scholarly journals “Wish You Were Here”: Examining Characteristics, Outcomes, and Statistical Solutions for Missing Cases in Web-Based Psychotherapeutic Trials

2018 ◽  
Vol 5 (2) ◽  
pp. e22 ◽  
Author(s):  
Eyal Karin ◽  
Blake F Dear ◽  
Gillian Z Heller ◽  
Monique F Crane ◽  
Nickolai Titov

Background Missing cases following treatment are common in Web-based psychotherapy trials. Without the ability to directly measure and evaluate the outcomes for missing cases, the ability to measure and evaluate the effects of treatment is challenging. Although common, little is known about the characteristics of Web-based psychotherapy participants who present as missing cases, their likely clinical outcomes, or the suitability of different statistical assumptions that can characterize missing cases. Objective Using a large sample of individuals who underwent Web-based psychotherapy for depressive symptoms (n=820), the aim of this study was to explore the characteristics of cases who present as missing cases at posttreatment (n=138), their likely treatment outcomes, and compare between statistical methods for replacing their missing data. Methods First, common participant and treatment features were tested through binary logistic regression models, evaluating the ability to predict missing cases. Second, the same variables were screened for their ability to increase or impede the rate symptom change that was observed following treatment. Third, using recontacted cases at 3-month follow-up to proximally represent missing cases outcomes following treatment, various simulated replacement scores were compared and evaluated against observed clinical follow-up scores. Results Missing cases were dominantly predicted by lower treatment adherence and increased symptoms at pretreatment. Statistical methods that ignored these characteristics can overlook an important clinical phenomenon and consequently produce inaccurate replacement outcomes, with symptoms estimates that can swing from −32% to 70% from the observed outcomes of recontacted cases. In contrast, longitudinal statistical methods that adjusted their estimates for missing cases outcomes by treatment adherence rates and baseline symptoms scores resulted in minimal measurement bias (<8%). Conclusions Certain variables can characterize and predict missing cases likelihood and jointly predict lesser clinical improvement. Under such circumstances, individuals with potentially worst off treatment outcomes can become concealed, and failure to adjust for this can lead to substantial clinical measurement bias. Together, this preliminary research suggests that missing cases in Web-based psychotherapeutic interventions may not occur as random events and can be systematically predicted. Critically, at the same time, missing cases may experience outcomes that are distinct and important for a complete understanding of the treatment effect.

2017 ◽  
Author(s):  
Eyal Karin ◽  
Blake F Dear ◽  
Gillian Z Heller ◽  
Monique F Crane ◽  
Nickolai Titov

BACKGROUND Missing cases following treatment are common in Web-based psychotherapy trials. Without the ability to directly measure and evaluate the outcomes for missing cases, the ability to measure and evaluate the effects of treatment is challenging. Although common, little is known about the characteristics of Web-based psychotherapy participants who present as missing cases, their likely clinical outcomes, or the suitability of different statistical assumptions that can characterize missing cases. OBJECTIVE Using a large sample of individuals who underwent Web-based psychotherapy for depressive symptoms (n=820), the aim of this study was to explore the characteristics of cases who present as missing cases at posttreatment (n=138), their likely treatment outcomes, and compare between statistical methods for replacing their missing data. METHODS First, common participant and treatment features were tested through binary logistic regression models, evaluating the ability to predict missing cases. Second, the same variables were screened for their ability to increase or impede the rate symptom change that was observed following treatment. Third, using recontacted cases at 3-month follow-up to proximally represent missing cases outcomes following treatment, various simulated replacement scores were compared and evaluated against observed clinical follow-up scores. RESULTS Missing cases were dominantly predicted by lower treatment adherence and increased symptoms at pretreatment. Statistical methods that ignored these characteristics can overlook an important clinical phenomenon and consequently produce inaccurate replacement outcomes, with symptoms estimates that can swing from −32% to 70% from the observed outcomes of recontacted cases. In contrast, longitudinal statistical methods that adjusted their estimates for missing cases outcomes by treatment adherence rates and baseline symptoms scores resulted in minimal measurement bias (<8%). CONCLUSIONS Certain variables can characterize and predict missing cases likelihood and jointly predict lesser clinical improvement. Under such circumstances, individuals with potentially worst off treatment outcomes can become concealed, and failure to adjust for this can lead to substantial clinical measurement bias. Together, this preliminary research suggests that missing cases in Web-based psychotherapeutic interventions may not occur as random events and can be systematically predicted. Critically, at the same time, missing cases may experience outcomes that are distinct and important for a complete understanding of the treatment effect.


2020 ◽  
Author(s):  
Eyal Karin ◽  
Monique Francis Crane ◽  
Blake Farran Dear ◽  
Olav Nielssen ◽  
Gillian Ziona Heller ◽  
...  

BACKGROUND Missing cases present a challenge to our ability to evaluate the effects of web-based psychotherapy trials. As missing cases are often lost to follow up, less is known about their characteristics, their likely clinical outcomes, or the likely effect of the treatment being trialled. OBJECTIVE To explore the characteristics of missing cases, their likely treatment outcomes, and the ability of different statistical models to approximate missing post-treatment data. METHODS A sample of internet-delivered cognitive behavioural therapy participants, in routine care (n = 6701 with 36% missing cases at post-treatment), was used to identify predictors of dropping out of treatment and predictors that moderated clinical outcomes, such as psychological distress, anxiety and depressive symptoms. These variables were then incorporated into a range of statistical models that approximated replacement outcomes for missing cases, with the results compared using sensitivity and cross-validation analyses. RESULTS Treatment adherence, as measured by the rate of an individual’s progress through the treatment modules, and higher symptom scores at pre-treatment, were identified as the dominant predictors of missing cases probability (Nagelkerke R2 = 60.8%), as well as the rate of symptom change. Low treatment adherence, in particular, was associated with increased odds for presenting as missing cases during post-treatment assessment (eg, OR = 161.1:1) and at the same time, attenuate the rate of symptom change across anxiety (up to 28% of the total symptom 48% reduction effect), depression (up to 41% of the total 48% symptom reduction effect) and psychological distress symptom outcomes (up to 52% of the total 37% symptom reduction effect) at the end of an eight week window. Reflecting this pattern of results, statistical replacement methods that overlooked the features of treatment adherence, and baseline severity, underestimated missing case symptom outcomes by as much as 40% at post-treatment. CONCLUSIONS The treatment outcomes of the cases that were missing at follow up were distinct from the remaining observed sample. Thus, overlooking the features of missing cases is likely to result in an inaccurate estimate of the effect of treatment. CLINICALTRIAL


Author(s):  
Arash Nikkholgh ◽  
◽  
Soltan Ahmad Ebrahimi ◽  
Enayatollah Bakhshi ◽  
Mohammad-Reza Zarrindast ◽  
...  

Introduction: Identification of a potent biomarker related to smoking cessation can play a key role in predicting prognosis and improving treatment outcomes. This study aimed to evaluate the contribution of new biomarkers based on levels of cotinine (Cot) and/or carbon monoxide (CO) to the short- and long-term quit rates of nicotine replacement therapies (nicotine patch (NP) and nicotine lozenge (NL)). Methods: In this prospective interventional study, a sample of 124 smokers under treatment with the 5A's method was selected between April 2016 and December 2018 in an outpatient smoking cessation center in 18th region of Tehran. They were divided into two groups for NP (n = 56) and NL (n = 61) interventions. The levels of Cot and CO were measured using ELISA and breath analysis at the beginning of the study. Three markers were calculated: Cot/CO, Cot to cigarette per day ratio (Cot/CPD), and CO/CPD. To determine the odds of smoking cessation success, binary logistic regression models and generalized estimating equations (GEE) model were analyzed by SPSS software. Results: Of the NP participants, 30.4% and 19.6% were abstinent in 2 and 6 months respectively, while NL was found less effective with 19.7% for 2-month follow-up and 13.1% for 6-month follow-up. The 6-month success of attempts to quit was significantly different for the NP participants at the second half of Cot/CO (P = 0.029). In the NL participants, CO/CPD would be a superior predictor for the success of smoking cessation (P > 0.05). Conclusions: The findings of this study suggested two markers, Cot/CO and CO/CPD in order, for the optimum treatment outcomes of NP and NL.


2020 ◽  
Author(s):  
Luan Nguyen Quang Vo ◽  
Andrew James Codlin ◽  
Rachel Jeanette Forse ◽  
Hoa Trung Nguyen ◽  
Thanh Nguyen Vu ◽  
...  

Abstract Background: Tuberculosis (TB) remains a major cause of avoidable deaths. Economic migrants represent a vulnerable population due to their exposure to medical and social risk factors. These factors expose them to higher risks for TB incidence and poor treatment outcomes. Methods: This cross-sectional study evaluated WHO-defined TB treatment outcomes among economic migrants in an urban district of Ho Chi Minh City, Viet Nam. We measured the association of a patient’s government-defined residency status with treatment success and loss to follow-up categories at baseline and performed a comparative interrupted time series (ITS) analysis to assess the impact of community-based adherence support on treatment outcomes. Key measures of interest of the ITS were the differences in step change (β6) and post-intervention trend (β7). Results: Short-term, inter-province migrants experienced lower treatment success (aRR=0.95 [95% CI: 0.92-0.99], p=0.010) and higher loss to follow-up (aOR=1.98 [95% CI: 1.44-2.72], p<0.001) than permanent residents. Intra-province migrants were similarly more likely to be lost to follow-up (aOR=1.86 [95% CI: 1.03-3.36], p=0.041). There was evidence that patients >55 years of age (aRR=0.93 [95% CI: 0.89-0.96], p<0.001), relapse patients (aRR=0.89 [95% CI: 0.84-0.94], p<0.001), and retreatment patients (aRR=0.62 [95% CI: 0.52-0.75], p<0.001) had lower treatment success rates. TB/HIV co-infection was also associated with lower treatment success (aRR=0.77 [95% CI: 0.73-0.82], p<0.001) and higher loss to follow-up (aOR=2.18 [95% CI: 1.55-3.06], p<0.001). The provision of treatment adherence support increased treatment success (IRR(β6)=1.07 [95% CI: 1.00, 1.15], p=0.041) and reduced loss to follow-up (IRR(β6)=0.17 [95% CI: 0.04, 0.69], p=0.013) in the intervention districts. Loss to follow-up continued to decline throughout the post-implementation period (IRR(β7)=0.90 [95% CI: 0.83, 0.98], p=0.019). Conclusions: Economic migrants, particularly those crossing provincial borders, have higher risk of poor treatment outcomes and should be prioritized for tailored adherence support. In light of accelerating urbanization in many regions of Asia, implementation trials are needed to inform evidence-based design of strategies for this vulnerable population.


2019 ◽  
pp. 135910531988459 ◽  
Author(s):  
Alessandra Caruso ◽  
Wendy Grolnick ◽  
Jonathan Rabner ◽  
Alyssa Lebel

This study examined parenting factors associated with children’s self-regulation and physician-rated treatment adherence using a self-determination theory framework in pediatric chronic headache. Participants were 58 children and adolescents (aged 10–17 years), who underwent initial and follow-up multidisciplinary evaluation at a headache clinic, and their mothers. Regression analyses showed that higher maternal autonomy support and structure were significantly related to children’s lower treatment-related reactance and higher adherence. Maternal controllingness had associations in the opposite directions. Children’s fear of pain was related to maternal controllingness. Results suggest the importance of parents’ provision of clear expectations and engaging children in treatment problem-solving and decision-making.


2021 ◽  
Vol 7 ◽  
Author(s):  
Lauren Powell ◽  
Darko Stefanovski ◽  
Carlo Siracusa ◽  
James Serpell

Human and canine parameters can affect the development of canine behavior problems, although their influence on the dog's response to veterinary behavioral treatment remains unclear. This study aimed to investigate the possible associations between canine behavior following clinical intervention and canine demographic characteristics, owner personality and owner-dog attachment. The study included 131 dog-owner dyads who attended a veterinary behavioral service. Owners completed the C-BARQ at baseline, 3-months and 6-months, and the 10 Item Personality Inventory and Lexington Attachment to Pet Scale at baseline. Data were analyzed for the effect of clinical intervention on C-BARQ subscale scores using mixed effect models. Binary logistic regression models were used to analyze the association between behavior change and canine and owner parameters. Within 6-months of veterinary consultation, trainability increased (coefficient 0.03, p = 0.01) and chasing (coefficient −0.04, p = 0.02), separation-related behavior (coefficient −0.04, p = 0.01) and energy level (coefficient −0.04, p = 0.05) decreased. Treatment outcomes were associated with both canine and owner variables. Canine behavior at baseline was the most consistent predictor of behavior change with less desirable baseline behavior associated with greater odds of decreased problem behavior at three- and 6-months post-consultation across most C-BARQ subscales. Canine age and weight; owner conscientiousness, extraversion and openness; and owner-dog attachment were also associated with treatment outcomes for some behavioral categories. These findings could be used by veterinarians to formulate more accurate prognoses and provide owners with targeted advice to reduce the influence of background factors on the dog's response to clinical behavioral intervention.


2020 ◽  
Vol 114 (9) ◽  
pp. 666-673
Author(s):  
Ahmad Fuady ◽  
Tanja A J Houweling ◽  
Muchtaruddin Mansyur ◽  
Erlina Burhan ◽  
Jan Hendrik Richardus

Abstract Background While the incidence of catastrophic costs due to tuberculosis (TB) remains high, there is little evidence about their impact on TB treatment outcomes and adherence. We assessed their effect on treatment outcomes and adherence in Indonesia. Methods We interviewed 282 adult TB patients who underwent TB treatment in urban, suburban and rural districts of Indonesia. One year after the interview, we followed up treatment adherence and outcomes. We applied multivariable analysis using generalized linear mixed models. Results Follow-up was complete for 252/282 patients. Eighteen (7%) patients had unsuccessful treatment and 40 (16%) had poor adherence. At a threshold of 30% of annual household income, catastrophic costs negatively impacted treatment outcomes (adjusted odds ratio [aOR] 4.15 [95% confidence interval {CI} 1.15 to 15.01]). At other thresholds, the associations showed a similar pattern but were not statistically significant. The association between catastrophic costs and treatment adherence is complex because of reverse causation. After adjustment, catastrophic costs negatively affected treatment adherence at the 10% and 15% thresholds (aOR 2.11 [95% CI 0.97 to 4.59], p = 0.059 and aOR 2.06 [95% CI 0.95 to 4.46], p = 0.07). There was no evidence of such an effect at other thresholds. Conclusions Catastrophic costs negatively affect TB treatment outcomes and treatment adherence. To eliminate TB, it is essential to mitigate catastrophic costs.


2019 ◽  
Author(s):  
Luan Nguyen Quang Vo ◽  
Andrew James Codlin ◽  
Rachel Jeanette Forse ◽  
Hoa Trung Nguyen ◽  
Thanh Nguyen Vu ◽  
...  

Abstract Background: Tuberculosis (TB) remains a major cause of avoidable deaths. Economic migrants represent an underserved population due to their exposure to medical and social risk factors, which can affect their health. Methods: This cross-sectional study evaluated WHO-defined TB treatment outcomes among economic migrants in an urban district of Ho Chi Minh City, Viet Nam. We measured the association of a patient’s government-defined residency status with treatment success and loss to follow-up categories at baseline and performed a comparative interrupted time series analysis to assess the impact of community-based adherence support on treatment outcomes. Results: Short-term, inter-province migrants experienced lower treatment success (aRR=0.95 [0.92-0.99], p=0.010) and higher loss to follow-up (aOR=1.98 [1.44-2.72], p<0.001) than permanent residents. Intra-province migrants were similarly more likely to be lost to follow-up (aOR=1.86 [1.03-3.36], p=0.041). There was evidence that patients >55 years of age (aRR=0.93 [0.89-0.96], p<0.001), relapse patients (aRR=0.89 [0.84-0.94], p<0.001), and retreatment patients (aRR=0.62 [0.52-0.75], p<0.001) had lower treatment success rates. TB/HIV co-infection was also associated with lower treatment success (aRR=0.77 [0.73-0.82], p<0.001) and higher loss to follow-up (aOR=2.18 [1.55-3.06], p<0.001). The provision of treatment adherence support increased treatment success (IRR(β6)=1.07 [1.00, 1.15], p=0.041) and reduced loss to follow-up (IRR(β6)=0.17 [0.04, 0.69], p=0.013) in the intervention districts. Loss to follow-up continued to decline throughout the post-implementation period (IRR(β7)=0.90 [0.83, 0.98], p=0.019). Conclusions: Economic migrants, particularly those crossing provincial borders, have higher risk of poor treatment outcomes and should be prioritized for tailored adherence support. In light of accelerating urbanization in many regions of Asia, implementation trials are needed to inform evidence-based design of strategies for this vulnerable population.


2021 ◽  
Author(s):  
Ying-An Chen ◽  
Tsen-Ju Shiu ◽  
Lien-Fen Tseng ◽  
Chien-Fu Cheng ◽  
Wei-Liang Shih ◽  
...  

Abstract Background With effective vector control and case management, substantial progress has been made in the elimination of malaria on the islands of São Tomé and Príncipe (STP). During the critical period from the low-transmission to the pre-elimination phase, this study tracked the dynamic changes in the genetic diversity in Plasmodium falciparum, the distribution of antimalarial drug-resistance genes, and the treatment outcomes in patients to provide insights for the prevention of rebounded malaria in STP. Methods Dried blood spots (DBSs) and case follow-up data were collected from malaria patients who had visited the Central Hospital between 2010 and 2016. Genomic DNA of P. falciparum was extracted from DBSs. The polymorphic regions on the genes for merozoite surface proteins 1 and 2 (msp1 and msp2) were amplified in 118 pre-treatment samples to identify the genetic diversity of the infected parasites. Anti-malarial drug resistance mutations in the multi-drug resistance (pfmdr1), chloroquine resistance transporter (pfcrt), and kelch 13 (pfK13) genes were genotyped using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) and DNA sequencing in 111 samples. Treatment outcomes were categorized based on the parasitological results from microscopy during the 28-day follow-up after treatment. Factors related to malaria recurrence were characterized by logistic regression models using case follow-up data (total number = 7,482). Results The circulating parasite strains in STP showed significant changes at the recent peak incidence in 2012, during which the prevalent allelic type in MSP1 changed from K1 to MAD20, and that in MSP2 changed from 3D7/IC to FC27. Genotyping results for antimalarial drug-resistance markers showed that the dominant alleles of pfmdr1 86 + 184 + 1246-pfcrt 76 were YFD-T (51.4%). Logistic regression models showed that significant factors related to parasitological failure after treatment were age (protective factor, OR = 0.97–0.98), log10-transformed parasite density (OR = 1.07–1.44), and treatment (quinine vs. artemisinin-based combination therapy, OR = 1.91–1.96). Overall, younger patients, those with higher parasitemia levels at enrollment, and those treated with quinine had a higher risk of recurrence during follow-up. Conclusions Although malaria treatment efficacy remained acceptable in STP, this study showed temporal changes in the dominant strains and the development of drug resistance mutations in the local parasite population. Therapeutic efficacy should be carefully monitored to adequately adjust the policy in the future.


2021 ◽  
Vol 9 (7_suppl3) ◽  
pp. 2325967121S0017
Author(s):  
Anne Skelton ◽  
Rachael Martino ◽  
Stephanie Mayer ◽  
Courtney Selberg

Background: Slipped capital femoral epiphysis (SCFE) is characterized by translation of the proximal femoral epiphysis posterior and medial relative to the metaphysis. The gold standard treatment of mild SCFE, defined as a slip angle <30°, remains in-situ pinning (ISP) to stabilize the epiphysis in its current position after slippage. Methods: 127 hips from 113 individuals met inclusion criteria: mild SCFE (Southwick angle <30°) that underwent ISP with available pre- and post-procedure radiographs. Medical records were reviewed to collect demographic data, preoperative symptoms, surgical details, radiographic measurements, and post-operative follow-up. Six hips were identified as having undergone additional joint preserving surgery of the hip (JPSH) while seven other hips were identified as having undergone screw removal and/or replacement within two years of initial ISP. Anterior-posterior (AP) and frog-leg lateral alpha angles, femoral epiphyseal-metaphyseal offset angle, and Southwick angle were all measured preoperatively, post-operatively, and at final radiographic follow-up. Chi-squared analyses, binary logistic regression models and Kruskal-Wallis tests were used to evaluate the association between clinical and radiographic parameters and the occurrence of additional surgery or screw failure. Results: Demographic variables, including age, body mass index, prodrome pain, sex, laterality, and chronicity were not found to significantly influence the likelihood of additional surgery. Preoperative AP alpha angle, frog-lateral alpha angle, epiphyseal-metaphyseal offset angle, and Southwick angle did not significantly impact the likelihood of additional surgery or screw failure. Radiographic measurements taken after ISP demonstrated that AP alpha angle significantly increased the likelihood of additional surgery. For every one degree increase, the likelihood of additional surgery increased 1.091 times (average 70.264° for no additional surgery and 82.333° for additional surgery, p=0.017). Conclusion: Mild SCFE can progress to residual pain and limited hip motion even after initial treatment with ISP. Of our cohort of 127 hips, six (4.72%) went on to have secondary JPSH while an additional seven (5.51%) presented with screw failure within two years of initial ISP. Increased AP alpha angle after ISP was correlated with an increased likelihood of secondary JPSH. This increased AP alpha angle may contribute to intra-articular pathology due to CAM-type morphology which may lead to the necessity of JPSH. These findings suggest that patients with increased AP alpha angle after ISP may need to be followed long-term for the development of further joint symptoms and may need to be counseled after ISP for mild SCFE for the risk of secondary JPSH. Tables/Figures: [Table: see text][Table: see text][Table: see text]


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