúde, defendemos os princípios bioéticos em prol do melhor e do mais aceitável para a população: − Não-maleficência: partindo do pressuposto hipocrático de "em primeiro lugar não causar dano" (primum non nocere), sempre levaremos em conta o fato de que, quanto maior o risco de causar dano, mais embasado cientificamente e isento de interesses diversos do científico deve ser o procedimento em questão para que este possa ser considerado um ato eticamente aceitável, mesmo que para tal se faça necessário questionar aspectos metodológicos e conflitos de interesses em protocolos e diretrizes (muitas destas tidas como conhecimento inquestionável, porém gerado sob uma perspectiva comercial), sempre pautados na melhor evidência cientifica isenta disponível, e evitando ao máximo a "Disease Mongering" (promoção da doença), a transformação de fatores de risco e eventos fisiológicos em doenças, a medicalização desses eventos ou o excesso diagnóstico, que podem por a pessoa em risco de estigmas e danos posteriores. − Beneficência: pensando no melhor para o paciente (do grego pathe ­ sentimento ­, com seus desdobramentos no latim patientem ­ aquele que sofre ­, e pax ­ paz, paciência), estaremos em busca sempre das melhores e mais adequadas evidências científicas livres de conflitos de interesses para promover a saúde das doenças, com o mínimo de intervenções possíveis. Significa que buscaremos desenvolver ações proativas "para o bem do paciente", livres de influências externas, lembrando que condutas expectantes ou mesmo a desprescrição também são ações proativas para o benefício das pessoas. E o efeito benéfico envolve também proteger as pessoas de informações inadequadas e reduzir a angústia causada pela Disease Mongering, além de fornecer informações adequadas a essas pessoas para que elas mesmas pesem riscos e benefícios e tomem suas decisões por meio da persuasão puramente profissional-relacional, visando ao melhor resultado possível para aquela pessoa. − Autonomia: a autonomia ou autodeterminação envolve dois aspectos durante o estabelecimento da relação médicopaciente: 1. capacidade para atuar deliberadamente, o que envolve razão e discernimento para decidir entre as alternativas que lhe são apresentadas e 2. liberdade, no sentido de estar livre de qualquer influência controladora para a emissão de um posicionamento.4 Portanto, é nossa premissa empoderar a população com as informações mais confiáveis possíveis para a tomada de decisão conjunta diagnóstica ou terapêutica, sem manipulação nem coerção, mas com a avaliação correta de riscos e benefícios, em especial naqueles procedimentos onde ainda há fraco embasamento cientifico e onde há fortes influências de indústrias farmacêuticas ou de produtos médicos-hospitalares, e mesmo de corporações com interesses mercantilistas, indo de encontro aos princípios aqui discorridos. É nossa premissa também tornar as pessoas conhecedoras para uma melhor tomada de decisão, já que o conhecimento, e não a desconfiança, é a melhor ferramenta para a prevenção quaternária.5 − Justiça: também é nossa premissa, enquanto promotores e defensores da prevenção quaternária, a luta pelo acesso equânime, justo e apropriado aos recursos em saúde, denunciando a mercantilização da saúde e o uso do sistema sanitário para finalidades diversas do benefício das pessoas, reforçando que justiça e acesso nem sempre estão relacionados às "últimas novidades tecnológicas em saúde". Nós não cuidamos de órgãos. Nós não promovemos doenças. Nós não superestimamos fatores de risco. Nós cuidamos de pessoas, e pessoas não são números, escores, fatores de risco e nem meros objetos de intervenções. Nós somos cautelosos com resultados surpreendentes de publicações científicas, pois dados podem ser manipulados para diagnosticar sintomas menores ou fatores de risco e assim reduzir os pontos de corte do diagnóstico de uma doença, bem como para criar "pré-doenças", aumentar o espectro de medicalização e gerar de forma perniciosa lucros para a indústria farmacêutica.6 Nós respeitamos o tempo na ciência e respeitamos a linha do tempo da relação médico-paciente, pois o aspecto relacional na atenção em saúde sempre prevalecerá sobre o aspecto populacional. Por todo o exposto, apontaremos sempre as indústrias e corporações mercantilistas da saúde com seus "achados extraordinários", lutaremos contra a criação de estigmas e rótulos nas pessoas, lutaremos contra o excesso diagnóstico e terapêutico, promovendo hábitos saudáveis pautados na ciência médica, livres de conflitos de interesses e de vieses de publicações puramente deterministas ou causais, mas acima de tudo promovendo uma boa comunicação com as pessoas para que elas possam também aprender a se proteger do excesso de intervenções em saúde. É nosso papel advogar pela legitimidade na relação profissional-paciente, reconhecendo as incertezas inerentes à ciência médica em si. Devemos orientar o cuidado de forma não normativa, apoiando-se em evidências isentas e permitindo o feedback do paciente, de modo que ele possa interpretar e ajustar a decisão para si enquanto protagonista do seu cuidado.

The shipwreck of the singular.

In 1962, Louis Lasagna was one of the central figures in the creation of our current drug regulation systems. His influence on the practice of modern medicine, through a series of unanticipated consequences of these systems, has been profound. In the 1960s, he was one of the most progressive thinkers in medicine. By the 1980s, he had apparently become one of the most reactionary. This article attempts to delineate the dilemmas he believed he was dealing with, dilemmas that stemmed from a system he had helped create, that produced this apparent change in orientation. The problems with which he grappled are ones that remain unresolved and indeed, have become more acute. The example of how he attempted to remedy what had gone wrong may provide pointers as to how to solve or how not to solve current difficulties.

Sudden cardiac death & the Reverse Dodo Verdict.

Adverse effects of treatment on cardiac QT intervals were first reported 50 years ago. A clear link to sudden death was established, but the problem remained relatively unknown. The issue of treatment related effects on the heart, and the contribution this might make to sudden cardiac deaths in general, came more clearly into focus 20 years ago, linked to regulatory actions. In an era of polypharmacy, and mixing of prescribed and non-prescribed pharmacologically active agents it is now becoming increasingly clear that unanticipated cardiac effects may be common and a significant cause of mortality. There is likely underreporting and also underdiagnosis, as recognition requires a timely ECG. This paper proposes two methods to handle the problem.

Ninety-three cases of alcohol dependence following SSRI treatment.

BACKGROUND: There have been recent reports linking serotonin reuptake inhibitor use with increased alcohol consumption. A syndrome of alcoholism precipitated by a common treatment has clear implications for both research and treatment if it is a common phenomenon. OBJECTIVE: To explore the profile of people affected, and drugs that might trigger the syndrome. METHODS: We have selected reports to RxISK.org reporting the problem and cases linked to a blog posting outlining the syndrome and mined these for data on age, gender, drug of use, pattern of outcome on treatment, and impact of the problem. RESULTS: The data make it clear that all treatments with significant effects on the serotonin reuptake system are likely to cause this problem. Both sexes, and all ages are affected and reports have come from a range of countries. While stopping treatment can lead to the problem clearing, a failure to stop can result in death. CONCLUSIONS: SSRI induced alcoholism is likely to be a relatively common problem. Recognizing the problem can lead to a gratifying cure. A failure to recognize it can be fatal.

One hundred and twenty cases of enduring sexual dysfunction following treatment.

BACKGROUND: There have been reports for over a decade linking serotonin reuptake inhibitors, finasteride and isotretinoin with enduring sexual dysfunction after treatment stops. OBJECTIVE: To explore the clinical pictures linked to all 3 drugs. METHODS: We have selected 120 reports to RxISK.org reporting the problem and mined these for data on age, gender, drug of use, and impact of the problem. RESULTS: The data make it clear that the three drugs show extensive overlap in symptom profile, regardless of sex or country of origin. CONCLUSIONS: The availability of 120 reports from over 20 countries add to the case for the validity of the syndrome. This is severe and enduring condition can result in death. An understanding of its physiology and an approach to treatment are needed.

Data based medicine and clinical judgement.

Randomized controlled trials (RCTs) are a useful tool to check the effectiveness of drugs but have come to shape the culture of medicine in a manner that increasingly compromises medical care. Dependence on RCT evidence is compromised by the well-known problems stemming non-publication of trials, lack of access to trial data, ghostwriting of those trials that are published and a variety of coding and other strategies to hide harms. But what is less appreciated is that whenever a drug and an illness can produce the same benefit or harm that the outcomes of RCTs can be profoundly misleading. This article gives examples of how RCTs can produce the wrong answer.

Chlamydia trachomatis testing sensitivity in midstream compared with first-void urine specimens.

PURPOSE: Traditionally first-void urine specimens are used to test for Chlamydia trachomatis. In contrast, midstream urine specimens are traditionally recommended for microscopy and culture of presumptive bacterial urinary tract infections. The ability to test for both C trachomatis and urinary tract infection on a single midstream urine specimen would greatly aid clinical practice, as an urinary tract infection is an extremely common complaint in primary care. This study set out to determine how well positive C trachomatis results obtained on first-void specimens would correlate with positive findings in matched midstream specimens. METHODS: One hundred women with a first-void urine specimen positive for C trachomatis also provided midstream specimens for comparison. All specimens had C trachomatis testing performed using a DNA detection method. RESULTS: Of the 100 eligible participants with a first-void specimen positive for C trachomatis, 96 (96%) also had a positive midstream specimen (95% exact confidence limits, 90.1%, 98.9%). CONCLUSIONS: These results suggest that by using newer nucleic acid amplification techniques (NAATs), timing of specimen collection is not so important in testing for C trachomatis as previously thought. The sensitivity of NAAT testing on midstream urine specimens in women is sufficiently equivalent to testing on first-void specimens to consider in clinical practice and research settings where first-void specimens have formerly been collected.