scholarly journals Pragmatic trials of complex psychosocial interventions: methodological challenges

2013 ◽  
Vol 22 (2) ◽  
pp. 105-109 ◽  
Author(s):  
G. Dunn
Keyword(s):  
Scientific Explanation ◽  
Psychosocial Interventions ◽  
Outcome Data ◽  
Adherence To Treatment ◽  
Technical Problems ◽  
Loss To Follow Up ◽  
Randomized Design ◽  
Subsequent Loss ◽  
Cluster Randomized

Having first introduced the pragmatic health care trial, the discussion then focuses on a selected list of technical problems that are important for the design, analysis and inference from such trials. The first is lack of independence of participants’ outcomes do to clustering either arising from a cluster randomized design or to the way treatment is delivered (therapist and group effects). The second and third concern the implications of non-adherence to treatment and subsequent loss to follow-up, particularly, when non-adherence is associated with missing outcome data. Finally, it is argued that pragmatism and a desire for a scientific explanation should not be regarded as mutually exclusive.

scholarly journals A systematic review of endpoint definitions in late phase tuberculosis therapeutic trials

2021 ◽  
Author(s):  
Nancy Kathryn Hills ◽  
Johnson Lyimo ◽  
Payam Nahid ◽  
Rada Savic ◽  
Patrick P.J. Phillips
Keyword(s):  
Systematic Review ◽  
Late Phase ◽  
Outcome Data ◽  
Binary Outcomes ◽  
Clinical Trial Registry ◽  
Loss To Follow Up ◽  
Therapeutic Trials ◽  
Considerable Morbidity ◽  
Broad Consensus

Abstract Background. Safe, more efficacious treatments are needed to address the considerable morbidity and mortality associated with tuberculosis (TB). However, the current practice in TB therapeutics trials is to use composite binary outcomes, which in the absence of standardization may inflate false positive and negative errors in evaluating regimens. The lack of standardization of outcomes is a barrier to the identification of highly efficacious regimens and the introduction of innovative methodologiesMethods. We conducted a systematic review of trials designed to advance new TB drugs or regimens for regulatory approval and inform practice guidelines. Trials were primarily identified from the WHO International Clinical Trial Registry Platform (ICTRP). Only trials that collected post-treatment follow-up data and enrolled at least 100 patients were included. Protocols and Statistical Analysis Plans (SAP) for eligible trials from 1995 to the present were obtained from trial investigators. Details of outcome data, both explicit and implied, were abstracted and organized into three broad categories: Favorable, Unfavorable, and Not Assessable. Within these categories, individual trial definitions were recorded and collated, and areas of broad consensus and disagreement were identified and described. Results. From 2205 TB-related trials, 51 were selected for protocol and SAP review, from which 31 were both eligible and had accessible documentation. Within the three designated categories, we found broad consensus in the definitions of Favorable and Unfavorable outcomes, although specific details were not always provided, and when explicitly addressed, were heterogeneous. Favorable outcomes were handled the most consistently but were widely variable with respect to specification. In some cases, the same events were defined differently by different protocols, particularly in distinguishing Unfavorable from Not Assessable events. Death was often interpreted conditional on cause. Patients who did not complete the study because of withdrawal or loss to follow-up presented a particular challenge to consistent interpretation and analytic treatment of outcomes.Conclusions. In a review of 31 clinical trials, we found that outcome definitions were heterogeneous, highlighting the need to establish clearer specification and a move towards universal standardization of outcomes across TB trials. The ICH E9 (R1) addendum provides guidelines for undertaking and achieving this goal.Registration PROSPERO 2020 CRD42020197993

Strengths and weaknesses of a stepped wedge cluster randomized design: its application in a colorectal cancer follow-up study

2014 ◽  
Vol 67 (4) ◽  
pp. 454-461 ◽  
Author(s):  
Zhuozhao Zhan ◽  
Edwin R. van den Heuvel ◽  
Peter M. Doornbos ◽  
Huib Burger ◽  
Charlotte J. Verberne ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Stepped Wedge ◽  
Follow Up Study ◽  
Randomized Design ◽  
Cluster Randomized

scholarly journals Incorporating Patient Concerns into Discharge Plans: Evaluation of a Patient-Generated Checklist

2006 ◽  
Author(s):  
Karen Grimmer ◽  
Lauren Dryden ◽  
Runthip Puntumetakul ◽  
Alexander Young ◽  
Michelle Guerin ◽  
...  
Keyword(s):  
Hospital Admission ◽  
Discharge Planning ◽  
Medical Condition ◽  
Outcome Data ◽  
Public Hospitals ◽  
Unplanned Readmission ◽  
Loss To Follow Up ◽  
Quasi Experimental ◽  
Post Hoc

Background: This paper reports on the effectiveness of a checklist that assists patients to transition safely and sustainably from hospital to home. Methods: Medical wards in three tertiary public hospitals in metropolitan Adelaide provided subjects during 2004. Eligible patients were English-literate and aged at least 60 years, provided written informed consent and had an unplanned hospital admission for a new medical condition. Data was excluded post-hoc if subjects had another hospital readmission for the same condition within seven days of discharge. The study had a quasi-experimental study design in which each hospital acted as its own control. In each hospital, the first half of the study period measured the outcome of usual discharge planning practices (control phase), and the second half of the study period measured the outcome following administration of the checklist (intervention). Quantitative and qualitative (grounded theory) evaluation methods were used. Results: 464 potentially eligible patients were approached and 317 (63.3%) consented to participate (210 control and 107 intervention subjects). Post-hoc exclusion and loss to follow-up reflected 60% (control) and 42% (intervention) subjects. Unplanned readmission to hospital (post hoc exclusion) reflected 21% control and 39% intervention phase subjects. A key reason for loss to follow-up was inability to contact subjects seven days after discharge (29% control, 16% intervention phases). Complete outcome data was collected from 148 subjects. For patients with family/ friends who visited them in hospital, the checklist provided the opportunity for joint discussion and decision-making prior to discharge about daily living activities. These activities were often additional to formal discharge plans. The short duration of hospital admission, and generally poor health precluded many patients without family/ friends from obtaining maximum benefit from the checklist. Conclusion: The checklist improved patients’ preparedness for discharge, particularly when family/ friends were involved.

scholarly journals Nationwide population genetic screening improves outcomes of newborn screening for hearing loss in China

2018 ◽  
Author(s):  
Qiuju Wang ◽  
Jiale Xiang ◽  
Jun Sun ◽  
Yun Yang ◽  
Jing Guan ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Genetic Screening ◽  
Outcome Data ◽  
Convincing Evidence ◽  
Hearing Screening ◽  
Loss To Follow Up ◽  
Screening Programs ◽  
Universal Newborn Hearing Screening ◽  
Newborn Hearing

Purpose: Concurrent newborn hearing and genetic screening has been reported, but its benefits have not been statistically proven due to limited sample sizes and outcome data. To fill this gap, we analyzed outcomes of a large number of newborns with genetic screening results. Methods: Newborns in China were screened for 20 hearing-loss-related genetic variants from 2012-2017. Genetic results were categorized as positive, at-risk, inconclusive, or negative. Hearing screening results, risk factors, and up-to-date hearing status were followed-up via phone interviews. Results: We completed genetic screening on one million newborns and followed up 12,778. We found that a positive genetic result significantly indicated a higher positive predictive value of the initial hearing screening (60% vs. 5.0%, P<0.001) and a lower rate of loss-to-follow-up (5% vs. 22%, P<0.001) than an inconclusive one. Importantly, 42% of subjects in the positive group with reported or presymptomatic hearing loss were missed by conventional hearing screening. Furthermore, genetic screening identified 0.23% of subjects predisposed to preventable ototoxicity. Conclusion: Our results demonstrate that limited genetic screening identified additional cases, reduced loss-to-follow-up, and informed families of ototoxicity risks, providing convincing evidence to support integrating genetic screening into universal newborn hearing screening programs.

scholarly journals A clinical decision support system is associated with reduced loss to follow-up among patients receiving HIV treatment in Kenya: a cluster randomized trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tom Oluoch ◽  
Ronald Cornet ◽  
Jacques Muthusi ◽  
Abraham Katana ◽  
Davies Kimanga ◽  
...  
Keyword(s):  
Decision Support ◽  
Clinical Decision Support ◽  
Controlled Trial ◽  
Clinical Decision ◽  
Hiv Treatment ◽  
Future Research ◽  
Hiv Patients ◽  
Loss To Follow Up ◽  
Cluster Randomized

Abstract Background Loss to follow-up (LFTU) among HIV patients remains a major obstacle to achieving treatment goals with the risk of failure to achieve viral suppression and thereby increased HIV transmission. Although use of clinical decision support systems (CDSS) has been shown to improve adherence to HIV clinical guidance, to our knowledge, this is among the first studies conducted to show its effect on LTFU in low-resource settings. Methods We analyzed data from a cluster randomized controlled trial in adults and children (aged ≥ 18 months) who were receiving antiretroviral therapy at 20 HIV clinics in western Kenya between Sept 1, 2012 and Jan 31, 2014. Participating clinics were randomly assigned, via block randomization. Clinics in the control arm had electronic health records (EHR) only while the intervention arm had an EHR with CDSS. The study objectives were to assess the effects of a CDSS, implemented as alerts on an EHR system, on: (1) the proportion of patients that were LTFU, (2) LTFU patients traced and successfully linked back to treatment, and (3) time from enrollment on the study to documentation of LTFU. Results Among 5901 eligible patients receiving ART, 40.6% (n = 2396) were LTFU during the study period. CDSS was associated with lower LTFU among the patients (Adjusted Odds Ratio—aOR 0.70 (95% CI 0.65–0.77)). The proportions of patients linked back to treatment were 25.8% (95% CI 21.5–25.0) and 30.6% (95% CI 27.9–33.4)) in EHR only and EHR with CDSS sites respectively. CDSS was marginally associated with reduced time from enrollment on the study to first documentation of LTFU (adjusted Hazard Ratio—aHR 0.85 (95% CI 0.78–0.92)). Conclusion A CDSS can potentially improve quality of care through reduction and early detection of defaulting and LTFU among HIV patients and their re-engagement in care in a resource-limited country. Future research is needed on how CDSS can best be combined with other interventions to reduce LTFU. Trial registration NCT01634802. Registered at www.clinicaltrials.gov on 12-Jul-2012. Registered prospectively.

KARAKTERISTIK KLINIS PASIEN YANG MENERIMA TERAPI ARV DI RSUD KABUPATEN BULELENG

2020 ◽  
Vol 6 (2) ◽  
pp. 212-216
Author(s):  
I Gusti Ngurah Putu Candra ◽  
Dewi Aprelia Meriyani ◽  
Luh Putu Desy Puspaningrat ◽  
Yopita Triguno ◽  
Ni Kadek Ayu Tamara Widya Sari
Keyword(s):  
Loss To Follow Up ◽  
Hiv Aids

  ABSTRAK Latar Belakang Penyakit menular yang selalu memberikan dampak tidak hanya kesehatan tetapi social dan ekomoni adalha HIV/AIDS.Tujuan untuk mendeskripsikan kondisi klinis dan dmeografi pasien yang menerima terapi ARV.MetodePenelitian deskriptif dengan pendekatan secara kohort retrospektifmenggunakan data sekunder dari register kohort ARV dari tahun 2005-2015 (11 tahun terapi ARV). Analisis yang digunakan adalah analisis univariat menggunakan SPSS versi 17.Hasil Karakteristik klinis dan demografi pada odha yang menerima terapi ARV yaitu 45,32% dalam kondisi ambulatory, 75.42% mendapatkan regimen NNRTI jenis zidovudine, 75.82 % mendapatkan terapi regimen NRTI nevirapine, 79.66% pada kondisi stadium 3 dan 4, dengan klasifikasi umur produktif (< 40 tahun sebanyak 82.05%, sebagian besar berjenis kelamin laki-laki 62.96%, dan memiliki pengawas minum obat (PMO) sebesar 68.25%. Proporsi kematian sebesar  9.3 % (112 orang), LTFU (loss to follow up) 18.52% (223 orang), subsitusi regimen lini satu 9.88% (119 orang),rujuk keluar 1.83% (22 orang) dan yang masih dalam pengobatan sebesar 69.93% (842).Kesimpulan Pasien yang mengalami LTFU terbagi dalam beberapa kondisi yaitu LTFU dalam kondisi meninggal 3.07% (37 orang), LTFU dalam kondisi hidup 0.5% (6 orang), dan LTFU yang tidak diketahui kondisinya sebesar 14.95% (180 orang).Saran Monitoring dan evaluasi pada program pengobatan dilakukan secara berkelanjutan untuk meningkatkan konsistensi terapi yang dilakukan.  Kata Kunci : Karakteristik, Terapi, HIV/AIDS 

scholarly journals Predictors of loss to follow-up in art experienced patients in Nigeria: a 13 year review (2004–2017)

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Ahmad Aliyu ◽  
Babatunde Adelekan ◽  
Nifarta Andrew ◽  
Eunice Ekong ◽  
Stephen Dapiap ◽  
...  
Keyword(s):  
Patient Adherence ◽  
Cross Sectional Study ◽  
Emergency Plan ◽  
Cross Sectional ◽  
Loss To Follow Up ◽  
Viral Loads ◽  
Review Period ◽  
Lost To Follow Up ◽  
Differentiated Care

Abstract Background Expanded access to antiretroviral therapy (ART) leads to improved HIV/AIDS treatment outcomes in Nigeria, however, increasing rates of loss to follow-up among those on ART is threatening optimal standard achievement. Therefore, this retrospective cross-sectional study is aimed at identifying correlates and predictors of loss to follow-up in patients commencing ART in a large HIV program in Nigeria. Methods Records of all patients from 432 US CDC Presidents Emergency Plan for AIDS Relief (PEPFAR) supported facilities across 10 States and FCT who started ART from 2004 to 2017 were used for this study. Bivariate and multivariate analysis of the demographic and clinical parameters of all patients was conducted using STATA version 14 to determine correlates and predictors of loss to follow-up. Results Within the review period, 245,257 patients were ever enrolled on anti-retroviral therapy. 150,191 (61.2%) remained on treatment, 10,960 (4.5%) were transferred out to other facilities, 6926 (2.8%) died, 2139 (0.9%) self-terminated treatment and 75,041 (30.6%) had a loss to follow-up event captured. Males (OR: 1.16), Non-pregnant female (OR: 4.55), Patients on ≥ 3-monthly ARV refills (OR: 1.32), Patients with un-suppressed viral loads on ART (OR: 4.52), patients on adult 2nd line regimen (OR: 1.23) or pediatric on 1st line regimen (OR: 1.70) were significantly more likely to be lost to follow-up. Conclusion Despite increasing access to anti-retroviral therapy, loss to follow-up is still a challenge in the HIV program in Nigeria. Differentiated care approaches that will focus on males, non-pregnant females and paediatrics is encouraged. Reducing months of Anti-retroviral drug refill to less than 3 months is advocated for increased patient adherence.

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